Amgen to Discuss Potential First-in-Class Oncolytic Immunotherapy for Metastatic Melanoma

Strategic Insights -

Amgen, a biotechnology pioneer since 1980, will present data supporting the Biologics License Application (BLA) for talimogene laherparepvec monotherapy at a joint meeting of the FDA's Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) and Oncologic Drugs Advisory Committee (ODAC). The meeting is crucial in the approval process for talimogene laherparepvec, an oncolytic immunotherapy designed to selectively replicate in tumors and initiate an immune response to target cancer cells. The therapy has shown promising results in a Phase 3 clinical trial for patients with injectable regionally or distantly metastatic melanoma. Metastatic melanoma is a significant public health concern, with an estimated 74,000 new diagnoses and nearly 10,000 deaths this year, according to the American Cancer Society.

Key Takeaways:

  • Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors and initiate an immune response to target cancer cells that have metastasized.
  • The pivotal Phase 3 OPTiM study demonstrated that talimogene laherparepvec monotherapy is the first oncolytic immunotherapy to demonstrate therapeutic benefit in a Phase 3 pivotal trial for patients with metastatic melanoma.
  • The OPTiM study showed a significant improvement in durable response rate (DRR) with 16.3% of talimogene laherparepvec patients achieving a complete response (CR) or partial response (PR) within the first 12 months of treatment and maintaining it continuously for at least six months.
  • Talimogene laherparepvec also showed improved overall (CR + PR) response rate compared with GM-CSF, 26.4% vs 5.7% respectively, with a strong trend in overall survival.
  • The most commonly reported treatment-related adverse events were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection-site pain, with most adverse reactions resolving within 72 hours.

Statistics:

  • 436 patients were involved in the OPTiM study.
  • 16.3% of talimogene laherparepvec patients achieved a complete response (CR) or partial response (PR) within the first 12 months of treatment and maintained it continuously for at least six months.
  • Overall survival (OS) was 4.4 months longer in the talimogene laherparepvec arm than in the GM-CSF arm (hazard ratio: 0.79; p =0.051).
  • 8 of 71 patients (11.3%) with visceral lesions that could not be injected had an overall decrease in those lesions of more than 50%.

Sources:

  • Amgen press release, "Amgen to Discuss Details of the Biologics License Application for Talimogene Laherparepvec for Patients with Metastatic Melanoma" (April 29, 2015)
  • American Cancer Society, "Cancer Facts & Figures 2014"
  • American Cancer Society, "Melanoma Skin Cancer"