Preliminary data from a Phase 1/2 trial, presented at the American Society of Clinical Oncology Annual 2017 Annual Meeting, shows that Opdivo (nivolumab) monotherapy was effective in more than 26 percent of patients with cervical cancer, regardless of their PD-L1 or HPV status, or number of prior systemic therapies. The study, "An open-label, multicohort, phase I/II study of nivolumab in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in recurrent or metastatic (R/M) cervical, vaginal, and vulvar cancers," was presented June 2 by Antoine Hollebecque, the study's lead investigator and a senior medical physician at Gustave Roussy Cancer Center outside Paris. Hollebecque said she is encouraged by early results the study, called CheckMate-358 (NCT02488759). "These CheckMate -358 results demonstrate the value of studying the potential of an Immuno-Oncology agent to address the significant challenge of treating patients with advanced cervical, vaginal and vulvar cancers,” Hollebecque said in a press release. Opdivo is a monoclonal antibody that targets the programmed death-1 (PD-1) checkpoint. By inhibiting the PD-1 molecule, it activates the immune system to attack tumor cells. Opdivo was the first PD-1 immune checkpoint inhibitor to receive FDA approval, and regulatory approval elsewhere, starting in 2014. As part of Bristol-Myers Squibb's Immune-Oncology program, Opdivo is continuing to be investigated in clinical trials covering many different cancer types. The CheckMate-358 trial is an open-label, multicenter, and multi-cohort study evaluating the safety and efficacy of Opdivo alone or in combination with other therapies in patients with HPV-associated (human papillomavirus-associated) tumors, including cancers of the cervix, vagina, and vulva. The trial has five cohorts: Opdivo as first-line therapy before surgery, Opdivo as monotherapy in advanced cancer patients with metastatic disease, and Opdivo in combination with Yervoy (ipilimumab), anti-LAG-3, or Darzalex (daratumumab) in advanced cancer patients. The first disclosure of data included results from a cohort of 24 patients with advanced cervical, vaginal, and vulvar cancers treated with Opdivo as monotherapy. Overall, the objective response rate, measured by an established reduction in tumor size, was 20.8%, and the median time to progression was 5.5 months. Most of the women — 19 of the 24 — had cervical cancer. Among these patients, an objective response to the treatment was achieved in 26.3%, and 70.8% responded positively, showing at least evidence of disease control (defined as complete or partial response or stable disease). Severe adverse reactions were noted in 12.5% of these patients. The trial, which aims to enroll about 500 patients, still recruiting at its 43 sites across the United States, Europe and elsewhere. More information is available on the study's clinical trials.gov webpage. “This first assessment of Opdivo’s activity in women with advanced cervical, vaginal and vulvar cancers enrolled in this cohort … supports further investigation, especially because these patients have very limited options after chemotherapy or radiation fails,” said Shinto Cheng, MD, development lead at Bristol-Myers Squibb.