FDA Grants Fast Track Designation to Balstilimab in Metastatic Cervical Cancer

The FDA has been granted Fast Track designation to balstilimab, an investigational anti-PD-1 agent for the treatment of patients with cervical cancer, based on comprehensive data that suggest balstilimab can fill an unmet medical need in the space, Agenus, Inc announced in a press release. In light of the new designation, the company now plans to submit 2 Biologic License Applications in 2020, for this indication and for the combination of balstilimab and zalifrelimab in metastatic cervical cancer.¹

"We are pleased to have now been granted Fast Track designation by FDA for both balstilimab as a monotherapy and in combination with zalifrelimab (anti-CTLA-4) in recognition of the high unmet medical need in second-line cervical cancer," said Anna Wijatyk, head of Clinical Development, Agenus, in a statement. "The Fast Track designation confers important benefits, including the potential eligibility for a Priority Review, and we are excited to work with the FDA to quickly advance novel agents for women who suffer from metastatic cervical cancer."

Updated results from the planned interim analysis of balstilimab plus zalifrelimab in metastatic cervical cancer showed potent and lasting responses. In patients with relapsed or refractory disease, the objective response rate (ORR) was 26.5%, which included 4 complete responses (CRs), 5 partial responses (PRs). The median duration of response for this study has not yet been reached.

For the study of balstilimab monotherapy, the ORR achieved was 14.3%, 1 of which was CR, and 5 of which were PRs. The findings from this analysis included to overall study population, as well as, a non-biomarker selected population of patients with refractory cervical cancer who failed previous platinum chemotherapy with or without bevacizumab (Avastin).

Prior data from the pre-planned interim analysis of balstilimab and zalifrelimab were announced in February, along with data for balstilimab monotherapy. In 34 evaluable patients, there was an ORR of 20.6% observed in the combination arm, which included an 8.8% CR rate. Among the 44 patients evaluable in the balstilimab monotherapy analysis, the ORR was 11.4%.²

In both clinical trials, the clinical activity observed was comparable with similar agents. Both the combination and monotherapy were also well-tolerated with no new safety signals observed.

References

1. Agenus receives fast track designation for balstilimab in advanced cervical cancer [news release]. Lexington, Massachusetts; Agenua; April 7, 2020. https://bit.ly/2VaggRx . Accessed April 7, 2020.
2. Agenus announces positive interim data from balstilimab and zalifrelimab clinical trials in second-line cervical cancer [news release]. Lexington, Massachusetts: Agenus, Inc; February 20, 2020. https://bit.ly/3d3NLxg. Accessed March 12, 2020.