Amgen presents new data on talimogene laherparepvec as single agent and combination therapy in metastatic melanoma at ASCO

Amgen (NASDAQ: AMGN) today announced new data from two key clinical trials that support the potential of talimogene laherparepvec, a novel, investigational oncolytic immunotherapy, as both a single agent and as part of a combination regimen in patients with metastatic melanoma. The findings were presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

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Data from the 19 patients in the Phase 1b combination study, presented for the first time at ASCO, showed no dose-limiting toxicities with talimogene laherparepvec in combination with ipilimumab (Abstract #9029). Additionally, tumors either shrank in size or were no longer detectable in 56 percent of patients when talimogene laherparepvec was given prior to and in combination with ipilimumab. The most common adverse events observed were chills, fevers, rash and fatigue.

“We are entering an era where new melanoma therapies are advancing clinical care for patients in ways not previously seen,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Talimogene laherparepvec has demonstrated the ability to produce durable and complete responses in patients with metastatic melanoma which provides a strong basis for a filing later this year and potential approval of talimogene laherparepvec as a novel treatment for this devastating disease.”

As previously reported, the pivotal Phase 3 trial met its primary endpoint showing a statistically significant improvement in durable response rate (16 percent in the talimogene laherparepvec arm versus two percent in the granulocyte-macrophage colony-stimulating factor [GM-CSF]). Among the 26 percent of patients who achieved an overall response (n=78) in the talimogene laherparepvec arm, 40 percent achieved a complete response (no evidence of disease).  Data presented today showed that among the talimogene laherparepvec responders, there was a 65 percent probability of responses lasting for at least 12 months.  

Detailed results of the overall survival analysis, a key secondary endpoint of the pivotal Phase 3 trial evaluating talimogene laherparepvec as a single agent, were also presented (Abstract #9008a). The results demonstrated a 4.4 month improvement in overall survival (HR=0.79; p=0.051) which closely approached statistical significance in the total patient population tested that included patients with and without visceral tumors (tumors involving solid organs such as the lungs and liver).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.

“Novel investigational therapies are creating exciting momentum in melanoma research and our challenge is to better understand how to most appropriately develop these therapies,” said Igor Puzanov, M.D., associate professor of Medicine at Vanderbilt-Ingram Cancer Center and lead author on the Phase 1b combination study. “These latest findings support the potential of talimogene laherparepvec as a single agent and provide a strong rationale for further investigation as a combination therapy in a broad range of appropriate patients.”