RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (United States), Conditional marketing approval (European Union)

Structure/Sequence

Sequence Code 528522334

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Sequence Code 528522342

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Sequence Code 528522349

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Clinical Trials associated with Zanidatamab

NCT07102381

/ Not yet recruitingPhase 2

A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer

Start Date01 Sep 2025

Sponsor / Collaborator

Jazz Pharmaceuticals Plc

[+1]

NCT06695845

/ RecruitingPhase 2

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.

Start Date14 Jan 2025

Sponsor / Collaborator

Jazz Pharmaceuticals Plc

[+1]

NCT06435429

/ RecruitingPhase 3

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment

The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous T-DXd treatment.

Start Date13 Aug 2024

Sponsor / Collaborator

Jazz Pharmaceuticals Plc

100 Clinical Results associated with Zanidatamab

100 Translational Medicine associated with Zanidatamab

100 Patents (Medical) associated with Zanidatamab

Literatures (Medical) associated with Zanidatamab

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

01 Jul 2025·LANCET ONCOLOGY

Zanidatamab, a bispecific monoclonal antibody for HER2-positive gastro-oesophageal adenocarcinoma patients: a new hope?

Article

Author: Coutzac, Clélia

01 Jul 2025·LANCET ONCOLOGY

Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: primary results of a multicentre, single-arm, phase 2 study

Article

Author: Elimova, Elena ; Ku, Geoffrey ; Burris, Howard ; Ozog, Mark A ; Kang, Yoon-Koo ; Seol, Young Mi ; Ajani, Jaffer ; Kim, Jwa Hoon ; Mehta, Rutika ; Denlinger, Crystal S ; Lin, Bruce ; Garfin, Phillip M ; Oh, Do-Youn ; Rha, Sun Young ; Yang, Lin ; Lee, Keun-Wook ; Iqbal, Syma

BACKGROUND:

Zanidatamab, a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, previously demonstrated encouraging antitumour activity and a manageable safety profile in patients with treatment-refractory HER2-expressing gastro-oesophageal adenocarcinoma. Here, we evaluated the antitumour activity and safety of zanidatamab plus chemotherapy in first-line HER2-positive advanced gastro-oesophageal adenocarcinoma.

METHODS:

This phase 2 trial enrolled patients in Canada, South Korea, and the USA who were aged 18 years and older with untreated, metastatic, or advanced HER2-positive gastro-oesophageal adenocarcinoma (HER2 IHC 3+ or 2+ by local or central assessment [part 1]; HER2 IHC 3+ or 2+ with FISH+ by central assessment [part 2]). Eligible patients, with an Eastern Cooperative Oncology Group performance status of 0 or 1 received zanidatamab intravenously plus standard chemotherapy (CAPOX [capecitabine plus oxaliplatin], FP [5-fluorouracil [5-FU] plus cisplatin], or modified FOLFOX6 [mFOLFOX6; leucovorin, 5-FU, and oxaliplatin]). In our study, part 1 aimed to characterise the safety and tolerability of zanidatamab and find the recommended dose when administered with combination chemotherapy and part 2 aimed to evaluate the antitumour activity of zanidatamab administered with combination chemotherapy in patients receiving first-line treatment for HER2-expressing advanced gastro-oesophageal adenocarcinoma. Two dosing schemes for zanidatamab were used in this study: a weight-based regimen and a two-tiered flat dosing regimen. In the CAPOX and FP groups, patients received either 30 mg/kg zanidatamab or 1800 mg or 2400 mg (patients weighing <70 kg and ≥70 kg, respectively) every 3 weeks. In the CAPOX group, patients also received 1000 mg/m² capecitabine orally twice daily on days 1-14 every 3 weeks, plus 130 mg/m² oxaliplatin intravenously every 3 weeks. In the FP cohort, patients also received 80 mg/m² cisplatin intravenously every 3 weeks, plus 800 mg/m² 5-FU per day continuous intravenous infusion on days 1-5 every 3 weeks. In the mFOLFOX6 group, patients received either 20 mg/kg zanidatamab or 1200 mg or 1600 mg for patients weighing under 70 kg or 70 kg and above, respectively, every 2 weeks, plus 400 mg/m² intravenous leucovorin every 2 weeks, 85 mg/m² intravenous oxaliplatin every 2 weeks, and 1200 mg/m² 5-FU per day as a continuous intravenous infusion for 48 h every 2 weeks. mFOLFOX6-1 included the administration of a 400 mg/m² 5-FU intravenous bolus on days 1 and 15; mFOLFOX6-2 omitted this 5-FU bolus. The primary endpoints of part 1 were safety and tolerability, which included frequencies of dose-limiting toxicities and dose reductions of zanidatamab and chemotherapy. The primary antitumour activity endpoint of part 2 was confirmed objective response rate assessed in the response-evaluable analysis set. Secondary endpoints included objective response rate, duration of response, disease control rate, clinical benefit rate, progression-free survival, and overall survival. Safety outcomes were assessed in all treated patients. We report the results from an interim analysis. This trial is registered at ClinicalTrials.gov (NCT03929666) and is complete for enrolment.

FINDINGS:

Between Aug 29, 2019, and Feb 18, 2022, 46 patients were enrolled (39 [85%] were male; seven [15%] were female; 28 [61%] were white, 17 [37%] were Asian, and 43 [93%] were not Hispanic or Latino). Median follow-up was 47·9 months (IQR 39·2-53·7); eight (17%) patients were on treatment and 19 (41%) were in survival follow-up. The confirmed objective response rate was 76·2% (95% CI 60·5-87·9) with a median duration of response of 18·7 months (95% CI 10·4-44·1). The median progression-free survival was 12·5 months (95% CI 8·2-21·8) and median overall survival was 36·5 months (23·6-not estimable). The disease control rate was 88·1% (95% CI 74·4-96·0) and clinical benefit rate was 78·6% (95% CI 63·2-89·7). In part 1, there were no dose-limiting toxicities in six patients treated with zanidatamab plus CAPOX. One (50%) of two patients treated with zanidatamab plus FP had dose-limiting toxicities of diarrhoea and acute kidney injury (both grade 3). Two dose-limiting toxicities of diarrhoea (both grade 3) occurred in 2 (15%) of 13 patients receiving 5-FU 400 mg/m² bolus on day 1 and 15 as part of the zanidatamab plus mFOLFOX6-1 regimen. 30 (65%) patients had treatment-related grade 3 or 4 adverse events. The most common treatment-related grade 3 or 4 adverse events were diarrhoea (18 [39%]; five [24%] in the 21 patients after implementing mandatory antidiarrhoeal prophylaxis) and hypokalaemia (ten [22%]). Six (13%) patients discontinued zanidatamab due to adverse events. No treatment-related deaths occurred.

INTERPRETATION:

Zanidatamab plus chemotherapy as first-line treatment of HER2-positive advanced gastro-oesophageal adenocarcinoma demonstrated clinically meaningful and durable antitumour activity, with a manageable safety profile.

FUNDING:

Jazz Pharmaceuticals, Zymeworks.

240

News (Medical) associated with Zanidatamab

05 Aug 2025

·www.prnewswire.com

Jazz Pharmaceuticals Announces Second Quarter 2025 Financial Results and Updates 2025 Financial Guidance

– Renee Gala named as President and CEO, effective August 11 – – Total revenues of $1.05 billion in 2Q25 – – Xywav ® revenues grew 13% year-over-year, with robust net patient adds of 625 quarter-over-quarter – – Zepzelca ® granted Priority Review in 1L ES-SCLC – DUBLIN, Aug. 5, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the second quarter of 2025 and updated financial guidance for 2025. "It has been a privilege to lead Jazz over my 22-year tenure. I am proud of what we have achieved on behalf of patients and confident that our new President and CEO, Renee Gala, will build on Jazz's momentum and serve as a catalyst in driving long-term growth," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. "We continue to see significant opportunity across our diversified portfolio in sleep, epilepsy, and oncology, as evidenced by the strong performance this quarter from our sleep portfolio with robust continued growth from Xywav in both narcolepsy and IH. We remain confident in the outlook of the business driven by multiple anticipated near-term oncology catalysts that each represent significant opportunities to drive greater revenue and create long-term value, most notably the top-line data readout for zanidatamab from the HERIZON-GEA-01 trial and upcoming PDUFA dates for dordaviprone and Zepzelca." Key Highlights Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 4Q25. Ziihera ® granted conditional marketing authorization by the European Commission in 2L BTC. Zepzelca and atezolizumab (Tecentriq®) combination granted U.S. FDA Priority Review for 1L maintenance treatment of ES-SCLC based on positive data from IMforte trial; PDUFA action date of October 7, 2025. 2025 Financial Guidance Updating total revenue range to $4.15 - $4.30 billion representing 4% growth at the midpoint. Raising lower end of net (loss)/income and (loss)/earnings per share ranges due to reductions in SG&A and R&D and improvement in the effective tax rate ranges. Business Updates Commercial Updates Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution: Xywav net product sales increased 13% to $415.3 million in 2Q25 compared to 2Q24. Meaningful Xywav net patient adds in 2Q25 (approximately 625 patients) with approximately 15,225 active Xywav patients exiting 2Q25, comprised of: Approximately 10,600 narcolepsy patients. Approximately 4,625 idiopathic hypersomnia (IH) patients, with 400 net patient adds. Presented data at the SLEEP 2025 meeting including results from the Phase 4 open-label XYLO trial showing that a switch from high-sodium oxybate to the same dose of low-sodium oxybate was associated with clinically meaningful reductions in blood pressure. Additionally, two presentations from the DUET trial evaluating sleep architecture demonstrated the effectiveness of Xywav on improvements in sleep quality among patients with IH or narcolepsy. Xywav, which the U.S. Food and Drug Administration (FDA) describes as clinically superior to Xyrem ® by means of greater safety, is the only low-sodium oxybate, the #1 branded treatment for narcolepsy1 and the only FDA-approved therapy to treat IH. Xyrem (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties: Xyrem net product sales were $35.3 million in 2Q25. Royalties from high-sodium oxybate AGs were $54.1 million in 2Q25. Epidiolex®/ Epidyolex® (cannabidiol): Epidiolex/Epidyolex net product sales increased 2% to $251.7 million in 2Q25 compared to 2Q24; underlying demand continues to be strong with year-over-year net product sales growth impacted by a number of factors, including inventory dynamics in the U.S. compared to 2Q24. Outside of the U.S., Epidyolex is approved in more than 35 countries. Remain confident in achieving blockbuster status for Epidiolex/Epidyolex in 2025. Rylaze®/ Enrylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn): Rylaze/Enrylaze net product sales decreased 7% to $100.7 million in 2Q25 compared to 2Q24. While updates to pediatric treatment protocols for acute lymphoblastic leukemia (ALL) have been broadly adopted, pediatric asparaginase use as a class remains below levels seen prior to protocol implementation; Rylaze use within the asparaginase class remains broadly stable. Zepzelca (lurbinectedin): Zepzelca net product sales decreased 8% to $74.5 million in 2Q25 compared to 2Q24. This decrease was driven by increased competition in second-line (2L) small cell lung cancer (SCLC) and treatment protocol updates delaying progression of first-line (1L) limited-stage SCLC patients to the 2L setting. Zepzelca and atezolizumab were granted U.S. FDA Priority Review for 1L extensive-stage (ES) SCLC in the maintenance setting with a Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025. Potentially practice-changing data from the Phase 3 IMforte trial have been submitted to the National Comprehensive Cancer Network® (NCCN®) for consideration. Ziihera® (zanidatamab-hrii): Ziihera net product sales were $6.0 million in 2Q25 following product launch in December 2024. The Company was granted conditional marketing authorization by the European Commission for Ziihera as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy. Corporate Development Chimerix Acquisition: The Company completed its acquisition of Chimerix, Inc in April 2025 (Chimerix Acquisition), adding dordaviprone to its late-stage pipeline. Dordaviprone is a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults. Key Pipeline Highlights Zanidatamab: The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is expected to read out in 4Q25. New data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting from an ongoing Phase 2 trial of zanidatamab in combination with physician's choice chemotherapy for the first-line treatment of HER2-positive metastatic GEA showed a median overall survival of 36.5 months after four-years of follow-up along with a 15.2 month median progression-free survival in patients who were centrally confirmed as HER2-positive. In August 2025, the Company initiated the Phase 2 EmpowHER-BC-208 trial to evaluate zanidatamab in patients with HER2-positive neoadjuvant and adjuvant breast cancer. Dordaviprone: A New Drug Application for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was accepted and granted Priority Review by FDA. FDA has set a target PDUFA action date of August 18, 2025. The ongoing Phase 3 ACTION trial is evaluating dordaviprone in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting. Share Repurchases of Approximately $125 Million The Company resumed repurchases of its ordinary shares in the second quarter of 2025 as part of the Company's previously authorized and announced repurchase program. Under this share repurchase program, the Company is authorized to repurchase its ordinary shares for up to an aggregate purchase price of $500 million, exclusive of any brokerage commissions. As of June 30, 2025, $225 million remained outstanding under this authorization, reflecting the purchase of shares worth approximately $125 million during the second quarter of 2025. Financial Highlights ____________________________ GAAP net loss for 2Q25 was $(718.5) million, or $(11.74) per diluted share, compared to GAAP net income of $168.6 million, or $2.49 per diluted share, for 2Q24. Non-GAAP adjusted net loss for 2Q25 was $(504.8) million, or $(8.25) per diluted share, compared to non-GAAP adjusted net income of $360.7 million, or $5.25 per diluted share, for 2Q24. The GAAP and non-GAAP adjusted net loss in 2Q25 included acquired in-process research and development (IPR&D) expense of $905.4 million representing the value allocated to dordaviprone in the Chimerix Acquisition, which impacted our results by $14.78 per share and $14.75 per share on a GAAP and non-GAAP adjusted basis, respectively. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release. Total Revenues Total revenues increased 2% in 2Q25 compared to the same period in 2024. Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $761.2 million in 2Q25, an increase of 3% compared to $738.3 million in 2Q24. The increase in 2Q25 was due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales. Oncology net product sales were $274.1 million in 2Q25, a decrease of 1% compared to $277.3 million in 2Q24. The decrease in 2Q25 was primarily due to lower net product sales of Rylaze/Enrylaze and Zepzelca, partially offset by the inclusion of Ziihera net product sales. Operating Expenses and Effective Tax Rate _________________________ _________________________ Changes in operating expenses in 2Q25 over the prior year period are primarily due to the following: Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 2Q25 compared to 2Q24, primarily due to changes in product mix. Cost of product sales, on a GAAP basis, included a higher acquisition accounting inventory fair value step-up expense in 2Q25 as compared to 2Q24. Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2Q25 compared to 2Q24, primarily due to compensation-related expenses driven by higher headcount in support of our commercial portfolio. Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 2Q25 compared to 2Q24, primarily due to lower clinical study costs primarily related to zanidatamab, as a result of timing of clinical trial activities, and JZP385 following discontinuation of this program, partially offset by the addition of costs relating to dordaviprone following the Chimerix Acquisition. Acquired IPR&D in 2Q25, on a GAAP and non-GAAP adjusted basis, represents the value allocated to dordaviprone in the Chimerix Acquisition. Cash Flow and Balance Sheet As of June 30, 2025, cash, cash equivalents and investments were $1.7 billion, and the outstanding principal balance of the Company's long-term debt was $5.4 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $885.0 million. For the six months ended June 30, 2025, the Company generated $518.6 million of cash from operations reflecting strong business performance and continued financial discipline. In April 2025, the Company acquired Chimerix for a total consideration of $944.2 million, which was funded with cash and cash equivalents. 2025 Financial Guidance Jazz Pharmaceuticals has updated its full-year 2025 financial guidance as follows: ___________________________ Conference Call Details Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EDT (9:30 p.m. IST) to provide a business and financial update and discuss its 2025 second quarter results. Interested parties may register for the call in advance here or via the Investors section of the Jazz Pharmaceuticals website at . To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at . About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Non-GAAP Financial Measures To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the Company presents non-GAAP adjusted net income (loss) (and the related per share measure) and its line-item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (loss) (and the related per share measure) and its line-item components exclude from GAAP reported net income (loss) (and the related per share measure) and its line-item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (loss) (and the related per share measure), adjust for the income tax effect of the non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income (loss), including non-GAAP adjusted cost of product sales, SG&A expenses and R&D expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income (loss) measure. The Company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts and that each of these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period, to its forward-looking guidance, and to identify operating trends in the Company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the Company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the Company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles in the reconciliation tables that follow. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. In this regard, commencing with the first quarter of 2025, the Company is no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures. For purposes of comparability, non-GAAP adjusted financial measures for the 2024 periods have been updated to reflect this change. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Caution Concerning Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the Company's 2025 financial guidance and the Company's expectations related thereto, including with respect to anticipated catalysts; expectations with respect to the transition of the CEO role; anticipated multiple near-term pipeline catalysts that each represent significant opportunities to drive greater revenue and create long-term value; expectations that Epidiolex will achieve blockbuster status in 2025; anticipated benefits and expenses relating to the Company's acquisition of Chimerix; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities and submissions related thereto; the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of dordaviprone in recurrent H3 K27M-mutant diffuse glioma and extend to use in first-line patients; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA; and the Company's development, regulatory and commercialization strategy; the Company's expectations with respect to its products and product candidates and the potential of the Company's products and product candidates and the potential regulatory path related thereto, including Zepzelca's potential to change current practice in 1L ES-SCLC and dordaviprone's potential to be a meaningful and durable revenue opportunity; the Company's capital allocation and corporate development strategy; the potential successful future development, manufacturing, regulatory and commercialization activities; the Company's ability to realize the commercial potential of its products; the Company's net product sales and goals for net product sales from new and acquired products; the Company's views and expectations relating to its patent portfolio, including with respect to expected patent protection, as well as expectations with respect to exclusivity; the Company's clinical trials confirming clinical benefit or enabling regulatory submissions; planned or anticipated regulatory submissions and filings, and the anticipated timing thereof; potential regulatory approvals; and other statements that are not historical facts. These forward-looking statements are based on the Company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of, and revenue from, Xywav, Rylaze and Epidiolex/Epidyolex and other marketed products; the introduction of new products into the U.S. market that compete with, or otherwise disrupt the market for the Company's products and product candidates; effectively launching and commercializing the Company's other products and product candidates; the successful completion of development and regulatory activities with respect to the Company's product candidates; obtaining and maintaining adequate coverage and reimbursement for the Company's products; the time-consuming and uncertain regulatory approval process, including the risk that the Company's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; geopolitical events, including international tariffs and trade restrictions and the conflict between Russia and Ukraine and related sanctions; macroeconomic conditions, including global financial markets, rising interest rates and inflation and recent and potential banking disruptions; regulatory initiatives and changes in tax laws; market volatility; protecting and enhancing the Company's intellectual property rights and the Company's commercial success being dependent upon the Company obtaining, maintaining and defending intellectual property protection and exclusivity for its products and product candidates; the ability of the parties to obtain court approval of certain Xyrem class action settlement agreements and the risk that the Company may incur other charges or cash expenditures not currently contemplated due to unanticipated events that may occur, including in connection with certain Xyrem class action settlement agreements, and the risk that the Company is unable to reach settlement agreements with other Xyrem antitrust plaintiffs that are not party to certain Xyrem class action settlement agreements; delays or problems in the supply or manufacture of the Company's products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements, including those governing the research, development, manufacturing and distribution of controlled substances; government investigations, legal proceedings and other actions; identifying and consummating corporate development transactions, financing these transactions and successfully integrating acquired product candidates, products and businesses, including Chimerix and the acquired product candidate dordaviprone; the Company's ability to realize the anticipated benefits of its corporate development transactions and its collaborations and license agreements with third parties; the sufficiency of the Company's cash flows and capital resources; the Company's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the Company's ability to meet its projected long-term goals and objectives, in the time periods that the Company anticipates, or at all, and the inherent uncertainty and significant judgments and assumptions underlying the Company's long-term goals and objectives; fluctuations in the market price and trading volume of the Company's ordinary shares; the timing and availability of alternative investment opportunities; and other risks and uncertainties affecting the Company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and future filings and reports by the Company, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. Other risks and uncertainties of which the Company is not currently aware may also affect the Company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. ________________________________________________ Contacts: Investors: Jack Spinks Executive Director, Investor Relations Jazz Pharmaceuticals plc [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717 Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc [email protected] Ireland +353 1 637 2141 U.S. +1 215 867 4948 SOURCE Jazz Pharmaceuticals plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug ApprovalPhase 2Acquisition

08 Jul 2025

·pmlive.com

EC approves Jazz Pharmaceuticals’ Ziihera for advanced biliary tract cancer

The European Commission (EC) has granted conditional approval to Jazz Pharmaceuticals’ Ziihera (zanidatamab) to treat a subset of advanced biliary tract cancer (BTC) patients. The human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody has been authorised for use as a monotherapy in adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) BTC who have received at least one prior line of systemic therapy. The EC’s decision was supported by results from the phase 2b HERIZON-BTC-01 trial, which included a cohort of 80 BTC patients with centrally confirmed HER2-positive tumours (cohort one). The study met its primary endpoint of confirmed objective response rate (cORR) in cohort one, with Ziihera demonstrating a cORR of 41.3%, including two complete responses, at a median follow-up of 21.9 months. The median duration of response (DoR) was 14.9 months, and the median overall survival (OS) was 15.5 months. Data from a pre-specified subgroup analysis in 62 patients with IHC 3+ tumours also showed that Ziihera demonstrated a cORR of 51.6%, with a median DoR of 14.9 months and median OS of 18.1 months. BTCs, including gallbladder cancer and cholangiocarcinoma, are a rare and aggressive group of cancers that are often diagnosed at an advanced stage, when curative surgery is no longer an option. Approximately 26% of BTC patients globally have HER2-positive disease, which is associated with poorer outcomes compared to HER2-negative disease. Robert Iannone, executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals, said the conditional approval “represents significant progress” for patients with advanced HER2-positive BTC. “Ziihera is the first HER2-targeted therapy authorised in the EU specifically for this population, and the EC’s decision reflects both the strength of the HERIZON-BTC-01 data and the urgency for innovation in rare gastrointestinal cancers,” Iannone said. In line with EC’s conditional approvals pathway, continued authorisation for Ziihera in this indication is contingent on the verification of clinical benefit in the ongoing phase 3 HERIZON-BTC-302 trial, which is evaluating the drug in combination with standard-of-care therapy in the first-line setting for patients with HER2-positive BTC.

Clinical ResultDrug ApprovalPhase 3Phase 2

02 Jul 2025

·pipelinereview.com

Jazz Pharmaceuticals Receives European Commission Marketing Authorization for Ziihera® (zanidatamab) for the Treatment of Advanced HER2-Positive Biliary Tract Cancer

– Conditional approval based on positive results from the HERIZON-BTC-01 Phase 2b trial – DUBLIN, Ireland I July 1, 2025 I Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) today announced that the European Commission (EC) has granted conditional marketing authorization 1 for Ziihera ® (zanidatamab), a dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC 3+) † biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy. 2 BTCs, which include gallbladder cancer (GBC) and cholangiocarcinoma (CCA), are a rare and aggressive group of cancers, 3 with most cases diagnosed at an advanced stage 4 when curative surgery is no longer an option. 5,6,7 Globally, approximately 26% of patients with BTC are HER2-positive, 8 a biomarker associated with poorer outcomes compared to HER2-negative disease. 9 Ziihera is the first HER2-targeted therapy given conditional authorization for HER2-positive BTC in the European Union (EU). Continued approval for this indication is contingent upon verification and description of clinical benefit in the ongoing Phase 3 HERIZON-BTC-302 trial, which is evaluating zanidatamab in combination with standard-of-care therapy versus standard-of-care therapy alone in the first-line setting for patients with HER2-positive BTC. 10 “People with HER2-positive biliary tract cancer who progress after first-line therapy face a challenging prognosis, with limited treatment options, poor tolerability, and median overall survival of only six to nine months,” said Arndt Vogel, MD, managing senior consultant and professor in the Department of Gastroenterology, Hepatology and Endocrinology at Hannover Medical School, Germany. “Zanidatamab provides a much-needed targeted monotherapy for this population, and in the HERIZON-BTC-01 trial, it demonstrated clinically meaningful and durable responses with a manageable safety profile. These data represent a welcome advance for patients with historically poor outcomes and highlight the importance of HER2 testing in biliary tract cancer to ensure eligible patients are identified for biomarker-driven treatment.” The EC decision is based on data from the Phase 2b HERIZON-BTC-01 trial, which evaluated Ziihera in patients with previously treated, unresectable, locally advanced or metastatic HER2-positive BTC. This is the largest Phase 2b trial conducted to date specifically in this population. 11,12 The study enrolled 87 patients, including 80 in Cohort 1 with centrally confirmed HER2-positive tumors (IHC 2+/ISH+ [n=18] or IHC 3+/ISH+ [n=62]). The trial achieved its primary endpoint of confirmed objective response rate (cORR) in Cohort 1, as assessed by independent central review (ICR). At a median follow-up of 21.9 months, zanidatamab demonstrated a cORR of 41.3% (95% CI: 30.4, 52.8), including two complete responses. 11 The median duration of response (DOR) was 14.9 months (95% CI: (7.4, not reached), and the median overall survival (OS) was 15.5 months (95% CI: 10.4, 18.5). 11 Findings from a pre-specified subgroup analysis in patients with IHC 3+ tumors (n=62) showed that Ziihera demonstrated a cORR of 51.6% (95% CI: 38.6, 64.5), with a median DOR of 14.9 months (95% CI: 7.4, 24.0). 2 The median OS in this subgroup was 18.1 months (95% CI: 12.2, 22.9). 2 The recommended dose of Ziihera is 20 mg/kg, administered as an intravenous infusion every two weeks until disease progression or unacceptable toxicity. 2 The safety profile for zanidatamab was evaluated in 87 patients with HER2-positive BTC (Cohorts 1 and 2) in HERIZON-BTC-01. The most common adverse reactions in this population were diarrhea (46%), infusion-related reaction (33.3%), abdominal pain (26.4%), anemia (25.3%) and fatigue (24.1%). Serious adverse reactions occurred in 16.1% of patients. The most frequent serious adverse reactions were diarrhea (2.3%), fatigue (2.3%), and increased alanine aminotransferase (2.3%). 2 “This conditional approval represents significant progress for the patients we serve who have been diagnosed with advanced HER2-positive BTC,” said Robert Iannone, MD., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. “ Ziihera is the first HER2-targeted therapy authorized in the European Union specifically for this population, and the European Commission’s decision reflects both the strength of the HERIZON-BTC-01 data and the urgency for innovation in rare gastrointestinal cancers. This milestone reinforces our commitment to advancing biomarker-driven therapies that address serious unmet needs and improve patient outcomes. We are actively recruiting for our global Phase 3 trial in first-line HER2-positive BTC and continue to explore zanidatamab’s potential in other HER2-expressing tumors.” “Biliary tract cancers are becoming more common worldwide and are increasingly affecting people under the age of 60, resulting in a significant social and economic burden,” said Zorana Maravic, chief executive officer at Digestive Cancers Europe (DiCE). “These cancers are typically diagnosed late, when patients have limited treatment options available and, unfortunately, their disease often progresses. Ziihera provides a much-needed alternative to chemotherapy for patients with HER2-positive BTC at this stage. It also brings hope to the digestive cancer patient community as another step in expanding the availability of targeted therapies.” The European Commission authorization extends to all European Union Member States, as well as Iceland, Norway, and Liechtenstein. For a full list of side effects and information on dosage and administration, contraindications, and other precautions when using Ziihera , please refer to the Summary of Product Characteristics for further information. About Ziihera ® (zanidatamab) Ziihera (zanidatamab) is a dual HER2-targeted bispecific antibody that simultaneously binds extracellular domains 2 and 4 on separate HER2 monomers (binding in trans). Binding of zanidatamab with HER2 results in internalization leading to a reduction of the receptor on the cell surface. Zanidatamab induces complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). These mechanisms result in tumor growth inhibition and tumor cell death. 2 On November 20, 2024, in the United States, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Ziihera (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. 13 This accelerated approval was granted based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing Phase 3 HERIZON-BTC-302 confirmatory trial. 13 It also received conditional approval from China’s National Medical Products Administration (NMPA) in May 2025 for the treatment of patients with previously treated, unresectable or metastatic HER2+BTC. Continued approval of this indication will depend on the verification of clinical benefit in the patient population through an ongoing confirmatory trial. Zanidatamab is also being investigated in multiple other clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeOne Medicines Ltd. (formerly BeiGene, Ltd) under license agreements from Zymeworks, which first developed the molecule. Jazz has rights to commercialize zanidatamab in the U.S., Europe, Japan and all other territories except for those Asia/Pacific territories that Zymeworks previously licensed to BeiGene, Ltd. [which are Asia (excluding Japan), Australia and New Zealand]. The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard-of-care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. About Biliary Tract Cancer Biliary tract cancers (BTC), which include gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma, are rare and aggressive epithelial tumors often associated with poor prognosis. 3,14 Although they account for less than 1% of all human cancers, cholangiocarcinoma is the second most common primary liver cancer after hepatocellular carcinoma and comprises approximately 10–15% of all primary liver cancers. Global mortality from BTC has risen in recent decades. 5 Because early symptoms are often vague or nonspecific, most BTCs are diagnosed at an advanced stage, 4 when curative surgery is not an option. 5,6,7 While chemotherapy and, more recently, immunotherapy-based combinations are used in the first-line setting, disease progression is common. In the absence of molecular profiling, treatment options following first-line therapy are largely limited to chemotherapy. 5,6,15 HER2 overexpression or amplification defines a distinct molecular subtype of BTC 16 and is observed in approximately 26% of patients globally. 8 HER2-positive BTC is associated with worse prognosis than HER2-negative disease. 9 Across the U.S., Europe, and Japan, an estimated 12,000 people are diagnosed with HER2-positive BTC each year. 17 About Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases – often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. References † IHC3+ stands for ImmunoHistoChemistry 3+ and refers to the highest level of HER2 protein overexpression in cancer cells 1 European Medicines Agency. Conditional marketing authorisation. European Medicines Agency website. Accessed July 1, 2025. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation 2 Ziihera Summary of Product Characteristics (SmPC). 3 Mirallas O, López-Valbuena D, García-Illescas D, et al. Advances in the systemic treatment of therapeutic approaches in biliary tract cancer. ESMO Open . 2022;7(3):100503. doi:10.1016/j.esmoop.2022.100503. 4 Rimassa, L., Khan, S., Koerkamp, B. G., Roessler, S.,et al. Mapping the landscape of biliary tract cancer in Europe: challenges and controversies. The Lancet Regional Health–Europe . 2025; 50, 101171. doi.org/10.1016/j.lanepe.2024.101171. 5 Vogel A, Bridgewater J, Edeline J, et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up. Ann Oncol . 2023;34(2):127-40. doi:10.1016/j.annonc.2022.10.506. 6 Chakrabarti, S., Kamgar, M., Mahipal, A. Targeted therapies in advanced biliary tract cancer: an evolving paradigm. Cancers . 2020; 12 (8), 2039. doi.org/10.3390/cancers12082039. 7 Valle JW, Kelley RK, et al. Biliary tract cancer. Lancet . 2021;397(10272):428-44. doi:10.1016/S0140-6736(21)00153-7. 8 Galdy S, Lamarca A, et al. HER2/HER3 pathway in biliary tract malignancies; systematic review and meta-analysis: a potential therapeutic target? Cancer Metastas Rev . 2017; doi: 10.1007/s10555-016-9645-x. 9 Vivaldi, C. HER2 overexpression as a poor prognostic determinant in resected biliary tract cancer. Oncologist . 2020;25(10):886-893. doi:10.1634/theoncologist.2019-0922. 10 ClinicalTrials.gov. Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer. Updated June 24, 2025. Accessed July 1, 2025. Available at: https://www.clinicaltrials.gov/study/NCT06282575 11 Pant, S et al. Zanidatamab in Previously Treated HER2-Positive Biliary Tract Cancer: Overall Survival and Longer Follow-Up From the Phase 2b HERIZON-BTC-01 Study. J Clin Oncol . 2024; 42(16_suppl). Abstract 4091. 12 Harding J, Fan J, Oh D-Y, et al. Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study. Lancet Oncol . 2023;24(7):772-82. doi:10.1016/S1470-2045(23)00242-5. 13 U.S. Food and Drug Administration. Ziihera® (zanidatamab-hrii) prescribing information. Accessdata.fda.gov. Updated November 2024. Accessed July 1, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761416s000lbl.pdf 14 Kam A, et al. Current and emerging therapies for advanced biliary tract cancers. Lancet Gastroenterol Hepatol . 2021;6(11):956-69. doi:10.1016/S2468-1253(21)00171-0. 15 Lamarca, A., Hubner, R. A., Ryder, W. D., et al. Second-line chemotherapy in advanced biliary cancer: a systematic review. Annals of Oncology . 2025; 25 (12), 2328-2338. doi.org/10.1093/annonc/mdu162. 16 Hechtman, J. F., Liu, W., Sadowska, J.,et al. Sequencing of 279 cancer genes in ampullary carcinoma reveals trends relating to histologic subtypes and frequent amplification and overexpression of ERBB2 (HER2). Modern Pathology . 2015; 28 (8), 1123-1129. doi: 10.1038/modpathol.2015.57. 17 Jazz Pharmaceuticals, Inc, Data on file. SOURCE: Jazz Pharmaceuticals

Clinical ResultOrphan DrugPhase 2Drug ApprovalFast Track

100 Deals associated with Zanidatamab

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KEGG	Wiki	ATC	Drug Bank
D12011	-	-	DB15471

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HER2 positive Biliary Tract Neoplasms	United States	Jazz Pharmaceuticals Ireland Ltd.	20 Nov 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Bile Duct Neoplasms	NDA/BLA	Canada	Jazz Pharmaceuticals Plc	01 Apr 2025
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	United States	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Japan	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Australia	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Austria	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Belgium	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Brazil	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Canada	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	France	Jazz Pharmaceuticals Plc	13 Aug 2024
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Germany	Jazz Pharmaceuticals Plc	13 Aug 2024

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03929666 (ZWI-ZW25-201, ESMO_GI2025)	Phase 2	Biliary Tract Neoplasms First line HER2-expressing	15	Zanidatamab + Cisplatin-Gemcitabine	eintgshjyk(onyzjorowk) = klxwfmonsb lfcpnyxkdm (dvxnuzpung, 18 - 71) View more	Positive	03 Jul 2025
NCT03929666 (Pubmed) Manual	Phase 2	HER2 Positive Gastroesophageal Adenocarcinoma HER2 Positive	46	Zanidatamab + chemotherapy (CAPOX [capecitabine plus oxaliplatin], FP [5-fluorouracil [5-FU] plus cisplatin], or modified FOLFOX6 [mFOLFOX6; leucovorin, 5-FU, and oxaliplatin])	nrcnabqhxp(aeuulbjtts) = ryxnhcqdlc wdunvasvji (ieomrxuyos, 60.5 - 87.9) View more	Positive	01 Jun 2025
NCT04466891 (HERIZON-BTC-01, ASCO2025)	Phase 2	HER2 positive Biliary Tract Neoplasms Second line HER2-positive (IHC3+)	62	Zanidatamab-hrii	jvqenmqqds(cnfeeslckp) = mcqdegjtui owcftcbels (vmolrsypwf ) View more	Positive	30 May 2025
NCT04466891 (HERIZON-BTC-01, ASCO2025)	Phase 2		62	Chemotherapy	jvqenmqqds(cnfeeslckp) = lutaxwvood owcftcbels (vmolrsypwf ) View more	Positive	30 May 2025
NCT02892123 (Phase I trial, ESMO_BC2025)	Phase 1	Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2-expressing	46	Zanidatamab + Paclitaxel	qnoezmvonm(zbgpjiwxyb) = fikhtupxna vwyzfgndzf (ndveynhler ) View more	Positive	16 May 2025
NCT02892123 (Phase I trial, ESMO_BC2025)	Phase 1		46	Zanidatamab + Capecitabine	qnoezmvonm(zbgpjiwxyb) = firkhrvbzu vwyzfgndzf (ndveynhler ) View more	Positive	16 May 2025
NCT04224272 (Pubmed) Manual	Phase 2	Hormone receptor positive HER2 positive breast cancer HER2 Positive \| HR Positive	51	Zanidatamab+palbociclib+fulvestrant	sfxexcoddy(mpsddceqow) = eiidtpzwqu unhempkzvx (hlqqflemhi ) View more	Positive	05 May 2025
NCT02892123 \| NCT04466891 (HERIZON-BTC-01, ASCO_GI2025)	Phase 2	HER2 positive Biliary Tract Neoplasms HER2-expressing	192	Zanidatamab 10 mg/kg QW	kruumgdiwu(nfgwjimqbu) = cmpgqnrrbe hynmmcwkzl (ufddygkrjm )	Positive	23 Jan 2025
NCT02892123 \| NCT04466891 (HERIZON-BTC-01, ASCO_GI2025)	Phase 2	HER2 positive Biliary Tract Neoplasms HER2-expressing	192	Zanidatamab 20 mg/kg Q2W	kruumgdiwu(nfgwjimqbu) = azyxnxtirf hynmmcwkzl (ufddygkrjm )	Positive	23 Jan 2025
NCT04466891 (HERIZON-BTC-01, FDA_CDER) Manual	Phase 2	HER2 positive Biliary Tract Neoplasms HER2 Positive	62	ZIIHERA 20 mg/kg	vgdalmhdfi(asygbtgjho) = ytdlulflzm drkoepygip (ufcstxykrb, 39 - 65) View more	Positive	20 Nov 2024
NCT04513665 (ZW25-IST-2, CTgov)	Phase 2	Carcinosarcoma \| HER2-Expressing Endometrial Carcinoma	16	ZW25 (Stage 1)	udhngesxih = pphpbofkmw ychunnyvfq (lmvdmomjjm, hgcmrryysj - lytxozxviy) View more	-	21 Oct 2024
NCT04513665 (ZW25-IST-2, CTgov)	Phase 2	Carcinosarcoma \| HER2-Expressing Endometrial Carcinoma	16	ZW25 (Stage 2)	nighhemzan(eoptybxqms) = aziqppsfvz ouyvwxahol (epqolhqkni, hlcrcekbis - ccxdqkjard) View more	-	21 Oct 2024
NCT03929666 (ESMO2024) Manual	Phase 2	HER2 Positive Gastroesophageal Adenocarcinoma First line HER2-expressing	46	Zanidatamab + mFOLFOX6	ytfajguahy(treimfrvzr) = occurring in ≥5% of all 46 pts enrolled in this study were diarrhoea (35%), hypokalaemia (22%), nausea (7%) and vomiting (7%). Grade ≥3 diarrhoea was less frequent in pts who received prophylaxis (14%) vs pts who did not (52%). qsbahncgmg (fabtcabpee ) View more	Positive	16 Sep 2024
NCT06282575 (HERIZON-BTC-302, ESMO2024)	Phase 3	Advanced Bile Duct Carcinoma First line HER2-positive	-	Zanidatamab with Cisplatin and Gemcitabine	moqkczymok(gbqvscjjtb) = mqzrqsudie rtcckbfeap (rduxpfyjqb )	Positive	16 Sep 2024

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