Amgen reports primary endpoint success for Phase 2 study

The combination more than doubled objective response rate in patients with unresectable Stage IIIB-IV melanoma.
The combination more than doubled objective response rate in patients with unresectable Stage IIIB-IV melanoma. | File photo

Amgen's Phase 2 study evaluating Imlygic combined with Yervoy as a treatment for patients with unresectable Stage IIIB-IV met its primary endpoint.

"Metastatic melanoma continues to be one of the most difficult-to-treat and aggressive cancers," Dr. Jason Chesney, acting director of the James Graham Brown Cancer Center at the University of Louisville, said in a statement. "The results from this study demonstrate the potential of combining the complementary mechanisms of action of an oncolytic viral immunotherapy and a checkpoint inhibitor to enhance anti-tumor effect in patients with advanced melanoma."

In the study, the combination of Imlygic with the immune checkpoint inhibitor Yervoy proved to be more effective than the use of Yervoy on its own. The combination more than doubled objective response rate (ORR), defined as the proportion of patients with tumor size reduction, in patients with unresectable Stage IIIB-IV melanoma. Amgen presented these results at the 53rd Annual Meeting of the American Society of Clinical Oncology.

"Patients with metastatic melanoma are in need of innovative, effective treatment options that can improve response rates and help prevent disease recurrence," Dr. Sean Harper, executive vice president of Research and Development at Amgen, said. "These are the first randomized, controlled, Phase 2 data demonstrating clear efficacy and safety of an oncolytic virus with a checkpoint inhibitor. We are excited to be exploring IMLYGIC with PD-1 and PDL-1 checkpoint inhibitors as well."

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