Study to examine varlilumab, Opdivo for treating melanoma, other cancers

Celldex Therapeutics and Bristol-Myers-Squibb have announced the beginning of a phase 1 / 2 study to examine the investigational combination of varlilumab and Opdivo in patients with metastatic melanoma and other cancers.

Varlilumab (Celldex) is a CD27-targeting investigational immune-activating antibody and Opdivo (nivolumab, Bristol-Myers-Squib) is a PD-1 blocking antibody that was recently approved by the FDA as treatment for patients with unresectable and metastatic melanoma who no longer respond to other drugs. The treatment combination will be conducted on adults with metastatic melanoma, advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), ovarian cancer and head and neck squamous cell carcinoma (SCCHN), according to a press release.

“This study will evaluate the safety and tolerability of the combination and address the hypothesis that the combination of these two mechanisms enhances the anti-tumor activity compared to either agent alone,” the release stated.

Safety and tolerability of varlilumab at doses from 0.1 to 1.0 mg/kg when administered with Opdivo (3 mg/kg) will be assessed in the phase 1 dose-escalation portion of the study, according to the release.

The phase 2 study will follow, in which 18 patients in each of the CRC, SCCHN and ovarian cancer cohorts and 35 patients in each of the NSCLC and metastatic melanoma cohorts will be treated with varlilumab “until intolerance, disease progression or completion of up to four cycles,” according to the release, while Opdivo treatment will have no limit on duration. Overall response rate will be the primary objective of the phase 2 portion of the study.

Celldex will conduct the study, with development costs shared by the companies, according to the release.

Reference: www.celldex.com, www.bms.com