Imlygic meets ORR endpoint in Phase II melanoma trial

Amgen Inc. (NASDAQ:AMGN) reported data from the Phase II portion of the Phase Ib/II '264 trial in 198 patients with unresectable stage IIIB-IV melanoma showing that intratumoral Imlygic talimogene laherparepvec plus Yervoy ipilimumab met the primary endpoint of improving objective response rate (ORR) vs. Yervoy alone (38.8% vs. 18%, p=0.002). Additionally, the combination led to a complete response rate of 13.3% vs. 7% for Yervoy alone. Median progression-free survival (PFS) for Imlygic plus Yervoy was 8.2 months vs. 6.4 months for Yervoy alone at a median follow-up of 68 weeks (p=0.35). Amgen said the PFS analysis is ongoing with only 50% of PFS events reported. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

The open-label, international trial's primary endpoints are safety and ORR. Secondary endpoints include duration of response, disease control rate (DCR), PFS, overall survival (OS) and time to response. Patients received Imlygic on day 1 of weeks 1 and 4 and every 2 weeks thereafter plus Yervoy every 3 weeks or Yervoy alone. Amgen previously reported data from the Phase Ib portion of the trial (see BioCentury, July 27, 2015)...