Amgen initiates Phase I trial of melanoma drug combination

Source: PBR, December 2014

US-based Amgen has commenced a Phase I trial of talimogene laherparepvec, an investigational oncolytic immunotherapy, for the treatment of patients with regionally or distantly metastatic melanoma.

The trial is designed to evaluate the safety of talimogene laherparepvec in combination with Merck’s FDA approved, anti-PD-1 therapy Keytruda, as well as the efficacy of this combination versus Keytruda alone and following progression after treatment with Keytruda alone.

The multicenter, open-label clinical trial will evaluate the combination of these two therapies in about 110 patients across 35 clinical trial sites in the US, Australia and Europe.

Amgen executive vice-president of Research and Development Sean Harper said: “This new trial underscores our commitment to researching different treatment approaches for patients with this aggressive and highly recurrent form of skin cancer.

“We are excited to partner with Merck and explore the potential of talimogene laherparepvec and Keytruda. This will also give us insights into talimogene laherparepvec beyond the monotherapy setting, where a Phase III trial has shown encouraging results."

The trial will be conducted in two phases and the Phase I 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 randomized phase will further evaluate the safety and efficacy of talimogene laherparepvec in combination with Keytruda.