Latest news with #EGFR
Associated Press
4 hours ago
- Business
- Associated Press
J INTS BIO to Present Global Clinical Results from JIN-A02, a Fourth-Generation EGFR-TKI, at ASCO 2025
Significant anti-tumor responses and reduction of brain metastases observed SEOUL, South Korea , June 1, 2025 /PRNewswire/ -- J INTS BIO, a company specializing in the development of therapeutics for cancer and rare diseases, officially announced interim results from the global Phase 1/2 clinical trial of JIN-A02, its fourth-generation EGFR-TKI drug candidate, at the American Society of Clinical Oncology 2025 (ASCO 2025), the world's largest oncology conference, held in Chicago, USA. JIN-A02 is an oral, fourth-generation EGFR-TKI designed to overcome resistance mutations (such as C797S) that develop after treatment failure with third-generation EGFR-TKIs, which are currently the first-line therapy for EGFR-mutant Non-small cell lung cancer (NSCLC). It is currently undergoing clinical trials in South Korea, the United States, Thailand, and other countries. Key efficacy and safety results from Part A (dose escalation) of the multi-center clinical trial (NCT05394831) were presented. 'Confirmed' clinical response observed in patients with disease progression after 3rd Generation EGFR TKI and chemotherapy One of the key findings of the ASCO presentation was that tumor responses were sustained in specific dose cohorts, with confirmed partial responses (PRs) verified by independent evaluation. Confirmed PRs were observed in 50mg,100mg and 300mg QD dose groups, providing clinical evidence of anti-tumor activity. In the 50 mg dose group, patients achieved a 77.3% reduction in tumor size, maintaining a PR over six consecutive treatment cycles (from cycle 3 to cycle 13). In the 300 mg dose group, a confirmed PR was observed with a 39.7% tumor size reduction, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable, further supporting the potential of JIN-A02 in treating brain metastases. Safety confirmed up to 300 mg, with therapeutic signals in brain metastases No dose-limiting toxicities (DLTs) or serious adverse events were observed with JIN-A02 at doses up to 300mg, which is six times the dose level when PR was first observed, demonstrating a favorable safety profile even at higher dose levels. The majority of adverse events reported at 300mg were mild (Grade 1-2) and included for the first time, Grade 1 skin rash, diarrhea, and skin desquamation in 3 out of 5 subjects – events commonly associated with EGFR inhibitors and generally considered clinically manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity, supporting the drug's excellent safety profile. This safety and tolerability have translated into extended treatment durations in real-world settings, with a patient still on JIN-A02 after one year and seven months. In addition, the trial demonstrated notable responses in brain metastases first noted at 100mg, suggesting that JIN-A02 achieves therapeutically relevant concentrations in brain tissue. JIN-A02 gains national spotlight as government grants accelerate development In addition to the ASCO announcement, J INTS BIO continues to achieve noteworthy results in Korea. Recently, it was selected for the '2025 Baby Unicorn Fostering Project' by the Ministry of SMEs and Startups, officially recognizing both our scientific technology and commercialization potential. The 'Baby Unicorn Fostering Project' is a government project that focuses on developing promising startups with innovative technologies and growth potential in the global market as 'potential unicorns'. Companies selected for this project will receive full government support in recognition of their technological prowess and growth potential. With these accolades, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years, which is expected to be a decisive point to significantly accelerate the pace of clinical and commercialization in parallel with private investment. It is also significant as a case of securing confidence in the 3 arena of technology, marketability, and global scalability, as the recognition came from different government departments. Based on these achievements, we plan to initiate the Phase 2 clinical trial of JIN-A02 in before the end of this year, in discussions with the US FDA. 'The ASCO presentation of JIN-A02's ability to induce anti-cancer responses and its ability to respond to central nervous system metastatic lesions is of great significance,' said Dr. Anna Jo, CEO. 'The government's continued support is a recognition of our technical capabilities and potential for growth. We will take advantage of this opportunity to accelerate global clinical expansion, technology transfer, and indication expansion to realize our goal of early commercialization' View original content to download multimedia: SOURCE J INTS BIO
Yahoo
4 hours ago
- Business
- Yahoo
J INTS BIO to Present Global Clinical Results from JIN-A02, a Fourth-Generation EGFR-TKI, at ASCO 2025
Significant anti-tumor responses and reduction of brain metastases observed SEOUL, South Korea , June 1, 2025 /PRNewswire/ -- J INTS BIO, a company specializing in the development of therapeutics for cancer and rare diseases, officially announced interim results from the global Phase 1/2 clinical trial of JIN-A02, its fourth-generation EGFR-TKI drug candidate, at the American Society of Clinical Oncology 2025 (ASCO 2025), the world's largest oncology conference, held in Chicago, USA. JIN-A02 is an oral, fourth-generation EGFR-TKI designed to overcome resistance mutations (such as C797S) that develop after treatment failure with third-generation EGFR-TKIs, which are currently the first-line therapy for EGFR-mutant Non-small cell lung cancer (NSCLC). It is currently undergoing clinical trials in South Korea, the United States, Thailand, and other countries. Key efficacy and safety results from Part A (dose escalation) of the multi-center clinical trial (NCT05394831) were presented. 'Confirmed' clinical response observed in patients with disease progression after 3rd Generation EGFR TKI and chemotherapy One of the key findings of the ASCO presentation was that tumor responses were sustained in specific dose cohorts, with confirmed partial responses (PRs) verified by independent evaluation. Confirmed PRs were observed in 50mg,100mg and 300mg QD dose groups, providing clinical evidence of anti-tumor activity. In the 50 mg dose group, patients achieved a 77.3% reduction in tumor size, maintaining a PR over six consecutive treatment cycles (from cycle 3 to cycle 13). In the 300 mg dose group, a confirmed PR was observed with a 39.7% tumor size reduction, including a significant reduction in brain metastatic lesions. In the 100 mg dose group, a PR was also reported with a 35.3% reduction in tumor size, and brain metastatic lesions remained stable, further supporting the potential of JIN-A02 in treating brain metastases. Safety confirmed up to 300 mg, with therapeutic signals in brain metastases No dose-limiting toxicities (DLTs) or serious adverse events were observed with JIN-A02 at doses up to 300mg, which is six times the dose level when PR was first observed, demonstrating a favorable safety profile even at higher dose levels. The majority of adverse events reported at 300mg were mild (Grade 1-2) and included for the first time, Grade 1 skin rash, diarrhea, and skin desquamation in 3 out of 5 subjects – events commonly associated with EGFR inhibitors and generally considered clinically manageable. Importantly, there were no reports of systemic toxicities such as cardiovascular events or hepatotoxicity, supporting the drug's excellent safety profile. This safety and tolerability have translated into extended treatment durations in real-world settings, with a patient still on JIN-A02 after one year and seven months. In addition, the trial demonstrated notable responses in brain metastases first noted at 100mg, suggesting that JIN-A02 achieves therapeutically relevant concentrations in brain tissue. JIN-A02 gains national spotlight as government grants accelerate development In addition to the ASCO announcement, J INTS BIO continues to achieve noteworthy results in Korea. Recently, it was selected for the '2025 Baby Unicorn Fostering Project' by the Ministry of SMEs and Startups, officially recognizing both our scientific technology and commercialization potential. The 'Baby Unicorn Fostering Project' is a government project that focuses on developing promising startups with innovative technologies and growth potential in the global market as 'potential unicorns'. Companies selected for this project will receive full government support in recognition of their technological prowess and growth potential. With these accolades, JIN-A02 will receive dual funding for its Phase 2 trial and global expansion over the next two years, which is expected to be a decisive point to significantly accelerate the pace of clinical and commercialization in parallel with private investment. It is also significant as a case of securing confidence in the 3 arena of technology, marketability, and global scalability, as the recognition came from different government departments. Based on these achievements, we plan to initiate the Phase 2 clinical trial of JIN-A02 in before the end of this year, in discussions with the US FDA. "The ASCO presentation of JIN-A02's ability to induce anti-cancer responses and its ability to respond to central nervous system metastatic lesions is of great significance," said Dr. Anna Jo, CEO. "The government's continued support is a recognition of our technical capabilities and potential for growth. We will take advantage of this opportunity to accelerate global clinical expansion, technology transfer, and indication expansion to realize our goal of early commercialization" View original content to download multimedia: SOURCE J INTS BIO Sign in to access your portfolio
Yahoo
6 hours ago
- Business
- Yahoo
HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting
— The all-oral chemotherapy-free combination of savolitinib plus osimertinib demonstrated significant PFS benefit with a favorable safety profile in the SACHI Phase III China study — — Webcast to be held at 8:30 am HKT on Tuesday, June 3 to discuss the data presented — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., June 02, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited ('HUTCHMED') (Nasdaq/AIM:HCM; HKEX:13) announces primary results from the interim analysis of the SACHI Phase III study. These results were presented in a late-breaking oral presentation on Sunday, June 1, 2025, during the American Society of Clinical Oncology ('ASCO') Annual Meeting in Chicago, USA. SACHI is a Phase III study of the savolitinib and osimertinib combination for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor ('EGFR') mutation-positive non-small cell lung cancer ('NSCLC') with MET amplification after disease progression on first-line EGFR inhibitor therapy ( identifier NCT05015608). Title: Savolitinib combined with osimertinib versus chemotherapy in EGFR-mutant and MET-amplification advanced NSCLC after disease progression on EGFR tyrosine kinase inhibitor: Results from a randomized Phase III SACHI study Lead Author: Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China Session: Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic Abstract Number: LBA8505 Date & Time: Sunday, June 1, 2025, 8:00 AM Central Daylight Time Location: Arie Crown Theater Prof. Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest Hospital, School of Medicine, Shanghai Jiaotong University, and Principal Investigator of the SACHI study, said, 'The results from the SACHI Phase III study represent a significant advancement in the treatment of EGFR mutation-positive NSCLC with MET amplification. The savolitinib and osimertinib combination demonstrates promising efficacy in patients who have progressed on prior EGFR inhibitor therapy. These findings highlight the potential of this novel, chemotherapy-free combination to enable a continued oral regimen, offering a convenient and well-tolerated treatment option that addresses critical unmet needs for patients with this challenging disease.' The event will be held in English and can be accessed via A replay will also be available on the website shortly after the event. As of the interim analysis data cut-off of August 30, 2024, a total of 211 patients were randomized to receive the savolitinib and osimertinib combination or chemotherapy. In the intention to treat (ITT) population, the median progression-free survival ('PFS') assessed by investigator was 8.2 months with savolitinib plus osimertinib, compared to 4.5 months with chemotherapy (hazard ratio ['HR'] 0.34; 95% confidence interval ['CI'] 0.23-0.49; p < 0.0001). The independent review committee ('IRC') assessed median PFS was 7.2 months vs 4.2 months, respectively (HR 0.40; 95% CI 0.28-0.59; p < 0.0001). The investigator-assessed objective response rate (ORR) was 58% in the savolitinib plus osimertinib group compared to 34% for patients in the chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the median duration of response (DoR) was 8.4 months vs 3.2 months, respectively. Overall survival was not mature at the time of the interim analysis. Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor ('TKI')–treated patients were comparable with those in the intention-to-treat and third-generation EGFR-TKI–naïve populations. In the third generation EGFR-TKI–treated subgroup, the investigator-assessed and IRC-assessed median PFS were highly consistent, both at 6.9 vs 3.0 months (HR 0.32; p < 0.0001). The safety profile of the savolitinib and osimertinib combination was tolerable and no new safety signals were observed. Treatment-emergent adverse events of Grade 3 or above occurred in 57% of patients in the savolitinib plus osimertinib group compared to 57% for patients in the chemotherapy group, suggesting a favorable safety profile. In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Supported by data from SACHI, a New Drug Application (NDA) for the combination of savolitinib and osimertinib for the treatment of patients with locally advanced or metastatic EGFR mutation-positive NSCLC with MET amplification after disease progression on first-line EGFR inhibitor therapy has been accepted and granted priority review by the China National Medical Products Administration (NMPA). About Savolitinib Savolitinib is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. MET is a tyrosine kinase receptor that has an essential role in normal cell development. Savolitinib blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is a known mechanism of acquired resistance to EGFR TKIs. The prevalence of MET depends on the sample type, detection method and assay cut-off used. Savolitinib is approved in China and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca, for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. It has been included in the National Reimbursement Drug List of China (NRDL) since March 2023. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers as a single treatment and in combination with other medicines. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED's current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of savolitinib, the further clinical development for savolitinib, its expectations as to whether any studies on savolitinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study's inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of savolitinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of savolitinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products such as osimertinib as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED's filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@ Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@ Ben Atwell / Alex Shaw +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@ Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Freddy Crossley / Rupert Dearden +44 20 7886 2500 HSBC Joint Broker Simon Alexander / Alina Vaskina / Arnav Kapoor +44 20 7991 8888 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500
Associated Press
18 hours ago
- Business
- Associated Press
Taiho Oncology and Cullinan Therapeutics Announce Pivotal REZILIENT1 Phase 1/2 Data Published in the Journal of Clinical Oncology
PRINCETON, N.J. and CAMBRIDGE, Mass., June 1, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO). REZILIENT1 is a Phase 1/2, global, multicenter study of zipalertinib (development code: CLN-081/TAS6417) in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who have received prior therapy. Results from the REZILIENT1 trial will be presented in a simultaneous oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8503). The full publication, titled Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab, can be found here. Highlights of the REZILIENT1 Phase 1/2 trial in the authors' conclusions include: 'Despite recent treatment advances for patients with EGFR ex20ins-mutant NSCLC, there is a lack of oral targeted therapies for patients whose tumors harbor these mutations,' said principal investigator Zofia Piotrowska, MD, Assistant Professor, Medicine, Harvard Medical School and a clinical researcher and lung cancer medical oncologist at the Massachusetts General Hospital Cancer Center. 'Findings from the Phase 1/2 REZILIENT1 trial support our understanding of zipalertinib as a potential targeted therapy option for patients living with previously treated recurrent or metastatic NSCLC harboring EGFR ex20ins mutations.' Taiho Oncology is actively recruiting patients in the Phase 3 REZILIENT3 trial ( NCT05973773 ). About REZILIENT1 REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial ( NCT04036682 ) to evaluate efficacy and safety of zipalertinib in adult patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The primary endpoints were ORR and DOR as assessed by blinded independent central review (ICR) per RECIST v1.1. Adverse events were characterized and graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0). 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, while sparing wild-type EGFR. 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 has received Breakthrough Therapy Designation from the FDA. 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 have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,3 with insertions at exon 20 accounting for up to 12% of these mutations.2 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. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at and follow us 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 our plans regarding future data presentations, the clinical development and regulatory filing plan and timeline of zipalertinib, the safety and efficacy profile of zipalertinib and its potential to address unmet medical need, 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 regulatory submissions; the risk that any NDA or other regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not 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 studies will not be predictive of future results in connection with future studies; 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 1. 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: 2. 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: 3. 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: Contacts Taiho Oncology Leigh Labrie + 609.664.9878 [email protected] Cullinan Therapeutics Investors Nick Smith +1 401.241.3516 [email protected] Media Jessica Weinstein +1 508.254.3881 [email protected] View original content to download multimedia: SOURCE Taiho Oncology
Yahoo
18 hours ago
- Business
- Yahoo
Taiho Oncology and Cullinan Therapeutics Announce Pivotal REZILIENT1 Phase 1/2 Data Published in the Journal of Clinical Oncology
PRINCETON, N.J. and CAMBRIDGE, Mass., June 1, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO). REZILIENT1 is a Phase 1/2, global, multicenter study of zipalertinib (development code: CLN-081/TAS6417) in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who have received prior therapy. Results from the REZILIENT1 trial will be presented in a simultaneous oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #8503). The full publication, titled Zipalertinib in Patients With Epidermal Growth Factor Receptor Exon 20 Insertion-Positive Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy With or Without Amivantamab, can be found here. Highlights of the REZILIENT1 Phase 1/2 trial in the authors' conclusions include: Zipalertinib demonstrated clinically meaningful efficacy in the primary efficacy population (n=176), including 51 patients who had received prior amivantamab. The confirmed objective response rate (ORR) was 35.2% overall, and median duration of response (mDOR) and progression-free survival were 8.8 months and 9.4 months, respectively. In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with mDOR of 8.8 months. The safety profile of zipalertinib was manageable and consistent with previously reported data.¹ In exploratory subgroup analyses: Patients who had received prior amivantamab without other ex20ins-targeted therapy showed a confirmed ORR of 30% and mDOR of 14.7 months. Patients with brain metastases showed a confirmed ORR of 30.9% and a mDOR of 8.3 months. "Despite recent treatment advances for patients with EGFR ex20ins-mutant NSCLC, there is a lack of oral targeted therapies for patients whose tumors harbor these mutations," said principal investigator Zofia Piotrowska, MD, Assistant Professor, Medicine, Harvard Medical School and a clinical researcher and lung cancer medical oncologist at the Massachusetts General Hospital Cancer Center. "Findings from the Phase 1/2 REZILIENT1 trial support our understanding of zipalertinib as a potential targeted therapy option for patients living with previously treated recurrent or metastatic NSCLC harboring EGFR ex20ins mutations." Taiho Oncology is actively recruiting patients in the Phase 3 REZILIENT3 trial (NCT05973773). About REZILIENT1REZILIENT1 (Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in adult patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy. The primary endpoints were ORR and DOR as assessed by blinded independent central review (ICR) per RECIST v1.1. Adverse events were characterized and graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0). About ZipalertinibZipalertinib (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, while sparing wild-type EGFR. 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 has received Breakthrough Therapy Designation from the FDA. 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 MutationsNSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,3 with insertions at exon 20 accounting for up to 12% of these mutations.2 About Taiho Oncology, 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. About Cullinan TherapeuticsCullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at and follow us on LinkedIn and X. Forward Looking StatementsThis 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 our plans regarding future data presentations, the clinical development and regulatory filing plan and timeline of zipalertinib, the safety and efficacy profile of zipalertinib and its potential to address unmet medical need, 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 regulatory submissions; the risk that any NDA or other regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not 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 studies will not be predictive of future results in connection with future studies; 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. References1. 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: 2. 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: 3. 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: Contacts Taiho OncologyLeigh Labrie+ 609.664.9878llabrie@ Cullinan TherapeuticsInvestorsNick Smith+1 401.241.3516nsmith@ MediaJessica Weinstein+1 508.254.3881jweinstein@ View original content to download multimedia: SOURCE Taiho Oncology Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
