Amgen Begins Melanoma Trial Of Talimogene Laherparepvec +Merck's Keytruda

Amgen and Merck have begun a trial of Amgen’s talimogene laherparepvec in combination with Merck’s Keytruda (pembrolizumab). The companies announced the trial initiation in a press release, stating that the Phase 1 trial will evaluate the agents in the treatment of regionally or distantly metastatic melanoma. Amgen has filed a Biologics License Application (BLA) with the Food and Drug Administration (FDA) for talimogene laherparepvec for the regionally or distantly metastatic melanoma indication and the FDA is expected to act on the BLA by July 28, 2015.

The Steering Committee Chair for the study, Stephen Hodi, M.D., from the Dana-Farber Cancer Institute, said, "Talimogene laherparepvec is designed to promote tumor antigen release and presentation to initiate an anti-tumor immune response, which may be complementary to Keytruda’s role in releasing PD-1 pathway-mediated inhibition of anti-tumor immune responses.”

Talimogene Laherparepvec, Keytruda Study

Dr. Hodi stated that releasing antigens and presenting them to the immune system is the step required for a system-wide response to melanoma. Combining talimogene laherparepvec and Keytruda may achieve a potent oncolytic immunotherapy response. Amgen states that the trial will enroll 110 patients from 35 clinical sites in the U.S., Australia, and Europe. Investigators will study the safety and tolerability of talimogene laherparepvec and Keytruda in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma. Sean E. Harper, M.D., executive VP of research and development at Amgen, also commented on the study, “This will also give us insights into talimogene laherparepvec beyond the monotherapy setting, where a Phase 3 trial has shown encouraging results."

Talimogene Laherparepvec Regulatory Progress

In addition to the BLA that Amgen filed with the FDA, the company has also applied for approval of talimogene laherparepvec in the European Union for the regionally or distantly metastatic melanoma indication. For its regulatory submissions, Amgen relied on data from 400 patients in a Phase 3 safety and efficacy trial. Patients with stage IIIB, IIIC, or IV melanoma, not surgically resectable, took talimogene laherparepvec or granulocyte-macrophage colony-stimulating factor (GM-CSF).

Amgen’s comprehensive clinical development program for talimogene laherparepvec in metastatic melanoma includes other combination studies. The company is evaluating other checkpoint inhibitors and their efficacy in a variety of solid tumor types.