PD-1 new drug Balstilimab single drug for cervical cancer approved by FDA fast-track

Agenus, a biopharmaceutical company dedicated to the development of immuno-oncology drugs, announced that the FDA has granted its PD-1 inhibitor balstilimab fast-track eligibility for the treatment of patients with advanced cervical canceris understood to have been granted this qualification based on comprehensive clinical data support that demonstrates Balstilimab's potential to address critical medical needsAgenus is expected to submit two biologic licensing applications (BLA) this year to accelerate the approval of balstilimab and CTLA-4 mono-anti-zalifremab combination therapy and balstilimab single-drug treatment for metastatic cervical cancerpreviously, the FDA has granted fast-track eligibility for balstilimab's joint zalifrelimab treatment for recurrent or difficult metastatic cervical cancer"We are pleased that the FDA has granted the Balstilimab single medicine and the fast-track qualification for balstilimab-zalifrelimab combination therapy," said DrAnna Wijatyk, Vice President of Clinical Development,AgenusFast-track eligibility will bring significant benefits, including potential priority review eligibility, and we are pleased to work with the FDA to rapidly develop new drugs for patients with metastatic cervical cancerbefore, whether the second-line treatment of cervical cancer has been a hot topic of academic controversyAgenus updated a pre-planned mid-term analysis to reveal the strong and persistent activity of balstilimab-combined zalifrelimab in patients with recurrent or refractory cervical cancer who have developed tumor metastasisThe data showed that the objective remission rate (ORR) of the combined drug was 26.5% (including 4 cases of total remission and 5 partial remissions), and the effect was long-lasting, and the median continuous remission time had not yet reachedFor balstilimab monotherapy, the ORR in all patients was 14.3% (including 1 case of complete remission and 5 partial remission)The above-tested population was selected for non-biomarkers, patients with refractory cervical cancer, and who failed treatment with cisplatin or no combined bevala monoantigenepidemiological survey data show that in 2015, the number of new cases and deaths of cervical cancer in China was 111,000 and 34,000, respectively, and the incidence rate increased year by yearFollowing the approval of pD-1 inhibitor pembrolizumab (KEYTRUDA) for treatment for advanced cervical cancer, researchers have been expecting more research on immunotherapy drugs in this areaCurrently, according to two clinical trial data published by Agenus, the resistance of dual antibody combination therapy and balstilimab monotherapy is also good, with no adverse safety signals observed, provided that the drug is effective and durablereference source:1, Agenus Receives Fast Track GenOne For Balstilimab in Advanced Cervical Cancer2, Agenus Receives Fast Note Track for Balstilimab and Zalifremab in Advanced Cervical Cancer