ImmunityBio said on Nov. 9 that ANKTIVA plus BCG met the primary endpoint in Cohort A of its randomized registrational trial in BCG-naïve, high-grade non-muscle invasive bladder cancer. The combination produced a statistically significant improvement over BCG alone in patients with carcinoma in situ, with or without papillary tumors, according to the company's announcement. The company said median duration of response had not been reached and that it remains on track to submit a supplemental biologics license application to the FDA before the end of the year.
The announcement did not include the complete response rate. That number is the center of the story. The trial's primary endpoint is the complete response rate at six months, and the company reported only that the endpoint was met and that the difference was statistically significant. Without the rate, clinicians cannot judge the size of the benefit, and investors cannot judge whether the result is strong enough to support a first-line label.
What the trial measured
QUILT-2.005 is a randomized, open-label, multicenter trial. Cohort A enrolled 366 patients with BCG-naïve, high-grade non-muscle invasive bladder cancer and carcinoma in situ, with or without papillary disease. Patients were assigned one to one to ANKTIVA plus BCG or BCG alone. Treatment was weekly intravesical instillation for a six-week induction, followed by response assessment and maintenance for eligible patients. The primary endpoint was complete response at six months, according to Urology Times.
The earlier interim data gave the combination a favorable signal but not a clean statistical win. At six months, 85% of patients on the combination maintained a complete response versus 57% on BCG alone, with a p-value of 0.0536. At nine months, the figures were 84% versus 52% in a smaller set of 40 patients, with a p-value of 0.0455. Those were interim analyses, not the final result. The final analysis has now met the primary endpoint, but the company has not disclosed the final rates or the durability distribution.
The safety picture was reassuring in the topline. Treatment-emergent adverse events were consistent with BCG alone, there were no treatment-related deaths, and patient-reported quality of life was maintained. The trial is open-label, which matters for quality-of-life reporting, but the safety profile is consistent with the drug's earlier studies.
What ANKTIVA is
ANKTIVA, or nogapendekin alfa inbakicept-pmln, is an IL-15 receptor agonist. It is a fusion complex of an IL-15 mutant and the IL-15 receptor alpha sushi domain, designed to mimic the way the body presents IL-15 to immune cells. Given intravesically with BCG, it activates natural killer cells, CD8-positive killer T cells, and memory T cells. The goal is to overcome the tumor's ability to escape the immune response that BCG starts.
The drug was first approved in April 2024 with BCG for adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. That approval was based on a single-arm study of 77 patients, in which 62% had a complete response; 58% of the responders stayed in response for at least 12 months, and 40% for at least 24 months, with durability followed for up to 47 months.
In October 2026, the FDA expanded the label to include BCG-unresponsive high-grade papillary-only disease. The agency did not require a new trial for that expansion. It extrapolated from the carcinoma in situ cohort, citing the frequency with which the two forms coexist and their shared risk of recurrence and progression. Papillary tumors account for about 85% of non-muscle invasive bladder cancer, so the expansion roughly doubled the addressable population in the BCG-unresponsive setting, according to analyst estimates. The decision was unusual enough that the FDA's oncology office described it as a new regulatory approach and said it was drafting guidance on using carcinoma in situ data to support papillary-only approvals.
That history matters for the current trial. The FDA has already shown that it will broaden ANKTIVA's label and accept extrapolation when the biology supports it. The BCG-naïve application is a different kind of test: it rests on a randomized trial against BCG alone, not a single-arm study or an extrapolation. The agency will have the final complete response rates, the durability data, and the safety database. The public has only the topline.
Why the BCG-naïve market matters
Non-muscle invasive bladder cancer accounts for the majority of bladder cancer diagnoses. For high-risk patients, the standard first-line treatment is BCG induction followed by maintenance. BCG is not a gentle therapy, and it is not always available. A 2025 global survey found that 45% of physicians had been affected by BCG shortages, with centers reserving the drug for the highest-risk patients. Gemcitabine and docetaxel combinations have filled some of the gap, but the supply problem has not disappeared.
The BCG-naïve population is also much larger than the BCG-unresponsive population that ANKTIVA currently serves. The first two approvals were for patients who had already failed BCG. A first-line label would move the drug into the initial treatment decision, where the number of eligible patients is higher and the commercial stakes are larger. ImmunityBio reported $48.7 million in net product revenue in the third quarter, up 53% from a year earlier, and $143.6 million in the first nine months of 2026, up 92%, according to Investing.com. The company had $334.3 million in cash and marketable securities at the end of September.
The competitive landscape is crowded. PD-1 and PD-L1 combinations with BCG have produced positive phase 3 results in BCG-naïve disease. The CREST trial of sasanlimab plus BCG reported a 36-month event-free survival rate of 82.1% versus 74.8% with BCG alone, and the POTOMAC trial of durvalumab plus BCG reported a 24-month disease-free survival rate of 86.5% versus 81.6%. The ALBAN trial did not show a benefit. Those checkpoint combinations come with immune-related toxicity, including high-grade treatment-related adverse events in roughly a quarter of patients in the CREST and POTOMAC reports, which ANKTIVA's local IL-15 mechanism is designed to avoid. Gemcitabine and docetaxel combinations are also used off label, with phase 2 data showing high response rates. ANKTIVA's argument is that it adds an immune signal without adding the systemic toxicity of a checkpoint inhibitor, and that it is already approved and familiar to urologists.
The evidence question
The primary endpoint is a surrogate. A complete response at six months is a meaningful milestone for a bladder-preserving strategy, but it is not the same as long-term freedom from recurrence or progression. The FDA has accepted complete response rates in this disease before, including in the BCG-unresponsive approvals, so the endpoint itself is not the obstacle. The question is the size and durability of the effect.
The interim data suggest the combination could be meaningfully better than BCG alone. An 85% versus 57% complete response rate at six months is a large difference, even if the p-value in that interim cut did not cross the conventional threshold. The nine-month data pointed in the same direction. But interim analyses are designed to be looked at, not to be quoted as final. The final analysis is the one that matters, and the company has not released the number.
The trial has other limits. It is open-label, so investigators and patients know which treatment they received, which can influence quality-of-life reporting and the decision to continue maintenance. The primary endpoint is a six-month snapshot, not a long-term recurrence or progression endpoint. And the topline is a company summary, not a peer-reviewed publication. The full data will need to survive both the FDA's review and the scrutiny of urologists who have seen promising interim results fade in larger trials.
There is also the question of what the FDA will require for a first-line label. The agency could approve the combination for BCG-naïve carcinoma in situ, for carcinoma in situ with or without papillary disease, or for a broader population. It could require a post-marketing study of durability. It could convene an advisory committee. The company's sBLA submission will start that process, and the review will take months.
What patients should know
For patients with high-risk non-muscle invasive bladder cancer, BCG remains the standard first-line treatment. ANKTIVA is approved only for patients whose disease has not responded to BCG. The new trial is a step toward a first-line option, not a change in the current standard of care, and the FDA has not yet reviewed the application.
The safety data in the topline are encouraging: adverse events were consistent with BCG alone, and there were no treatment-related deaths. But the trial is open-label, and the final safety database will be larger than the topline summary. Patients considering the combination should talk with their urologist about the current evidence, the availability of BCG, and the alternatives.
What to watch
The sBLA submission is the next milestone. The company says it will file before the end of the year. The FDA will then decide whether to accept the application, how quickly to review it, and whether to convene an advisory committee. The full data will likely be presented at a medical meeting, where clinicians can see the complete response rates, the durability curves, and the subgroup analyses.
The label decision will also be a test of how the FDA treats first-line immunotherapy combinations in bladder cancer. The checkpoint inhibitor combinations are further along in development but carry more toxicity. ANKTIVA's advantage is its safety profile and its existing approval. Its disadvantage is the missing final data and the possibility that the effect is smaller than the interim numbers suggested.
The company's commercial position adds pressure. ANKTIVA is the core of ImmunityBio's revenue, and a first-line label would expand the market substantially. The company has said the results support using the combination earlier in the treatment journey. The FDA will decide whether the evidence supports that claim.
The topline is a milestone. The complete response rate is the number that will decide whether the drug moves to the front of the line.
Primary sources
- ImmunityBio's Nov. 9, 2026 announcement for the QUILT-2.005 Cohort A topline, the primary endpoint, safety summary, and sBLA timeline.
- Urology Times for the trial design, the 366-patient Cohort A, the six-month complete response endpoint, and the prior interim results.
- Investing.com for the October 2026 label expansion, the Q3 2026 revenue, and the company's cash position.
- ClinicalTrials.gov record NCT02138734 for the QUILT-2.005 trial design and population.
- Medthority for the 2025 global survey on BCG shortages and the treatment alternatives.