Sanofi Discontinues Tusamitamab Ravtansine Development After Phase 3 Trial Failure
Sanofi has halted its tusamitamab ravtansine clinical development program after a Phase 3 trial in second-line non-small cell lung cancer (NSCLC) failed to meet its primary endpoint.
Sanofi announced on December 21, 2023, that it is discontinuing the global clinical development program for tusamitamab ravtansine. This decision follows the outcome of a pre-specified interim analysis of the Phase 3 CARMEN-LC03 trial, which evaluated the drug as a monotherapy for patients with previously treated metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors express high levels of CEACAM5.
The Independent Data Monitoring Committee (IDMC) determined that tusamitamab ravtansine did not meet its dual primary endpoint of improving progression-free survival (PFS) compared to the control arm, docetaxel. While an overall survival (OS) trend showed improvement, the program's termination was based on the lack of PFS benefit at the final analysis. The drug exhibited a safety profile consistent with prior presentations, with a lower incidence of certain adverse events compared to docetaxel.
Despite this setback, Sanofi stated it will continue to explore the potential of tusamitamab-based antibody-drug conjugates (ADCs) and CEACAM5 research across various cancer types. The company reaffirmed its commitment to its broader oncology development programs, with additional trials anticipated.
The CARMEN-LC03 trial was a randomized, open-label study designed to assess tusamitamab ravtansine against docetaxel in metastatic NSCLC patients with high CEACAM5 expression. Its dual primary endpoints were progression-free survival and overall survival.