Paris-based Sanofi and Tarrytown, New York-based Regeneron Pharmaceuticals announced topline data for the companies’ pivotal Phase II trial of the PD-1 checkpoint inhibitor Libtayo (cemiplimab) in advanced basal cell carcinoma patients that had progressed on or could not tolerate previous hedgehog pathway inhibitor therapies.
Merck’s vaunted checkpoint inhibitor Keytruda picked up another regulatory approval. The U.S. Food and Drug Administration approved an additional recommended dosage of 400 mg every six weeks for the anti-PD-1 therapy across all adult indications, including as a monotherapy and in combination treatments.
Merck & Co. reported that the checkpoint inhibitor Keytruda had mixed results as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda as monotherapy for the first-line treatment of patients with stage III non-small cell lung cancer who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
Bristol-Myers Squibb Company announced results from pooled analyses of survival data from four studies (CheckMate -017, -057, -063 and -003; n=664) in patients with previously treated advanced non-small cell lung cancer (NSCLC) who were treated with Opdivo (nivolumab).
Merck & Co. announced presentation of the full results from the pivotal Phase 3 KEYNOTE-426 trial investigating the company’s anti-PD-1 therapy Keytruda in combination with Inlyta, a tyrosine kinase inhibitor, for the first-line treatment of advanced renal cell carcinoma (RCC) at the 2019 Genitourinary Cancers Symposium.
Bristol-Myers Squibb Company announced new results from the Phase 3 CheckMate -214 study, showing that therapy with Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC).
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The European Commission approved Merck’s anti-PD-1 therapy Keytruda for treating adult patients with relapsed or refractory classical Hodgkin lymphoma.
Bristol-Myers Squibb and Ono Pharmaceutical announced a global patent license agreement with Merck & Co. to settle all patent-infringement litigation related to Merck’s PD-1 antibody Keytruda.
