Sanofi’s pipeline aspirations take a hit with ADC failure

21 Dec 2023
firstwordpharma.com
Phase 2License out/inADCPhase 3Phase 1
Sanofi is ending development of tusamitamab ravtansine after the antibody-drug conjugate (ADC) failed to meet the primary endpoint of a Phase III study for lung cancer. The news deals an early setback to R&D head Houman Ashrafian, who only took over the role in September, as well as the company’s ambitions in oncology.
The CARMEN-LC03 trial enrolled patients with metastatic non-squamous non-small-cell lung cancer whose tumours express high levels of CEACAM5, the target of tusamitamab ravtansine. Sanofi said Thursday that an independent data monitoring committee found that the study missed its dual primary endpoint of improving progression-free survival versus docetaxel.
The drugmaker added that although there was a trend for improved overall survival - the trial’s other dual primary goal - the study was terminated based on non-improvement in PFS at the final analysis. Chief medical officer Dietmar Berger remarked “although the results are not what we hoped for… We will continue to explore the potential of CEACAM5 as a biomarker in cancer types where it is highly expressed,” with the company adding that it will also continue work on antibody tusamitamab-based ADCs.
Tusamitamab ravtansine, also known as SAR408701, was developed through a partnership with ImmunoGen, although Sanofi was granted an exclusive license to the ADC in 2017. According to the French company’s pipeline, tusamitamab ravtansine was also being investigated in Phase II studies, both as a monotherapy and as part of combination regimens, in gastric cancer and earlier stages of lung cancer.
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