Regeneron's Matthew Fury, MD, said the decision to move immediately to a phase 3 trial came after 2 of 3 patients in a phase 1 trial showed durable responses.
Several studies involving immunotherapy to treat cervical cancer have reached phase 2. But a phase 3 trial is under way with cemiplimab, after researchers at Regeneron saw a positive signal in a phase 1 study and opted to move immediately to a randomized clinical trial. GOG 3016, which is now recruiting participants at 53 locations in the United States and internationally, activated in late 2017 to study patients with recurrent and metastatic cervical carcinoma.
While patients with cervical cancer may experience modest survival benefits with initial treatment (with or without bevacizumab), those who have a recurrence after being treated with platinum-based chemotherapy have a median survival of just 7 months, according to the research being presented Monday at the annual meeting of the American Society of Clinical Oncology, held in Chicago, Illinois. But the nature of cervical cancer meant that immunotherapy could be a treatment choice.
“For women with metatstatic cervical cancer who have progressed on first-line therapy, there really has been nothing out there for them,” Matthew Fury, MD, senior director of clinical sciences in oncology for Regeneron, said in an email to The American Journal of Managed Care®. “Because almost all cervical cancers are HPV-associated, the presence of a viral antigen in these tumors creates the potential for robust anti-tumor immune responses and prolonged survival.”
GOG 3016 is a randomized (1:1), open-label trial, that seeks to enroll 436 patients who have previously been treated with platinum-based chemotherapy, will receive either cemiplimab, a human monoclonal anti-programmed death cell-1 therapy, or chemotherapy of the investigator’s choice of several forms of chemotherapy:
Fury said GOG 3016 results from the phase 1 study of cemiplimab showed durable responses in 2 of the 3 cervical cancer patients who were enrolled in the dose escalation portion of the study. “We thought that this was a potentially important efficacy signal in a patient population with unmet need,” Fury said, and the results dovetailed with those being seen with immune checkpoint inhibitors in other virally-associated cancers, like oropharynx cancer and Merkel cell carcinoma.
“These observations suggested to use that cemiplimab has the potential to improve survival in women with advanced cervical cancer who have exhausted the potential for clinical benefit with currently available treatments, and that a phase 3 trial was the way to go,” Fury said.
Similarly, Regeneron moved quickly on an early impressive signal in a patient with advanced cutaneous squamous cell carcinoma, he said.
Tewari KS, Vergote I, Oaknin A, et al. GOG 3016/ENGOT-cx9: an open-label, multi-national, randomized, phase 3 trial of cemiplimab, an anti-PD-1, versus investigator’s choice (IC) chemotherapy in ≥2 line recurrent or metastatic cervical cancer. J Clin Oncol 2018;36 (suppl; abstr TPS5600).