SpringWorks has a new collaboration, and it’s one with a prominent pharma partner.
The Connecticut biotech is teaming up with Seagen on a new clinical trial to evaluate the company’s gamma secretase inhibitor nirogacestat with SEA-BCMA. Seagen’s candidate is a monoclonal antibody targeting BCMA, and the combo will look at patients with relapsed or refractory multiple myeloma.
The duo noted in a release that “gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells,” likely proving the impetus for the deal. Under the deal, Seagen will sponsor and conduct the Phase I study expected to begin before the end of 2021.
No financial terms were disclosed, though Seagen will be managing all costs related to the trial.
Merck and Eisai build out Keytruda/Lenvima data
Merck and Eisai revealed new Phase III data for their Keytruda and Lenvima combination in first-line advanced renal cell carcinoma, currently before the FDA for review.
In an analysis of a secondary endpoint from patient-reported quality of life surveys, the combo demonstrated similar changes from baseline in 14 out of 18 evaluable symptoms and better scores in the rest after an average follow-up of 46 weeks, compared to the sunitinib control. The areas where the combo showed improvement were fatigue, labored breathing, physical functioning and constipation.
“This analysis addresses questions of interest to healthcare professionals who treat patients with advanced renal cell carcinoma,” Takashi Owa, chief medicine creation officer at Eisai’s oncology division, said in a statement.
Regulators granted the combo a priority review last month. The PDUFA dates are slated for August 25 and 26 for the advanced RCC sNDA and sBLA applications, respectively, and September 3 for advanced endometrial carcinoma.