“Merck and Moderna plan to initiate a Phase 3 study in adjuvant melanoma this year, and rapidly expand to additional tumor types, including non-small cell lung cancer.”

In context

“ration with Moderna, we announced detailed results from KEYNOTE-942, a Phase 2b study evaluating KEYTRUDA in combination with V940 also known as mRNA-4157, an individualized neoantigen therapy, for the adjuvant treatment of stage III and IV melanoma in patients with high risk of disease recurrence following complete resection. These results are the first to demonstrate improvement of recurrence-free survival over adjuvant standard of care PD-1 blockade in resected high-risk melanoma, and provide the first randomized evidence that an individualized neoantigen therapy has potential benefit. The FDA has granted this combination Breakthrough Therapy Designation and the European Medicines Agency has awarded PRIME designation for high-risk stage III and IV melanoma following complete resection. Merck and Moderna plan to initiate a Phase 3 study in adjuvant melanoma this year, and rapidly expand to additional tumor types, including non-small cell lung cancer. Together with Astellas and Seagen, we announced the FDA’s accelerated approval of KEYTRUDA in combination with enfortumab vedotin, an 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 positione”