publication date: May. 1, 2014



Phase III Trial Fails to Extend OS

After Meeting Primary Endpoint Of Durable Response Rate

Top-line results of a phase III trial evaluating talimogene laherparepvec in melanoma failed to meet its secondary endpoint of overall survival. The trial had previously reached its primary endpoint of durable response rate.

Amgen, the drug’s sponsor, said there was a strong trend in favor of talimogene laherparepvec (p=0.051) and that the estimated OS hazard ratio and improvement in median OS were similar to what was previously reported at the interim OS analysis.

“We missed statistical significance on the secondary endpoint of overall survival but the strong trend in survival benefit supports further research of talimogene laherparepvec to better understand its role in melanoma, both as a single-agent and in combination with other therapies,” said Sean Harper, executive vice president of research and development at Amgen.

The trial examined talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor. Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors and to initiate an immune response to target cancer that has metastasized.

Patients were randomized 2:1 to receive either talimogene laherparepvec every two weeks through direct tumor injection or GM-CSF subcutaneously for the first 14 days of each 28-day cycle, for up to 18 months. 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.

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