Sanofi Ends Lung Cancer ADC Development After Failed Phase III Trial.

(CTN News) – Sanofi has decided to discontinue the development of its antibody-drug conjugate tusamitamab maytansine after the results of a Phase III study showed that it did not meet its primary endpoint in non-small cell lung cancer.

The study, known as CARMEN-LC03, compared the ADC with the chemotherapy drug docetaxel in NSCLC patients with high levels of CEACAM5.

The analysis conducted by an independent data monitoring committee revealed that the ADC did not achieve its dual primary endpoint of progression-free survival. Despite showing an “improved” trend in overall survival, Sanofi has chosen to terminate the program due to the lack of improvement in PFS.

Participants in the trial will have the option to continue with the therapy if they are benefiting from it or switch to an alternative treatment.

However, Sanofi remains committed to exploring the potential of tusamitamab-based ADCs and CEACAM5 research in other types of cancer.

The company’s Chief Medical Officer, Dietmar Berger, emphasized that although the results were not as expected, Sanofi will continue its research efforts to advance transformative therapies for cancer patients with high unmet needs.

The safety profile of tusamitamab maytansine was found to be favorable, with adverse effects being described as “nonserious and reversible” in a document from ASCO.

Sanofi obtained the rights to the ADC from Innovent outside of China in 2017 and expanded the agreement in 2022 to include China and another asset from Innovent. Sanofi has been actively involved in the ADC field for several years, forging collaboration deals since at least 2015.

Sanofi and Seagen collaborated to jointly fund the development activities for a maximum of three cancer targets, and the profits were divided between the two companies. Additionally, Made an undisclosed payment to Seagen for the three targets.

Amidst significant deals in the ADC sector by renowned pharmaceutical companies like Pfizer, BMS, AbbVie, and AstraZeneca, Sanofi has decided to discontinue the global clinical development program for tusamitamab ravtansine.

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