Today’s Daily Dose brings you news about Amgen’s multiple myeloma trial results with XGEVA; Merck’s findings from Cohort 1 of phase 2 registrational trial of KEYTRUDA in gastric cancer patients; Prima BioMed’s phase II results of IMP321 in breast cancer; TG Therapeutics’ phase III study results of TG-1101 in patients with previously treated high risk Chronic Lymphocytic Leukemia and NewLink’s disappointment in phase II trial of Indoximod in breast cancer.
Amgen (AMGN) on Sunday announced that its drug XGEVA has proven to be non-inferior to Zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma in a phase III trial. XGEVA-treated patients also had a significantly lower rate of renal adverse events compared to Zometa in the study.
Amgen’s XGEVA is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumors, and for the treatment of giant cell tumor of the bone. XGEVA is currently not indicated for the prevention of skeletal-related events in patients with multiple myeloma.
Zoledronic acid is marketed by Novartis under the trade names Zometa, Zomera, Aclasta and Reclast. Novartis’ Zometa is indicated for the treatment of bone complications in patients with multiple myeloma.
Amgen is seeking to expand the currently approved XGEVA indication to include patients with multiple myeloma, and has made regulatory submissions in the U.S. and EU for the same.
XGEVA recorded sales of $1.53 billion in 2016, up 9% over the prior year. Novartis’ Zometa went off patent in 2013.
AMGN closed Friday’s trading at $159.15, up 1.86%.
Shares of Endocyte Inc. (ECYT) plunged over 30% on Friday, following its plans to trim its workforce by approximately 40 percent and end the clinical development of its drug candidate EC1456, under phase I development for ovarian cancer.
The Company noted that an assessment of the study did not yield the level of clinical activity necessary to…