Full Press Release Details
Sanofi announces end of program evaluating tusamitamab ravtansine after a 2L NSCLC
Phase 3 trial did not meet a primary endpoint
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 profile as 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.
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
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Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com
Victor Rouault | + 33 6 70 93 71 40 |
Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com
Arnaud Del pine | + 33 06 73 69 36 93 |
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 |
+ 33 07 85 93 30 17 | nathalie.pham@sanofi.com
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