This phase II trial tests how well zipalertinib with carboplatin and pemetrexed works in treating stage II-IIIB non small cell lung cancer. that can be removed by surgery (resectable). Zipalertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill tumor cells. Giving zipalertinib with carboplatin and pemetrexed may kill more tumor cells in patients with resectable, stage II-IIIB non-small cell lung cancer.

Start Date01 Jun 2027

Sponsor / Collaborator

Jonsson Comprehensive Cancer Center

[+1]

NCT07802834

/ Not yet recruitingPhase 2IIT

Adjuvant ctDNA-Adapted Personalized Treatment With Zipalertinib in Early-Stage Atypical EGFR-Mutant NSCLC

This study will evaluate the novel, oral EGFR TKI, zipalertinib, in the adjuvant ctDNA-adapted treatment of stage IA2 to IIIC atypical EGFR-mutant NSCLC after completion of definitive therapy with a primary endpoint of molecular response in participants identified as having minimal residual disease (MRD).

Start Date01 Nov 2026

Sponsor / Collaborator

Stanford University

[+2]

JPRN-jRCT2031260096

/ RecruitingPhase 1

A Phase 1, Open-Label Study to Evaluate the Effect of Food on the Pharmacokinetics of Zipalertinib (TAS6417 FE study)

Start Date05 Jun 2026

Sponsor / Collaborator

Taiho Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zipalertinib

100 Translational Medicine associated with Zipalertinib

100 Patents (Medical) associated with Zipalertinib

Literatures (Medical) associated with Zipalertinib

10 Sep 2026·JOURNAL OF CLINICAL ONCOLOGY

Erratum: Safety, Tolerability, and Antitumor Activity of Zipalertinib Among Patients With Non–Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertions

Article

Author: Wrangle, John M. ; Soo, Ross A. ; Piotrowska, Zofia ; Socinski, Mark A. ; Janik, John E. ; Smit, Egbert F. ; Nguyen, Danny ; Shao-Weng Tan, Daniel ; Koczywas, Marianna ; Yu, Helena Alexandra ; Jones, Jeffrey ; Chih-Hsin Yang, James ; Spira, Alexander I. ; Ho-Fun Lee, Victor ; Velcheti, Vamsidhar

01 Mar 2026·JOURNAL OF CLINICAL ONCOLOGY

Blind Spots in REZILIENT-1: Does Post-Platinum Zipalertinib Address Needs in Epidermal Growth Factor Receptor ex20ins+ Non–Small Cell Lung Cancer?

Letter

Author: Luo, Lei ; Shi, Taotao ; Xu, Lei ; Yao, Wenjian ; Zhou, Qianjun ; Jia, Xiangbo ; Wei, Li

01 Mar 2026·JOURNAL OF CLINICAL ONCOLOGY

Reply to: Blind Spots in REZILIENT-1: Does Post-Platinum Zipalertinib Address Needs in Epidermal Growth Factor Receptor ex20ins+ Non–Small Cell Lung Cancer?

Article

Author: Piotrowska, Zofia ; Yu, Helena A.

News (Medical) associated with Zipalertinib

19 Oct 2026

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Zipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS Metastases

Intracranial Objective Response Rate of 30.2% was observed in 43 evaluable patients Results to be shared in poster presentation at ESMO Congress 2026 PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced results from Cohort C of the Phase 2 REZILIENT2 trial evaluating zipalertinib monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations or other uncommon EGFR mutations and active central nervous system (CNS) metastases. The data will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, October 23-27, in Madrid, Spain. Mature results from the first prospective study evaluating intracranial activity of an EGFR tyrosine kinase inhibitor in this patient population demonstrated clinically meaningful intracranial antitumor activity. Among 43 evaluable patients, zipalertinib achieved an intracranial objective response rate of 30% and an intracranial disease control rate of 72%, with a median intracranial duration of response of 9.7 months. Zipalertinib was well tolerated. “Patients with NSCLC harboring EGFR exon 20 insertion mutations or other uncommon EGFR mutations and active CNS metastases have a significant need for therapies that can effectively address disease in the brain,” said Helena A. Yu, MD, Thoracic Medical Oncologist at Memorial Sloan Kettering Cancer Center and study investigator. “The intracranial responses observed with zipalertinib in REZILIENT2 are encouraging and support continued evaluation of zipalertinib in this difficult-to-treat patient population.” “The REZILIENT2 results reflect a rigorous examination of the CNS activity of zipalertinib as monotherapy in patients with EGFR ex20ins or uncommon EGFR-mutated NSCLC and active CNS metastases,” said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. “The findings add to the growing clinical evidence supporting the continued evaluation of zipalertinib in patients with EGFR-mutated NSCLC and brain involvement.” “The REZILIENT program was designed to explore zipalertinib's potential in clinically important settings where additional treatment options are needed,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “Today's REZILIENT2 update extends that commitment by providing evidence of intracranial activity in patients with active CNS metastases.” Summary of Results: Cohort C of REZILIENT2 enrolled patients with NSCLC harboring EGFR ex20ins or other uncommon EGFR mutations and active CNS metastases, including leptomeningeal disease (LMD), irrespective of prior therapy. At the data cutoff, 59 patients were enrolled, with a median follow-up of 9.2 months. Intracranial efficacy was evaluated by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM), and systemic response was measured by RECIST v1.1. Among 43 RANO-BM-evaluable patients, including 9 with LMD, 29 (67.4%) had EGFR ex20ins mutations. The median number of prior lines of therapy was two (range 1-6), and 19 patients (44.2%) had received prior EGFR tyrosine kinase inhibitor therapy. In these 43 patients, zipalertinib achieved an intracranial objective response rate (iORR) of 30.2% (95% CI: 17.2, 46.1), an intracranial disease control rate (iDCR) of 72.1% (95% CI: 56.3, 84.7), and a median intracranial duration of response (iDoR) of 9.7 months (95% CI: 3.3, not estimable). Among 24 patients without prior EGFR tyrosine kinase inhibitor exposure, iORR was 37.5%. Systemic efficacy was consistent with intracranial outcomes. Zipalertinib 100 mg twice daily was well tolerated. Common treatment-related adverse events (TRAEs) included paronychia (32.6%) and diarrhea (25.6%). Grade ≥3 TRAEs occurred in 9 patients (20.9%), including dermatitis acneiform in 4.7% of patients. Session Information for the ESMO Presentation: T itle: 2621P - Central Nervous System (CNS) Activity of Zipalertinib in Non-Small Cell Lung Cancer (NSCLC) Patients with Uncommon EGFR Mutations (EGFRmt) Presenting Author: Helena A. Yu, MD, Thoracic Medical Oncologist at Memorial Sloan Kettering Cancer Center and study investigator Session Date: Monday, October 26, 2026 Session Time: 12:00 p.m.–12:45 p.m. CET About Zipalertinib Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S. About the REZILIENT2 Trial REZILIENT2 is a Phase 2b clinical trial ( NCT05967689 ) evaluating zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins and uncommon single or compound EGFR mutations. Patients were treated with oral zipalertinib 100 mg twice daily. The primary endpoint was ORR and confirmed per investigator-assessed Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 and the secondary endpoints included duration of response (DOR), disease control rate (DCR) and safety. About EGFR Exon 20 Insertion Mutations NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins, which makes them the third most common EGFR mutation subtype. 2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations, 2 with insertions at exon 20 accounting for up to 12% of these mutations. 3 About Taiho Oncology, Inc. The mission of Taiho Oncology, Inc. is to improve the lives of patients with cancer, their families and their caregivers. The company specializes in the development and commercialization of orally administered anti-cancer agents for various tumor types. Taiho Oncology has a robust pipeline of small-molecule clinical candidates targeting solid-tumor and hematological malignancies, with additional candidates in pre-clinical development. Taiho Oncology is a subsidiary of Taiho Pharmaceutical Co., Ltd. which is part of Otsuka Holdings Co., Ltd. Taiho Oncology is headquartered in Princeton, New Jersey and oversees its parent company’s European and Canadian operations, which are located in Baar, Switzerland and Oakville, Ontario, Canada. For more information, visit , and follow us on LinkedIn and X . Taiho Oncology and the Taiho Oncology logo are registered trademarks of Taiho Pharmaceutical Co., Ltd. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at , and follow Cullinan on LinkedIn and X . Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding the clinical development of zipalertinib, the safety and efficacy pro zipalertinib and its potential to address unmet medical need, our plans regarding future data presentations , and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of clinical trial data and regulatory submissions; the risk that any NDAs, INDs or other global regulatory submissions we may the United States Food and Drug Administration or other global regulatory agencies are not accepted or cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical trials will not be predictive of future results in connection with future studies or clinical trials; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. References Piotrowska Z, Tan DS, Smit EF, et al. Safety, tolerability, and antitumor activity of zipalertinib among patients with non-small-cell lung cancer harboring epidermal growth factor receptor exon 20 insertions. Journal of Clinical Oncology . Available at: . Burnett H, Emich H, Carroll C, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. PLOS ONE . 2021;16(3):e0247620. Available at: . Riess JW, Gandara DR, Frampton GM, et al. Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC. Journal of Thoracic Oncology . 2018 Jul 5;13(10):1560–1568. Available at: (18)30770-6/pdf . Contacts Taiho Oncology Leigh Labrie +1 609.664.9878 llabrie@taihooncology.com Cullinan Therapeutics Investors Nick Smith +1 401.241.3516 nsmith@cullinantx.com Media Rose Weldon +1 215.801.7644 rweldon@cullinantx.com

Clinical ResultPhase 2Drug ApprovalASCOPhase 1

02 Oct 2026

·www.biospace.com

New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program

In the Phase 3 REZILIENT3 study, zipalertinib combination therapy demonstrated longest median progression-free survival observed to date in first-line EGFR exon20ins NSCLC After agreement with the U.S. FDA, Real-Time Oncology Review program submission process initiated; completion of NDA submission expected by year-end 2026 CAMBRIDGE, Mass., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced the initiation of a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zipalertinib in combination with platinum-based chemotherapy for the treatment of patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations under the FDA’s Real-Time Oncology Review (RTOR) program. The RTOR program allows sponsors to submit clinical data in advance of the complete application to facilitate earlier review of efficacy and safety results. Completion of the NDA submission is expected by year-end 2026. The NDA submission is based on data from the Phase 3 REZILIENT3 trial, which met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy compared to chemotherapy alone. These results were recently presented at the International Association for the Study of Lung Cancer’s (IASLC) 2026 World Conference on Lung Cancer (WCLC) during a Presidential Symposium, where potentially practice-changing clinical data are highlighted. Zipalertinib holds FDA Breakthrough Therapy designation for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy. An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027. Cullinan Therapeutics is eligible to receive $30 million and $100 million in milestone payments upon second-line and first-line U.S. regulatory approvals, respectively. About Zipalertinib Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority. Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S. About EGFR Exon 20 Insertion Mutations NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins. 1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations, 1 with insertions at exon 20 accounting for up to 12% of these mutations. 2 About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at , and follow Cullinan on LinkedIn and X . Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding the clinical development of zipalertinib, the safety and efficacy pro zipalertinib and its potential to address unmet medical need, the potential of zipalertinib to become a first-line treatment option, the anticipated timing of the completion of the NDA submission under the RTOR program and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of clinical trial data and regulatory submissions; the risk that any NDAs, INDs or other global regulatory submissions we may the United States Food and Drug Administration or other global regulatory agencies are not accepted or cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical trials will not be predictive of future results in connection with future studies or clinical trials; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Investors Nick Smith  +1 401.241.3516  nsmith@cullinantx.com Media Rose Weldon   +1 215.801.7644   rweldon@cullinantx.com References Burnett H, Emich H, Carroll C, et al. Epidemiological and clinical burden of EGFR exon 20 insertion in advanced non-small cell lung cancer: a systematic literature review. PLOS ONE . 2021;16(3): e0247620. Available at: . Riess JW, Gandara DR, Frampton GM, et al. Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC. Journal of Thoracic Oncology . 2018 Jul 5;13(10):1560–1568. Available at: (18)30770-6/pdf .

15 Sep 2026

·www.biospace.com

Despite 3 patient deaths, Cullinan-Taiho plan FDA filing for lung cancer pill on survival benefit

iStock, francescoch Analysts believe Cullinan Therapeutics and Taiho Oncology can overcome the safety risks as zipalertinib “sets [a] new bar” for first-line treatment of a type of lung cancer. The candidate is already under review for the the second-line setting, with a decision expected by early next year. Taiho Oncology and Cullinan Therapeutics’ oral drug candidate zipalertinib significantly improved progression-free survival in certain patients with non-small cell lung cancer during a late-stage study. The partners also reported some safety events, including three deaths from septic shock, but analysts say the otherwise strong survival benefit and mitigation strategies will likely outweigh the risks as zipalertinib heads toward the market. Zipalertinib’s PFS benefit “sets a new bar” for the first-line treatment of NSCLC, analysts at William Blair told investors in a Monday note. The partners are testing zipalertinib in the Phase 3 REZILIENT3 trial, which enrolled 280 patients with first-line advanced non-squamous NSCLC who are harboring exon 20 mutations to the EGFR gene. Participants were randomly assigned to receive zipalertinib plus chemotherapy or chemotherapy alone. REZILIENT3’s primary endpoint is PFS. Patients who received the zipalertinib regimen had a 50% reduction in the risk of death or disease progression. Median PFS was 14.5 months compared to 8.5 months in the control group, according to a Sunday presentation at the World Conference on Lung Cancer. An interim overall survival analysis showed a 28% benefit in favor of the zipalertinib combo, though follow-up for this secondary endpoint is still ongoing. As for safety, Taiho and Cullinan reported that adverse events grade 3 or higher—those classified as severe or medically significant—arose in 87% of patients in the zipalertinib combo arm, as opposed to 54.4% of chemotherapy controls. Three patients died following septic shock, episodes that the companies deemed related to the study regimen. Common side effects included rashes, diarrhea and mouth inflammation. Nevertheless, analysts believe the partners can overcome the safety risks. Taiho plans to bring these data to the FDA, Leerink Partners said in a Monday note. “The efficacy appears robust and approvable in our view,” the firm said. Zipalertinib is currently under regulatory review for the same type of NSCLC, but in the second-line setting. A decision is expected by Feb. 27, 2027. Leerink projects $235 million in peak zipalertinib revenues in the second-line setting and $791 million in first-line disease. Sunday’s readout comes after Taiho and Cullinan announced REZILIENT3’s success last month—though the partners at the time didn’t provide specific PFS data. Phase 3 Taiho and Cullinan’s zipalertinib clears Phase 3, teeing up first-line competition Taiho Pharmaceutical and Cullinan Therapeutics’ cancer asset is already under FDA review in a later setting, with a decision expected by February. August 13, 2026 · 3 min read · Gabrielle Masson Read more Ready for a challenge Taiho and Cullinan will have plenty of competition as the proceed into the NSCLC space, including Johnson & Johnson’s Rybrevant, AstraZeneca’s Zegfrovy and Arrivent’s upcoming firmonertinib, according to Leerink. “The efficacy pro the REZILIENT3 regimen is very competitive with Rybrevant plus chemotherapy and should support meaningful uptake of zipalertinib in the frontline” NSCLC setting in the U.S., William Blair said. “REZILIENT3 PFS results showed the strongest median PFS reported to date,” the analysts added, pointing to J&J’s PAPILLON trial in which Rybrevant plus chemotherapy resulted in median PFS of 11.4 months. The firm flagged zipalertinib’s safety pro a point of concern for investors, however. The zipalertinib combo “did meaningfully increase the rates of hematologic adverse events during the first four cycles of chemotherapy and also resulted in an imbalance in treatment-related adverse event deaths.” Nevertheless, the group believes that “the positive trends already observed in overall survival show the side effect pro not detract from improved outcomes for patients.” There is also potential for greater supportive care, including transfusions, when the drug is used in a U.S. healthcare setting, William Blair said. Available orally, zipalertinib is a small molecule drug that targets activating mutations to the EGFR gene, a known cancer driver. The drug was originally developed by Cullinan but came to Taiho in 2022 when the latter acquired a Cullinan subsidiary. The companies had previously said that they plan to seek approval for zipalertinib plus chemotherapy in the first-line NSCLC setting.

Phase 3Clinical ResultAcquisitionDrug Approval

100 Deals associated with Zipalertinib

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KEGG	Wiki	ATC	Drug Bank
D13062	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR ex20ins mutation in non-small cell lung cancer	NDA/BLA	United States	Taiho Pharmaceutical Co., Ltd.	28 Nov 2025
Pain, Postoperative	Phase 3	United States	Taiho Oncology, Inc.	22 Dec 2025
Pain, Postoperative	Phase 3	Japan	Taiho Oncology, Inc.	22 Dec 2025
Pain, Postoperative	Phase 3	Argentina	Taiho Oncology, Inc.	22 Dec 2025
Pain, Postoperative	Phase 3	Australia	Taiho Oncology, Inc.	22 Dec 2025
Pain, Postoperative	Phase 3	Belgium	Taiho Oncology, Inc.	22 Dec 2025
Pain, Postoperative	Phase 3	Brazil	Taiho Oncology, Inc.	22 Dec 2025
Pain, Postoperative	Phase 3	Canada	Taiho Oncology, Inc.	22 Dec 2025
Pain, Postoperative	Phase 3	France	Taiho Oncology, Inc.	22 Dec 2025
Pain, Postoperative	Phase 3	Germany	Taiho Oncology, Inc.	22 Dec 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05967689 (REZILIENT2, ESMO2026)	Phase 2	EGFR-mutated non-small Cell Lung Cancer uncommon EGFR mutations	59	Zipalertinib 100 mg twice daily	kznujqramr(dvhkyqdzkr) = dvnwxdmphu htcuytmktx (ugqhkammhs, 56.3 - 84.7) View more	Positive	23 Oct 2026
				Zipalertinib 100 mg twice daily (without prior EGFR TKI)	aznjklktvm(guzmbjhodi) = dxepblpbun aqwqzmpphr (aujfnqfoqg )
NCT05973773 (REZILIENT 3, WCLC2026)	Phase 3	Non-Small Cell Lung Cancer First line EGFR ex20ins	279	Zipalertinib plus chemotherapy	pfntjgjsbk(khocywzxqm) = dwftgbgwlb oppnqfdlnz (qdpqynstgt ) View more	Positive	12 Sep 2026
				Chemotherapy alone	pfntjgjsbk(khocywzxqm) = omierjmbdd oppnqfdlnz (qdpqynstgt ) View more
NCT05973773 (ESMO_ASIA2025)	Phase 1	EGFR ex20ins mutation in non-small cell lung cancer	176	Zipalertinib 100 mg oral twice daily (Asia pts)	niybdnynvi(yxvcpvxxjh) = zyijgvuzch tlyjhllwgj (yggegnspij, 23 - 45) View more	Positive	05 Dec 2025
				Zipalertinib 100 mg oral twice daily (ROW pts)	niybdnynvi(yxvcpvxxjh) = ixyvnfhleu tlyjhllwgj (yggegnspij, 27 - 47) View more
NCT05967689 (REZILIENT2, PRNewswire \| ESMO2025) Manual	Phase 2	EGFR ex20ins mutation in non-small cell lung cancer EGFR S768I \| EGFR Exon 20 Insertion \| EGFR L861Q ... View more	32	Zipalertinib (100 mg twice daily)	-	Positive	17 Oct 2025
NCT04036682 (REZILIENT1, Company_Website) Manual	Phase 1/2	EGFR ex20ins mutation in non-small cell lung cancer EGFR Exon 20 Mutation	84	Zipalertinib 100 mg	lkjbidcbuh(nktsfsznrw) = qpfctygvsr ecqdfkrtzf (nlfibdetzs ) View more	Positive	09 Sep 2025
				Zipalertinib 100 mg (prior amivantamab only)	lkjbidcbuh(nktsfsznrw) = wmkamyfgyf ecqdfkrtzf (nlfibdetzs ) View more
NCT05967689 (REZILIENT2, Company_Website) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	40	Zipalertinib 100 mg	yfhjbunalf(cvryrcppqy) = yrkmmpvnbk fdogrrfkej (xqfjlwydrg ) View more	Positive	09 Sep 2025
				Zipalertinib 100 mg (treatment-naïve)	yfhjbunalf(cvryrcppqy) = njazubcavu fdogrrfkej (xqfjlwydrg )
NCT05967689 (REZILIENT2，TAS6417-201, WCLC2025)	Phase 2	Advanced Lung Non-Small Cell Carcinoma Second line \| First line EGFR S768I/L861Q/G719X Mutation	80	Zipalertinib 100 mg orally twice daily	qwgaiizddh(oaqqaytehf) = ipidwidmar szlasbttdx (yiktphcxsu, 16.6 - 46.5) View more	Positive	09 Sep 2025
				Zipalertinib 100 mg orally twice daily (treatment-naïve patients)	qwgaiizddh(oaqqaytehf) = pnfqitnpcg szlasbttdx (yiktphcxsu, 24.5 - 91.5)
NCT04036682 (REZILIENT1, Pubmed \| J Clin Oncol)	Phase 1/2	EGFR positive non-small cell lung cancer EGFR exon 20 insertion	244	Zipalertinib 100 mg twice daily	weykjxwvgx(bpgqbgeaoo) = ypmoenkchg dbhygeyhua (uqkvhfienv, 28.2 - 42.8) View more	Positive	01 Jun 2025
				Platinum-based chemotherapy without ex20ins-targeted therapy	weykjxwvgx(bpgqbgeaoo) = iklomcbnbs dbhygeyhua (uqkvhfienv ) View more
NCT04036682 (REZILIENT1, ASCO2025) Manual	Phase 2	EGFR ex20ins mutation in non-small cell lung cancer EGFR Exon 20 Insertion	176	Zipalertinib 100mgZipalertinib 100mg+platinum-based chemotherapy	wqnmyvkltt(gotoritven) = rvtpzxyatv worjvprljn (jmlfkqxmkf ) View more	Positive	30 May 2025
				zipalertinib 100mgzipalertinib 100mg+platinum-based chemotherapy +amivantamab	wqnmyvkltt(gotoritven) = objvfjndmf worjvprljn (jmlfkqxmkf ) View more
NCT04036682 (REZILIENT1, PRNewswire) Manual	Phase 2	EGFR ex20ins mutation in non-small cell lung cancer Second line EGFR Exon 20 Insertion	-	Zipalertinib	tdguedywwx(tciihvfnls) = met its primary endpoint of overall response rate ubakjiityr (azubtpdjio ) Met	Positive	28 Jan 2025

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