May 20 Clinical Quick Takes: Keytruda misses in TNBC; plus Medicines Co., Acadia, Takeda, Ocular
Keytruda fails in previously treated TNBC
Monotherapy with PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) missed the primary endpoint of improving overall survival vs. physician’s choice of single agent chemotherapy in the Phase III KEYNOTE-119 trial as second- or third-line treatment of metastatic triple-negative breast cancer.
Inclisiran shows sustained LDL-C lowering
Ahead of Phase III readouts expected in 3Q19 for inclisiran, The Medicines Co. (NASDAQ:MDCO) reported interim data from the open-label Phase II ORION-3 extension showing that twice per year dosing of the siRNA against PCSK9 lowered LDL-C by 51% (64 mg/dL, p<0.001) through day 210. Inclisiran, to which Medicines Co. has rights from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY), was well tolerated with no elevations in liver enzymes or changes in renal function considered related to treatment reported through three years of follow-up. Regulatory submissions are expected in the U.S. in 4Q19 and in Europe in 1Q20...