On April 7, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Agenus Fast Track designation for investigation of balstilimab (anti-PD-1) for the treatment of cervical cancer (Press release, Agenus, APR 7, 2020, View Source [SID1234556165]). This designation was based on comprehensive data that support the potential for balstilimab to address a significant unmet medical need. Agenus expects to file 2 BLAs this year for accelerated approval of the combination of balstilimab and zalifrelimab and balstilimab monotherapy in metastatic cervical cancer.
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"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 Dr. Anna Wijatyk, Head of Clinical Development, Agenus. "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."
Agenus has updated data from a pre-planned interim analysis revealing robust and durable activity for balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer. The data for the combination demonstrated 26.5% objective response rates (ORR) (4 CRs, 5 PRs) which are durable (median not yet reached) and for balstilimab monotherapy, a 14.3% ORR (1 CR, 5 PRs) in an all-comer, non-biomarker selected population of patients with refractory cervical cancer who have failed prior platinum chemotherapy with or without bevacizumab.
Fast Track designation1 is granted by the FDA for products that are intended for the treatment of serious or life-threatening disease or conditions, which demonstrate the potential to address an unmet medical need. The designation offers the opportunity for frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, as well as eligibility for rolling submission of a Biologic Licensing Application (BLA).