RegulationBreakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia)

Structure/Sequence

Molecular FormulaC30H35ClN4O2

InChIKeyGYABBVHSRIHYJR-UHFFFAOYSA-N

CAS Registry1256589-74-8

Clinical Trials associated with Alectinib Hydrochloride

NCT07573696

/ Not yet recruitingPhase 2IIT

A Multicenter, Phase 2 Non-Randomized Study of Unresectable Stage III ALK+ NSCLC Treated With Neoadjuvant Alectinib Plus Chemotherapy Followed by Multidisciplinary Approach for Optimal Local Treatment

This is a multicenter, phase 2 non-randomized study to investigate the clinical feasibility and therapeutic efficacy of employing a MDT-based strategy in unresectable stage III ALK positive NSCLC following neoadjuvant alectinib in combination with platinum-based chemotherapy. Participants in this study must not have received any previous systemic anticancer therapy before enrollment.
The study will consist of a 42-day screening period, a neoadjuvant treatment period, a local radical treatment period, a post-local treatment period, a safety follow-up visit occurring 28 days after the final dose of alectinib, and a survival follow-up period.
In the neoadjuvant treatment period, participants will be provided with alectinib (600mg PO BID for 3 cycles) plus platinum-based chemotherapy for a maximum of 3 cycles (each cycle is 21 days).
Following the completion of neoadjuvant therapy, all participants who are reassessed by MDT to be resectable after neoadjuvant treatment and have adequate lung functions would be provided with definite surgery. Otherwise, patients would be provided with radical radiotherapy through MDT discussion.
For the surgery cohort, participants meet both the R0 resection, the pathological assessment criteria of pCR and have two consecutive landmark ctDNA tests that are negative will receive surveillance after surgery. Participants who do not meet all the above conditions will receive alectinib after surgery, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, treatment will continue until completion of treatment period (24 months), disease recurrence, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
For the radical radiotherapy cohort, participants will receive alectinib after radiotherapy, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, the treatment will continue until completion of treatment period (24 months), disease progression, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.

Start Date15 Jun 2026

Sponsor / Collaborator

Guangdong General Hospital

ChiCTR2600125803

/ SuspendedNot ApplicableIIT

A Prospective, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Alectinib in Conversion Surgery for Locally Advanced ALK Fusion-Positive NSCLC

Start Date01 Jun 2026

Sponsor / Collaborator-

CTIS2025-523610-83-00

/ Not yet recruitingPhase 4IIT

Randomized study evaluating the impact of an innovative and cooperative pathway integrating oncogeriatric, pharmaceutical and pharmacological follow-up in elderly patients (>70 years old) presenting with cancer and treated with oral therapy _ POG

Start Date01 Jun 2026

Sponsor / Collaborator

Institut Gustave Roussy EURL

100 Clinical Results associated with Alectinib Hydrochloride

100 Translational Medicine associated with Alectinib Hydrochloride

100 Patents (Medical) associated with Alectinib Hydrochloride

1,496

Literatures (Medical) associated with Alectinib Hydrochloride

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of lorlatinib as first-line treatment for anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer in Italy

Article

Author: Pasello, Giulia ; Novelli, Giuseppe ; Rumi, Filippo ; Di Virgilio, Roberto ; Bearz, Alessandra ; Basile, Michele ; Di Brino, Eugenio ; Valentini, Ilaria

BACKGROUND:

Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) with high central nervous system penetration and activity against resistance mutations. Although its clinical efficacy as first-line treatment for ALK-positive advanced non-small cell lung cancer (NSCLC) has been demonstrated, its economic value within the Italian healthcare system remains to be fully established. This study evaluated the cost-effectiveness of lorlatinib compared with alectinib as first-line therapy in Italy.

METHODS:

A partitioned survival model with three health states (progression-free, progressed disease, and death) was developed from the Italian National Health Service and societal perspectives over a 30-year time horizon. Clinical efficacy inputs were derived from the CROWN trial and indirect treatment comparisons using network meta-analysis. Costs (2026 euros) included drug acquisition, subsequent treatments, healthcare resource use, adverse events, end-of-life care, and societal costs. Health outcomes were expressed as life-years (LYs) and quality-adjusted life-years (QALYs). Deterministic, probabilistic, and scenario analyses were conducted to assess uncertainty.

RESULTS:

In the base case, lorlatinib was dominant over alectinib, providing higher benefits (+2.01 LYs; +1.66 QALYs) at lower costs (-€19,210 per patient). This finding was robust across pricing scenarios. Probabilistic sensitivity analysis showed an almost 98,40% probability of cost-effectiveness at Italian willingness-to-pay thresholds.

CONCLUSIONS:

From both NHS and societal perspectives, lorlatinib represents a cost-saving and clinically superior first-line treatment option compared with alectinib for patients with ALK-positive advanced NSCLC in Italy.

31 Dec 2026·Lung Cancer Management

Clinical characteristics of ALK-positive NSCLC patients treated with sequential ALK-TKI therapies in a single-centre

Article

Author: Yoshimura, Saiki ; Imakita, Takuma ; Yamamoto, Yuki ; Fujita, Kohei ; Fujimoto, Naoki ; Tanizawa, Kiminobu ; Ito, Takanori ; Oi, Issei ; Toyama, Shogo ; Kanai, Osamu

INTRODUCTION:

Although sequential treatment with ALK-TKIs for ALK-positive lung cancer is commonly practiced in clinical settings, there are few reports on the actual treatment choices, efficacy and safety.

METHODS:

This retrospective study evaluated the treatment sequence, progression-free survival (PFS), overall survival (OS), and adverse events (AEs) for the patients who received two or more ALK-TKIs.

RESULTS:

Eleven patients were included in the study. The median age was 59 years, and five patients (45.5%) were female. The number of ALK-TKIs administered was two in five patients, three in five patients, and four in one patient. The drugs used were Alectinib in 10 patients, Lorlatinib in eight, Brigatinib in six, Ceritinib in three, and Crizotinib in two. Six patients (54.5%) had a history of treatment with cytotoxic chemotherapy in addition to ALK-TKIs. The most common first-line drug was Alectinib, followed by Brigatinib and Crizotinib. The median PFS for each treatment line was 23 months for the first line, 17 months for the second, 14 months for the third, and 5 months for the fourth. The median OS from 1^st ALK-TKI was 58 months. Discontinuation of ALK-TKI due to adverse events occurred in six of the total treatment cases, and five of these (83.3%) were attributed to Brigatinib.

CONCLUSION:

Sequential treatment with different types of ALK-TKIs demonstrated a certain degree of efficacy. However, the incidence of discontinuation due to adverse events was higher for Brigatinib than for other ALK-TKIs.

31 Dec 2026·Lung Cancer Management

Cost of managing brain metastases in ALK-positive advanced NSCLC patients receiving first-line ALK TKIs in China

Article

Author: Zhu, Fanfan ; Li, Hongchao ; Xue, Jing ; Le, Hannah ; Duan, Jia ; Hu, Bingqi ; Li, Dingsiman ; Rifi, Nada ; Dong, Peng ; Luan, Luan

AIM:

To estimate brain metastases (BM) management costs in Chinese ALK+ advanced non-small-cell lung cancer (NSCLC) patients receiving first-line (1 L) ALK tyrosine kinase inhibitors (TKIs).

METHODS:

A survey of 105 clinical experts across 23 Chinese regions evaluated healthcare resource utilization (HCRU). Total annual costs with TKIs were calculated by weighting the management costs of patients with and without BM using the cumulative incidence rate (CIR) of BM from ALK-TKI clinical trials.

RESULTS:

First-year management cost averaged ¥24,974 per-patient without BM versus ¥89,859 per-patient with BM, saving ¥64,885. Subsequent years saved ¥33,231. Applying 12-month CIR of BM, the annual costs per-patient were ¥26,791 for 1 L lorlatinib versus ¥46,516 for crizotinib in the intention-to-treat (ITT) population. Subgroup analysis showed annual costs of ¥25,623 per-patient with lorlatinib in those without BM and ¥29,775 in those with BM. Alectinib's and brigatinib's costs were ¥31,073 and ¥32,760 respectively, using the 12-month CIR of BM. Lorlatinib's cost savings increased progressively over 1-4 years. Limited CIR beyond 12 months existed for brigatinib and ensartinib. Results from the Asian group's CIR aligned with global trials.

CONCLUSION:

Due to lower BM CIR, lorlatinib showed higher BM management cost savings compared to crizotinib and alectinib in Chinese 1 L patients.

168

News (Medical) associated with Alectinib Hydrochloride

16 Sep 2026

·www.globenewswire.com

Roche’s collaborator MediLink announces phase III data for Tam-Peli showing significantly improved overall survival in Chinese patient population with relapsed small-cell lung cancer

Roche’s collaborator MediLink announces phase III data for Tam-Peli showing significantly improved overall survival in Chinese patient population with relapsed small-cell lung cancer Tambotatug pelitecan (Tam-Peli) demonstrated statistically significant efficacy over topotecan in a phase III study conducted in China, reducing the risk of death by 54% and disease progression by 71%, while achieving an objective response rate of 59.1% vs 9.7%1 The novel B7-H3-targeted antibody-drug conjugate with a dual release mechanism of the payload is based on MediLink’s proprietary TMALIN® platform, designed to maximise antitumour activity while minimising off-target toxicity2,3 Roche is developing and commercialising Tam-Peli outside mainland China, Hong Kong, and Macau across multiple tumour types, with plans to rapidly initiate global trials Tam-Peli has received U.S. FDA and China CDE Breakthrough Therapy Designations for relapsed small-cell lung cancer (SCLC) 13 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) today announced that its collaborator MediLink released interim results from the randomised phase III TAISHAN-302 trial evaluating Tam-Peli (tambotatug pelitecan, YL201) versus topotecan in Chinese patients with relapsed small-cell lung cancer (SCLC) who progressed after prior platinum-based chemotherapy with or without a PD-L1 inhibitor.1 The trial met its primary endpoint of overall survival (OS) with Tam-Peli demonstrating a statistically significant and clinically meaningful OS benefit, reducing the risk of death by 54% (median OS 13.3 vs. 9.4 months; stratified HR=0.46; p<0.0001). Tam-Peli also showed robust efficacy across secondary endpoints, significantly extending progression-free survival (PFS) (median PFS 7.4 vs. 2.8 months) and response rates (59.1% vs. 9.7%) compared to standard-of-care topotecan.1 The trial results are being presented as a Late-Breaking Abstract during a Presidential Presentation at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC) in Seoul with simultaneous publication in The New England Journal of Medicine.1 Additionally, the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for filing. “The second positive phase III trial for Tam-Peli, TAISHAN-302, reinforces our confidence in its potential to improve outcomes for people with cancer," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "These data demonstrate clinically meaningful survival and response rate improvements in an aggressive and hard-to-treat disease, supporting our plans to initiate global phase III trials quickly.” Consistent OS and PFS improvements were observed across prespecified subgroups, including age, chemotherapy-free interval (<90 vs. ≥90 days), and baseline liver or brain metastatic status. In patients with baseline brain metastases, Tam-Peli extended median intracranial PFS (6.1 months vs. 4.2 months; unstratified HR=0.43; 95% CI: 0.27–0.68) and achieved a higher intracranial response rate (32.4% vs. 2.9%).1 Tam-Peli showed a favourable and manageable safety profile, demonstrating lower rates of Grade ≥3 treatment-related adverse events (TRAEs) compared with topotecan (46.4% vs. 74.7%). Serious TRAEs occurred in 25.9% of patients receiving Tam-Peli versus 36.4% with topotecan. Treatment-emergent interstitial lung disease (ILD/pneumonitis) across all grades occurred in 4.9% of Tam-Peli patients versus 1.4% with topotecan; grade 3 ILD/pneumonitis events were low in both groups (0.9% each), with no Grade 4 or 5 events reported.1 Tam-Peli is designed to target B7-H3, a protein broadly expressed in solid tumours but minimally in normal tissue, allowing it to target cancer cells with high selectivity. Built on MediLink's TMALIN® platform, its stable linker and dual-release mechanism are designed to maximise therapeutic efficacy while limiting off-target toxicity.2,3 Following the positive phase III TAISHAN-301 trial (NCT06629597) in nasopharyngeal carcinoma, TAISHAN-302 represents the second positive phase III readout for Tam-Peli, conducted in patients in China. Under a collaboration and exclusive licensing agreement between Roche and MediLink Therapeutics, Roche holds development, manufacturing, and commercialisation rights for Tam-Peli worldwide, outside mainland China, Hong Kong, and Macau. Roche is advancing clinical development in its licensed territories across multiple solid tumour types and plans to rapidly initiate global phase III trials. TAISHAN-302 (NCT06612151) is a randomised, open-label phase III study evaluating the efficacy and safety of Tam-Peli (2.0 mg/kg intravenously on day 1 of each 21-day cycle, maximum dose 200 mg) compared with topotecan in patients with small-cell lung cancer (SCLC) who have progressed after one prior line of platinum-based chemotherapy with or without a PD-L1 inhibitor. The trial enrolled 451 patients across 85 study sites in China. The primary endpoint of the trial is overall survival (OS). Key secondary endpoints include investigator-assessed progression-free survival (PFS) and objective response rate (ORR), alongside disease control rate (DCR), duration of response (DoR), time to response (TTR), safety, pharmacokinetics, and immunogenicity.1 Tambotatug pelitecan (Tam-Peli; YL201) is an investigational antibody-drug conjugate (ADC) targeting B7-H3, a protein highly expressed across various solid tumours, both on the tumour cells and in the microenvironment, but limited in healthy tissues.1,2 Utilising MediLink Therapeutics’ TMALIN® (Tumour Microenvironment-Activatable Linker) platform, Tam-Peli links a B7-H3-specific monoclonal antibody to a novel topoisomerase 1 inhibitor payload with a drug-to-antibody ratio (DAR) of 8. By combining a stable, hydrophilic linker with a dual-release mechanism, Tam-Peli is designed to deliver its cytotoxic payload both inside tumour cells as well as extracellularly in the tumour microenvironment, maximising therapeutic efficacy while minimising systemic toxicity.2,3 Beyond SCLC, Tam-peli holds two U.S. Food and Drug Administration (FDA) Orphan Drug Designations and three China Center of Drug Evaluation (CDE) Breakthrough Therapy Designations (BTDs) across additional indications, including nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), and pancreatic cancer. In January 2026, Roche entered into an exclusive licensing agreement with MediLink Therapeutics for the development, manufacturing, and commercialisation of Tam-Peli worldwide, excluding mainland China, Hong Kong SAR and Macau. Lung cancer remains the leading cause of cancer-related deaths worldwide, surpassing the combined mortality rates of breast, prostate, and stomach cancers. Each year, it claims the lives of 1.8 million people. SCLC accounts for 15% of lung cancer diagnoses.4 It is a highly aggressive form of lung cancer which progresses rapidly, regardless of the stage of disease at diagnosis. Despite advances in first-line treatment, SCLC frequently relapses or progresses and outcomes remain poor for many people with recurrent disease, highlighting the continued need for more effective treatment options. Roche is committed to advancing the field of lung cancer treatments, leveraging more than 20 years of scientific expertise to improve patient outcomes. Roche’s portfolio includes approved medicines such as Alecensa® (alectinib), Tecentriq® (atezolizumab), and Rozlytrek® (entrectinib). Its extensive pipeline includes investigational treatments across three key focus areas: small-cell lung cancer, non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGA), and NSCLC without AGA. Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. References [1] Zhang L, Zhao Y, Liu H, et al. Tam-Peli, an Anti-B7-H3 Antibody-Drug Conjugate, Versus Topotecan in Relapsed SCLC: A Randomized, Open-Label, Phase 3 Study (TAISHAN-302). WCLC 2026: Abstract PL02.03. [2] Xu J, et al. Cancer Res. 2023;83:6304. [3] Ma Y, et al. Nat Med. 2025;31:1949-1957. [4] Rudin CM, et al. Small-cell lung cancer. Nat Rev Dis Primers. 2021;7(1):3. The content above comes from the network. if any infringement, please contact us to modify.

License out/inClinical ResultBreakthrough TherapyOrphan Drug

08 Sep 2026

·www.globenewswire.com

Pyxis Oncology Appoints Thomas Civik Chief Executive Officer and Chairman of the Board

John Flavin, Co-Founder and Founding Chairman, to serve as Lead Independent Director of the Board Leadership transition reflects continued focus on advancing MICVO through key clinical milestones BOSTON, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, announced today that its Board of Directors has appointed Thomas Civik as Chief Executive Officer and Chairman of the Board, effective as of September 4, 2026. Mr. Civik has served as Interim Chief Executive Officer since February 2026 and as a member of Pyxis Oncology’s Board of Directors since 2021. In connection with Mr. Civik’s appointment as Chairman, John Flavin, co-founder and founding Chairman of Pyxis Oncology, will transition to Lead Independent Director and will continue to serve as a member of the Board. Mr. Flavin has provided leadership to Pyxis Oncology since its founding and has played an instrumental role in the Company’s formation, growth and evolution into the clinical-stage organization it is today. “Over the past several months, Tom has demonstrated the leadership, strategic focus and disciplined execution the Board believes are needed as Pyxis Oncology approaches key clinical milestones for MICVO,” said John Flavin, Lead Independent Director of Pyxis Oncology. “He brings a deep understanding of the Company, its science and its strategy, and during his time as Interim Chief Executive Officer, the Company has continued to advance MICVO, strengthen its financial position and remain focused on generating the clinical evidence needed to evaluate MICVO’s potential for patients. The Board has full confidence in Tom and is pleased to appoint him Chief Executive Officer and Chairman of the Board.” “I am honored by the Board’s confidence and proud to continue leading Pyxis Oncology at such an important time for the Company,” said Thomas Civik, Chief Executive Officer and Chairman of the Board. “I want to thank John for his tremendous leadership and commitment to Pyxis Oncology. His vision and guidance have helped shape the Company from its earliest days, and I am grateful that we will continue to benefit from his experience and perspective as Lead Independent Director.” Mr. Civik continued, “Our extraordinary team at Pyxis Oncology has executed with speed, precision, and a deep commitment to finding new treatment options for difficult-to-treat cancers. With important clinical milestones ahead, our focus remains on generating the clinical evidence needed to evaluate MICVO’s potential to address the significant unmet need in head and neck cancer. I look forward to working alongside our talented team as we continue to execute on our strategy and deliver meaningful progress for patients while building long-term value for shareholders.” Mr. Civik most recently served as the Chairman of ImCheck Therapeutics (acquired by Ipsen) and Repare Therapeutics (acquired by Xoma). He also served as President and Chief Executive Officer of Five Prime Therapeutics until its acquisition by Amgen for $1.9 billion in April 2021. He was previously Chief Commercial Officer at Foundation Medicine, and before that, held various roles over a 17-year career at Genentech, with responsibility for several important therapies such as Avastin, Tecentriq, Alecensa and Tarceva. Mr. Civik earned a B.A. from St. Norbert College, and an M.B.A. from Northwestern University Kellogg School of Management. Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study in second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the Fall of 2026. The update is expected to include detailed analysis of patients treated at or below dose cap, including the impact on safety, tolerability, efficacy and initial durability. The Company also expects to report updated data from its ongoing Phase 1/2 combination study with pembrolizumab in first-line (1L) R/M HNSCC in the fourth quarter of 2026. About Pyxis Oncology, Inc.Pyxis Oncology, Inc. is a clinical-stage biopharmaceutical company developing therapeutics for difficult-to-treat cancers. The Company’s lead candidate, micvotabart pelidotin (MICVO), is a first-in-concept antibody-drug conjugate (ADC) that targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM). EDB+FN is selectively overexpressed in the tumor microenvironment of a wide range of solid tumors and largely absent from normal adult tissues. MICVO is designed to treat solid tumors through a three-pronged mechanism of action: direct cancer cell killing, bystander effect and immunogenic cell death. MICVO is currently being evaluated as monotherapy in a Phase 1 clinical study in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in a Phase 1/2 clinical study in patients with R/M HNSCC and other solid tumors. Pyxis Oncology is focused on advancing MICVO, with the goal of improving outcomes for patients living with R/M HNSCC and contributing to meaningful progress in cancer treatment. MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. To learn more, visit www.pyxisoncology.com or follow us on LinkedIn. Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part II, Item 1A. of the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 13, 2026, and our other filings, each of which is on file with the Securities and Exchange Commission. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date hereof and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Pyxis Oncology ContactIR@pyxisoncology.com

Phase 1Executive ChangeFast TrackAcquisition

08 Sep 2026

·www.biospace.com

Pyxis Oncology Appoints Thomas Civik Chief Executive Officer and Chairman of the Board

John Flavin, Co-Founder and Founding Chairman, to serve as Lead Independent Director of the Board Leadership transition reflects continued focus on advancing MICVO through key clinical milestones BOSTON, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, announced today that its Board of Directors has appointed Thomas Civik as Chief Executive Officer and Chairman of the Board, effective as of September 4, 2026. Mr. Civik has served as Interim Chief Executive Officer since February 2026 and as a member of Pyxis Oncology’s Board of Directors since 2021. In connection with Mr. Civik’s appointment as Chairman, John Flavin, co-founder and founding Chairman of Pyxis Oncology, will transition to Lead Independent Director and will continue to serve as a member of the Board. Mr. Flavin has provided leadership to Pyxis Oncology since its founding and has played an instrumental role in the Company’s formation, growth and evolution into the clinical-stage organization it is today. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “Over the past several months, Tom has demonstrated the leadership, strategic focus and disciplined execution the Board believes are needed as Pyxis Oncology approaches key clinical milestones for MICVO,” said John Flavin, Lead Independent Director of Pyxis Oncology. “He brings a deep understanding of the Company, its science and its strategy, and during his time as Interim Chief Executive Officer, the Company has continued to advance MICVO, strengthen its financial position and remain focused on generating the clinical evidence needed to evaluate MICVO’s potential for patients. The Board has full confidence in Tom and is pleased to appoint him Chief Executive Officer and Chairman of the Board.” “I am honored by the Board’s confidence and proud to continue leading Pyxis Oncology at such an important time for the Company,” said Thomas Civik, Chief Executive Officer and Chairman of the Board. “I want to thank John for his tremendous leadership and commitment to Pyxis Oncology. His vision and guidance have helped shape the Company from its earliest days, and I am grateful that we will continue to benefit from his experience and perspective as Lead Independent Director.” Mr. Civik continued, “Our extraordinary team at Pyxis Oncology has executed with speed, precision, and a deep commitment to finding new treatment options for difficult-to-treat cancers. With important clinical milestones ahead, our focus remains on generating the clinical evidence needed to evaluate MICVO’s potential to address the significant unmet need in head and neck cancer. I look forward to working alongside our talented team as we continue to execute on our strategy and deliver meaningful progress for patients while building long-term value for shareholders.” Mr. Civik most recently served as the Chairman of ImCheck Therapeutics (acquired by Ipsen) and Repare Therapeutics (acquired by Xoma). He also served as President and Chief Executive Officer of Five Prime Therapeutics until its acquisition by Amgen for $1.9 billion in April 2021. He was previously Chief Commercial Officer at Foundation Medicine, and before that, held various roles over a 17-year career at Genentech, with responsibility for several important therapies such as Avastin, Tecentriq, Alecensa and Tarceva. Mr. Civik earned a B.A. from St. Norbert College, and an M.B.A. from Northwestern University Kellogg School of Management. ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study in second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in the Fall of 2026. The update is expected to include detailed analysis of patients treated at or below dose cap, including the impact on safety, tolerability, efficacy and initial durability. The Company also expects to report updated data from its ongoing Phase 1/2 combination study with pembrolizumab in first-line (1L) R/M HNSCC in the fourth quarter of 2026. About Pyxis Oncology, Inc. Pyxis Oncology, Inc. is a clinical-stage biopharmaceutical company developing therapeutics for difficult-to-treat cancers. The Company’s lead candidate, micvotabart pelidotin (MICVO), is a first-in-concept antibody-drug conjugate (ADC) that targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM). EDB+FN is selectively overexpressed in the tumor microenvironment of a wide range of solid tumors and largely absent from normal adult tissues. MICVO is designed to treat solid tumors through a three-pronged mechanism of action: direct cancer cell killing, bystander effect and immunogenic cell death. MICVO is currently being evaluated as monotherapy in a Phase 1 clinical study in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab) in a Phase 1/2 clinical study in patients with R/M HNSCC and other solid tumors. Pyxis Oncology is focused on advancing MICVO, with the goal of improving outcomes for patients living with R/M HNSCC and contributing to meaningful progress in cancer treatment. MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy. KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); To learn more, visit or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part II, Item 1A. of the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 13, 2026, and our other filings, each of which is on the Securities and Exchange Commission. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date hereof and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Pyxis Oncology Contact IR@pyxisoncology.com ezstandalone.cmd.push(function () { ezstandalone.showAds(134); });

Phase 1Executive ChangeFast TrackAcquisition

100 Deals associated with Alectinib Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D10450	Alectinib Hydrochloride	L01XE	DB11363

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
ALK Positive Solid Tumors	Japan	Chugai Pharmaceutical Co., Ltd.	18 May 2026
Resectable Lung Non-Small Cell Carcinoma	European Union	Roche Registration GmbH	19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma	Iceland	Roche Registration GmbH	19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma	Liechtenstein	Roche Registration GmbH	19 Jun 2024
Resectable Lung Non-Small Cell Carcinoma	Norway	Roche Registration GmbH	19 Jun 2024
ALK-positive anaplastic large cell lymphoma	Japan	Chugai Pharmaceutical Co., Ltd.	21 Feb 2020
Advanced Lung Non-Small Cell Carcinoma	European Union	Roche Registration GmbH	16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma	Iceland	Roche Registration GmbH	16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma	Liechtenstein	Roche Registration GmbH	16 Feb 2017
Advanced Lung Non-Small Cell Carcinoma	Norway	Roche Registration GmbH	16 Feb 2017
Non-Small Cell Lung Cancer	Canada	Hoffmann-La Roche Ltd.	29 Sep 2016
ALK positive Non-Small Cell Lung Cancer	United States	Hoffmann-La Roche, Inc.	11 Dec 2015
ALK positive Non-Small Cell Lung Cancer	United States	Hoffmann-La Roche Ltd.	11 Dec 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-small cell lung cancer stage IIIB	Phase 3	China	Hoffmann-La Roche Ltd.	18 Nov 2024
Non-small cell lung cancer stage IIIB	Phase 3	Australia	Hoffmann-La Roche Ltd.	18 Nov 2024
Non-small cell lung cancer stage IIIB	Phase 3	Brazil	Hoffmann-La Roche Ltd.	18 Nov 2024
Non-small cell lung cancer stage IIIB	Phase 3	Chile	Hoffmann-La Roche Ltd.	18 Nov 2024
Non-small cell lung cancer stage IIIB	Phase 3	Italy	Hoffmann-La Roche Ltd.	18 Nov 2024
Non-small cell lung cancer stage IIIB	Phase 3	South Korea	Hoffmann-La Roche Ltd.	18 Nov 2024
Anaplastic Large-Cell Lymphoma	Phase 3	United Kingdom	-	18 Dec 2023
Hematologic Neoplasms	Phase 3	United Kingdom	-	18 Dec 2023
Neuroblastoma	Phase 3	United Kingdom	-	18 Dec 2023
Renal Cell Carcinoma	Phase 3	United Kingdom	-	18 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line	34	First-line Alectinib	rwgbavptdo(hcbyfxifex) = uruevxzyaf mbivvqexfj (pcghyaqcby, 17.3 - 26.3) View more	Positive	12 Sep 2026
J-ALINA (WCLC2026)	Phase 3	Non-Small Cell Lung Cancer Adjuvant ALK fusions	112	Alectinib 300 mg	kautpskhpv(vvuqartvcu) = atqettefhc jqcqgulbni (ykjllmlgcs ) View more	Positive	12 Sep 2026
NCT04302025 (NAUTIKA1, WCLC2026)	Phase 2	ALK positive Non-Small Cell Lung Cancer Neoadjuvant ALK+	48	Neoadjuvant Alectinib	hwrypokwjs(bmlzgtlxms) = pmypzonwph cxembgsqey (zryhesihnu ) View more	Positive	12 Sep 2026
NCT04302025 (NAUTIKA1, WCLC2026)	Phase 2	Non-Small Cell Lung Cancer Neoadjuvant ALK+	27	Alectinib	uyypioiwot(tpmcahlutl) = iwmektcwzj zyqhanzeay (opgigemkvg ) View more	Positive	12 Sep 2026
ASCO_Breakthrough2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line	1,688	Lorlatinib	hcdroyhbpa(cdoufchfej) = ookhzyliip reardmyozf (femjzpwjyy ) View more	Positive	25 Jun 2026
ASCO_Breakthrough2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer First line	1,688	Alectinib	hcdroyhbpa(cdoufchfej) = hionebtggj reardmyozf (femjzpwjyy ) View more	Positive	25 Jun 2026
ESMO_ELCC2026	Not Applicable	ALK positive Non-Small Cell Lung Cancer Adjuvant ALK-positive	55	Adjuvant Alectinib	ozyecnvpjy(fwznjrxxua) = rmdummpfst waboznclfm (ywxvlwbkfv ) View more	Positive	25 Mar 2026
J-ALEX (ESMO_ASIA2025)	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK secondary mutations (SMs)	67	Alectinib	edwcpnjlhc(wxdevqsmba) = onhkikpsmw xjpusapkdn (velxjietny ) View more	Positive	05 Dec 2025
J-ALEX (ESMO_ASIA2025)	Phase 3		67	Alectinib (Patients with detected ALK SMs)	edwcpnjlhc(svwenwqzzb) = zoqxuzytsw wgbvpnpria (llubgaekby, 10.2 - 25.2)	Positive	05 Dec 2025
ESMO_ASIA2025	Not Applicable	ALK positive Lung Cancer	70	Crizotinib	ydiijrlica(cziarzuarm) = qbryrncxgg fpvgrntjnn (hfjfbjirnz, 34 - 65) View more	Positive	05 Dec 2025
NCT02075840 (ALEX, ESMO2025) Manual	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK Positive	303	Alectinib 600 mg BID	uzufkofkzf(opngrwggde) = tizuhtfepa wdaqwkqyuk (wufnyvxhjt, 62.3 - NE) View more	Positive	17 Oct 2025
NCT02075840 (ALEX, ESMO2025) Manual	Phase 3		303	Crizotinib 250 mg BID	uzufkofkzf(opngrwggde) = lsycpbqlju wdaqwkqyuk (wufnyvxhjt, 34.6 - 75.6) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable	ALK positive Non-Small Cell Lung Cancer Adjuvant ALK-positive	48	Alectinib 600 mg BID	aubckobytb(uaqloohlhs) = owykzvycjp lrppdiwich (qyozmdekov ) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable		48	Crizotinib 250 mg BID	aubckobytb(uaqloohlhs) = rfidmexyab lrppdiwich (qyozmdekov ) View more	Positive	17 Oct 2025

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