Sanofi Terminates Phase 3 ADC Project Tusamitamab Ravtansine!
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Sanofi Terminates Phase 3 ADC Project Tusamitamab Ravtansine!
On December 21, Sanofi announced the cessation of the global clinical development plan for tusamitamab ravtansine.
Tusamitamab ravtansine, an antibody-drug conjugate (ADC) targeting carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5), was introduced by Sanofi in collaboration with Immunogen in 2014. It is currently the fastest progressing drug against this target.
CEACAM5, a member of the CEACAM family composed of 12 glycoproteins, is involved in driving cell adhesion and migration, inhibiting apoptosis, and may be overexpressed in various cancer types.
Sanofi’s decision was based on the pre-specified interim analysis results of the Phase 3 CARMEN-LC03 trial, which assessed the efficacy of tusamitamab ravtansine as monotherapy compared to docetaxel in previously treated patients with high CEACAM5-expressing metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC). Sanofi announced the termination of the evaluation of the tusamitamab ravtansine project after the Phase 3 trial in second-line NSCLC did not meet its primary endpoint.
The dual primary endpoints of the CARMEN-LC03 trial were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included objective response rate, health-related quality of life, safety, and duration of response.
The Independent Data Monitoring Committee (IDMC) found that tusamitamab ravtansine as a monotherapy did not meet the PFS primary endpoint compared to docetaxel. Although there was an improvement in the trend of OS, the final analysis showed that the termination of the project was based on the lack of improvement in PFS. Tusamitamab ravtansine demonstrated a safety profile similar to previous trials and a lower incidence of various clinically relevant adverse events compared to docetaxel. Participants in the trial who benefited from it could choose to continue with the current treatment or transition to appropriate standard care.
Sanofi’s announcement stated, “We will continue to explore the potential of ADCs and CEACAM5 research based on tusamitamab antibodies in several cancers.”
Tusamitamab ravtansine is the “ADC lone warrior” in Sanofi’s research pipeline, and this failure is undoubtedly a significant setback for the company.
Although Sanofi reached a collaboration agreement with Seagen in March 2022 to jointly develop three anti-cancer ADCs, it is still in the early stages. Moreover, the impact of Pfizer’s acquisition of Seagen on its collaboration with Sanofi remains unknown.
In the fiercely competitive ADC field, Sanofi’s presence is challenging to find in the short term!
Reference: Sanofi Press Release
Sanofi Terminates Phase 3 ADC Project Tusamitamab Ravtansine!
(source:internet, reference only)
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