Tusamitamab ravtansine

Pictured: Sanofi's Germany office at night/iStock, Panama7 Sanofi is putting the kibosh on developing its antibody-drug conjugate tusamitamab ravtansine after an analysis of a Phase III readout showed it did not meet a primary endpoint in non-small cell lung cancer, according to the company’s announcement on Thursday. The Phase III CARMEN-LC03 trial evaluated the antibody-drug conjugate (ADC) in a monotherapy setting against the chemotherapy docetaxel in non-small cell lung cancer (NSCLC) patients with tumors that had high levels of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). An independent data monitoring committee analysis found that the ADC did not reach its dual primary endpoint of progression-free survival (PFS). Despite an “improved” overall survival trend, Sanofi said it is terminating the program due to the “non-improvement” in PFS. The trial participants can stay on the therapy if benefit is seen or switch to another treatment, according to the company. However, Sanofi is not giving up on the drug as it plans to continue to “explore” the potential of tusamitamab-based ADCs and CEACAM5 research in other cancers. “Although the results are not what we hoped for, our research and work to advance potentially transformative therapies in areas of high unmet need for people living with cancer will not stop. We will continue to explore the potential of CEACAM5 as a biomarker in cancer types where it is highly expressed,” Sanofi CMO Dietmar Berger said in a statement. The ADC was looking encouraging, according to a document from ASCO related to the ADC’s safety which found the adverse effects of tusamitamab ravtansine were “nonserious and reversible.” Sanofi licensed the rights to the ADC outside of China from Innovent in 2017 and expanded the agreement in 2022 to nab the rights in China and grab another one of Innovent’s assets, according to Pharmaphorum. Sanofi has been playing in the ADC space for a number of years, as it has been inking collaboration deals since at least 2015. Last year, the French pharma secured an exclusive agreement with Seagen to develop and commercialize ADCs for cancer treatments. The deal had Sanofi and Seagen co-funding the development activities for up to three cancer targets, with the companies splitting the profit. Sanofi also paid Seagen an unknown amount for the three targets. Sanofi’s decision to discontinue the global clinical development program for tusamitamab ravtansine comes amid some high-pro in the ADC space by prominent pharma players including Pfizer, BMS, AbbVie and AstraZeneca. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Sanofi announces end of program evaluating tusamitamab ravtansine after a 2L NSCLC Phase 3 trial did not meet a primary endpoint CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival; tusamitamab ravtansine clinical development program will be discontinued Sanofi reinforces commitment to broader oncology development program including CEACAM5-directed antibody drug conjugates (ADC) with additional anticipated trials PARIS, December 21, 2023. Sanofi is discontinuing the global clinical development program of tusamitamab ravtansine. The decision is based on the outcome of a prespecified interim analysis of the Phase 3 CARMEN-LC03 trial evaluating tusamitamab ravtansine as monotherapy compared to docetaxel in previously treated patients with metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) whose tumors express high levels of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5). An Independent Data Monitoring Committee (IDMC) found that tusamitamab ravtansine as a monotherapy did not meet its dual primary endpoint of progression-free survival (PFS) compared to docetaxel. Despite an improved overall survival (OS) trend, termination of the program was based on non-improvement in PFS at the final analysis. Tusamitamab ravtansine had a similar safety pro previously presented with a lower incidence of various important clinical categories of adverse events versus docetaxel. Trial participants will have the option to stay on their current therapy if they are benefitting, as deemed by their provider, or to transition to an appropriate standard-of-care therapy. Sanofi will continue exploring the potential of antibody tusamitamab-based ADCs and CEACAM5 research in several types of cancer. Dietmar Berger Chief Medical Officer and Head of Development “Our team is grateful to the patients, families and healthcare professionals involved in the tusamitamab ravtansine development program. Although the results are not what we hoped for, our research and work to advance potentially transformative therapies in areas of high unmet need for people living with cancer will not stop. We will continue to explore the potential of CEACAM5 as a biomarker in cancer types where it is highly expressed.” CEACAM5 is a member of the CEACAM family of 12 glycoproteins and may drive cell adhesion and migration, as well as inhibit apoptosis, and may be overexpressed in many different cancer types. About the CARMEN-LC03 Trial CARMEN-LC03 was a randomized, open-label Phase 3 study evaluating tusamitamab ravtansine as monotherapy compared to docetaxel in patients with metastatic NSq NSCLC and high CEACAM5 expression. The dual primary endpoints of CARMEN-LC03 were progression-free survival and overall survival. Secondary endpoints included objective response rate, health-related quality of life, safety and duration of response. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media Relations Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Victor Rouault | + 33 6 70 93 71 40 | victor.rouault@sanofi.com Investor Relations Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delépine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. 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