Varlilumab: Additional Phase I data

Data from 16 patients with metastatic melanoma in an expansion cohort of an open-label, dose-escalation, U.S. Phase I trial showed that once-weekly 3 mg/kg varlilumab led to 3 cases of stable disease and a progression-free survival (PFS) range of 2.7 to 11.5 months. One patient with uveal melanoma had 12% shrinkage of measurable disease. In 15 patients with renal cell carcinoma (RCC) in a separate expansion cohort, once-weekly 3 mg/kg varlilumab led to 1 partial response and 3 cases of stable disease. Data were presented at the American Society of Clinical Oncology meeting in Chicago.

In May, Celldex partnered with Bristol-Myers Squibb Co. (NYSE:BMY, New York, N.Y.) to conduct a Phase I/II trial of varlilumab with BMS’s nivolumab in patients with multiple tumor types. Nivolumab is a human IgG4 mAb against programmed cell death 1 ( PDCD1; PD-1; CD279) (see BioCentury, May 19). Last month, Ono Pharmaceutical Co. Ltd. (Tokyo:4528, Osaka, Japan) said Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Opdivo nivolumab to treat unresectable melanoma. Under an expanded deal, BMS has worldwide rights to nivolumab from Ono, except in Japan, South Korea and Taiwan, where Ono and BMS are partnered for the product. Earlier this year, BMS said it started submission of a rolling BLA to FDA for nivolumab as third-line treatment of squamous NSCLC. The pharma expects to complete the application by year end. ...