ImmunityBio Nears Full Enrollment in Pivotal ANKTIVA Trial for BCG-Naïve Bladder Cancer

Reuters01-16

ImmunityBio Nears Full Enrollment in Pivotal ANKTIVA Trial for BCG-Naïve Bladder Cancer

ImmunityBio, Inc. has provided an update on its randomized registrational trial, QUILT-2.005, evaluating ANKTIVA® (nogapendekin alfa inbakicept) in combination with BCG for BCG-naïve non-muscle-invasive bladder cancer (NMIBC). The company reported that enrollment has exceeded 85% and is expected to be fully completed by the second quarter of 2026, with a Biologics License Application (BLA) submission to the U.S. FDA anticipated by the end of 2026. Interim analysis results, which were presented at the American Urological Association (AUA) Annual Meeting in 2024, showed that the combination of ANKTIVA and BCG significantly prolonged the duration of complete response compared to BCG alone. At nine months, 84% of patients in the experimental arm maintained a complete response, versus 52% for BCG alone, with the difference reaching statistical significance.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Immunitybio Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20260116479411) on January 16, 2026, and is solely responsible for the information contained therein.

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The company reported that enrollment has exceeded 85% and is expected to be fully completed by the second quarter of 2026, with a Biologics License Application (BLA) submission to the U.S. FDA anticipated by the end of 2026. Interim analysis results, which were presented at the American Urological Association (AUA) Annual Meeting in 2024, showed that the combination of ANKTIVA and BCG significantly prolonged the duration of complete response compared to BCG alone. At nine months, 84% of patients in the experimental arm maintained a complete response, versus 52% for BCG alone, with the difference reaching statistical significance.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. 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While PUBT strives to provide accurate and timely information, this AI-generate","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"IBRX":"ImmunityBio, Inc.","BK4139":"生物科技"},"translate_title":"ImmunityBio即将全面参与治疗未接受卡介苗治疗膀胱癌的关键ANKTIVA试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"IBRX":0.9},"content_text":"ImmunityBio Nears Full Enrollment in Pivotal ANKTIVA Trial for BCG-Naïve Bladder Cancer\n    \n\nImmunityBio, Inc. has provided an update on its randomized registrational trial, QUILT-2.005, evaluating ANKTIVA® (nogapendekin alfa inbakicept) in combination with BCG for BCG-naïve non-muscle-invasive bladder cancer (NMIBC). The company reported that enrollment has exceeded 85% and is expected to be fully completed by the second quarter of 2026, with a Biologics License Application (BLA) submission to the U.S. FDA anticipated by the end of 2026. 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