Amgen, Merck to study combined treatment for advanced melanoma

Amgen and Merck announced an agreement to conduct a phase 1b/2 study evaluating the safety and efficacy of the combination of talimogene laherparepvec and MK-3475 to treat patients with mid- to late-stage melanoma.

Talimogene laherparepvec, Amgen’s investigational oncolytic immunotherapy, selectively replicates tumor tissue and initiates a systemic anti-tumor immune response when injected directly into the tumor, according to a press release. Merck’s MK-3475 is an investigational anti-PD-1 immunotherapy designed to allow the immune system to target cancer cells by selectively achieving dual ligand blockade of the PD-1 protein.

The open-label clinical trial is scheduled to begin in the fall and will be conducted in two parts, the release said. Safety and tolerability of the combination therapy in patients with previously untreated, unresected stage IIIB to IVM1a melanoma will be studied in phase 1b.

Objective response rate will be used to measure efficacy in the phase 2 portion of the trial, with talimogene laherparepvec/MK-3475 compared with MK-3475 monotherapy in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma. Efficacy of talimogene laherparepvec/MK-3475 treatment after disease progression during treatment of MK-3475 monotherapy also will be studied.

“Talimogene laherparepvec has shown encouraging phase 3 clinical results as a monotherapy in patients with metastatic melanoma,” David D. Chang, MD, PhD, vice president of global development of Amgen, said in the release. “We look forward to working with Merck on this collaboration to evaluate the potential of these two novel immunotherapies to improve clinical outcomes for patients.”

“Early evaluation of immunotherapeutic combinations is important in accelerating the development of new options for patients with cancer,” Eric Rubin, MD, vice president, clinical development for oncology, Merck Research Laboratories, said in the release.