ImmunityBio reports Anktiva endpoint success in BCG‑naïve bladder cancer
The 370-patient randomized trial supports a planned year-end FDA filing, but response rates and detailed safety data remain undisclosed.
Adrian Kessler
Anktiva plus BCG improved efficacy against BCG alone in a randomized Phase 2b bladder-cancer trial, as ImmunityBio, Inc. NASDAQIBRX reported a primary-endpoint success on Monday. The company reported 370 randomized patients but withheld response rates and statistical estimates, leaving the size of the benefit undisclosed.
The Nov. 9 announcement concerns patients receiving BCG for the first time, an earlier treatment setting than Anktiva's existing indication. ImmunityBio plans to submit a supplemental biologics licence application to the U.S. Food and Drug Administration before the end of 2026, seeking to expand that indication.
ImmunityBio is a commercial-stage biotechnology company based in Culver City, Calif., developing and selling cancer immunotherapies.
ImmunityBio shares NASDAQIBRX closed at US$8.64 on Nasdaq at 4 p.m. EST on Nov. 6. That close preceded Monday's announcement and provides no measure of the market's reaction to the results.
Response Rates Remain Undisclosed
The ClinicalTrials.gov record for QUILT-2.005 describes an open-label Phase 1b/2b study, with the randomized expansion comparing Anktiva plus BCG against BCG alone. Cohort A's primary endpoint is complete response at six months, assessed using cystoscopy, confirmatory bladder biopsy and urine cytology.
Monday's result concerns Cohort A, patients with carcinoma in situ, with or without papillary tumours. The registry describes a separate papillary-disease cohort with a disease-free-survival endpoint, which should not be confused with the complete-response result announced on Monday.
The registry, last updated March 31, lists actual enrollment of 369 participants, while Monday's release reports 370 randomized patients. The announcement does not provide treatment-arm totals, response percentages, a p value or a confidence interval.
ImmunityBio said median response duration had not been reached with the combination and patient-reported quality of life was maintained. The topline disclosure provides no numerical comparison for those findings or follow-up duration with which to interpret them.
The most common treatment-emergent and treatment-related adverse events were consistent with BCG alone, the company said, and no treatment-related deaths were reported. The disclosed safety summary gives no event rates or severe-event counts.
"The statistically significant improvement in efficacy supports our efforts to extend this therapeutic approach to patients earlier in their treatment journey," ImmunityBio executive chairman and chief scientific and medical officer Patrick Soon-Shiong said in the release.
BCG Combinations Target Earlier Treatment
Anktiva is an interleukin-15 receptor agonist administered directly into the bladder with BCG. The existing U.S. indication covers BCG-unresponsive non-muscle invasive bladder cancer; the company reported an October expansion to include papillary disease alongside carcinoma in situ.
The existing label warns that delaying cystectomy, surgery to remove the bladder, can allow progression to muscle-invasive or metastatic bladder cancer.
The BCG-naïve setting also features in Pfizer Inc. NYSEPFE's Phase 3 CREST announcement. Pfizer described sasanlimab plus BCG and an event-free-survival result, an endpoint distinct from QUILT-2.005's six-month complete-response measure.
Read more: FDA expands ImmunityBio's Anktiva label to papillary-only bladder cancer
An independent monitoring committee review disclosed March 26 concluded that no additional enrollment was needed to retain the study's prespecified statistical power. The company's account of that review does not establish FDA agreement with the trial design or approval of the proposed indication.
The company completed database lock on Oct. 20 and plans to present further results at an upcoming medical congress, without naming a date in Monday's announcement. Its next dated milestone is the planned FDA submission before the end of 2026, when the application would seek permission to treat BCG-naïve patients.
