June 12 Quick Takes: AZ’s first-in-class AKT inhibitor under review

After receiving priority review from FDA, AstraZeneca plc (LSE:AZN; NYSE:AZN) is looking ahead to a fourth quarter PDUFA date for Akt inhibitor capivasertib plus selective-estrogen receptor degrader (SERD) fulvestrant to treat HR-positive, HER2-negative breast cancers after endocrine therapy. The combination builds on the efficacy of fulvestrant, a first-generation SERD, as a crop of next-generation SERDs moves toward the market. The submission is based on data from the Phase III CAPItello-291 study, where the combination led to 7.2 months of progression-free survival vs. 3.6 months with fulvestrant alone. The NDA is being reviewed under Project Orbis, which enables concurrent review of cancer products among international partners. AstraZeneca also has a next-generation SERD, camizestrant, in Phase III testing.

In a pair of moves in Massachusetts, China-based Simcere Pharmaceutical Group Ltd. (HKEX:2096) has entered into a sponsored research agreement with Mass General Brigham, a health system that includes the Massachusetts General and Brigham and Women’s Hospitals, and established the Simcere Zaiming Inc. subsidiary in the state. In the Mass General Brigham agreement, Simcere will fund up to eight research groups for two years to work in cancer, autoimmune and CNS diseases, in exchange for access to the institution’s research and clinical capabilities that it believes will help accelerate its global R&D efforts. Simcere did not disclose the amount it intends to invest, but noted Brigham would also contribute resources for research and clinical trials. The Simcere Zaiming subsidiary will focus on R&D, production and commercialization of the company’s cancer therapies...