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Amgen: Phase 3 trial results for melanoma therapy successful
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Amgen this week announced successful results of a phase 3 trial of its investigational therapy talimogene laherparepvec in treating patients with advanced stages of melanoma.
Talimogene laherparepvec is an oncolytic immunotherapy designed to selectively replicate in tumor tissue. In a global, randomized, open-label trial, researchers studied more than 400 patients with unresected stage IIIB, IIIC or IV melanoma, to evaluate the safety and efficacy of talimogene laherparepvec compared with granulocyte-macrophage colony-stimulating factor (GM-CSF). In 2:1 ratio, patients received talimogene laherparepvec intralesionally every 2 weeks or GM-CSF subcutaneously for the first 14 days of each 28-day cycle. Treatment lasted up to 18 months.
Primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least 6 months, was met. DRR was achieved in 16% of patients treated with talimogene laherparepvec compared with 2% of GM-CSF patients. A secondary endpoint of overall survival showed a trend in favor of talimogene laherparepvec compared with GM-CSF, Amgen reported in a press release.
Sean E. Harper
“These are the first phase 3 results of this novel approach to cancer therapy,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said. “A high unmet need exists in melanoma, and we believe the innovative mechanism of action of talimogene laherparepvec may offer a promising approach for these patients.”
Fatigue, chills and pyrexia were the most frequent adverse events reported. Disease progression, cellulitis and pyrexia were the most common serious adverse events.
Amgen plans to submit additional safety and efficacy data to the American Society of Clinical Oncology for its annual meeting May 31-June 4 in Chicago, according to the release.