Sanofi has announced plans for the discontinuation of the tusamitamab ravtansine clinical development programme after a Phase III clinical trial failure.
The development is based on the data from an interim analysis of the Phase III CARMEN-LC03 clinical trial of tusamitamab ravtansine monotherapy in priorly treated metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) patients.
Following the analysis, an Independent Data Monitoring Committee (IDMC) of the randomised, open-label trial concluded that tusamitamab ravtansine failed to meet the primary endpoint of progression-free survival versus docetaxel.
Patients in the trial had tumours expressing greater carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5).
Progression-free survival and overall survival were the dual primary endpoints of the trial while objective response rate, health-related quality of life, safety, and duration of response were the secondary endpoints.
Even though the treatment showed a trend towards enhanced overall survival, the company decided to discontinue the clinical programme due to a lack of improvement in progression-free survival at the final assessment.
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Tusamitamab ravtansine’s safety profile in the trial was in line with prior data, indicating a reduced occurrence of clinical adverse events versus docetaxel.
Sanofi Development chief medical officer and head Dietmar Berger said: “Our team is grateful to the patients, families and healthcare professionals involved in the tusamitamab ravtansine development programme.
“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.”
The latest development comes after the company reported that the Phase III IMROZ clinical trial of its monoclonal antibody Sarclisa (isatuximab) plus standard-of-care for multiple myeloma (MM) met the primary endpoint.
Planned interim efficacy analysis showed that the Sarclisa regimen offered statistically significant progression-free survival improvement versus VRd alone, thereby meeting the primary endpoint.