Amgen initiates study to evaluate combined talimogene laherparepvec, Keytruda for melanoma

Source: Healio.com-dermatology, December 2014

Amgen announced the beginning of a study to evaluate the safety and efficacy of talimogene laherparepvec in combination with the investigational use of Merck’s pembrolizumab in patients with regionally or distantly metastatic melanoma, according to a press release.

Talimogene laherparepvec is an investigational oncolytic immunotherapy and Keytruda (pembrolizumab) is a U.S. Food and Drug Administration-approved anti-PD-1 therapy. The trial has started enrollment and will evaluate the combined therapy in 110 patients at 35 clinical trial sites in the United States, Australia and Europe.

“Talimogene laherparepvec is designed to promote tumor antigen release and presentation to initiate an anti-tumor response, which may be complementary to Keytruda’s role in releasing PD-1 pathway-mediated inhibition of anti-tumor responses,” F. Stephen Hodi, MD, steering committee chair for the study, said in the release.

Data from a phase 3 trial that evaluated the safety and efficacy of intralesional talimogene laherparepvec in more than 400 patients with stage IIIB, IIIC or IV melanomas that were not surgically resectable compared with granulocyte-macrophage colony-stimulating factor were included in the regulatory filings, according to the release.

The new trial will evaluate talimogene laherparepvec in combination with pembrolizumab vs. pembrolizumab alone and will follow the progression after treatment of pembrolizumab alone, according to the release.

The study will be conducted in two phases, with phase 1 determining safety and tolerability of talimogene laherparepvec in combination with pembrolizumab in patients with previously untreated, unresected stage IIB and IVM1c melanoma, according to the release. Phase 2 will further evaluate safety and efficacy of the combined treatment.