European Drugmaker Sanofi Ends Tusamitamab Ravtansine Lung Cancer Program After Disappointing Data

Sanofi SA 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.