- Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) initiate a collaborative study to evaluate the safety and efficacy of the former's talimogene laherparepvec and the latter's Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma.
- The study will have two phases: Phase 1 will determine the safety and tolerability of talimogene laherparepvec in combination with Keytruda in patients with previously untreated, unresected stage IIIB to IVM1c melanoma. The second phase will be randomized to evaluate the safety and efficacy of the two drugs. Approximately 110 patients will be enrolled across 35 sites in the U.S., Europe and Australia.
- Pembrolizumab is a PD-1 inhibitor. Talimogene laherparepvec is designed to promote tumor antigen release to initiate an anti-tumor immune response which may be complimentary to pembrolizumab's role in releasing PD-1 pathway-mediated inhibition of anti-tumor immune responses.
- The FDA recently accepted for review Amgen's BLA for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma. The PDUFA date is July 28, 2015. An MAA has also been submitted in Europe.
- Previously: Amgen submits MAA for cancer immunotherapeutic (Sept. 2, 2014)