Feb. 3 Quick Takes: Sanofi terminates myasthenia gravis Btk program

Sanofi (Euronext:SAN; NASDAQ:SNY) said its rationale for terminating the Phase III URSA study of brain-penetrant Btk inhibitor tolebrutinib pertained to “careful evaluation of the emerging competitive treatment landscape” for myasthenia gravis. The pharma, which revealed the trial stoppage with its earnings report Friday, had paused enrollment in the study last year after FDA placed a partial clinical hold related to cases of liver injury. Sanofi obtained tolebrutinib via its 2020 acquisition of Principia Biopharma Inc. for $3.4 billion; it is continuing to develop the molecule for multiple sclerosis.

Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) is positioning to again expand its reach into earlier lines of treatment after meeting the primary endpoint as first-line therapy for endometrial cancer in the Phase III NRG-GY018 trial. At an interim analysis, Keytruda plus chemotherapy followed by single agent Keytruda every six weeks led to an undisclosed clinically meaningful and statistically significant improvement in PFS vs. chemotherapy alone in endometrial carcinoma patients regardless of mismatch repair status. Keytruda is approved as second-line monotherapy in the mismatch repair deficient (dMMR) and microsatellite instability-high (MSI-H) endometrial cancer indications, and as second-line combination therapy with Lenvima lenvatinib in MMR proficient endometrial cancer. ...