Amgen Announces Results of Phase III Talimogene Laherparepvec Trial in Late-stage Melanoma
Amgen has announced results from a phase III trial evaluating the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC, or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to work in two important and complementary ways: to cause local lytic destruction of tumors while also stimulating a systemic antitumor immune response.
Trial Design
The global, randomized, open-label, phase III trial was designed to evaluate the safety and efficacy of talimogene laherparepvec compared to a control therapy with GM-CSF in over 400 patients with unresected stage IIIB, IIIC, or IV melanoma.
Patients were randomly assigned 2:1 to receive either talimogene laherparepvec intralesionally every 2 weeks or GM-CSF subcutaneously for the first 14 days of each 28-day cycle. Treatment could last for up to 18 months. Where appropriate, stable or responding patients could receive additional treatment on an extension protocol.
Results
The study met its primary endpoint of durable response rate, defined as the rate of complete or partial response lasting continuously for at least 6 months. A statistically significant difference was observed in durable response rate: 16% in the talimogene laherparepvec arm vs 2% in the GM-CSF arm. The analysis of overall survival, a key secondary endpoint of the study, is event-driven. A preplanned interim analysis conducted with the analysis of durable response rate has shown an overall survival trend in favor of talimogene laherparepvec as compared to GM-CSF. The overall survival data is expected to mature in late 2013 in line with previous guidance.
The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.
Additional safety and efficacy data will be submitted to ASCO for the 2013 Annual Meeting.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
