Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.

Start Date09 Mar 2027

Sponsor / Collaborator

SWOG

[+1]

NCT07679269

/ Not yet recruitingPhase 2

An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Start Date01 Jan 2027

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

CTIS2025-522431-34-00

/ Not yet recruitingPhase 2

TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)

Start Date01 Oct 2026

Sponsor / Collaborator

Region Hovedstadens Apotek

100 Clinical Results associated with Trastuzumab

100 Translational Medicine associated with Trastuzumab

100 Patents (Medical) associated with Trastuzumab

12,530

Literatures (Medical) associated with Trastuzumab

31 Dec 2026·Human Vaccines & Immunotherapeutics

Cost-effectiveness of pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma

Article

Author: Yu, Kexin ; Xu, Qiaoping

To investigate the cost-effectiveness of pembrolizumab in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive gastric or gastro-esophageal junction adenocarcinoma from the perspective of the U.S. and Chinese healthcare systems. In this economic evaluation, a Markov model is constructed from the perspective of the U.S. and Chinese healthcare systems. The survival data were derived from the clinical trial (KEYNOTE-811), while cost data generated during treatment were sourced from pricing, databases, and expert consultations in local hospitals. Total costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs) were estimated in US dollars. Its robustness is evaluated by deterministic and probabilistic sensitivity analysis. Basic case analysis showed that pembrolizumab in combination with trastuzumab and chemotherapy, as a new treatment strategy, had higher cost-effectiveness compared with trastuzumab plus chemotherapy treatment, with willingness-to-pay (WTP) thresholds set at $150,000 per QALY for the United States population and $40,334.05 per QALY for the China population The ICER was $88,507.57 per QALY in the United States and $22,461.22 per QALY in China, both below the respective thresholds. Sensitivity analysis demonstrated that the results were robust. From the perspective of the U.S. and Chinese medical and health services, pembrolizumab in combination with trastuzumab and chemotherapy is more cost-effective than chemotherapy in the treatment of HER2-positive gastric or gastro-esophageal junction adenocarcinoma patients. Within the context of China's health technology assessment and National Reimbursement Drug List negotiation framework, the ICER below the three-times-GDP threshold suggests preliminary economic feasibility at current price levels, indicating that the regimen may warrant consideration for reimbursement decisions, subject to further budget impact analysis and price negotiation. The evidence-based pricing strategies provided in this study may be helpful for decision makers and clinicians to make the best decisions in general clinical practice. More evidence on budgetary impact and patient affordability is needed.

31 Dec 2026·mAbs

A novel insulin-like growth factor II-based masking domain for conditional activation of therapeutic antibodies

Article

Author: Shi, Lihua ; Cho, Minseon ; Nishida, Motohiko ; Chiu, Mark L. ; Zhang, Di

Systemic target engagement constrains the therapeutic index of many antibody drugs, particularly in inflammatory disease and immuno-oncology. Protease-cleavable masking can localize activity to disease sites, but existing approaches often tradeoff masking strength, reversibility, and developability. Here, we evaluated the insulin-like growth factor II (IGF-II) as a compact, structurally defined steric masking domain for protease-dependent conditional activation of therapeutic antibodies. IGF-II masking domains, including a receptor-silent variant (IGF-II-s), were engineered as N-terminal fusions to therapeutic antibodies via protease-cleavable linkers and characterized using antigen-binding and cell-based functional assays. IGF-II masking attenuated anti-TNFα binding and neutralization potency in a protease-dependent manner and activity was largely restored following cleavage. In vivo, an MMP2/9-cleavable masked anti-TNFα antibody retained efficacy comparable to adalimumab and infliximab in a collagen antibody-induced arthritis model, yet, unlike the reference antibodies, did not measurably reduce survival in a Listeria monocytogenes infection challenge model at the dose tested. IGF-II-s showed no detectable IGF receptor binding and provided stronger masking than native IGF-II. This generalized approach was demonstrated across multiple antibodies, enabling efficient protease-dependent conditional activation of trastuzumab (anti-HER2), an anti-IL-1β antibody, and bevacizumab (anti-VEGF). Together, these results established an engineered IGF-II-based masking domain as a versatile, IGF-II receptor-silent platform enabling protease-dependent conditional activation of therapeutic antibodies, with potential to improve safety and expand therapeutic windows.

01 Oct 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Systematic development and optimization of a cIEF method for the charge variants analysis of moderately basic to basic monoclonal antibodies using the Analytical Quality by Design strategy

Article

Author: Orlandini, Serena ; Massolini, Gabriella ; Furlanetto, Sandra ; Pasquini, Benedetta ; Luciani, Francesca ; Floris, Lucrezia ; Gotti, Roberto

This study proposes a Capillary IsoElectric Focusing Analytical Procedure Platform for the charge heterogeneity characterization of monoclonal antibodies. The Analytical Quality by Design approach was implemented to define a robust Method Operable Design Region using Infliximab as the primary model compound. The Analytical Target Profile consisted in a robust Analytical Procedure Platform able to measure the monoclonal antibody isoforms pI values with a bias lower than 4%. Risk Management tools were used to evaluate and control the risk of Analytical Target Profile failure. Risk Analysis identified several potential Critical Procedure Parameters, including urea and methyl cellulose concentrations, cathodic/anodic stabilizer levels, carrier ampholytes composition. The carrier ampholytes composition was optimized utilizing a mixture design. A Scheffé mixture model allowed the selection of experiments, and the Partial Least Squares regression provided high predictive power models for the three defined responses, i.e. the calibration biases at the bracketing markers of Infliximab (pI 9.5 and pI 7.0) and the overall fit of the pI vs. migration time relationship. Within the Method Operable Design Region, the optimized conditions were achieved using as the specific carrier ampholyte a blend constituted of 1.5% at pH 3-10, 1.5% at pH 5-8, and 2.0% at pH 8-10.5. The validation results demonstrated the robustness of the Analytical Procedure Platform, with a bias in pI measurement lower than 0.3% for the markers bracketing the Infliximab isoforms. In addition, the method was validated for linearity, trueness and precision as degree of repeatability in the quantification of the charge variants of Infliximab. Under the same optimized experimental conditions, the method was applied to successfully profile Bevacizumab, Daratumumab, Trastuzumab and Durvalumab. By including molecules exhibiting a broader range of physicochemical properties compared to the Infliximab model, the study confirms the versatility of the proposed Capillary IsoElectric Focusing method for moderately basic to basic antibodies. This work provides a refined, regulatory-compliant conventional electrokinetic methodology for biopharmaceutical quality control.

1,087

News (Medical) associated with Trastuzumab

06 Aug 2026

·www.biospace.com

ALX Oncology Reports Second Quarter 2026 Financial Results and Provides Corporate Update

– On track for mid-2027 topline data readout from 80 patients in the Phase 2 ASPEN-09-Breast clinical trial evaluating evorpacept in combination with trastuzumab and chemotherapy in HER2-positive metastatic breast cancer – – Presented encouraging Phase 1b/2 breast cancer data at ESMO Breast Cancer 2026 that further validate a biomarker-driven development strategy for evorpacept – – Strong enrollment momentum in Phase 1 clinical trial of ALX2004 in EGFR expressing solid tumors with initial safety data on-track for 2H 2026 – – Strengthened leadership team with the appointments of Scott Garland as Chairman of the Board of Directors and Michael Listgarten as General Counsel – ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); SOUTH SAN FRANCISCO, Calif., Aug. 06, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology," Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today reported financial results for the second quarter ended June 30, 2026, and provided a corporate update. "We continue to execute against our strategy with discipline and focus, advancing both of our clinical programs toward meaningful value-creating milestones," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "Enrollment in our ASPEN-09-Breast trial remains on track as we work toward a topline data readout from 80 patients in mid-2027, while ALX2004 continues to advance through dose escalation with initial safety data expected later this year. The encouraging clinical data we presented at ESMO Breast Cancer further strengthens our confidence in evorpacept’s biomarker-driven strategy, while ALX2004 continues to advance as a differentiated EGFR-targeted ADC built around a clinically validated target with broad applicability across multiple EGFR-expressing solid tumors. Together, these programs highlight the breadth of our pipeline. Combined with our strong balance sheet, an experienced leadership team, and multiple upcoming catalysts, we believe ALX is well-positioned to advance innovative therapies for cancer patients while creating long-term value for shareholders." ALX Oncology Q2 2026 Highlights and Recent Developments Evorpacept In May, ALX Oncology presented new data at ESMO Breast Cancer 2026 from exploratory analyses of its Phase 1b/2 clinical trial evaluating the Company’s investigational CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab (ZIIHERA ® ). The new data demonstrated promising and durable responses in heavily pre-treated metastatic breast cancer (mBC) patients previously treated with ENHERTU ® (fam-trastuzumab deruxtecan-nxki), particularly among patients with centrally confirmed HER2-positive (ccHER2-positive) disease and high CD47 expression. Enrollment in the ongoing ASPEN-09-Breast Phase 2 trial evaluating evorpacept in combination with trastuzumab remains on track, with topline data from 80 patients expected in mid-2027. ALX2004 Enrollment continues in the dose-escalation portion of the Phase 1 trial of ALX2004, a novel antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors, and is on track to report safety data in the second half of 2026. Corporate Update In June, the Company strengthened its leadership team and Board of Directors with the appointments of Scott Garland as Chairman of the Board and Michael Listgarten as General Counsel. A Board member since 2022, Mr. Garland brings more than three decades of biopharmaceutical commercial, operational, and strategic leadership experience, while Mr. Listgarten adds deep expertise in legal affairs, corporate governance, and business development, with a proven track record of guiding biopharmaceutical companies through critical stages of growth and transformation. Together, these appointments reinforce ALX's leadership foundation and enhance the company's ability to execute on its strategic priorities, capitalize on future opportunities, and support long-term growth. Also in June, ALX Oncology strengthened its balance sheet by refinancing its existing $10 million debt with HSBC Ventures USA Inc. and securing the ability to draw up to an additional $20 million at the Company’s discretion through the end of June 2028. The Loan Agreement in totality provides for a secured multi-tranche term loan facility in an aggregate principal amount of up to $50 million, of which $10 million is uncommitted. This new debt facility replaces the Company’s prior loan and security agreement with Oxford Finance LLC and Silicon Valley Bank, significantly lowering ALX Oncology’s cost of capital, enhances financial flexibility and supports the continued advancement of the Company’s clinical portfolio. Second Quarter 2026 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of June 30, 2026, were $153.4 million. The Company believes its cash, cash equivalents and investments are sufficient to fund planned operations through the first half of 2028. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of clinical and development costs related to the development of the Company’s current product candidates, evorpacept and ALX2004, and R&D personnel-related expenses, including stock-based compensation. R&D expenses for the three months ended June 30, 2026 were $13.1 million compared to $18.0 million for the prior-year period, or a decrease of $4.9 million. This decrease was primarily attributable to a decrease of $4.8 million in clinical and development costs, reflecting lower expenses associated with legacy trials, partially offset by continued investment in evorpacept ASPEN-09 Phase 2 trial and ALX2004 Phase 1 study. General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended June 30, 2026 were $5.1 million compared to $5.5 million for the prior year period, or a decrease of $0.4 million. This decrease was primarily attributable to a decrease in $0.4 million in corporate legal and patent costs. Net loss: GAAP net loss was ($18.0) million for the three months ended June 30, 2026, or ($0.13) per basic and diluted share, as compared to a GAAP net loss of ($25.9) million for the three months ended June 30, 2025, or ($0.49) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses as well absence of the $3.2 million lease impairment charge recorded in the three months ended June 30, 2025 related to leased lab space following the workforce reduction in preclinical research in March 2025. Non-GAAP net loss was ($14.3) million for the three months ended June 30, 2026, as compared to a non-GAAP net loss of ($20.6) million for the three months ended June 30, 2025. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release. ZIIHERA ® and ENHERTU ® are the registered trademarks of their respective owners. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action. A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors. More information is available at and on LinkedIn and X . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission (SEC), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. ALX ONCOLOGY HOLDINGS INC. Consolidated Statements of Operations (unaudited) (in thousands, except share and per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Operating expenses: Research and development $ 13,138 $ 18,022 $ 26,744 $ 41,910 General and administrative 5,133 5,451 10,493 13,383 Lease termination (gain) and impairment charge (238 ) 3,175 (238 ) 3,175 Total operating expenses 18,033 26,648 36,999 58,468 Loss from operations (18,033 ) (26,648 ) (36,999 ) (58,468 ) Interest income 1,508 1,106 2,690 2,589 Interest expense (285 ) (405 ) (616 ) (811 ) Other expense, net (257 ) (2 ) (69 ) (13 ) Loss on debt extinguishment (904 ) — (904 ) — Net loss $ (17,971 ) $ (25,949 ) $ (35,898 ) $ (56,703 ) Net loss per share, basic and diluted $ (0.13 ) $ (0.49 ) $ (0.30 ) $ (1.05 ) Weighted-average shares of common stock used to compute net loss per shares, basic and diluted 135,639,684 53,445,631 120,097,125 54,031,176 Consolidated Balance Sheet Data (unaudited) (in thousands) June 30, December 31, 2026 2025 Cash, cash equivalents and investments $ 153,376 $ 48,284 Total assets $ 160,550 $ 59,046 Total liabilities $ 24,363 $ 33,065 Accumulated deficit $ (758,715 ) $ (722,817 ) Total stockholders’ equity $ 136,187 $ 25,981 GAAP to Non-GAAP Reconciliation (unaudited) (in thousands) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 GAAP net loss, as reported $ (17,971 ) $ (25,949 ) $ (35,898 ) $ (56,703 ) Adjustments: Stock-based compensation expense 2,683 2,136 5,192 7,352 Accretion of term loan discount and issuance costs 66 69 134 136 Lease termination (gain) and impairment charge (238 ) 3,175 (238 ) 3,175 Loss on disposal of fixed asset 246 — 246 — Loss on early debt extinguishment 904 — 904 — Total adjustments 3,661 5,380 6,238 10,663 Non-GAAP net loss $ (14,310 ) $ (20,569 ) $ (29,660 ) $ (46,040 ) Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP. "Non-GAAP net loss" is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies. Investor Relations Contact: Kevin Lui Director, Investor Relations Precision AQ kevin.lui@precisionaq.com Media Contact: Genevieve Britton Senior Director, Public Relations Precision AQ genevieve.britton@precisionaq.com

Phase 1Phase 2Financial StatementExecutive ChangeClinical Result

05 Aug 2026

·www.oncolines.com

Comprehensive cell line profiling reveals sensitivity predictors and bystander effects of HER2-targeted ADCs

Antibody drug conjugates (ADCs) represent a promising class of anti-cancer drugs combining a monoclonal antibody with a potential cytotoxic agent for selective tumor killing. With many ADCs in clinical trials and over 10 approvals by the U.S. Food and Drug Administration (FDA) since the beginning of this century, it is a rapidly expanding field. Despite this progress, many ADC programs face challenges such as limited efficacy or off-target toxicity, leading to early termination of clinical trials. At Oncolines, we support ADC development by profiling ADCs and their payloads in our comprehensive cancer cell line panel combined with bioinformatics analyses. This approach enhances understanding of drug responses observed in the clinic. Besides, the choice of relevant cellular models is critical to the success of preclinical studies. Using our receptor quantification assay, we can accurately determine the number of target receptors in each cell line, enabling the selection of the most suitable models for ADC research. Besides, with co-cultures experiments we can study the bystander effects of ADCs. At the AACR Annual Meeting, we will present cell panel profiling data of trastuzumab emtansine (T-DM1, Kadcyla®), trastuzumab deruxtecan (T-DXd, Enhertu®), their corresponding free payloads, the monoclonal antibody trastuzumab, and small molecule HER2 inhibitor tucatinib. Comparative analyses of the responses of these agents, correlated with HER2 expression levels, provide valuable insights into sensitivity predictors and differentiators. Our data show that trastuzumab deruxtecan exhibits activity beyond the HER2-positive indication, highlighting its potential in broader tumor types. Moreover, trastuzumab deruxtecan induces a bystander effect in the HER2-negative cell line U-87MG, an effect not observed with trastuzumab emtansine. These findings underscore the importance of understanding ADC mechanisms in diverse cellular contexts to optimize therapeutic efficacy and safety. Oncolines B.V. is a precision medicine services company in oncology and cancer immunotherapy. Oncolines is part of the Symeres group of companies, a group of high-quality CROs and CDMOs based in Europe and the United States.

AACRADCImmunotherapy

05 Aug 2026

·www.biospace.com

Puma Biotechnology Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - August 5, 2026

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that on August 3, 2026, the Compensation Committee of Puma’s Board of Directors approved the grant of inducement restricted stock unit awards covering 35,375 shares of Puma common stock to five new non-executive employees. The awards were granted under Puma’s 2017 Employment Inducement Incentive Award Plan, which was adopted on April 27, 2017 and provides for the granting of equity awards to new employees of Puma. The restricted stock unit awards vest over a three-year period, with one-third of the shares underlying the award vesting on the first anniversary of the award’s vesting commencement date, August 1, 2026, and one-sixth of the shares underlying the award vesting on each six-month anniversary of the vesting commencement date thereafter, subject to continued service. The awards were granted as an inducement material to the new employees entering into employment with Puma, in accordance with Nasdaq Listing Rule 5635(c)(4). About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX ® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX ® is a registered trademark of Puma Biotechnology, Inc. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA ® -Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA ® -Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. ALISCA ® is a registered trademark of Puma Biotechnology, Inc. Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com

Drug ApprovalLicense out/inPhase 2

100 Deals associated with Trastuzumab

External Link

KEGG	Wiki	ATC	Drug Bank
D03257	Trastuzumab	L01XC03	DB00072

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HER2 Positive Colorectal Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	28 Mar 2022
HER2 positive salivary gland cancer	Japan	Chugai Pharmaceutical Co., Ltd.	25 Nov 2021
HER2-positive gastric cancer	Japan	Chugai Pharmaceutical Co., Ltd.	10 Mar 2011
Stomach Cancer	United States	Genentech, Inc.	20 Oct 2010
Breast Cancer	Japan	Chugai Pharmaceutical Co., Ltd.	04 Apr 2001
Early Stage Breast Carcinoma	European Union	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
Early Stage Breast Carcinoma	Norway	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	European Union	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 Positive Breast Cancer	Norway	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	European Union	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Iceland	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Liechtenstein	Roche Registration GmbH	28 Aug 2000
HER2 positive Gastroesophageal Junction Adenocarcinoma	Norway	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	European Union	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Iceland	Roche Registration GmbH	28 Aug 2000
Hormone receptor positive breast cancer	Liechtenstein	Roche Registration GmbH	28 Aug 2000

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bladder Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Colorectal Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Gallbladder Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Lung Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Ovarian Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Pancreatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Prostatic Cancer	Phase 3	United Kingdom	-	07 Mar 2023
Salivary Gland Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023
Skin Neoplasms	Phase 3	United Kingdom	-	07 Mar 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02252887 (CTgov)	Phase 2	Advanced HER2-Positive Breast Carcinoma \| Metastatic human epidermal growth factor 2 positive carcinoma of breast	45	Trastuzumab+Gemcitabine+Pertuzumab	tabweyzuqt = enecafstvh ohaxeysrzz (pwwnqgvzuq, cgaugdyuar - rairmgwoqb) View more	-	24 Jul 2026
ESMO_GI2026 \| ESMO_GCC2026	Not Applicable	HER2 Positive Colorectal Cancer First line	26	chemotherapy with anti-EGFR	oktceeqmlv(dgzbmyximz) = kmvlltxurq fmkxonmipx (wndihneksj )	Positive	02 Jul 2026
				chemotherapy with anti-VEGF	oktceeqmlv(dgzbmyximz) = przqltqaua fmkxonmipx (wndihneksj )
NCT03716180 (DAPHNe, Pubmed \| JAMA Oncol)	Phase 2	Neoadjuvant ERBB2-positive	98	Neoadjuvant Paclitaxel, Trastuzumab, and Pertuzumab (THP) (Stage II to III ERBB2-Positive Breast Cancer)	unofifhlwi(zgltktehqh) = pqbjojnhxb krzrjxdgpr (vngtferdoa, 97 - 100) View more	Positive	25 Jun 2026
NCT04858529 (neoCARHP, Pubmed \| J Clin Oncol)	Phase 3	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	766	Taxane + Trastuzumab + Pertuzumab + Carboplatin	ijuqzyyugg(srkbvepcwn) = jtsbjkmlkc oiyvypyhzc (iqqmpedctj, 60.9 - 70.6) View more	Positive	10 Jun 2026
				Taxane + Trastuzumab + Pertuzumab	ijuqzyyugg(srkbvepcwn) = sheiawtyvy oiyvypyhzc (iqqmpedctj, 59.1 - 69.0) View more
ASCO2026	Not Applicable	HER2 positive Biliary Tract Neoplasms HER2 overexpression \| HER2 amplification	67	Trastuzumab plus chemotherapy	ixkvedkqyo(ptmvohkqzv) = ialebgawqk uxchroppws (jdtseanhmu, 6.4 - 9.4) View more	Positive	29 May 2026
				Chemotherapy	ixkvedkqyo(ptmvohkqzv) = yhqmszngkn uxchroppws (jdtseanhmu, 1.5 - 2.7) View more
ASCO2026	Not Applicable	HER2-positive gastric cancer HER2-positive	229	Trastuzumab plus chemotherapy (HER2-positive gastric cancer)	hyqjrxiozl(exuqomvolo): HR = 0.74 (95.0% CI, 0.44 - 1.25), P-Value = 0.26 View more	Negative	29 May 2026
				Chemotherapy alone (HER2-positive gastric cancer)
ASCO2026	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2-positive	128	Adjuvant Trastuzumab	dsfdukffxm(dwahbllvos) = wluuqujwgq gvrdpxolxr (xfavnkraph ) View more	Positive	29 May 2026
				Adjuvant Trastuzumab and Pertuzumab	dsfdukffxm(dwahbllvos) = qhrbnrjzth gvrdpxolxr (xfavnkraph ) View more
ASCO2026	Not Applicable	HER2 Positive Breast Cancer Neoadjuvant HER2-positive	53	Neoadjuvant TCHP	ypycekdbyo(kgnbrdhwmf) = skxacmwhei xcfbauxgot (ztqdktzqvv, 44.1 - 71.9) View more	Positive	29 May 2026
				Neoadjuvant TCHP (HR-positive)	ypycekdbyo(kgnbrdhwmf) = qastuzfwvu xcfbauxgot (ztqdktzqvv, 32.8 - 74.4)
ASCO2026	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2-positive	87	Trastuzumab+pertuzumab	qplbrietqw(qyqbqtdynz) = ioeknxdkua nppznffpmh (bleqigcuqz, 28.5) View more	Positive	29 May 2026
				Trastuzumab	knufvnozkq(tylbsxxake) = plcmfgjyzg ynuokqbxmb (olkimbauld )
ASCO2026	Not Applicable	HER2 Positive Breast Cancer HER2+	208	trastuzumab (6 months)	htgfrrbiyp(emiwyvczav) = vvpnygcolc hwjciidgzg (gmvtjthwst ) View more	Positive	29 May 2026
				trastuzumab (12 months)	htgfrrbiyp(emiwyvczav) = xfspncdllm hwjciidgzg (gmvtjthwst ) View more

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