Sanofi SA (NASDAQ:SNY) is discontinuing the global clinical development program of tusamitamab ravtansine.
The decision is based on the outcome of a prespecified interim analysis of Phase 3 CARMEN-LC03 trial evaluating tusamitamab ravtansine as monotherapy compared to docetaxel in previously treated patients with metastatic non-squamous non-small cell lung cancer whose tumors express high levels of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5).
An Independent Data Monitoring Committee found that tusamitamab ravtansine as monotherapy did not meet its dual primary endpoint of progression-free survival (PFS) compared to docetaxel.
Despite an improved overall survival 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.
Trial participants can 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 antibody-drug conjugates (ADCs) and CEACAM5 research in several types of cancer.
Last week, Sanofi SA said to terminate the licensing agreement for Maze Therapeutics Inc.’s treatment for a rare genetic disorder after the Federal Trade Commission sued to block the deal.
Also, Sanofi, DNDi, and the HAT-r-ACC consortium announce that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive scientific opinion of Fexinidazole Winthrop as the first oral treatment of an acute form of sleeping sickness (rhodesiense).
Price Action: SNY shares are up 1.1% at $48.74 premarket on the last check Thursday.
