“Planning is underway for an expansive global clinical development program and we look forward to initiating Phase 3 trials for MK-2870, our TROP-2 targeting ADC, as both monotherapy and in combination with KEYTRUDA.”

In context

“antibody drug conjugate, for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. This accelerated approval followed Priority Review and is based on data from the KEYNOTE-869 trial. This is an important advancement as this is the first U.S. approval of a regimen combining an anti-PD-1 therapy with an antibody-drug conjugate in these patients. The approval adds to the success of our foundational work evaluating KEYTRUDA in combination with chemotherapy and provides promising evidence for combining immunotherapy with tissue targeted anticancer agents. We are well positioned to build upon this work, with a portfolio of next generation antibody drug conjugates through our collaboration with Kelun Biotech. Planning is underway for an expansive global clinical development program and we look forward to initiating Phase 3 trials for MK-2870, our TROP-2 targeting ADC, as both monotherapy and in combination with KEYTRUDA. We also announced that the FDA has accepted our application for KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This filing is based on results from the Phase 3 KEYNOTE-859 trial, in which KEYTRUDA plus chemotherapy demonstrated a significant improvement in overall survival, reducing the risk of death by 22% compared to chemotherapy alone in these patients, regardless of PD-L1 expression. The agency has set a PDUFA action date of December 16th. This provides us the opportunity to expand upon our approval for patients with HER2 positive disease based on KEYNOTE-811. We recently announced positive data from the Phase 3 NRGGY018 trial investi”