sBLA Filed for Nogapendekin Alfa in Bladder Cancer
The FDA has received a supplemental biologics license application (sBLA) seeking the approval of nogapendekin alfa inbakicept-pmln (Anktiva) for the treatment of patients with Bacillus Calmette–Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC) with papillary disease
Additionally, ImmunityBio—the developer of nogapendekin alfa inbakicept—has submitted an expanded access protocol for nogapendekin alfa inbakicept for the management of lymphopenia.
The sBLA is supported by data from the phase II/III QUILT-3.032 trial (NCT0302285). In the study, patients with papillary NMIBC (n = 72) were enrolled in cohort B, where they received nogapendekin alfa inbakicept in combination with BCG. Data published in NEJM Evidence demonstrated that, at a median follow-up of 20.7 months (range, 2.9-37.1), patients achieved a median disease-free survival (DFS) of 19.3 months (95% CI, 7.4-not reached). The 12-, 18-, and 24-month DFS rates were 55.4% (95% CI, 42.0%-66.8%), 51.1% (95% CI, 37.6%-63.1%), and 48.3% (95% CI, 34.5%-60.7%), respectively.
Previously reported findings from QUILT-3.032 supported the April 2024 FDA approval of nogapendekin alfa inbakicept in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. These data showed that patients treated with the combination (n = 77) experienced a complete response (CR) rate of 62% (95% CI, 51%-73%), and 58% of patients with a CR achieved a duration of response (DOR) of at least 12 months. Forty percent of patients with a CR had a DOR lasting at least 24 months.
Citation; Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non-muscle-invasive bladder cancer. NEJM Evid. 2023;2(1):EVIDoa2200167. doi:10.1056/EVIDoa2200167.
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