Anktiva targets expanded indication in US and global approvals in EU and UK

ImmunityBio has announced plans to submit a supplemental biologics license application (sBLA) to the FDA in 2025 for an additional approval of nogapendekin alfa inbakicept-pmln (Anktiva) for patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) in the papillary indication.¹

The anticipated sBLA is supported by data from cohort B of the QUILT-3.032 trial.

Anktiva was previously approved in the US in April 2024 for use in combination with BCG in the treatment of patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors.

According to the company, “This immunotherapy of rescuing BCG with ANKTIVA (nogapendekin alfa inbakicept-pmln), now approved in the CIS indication, represents a step towards providing therapeutic options in patients with BCG unresponsive NMIBC in papillary disease who currently have limited treatment choices and face radical total cystectomy (removal of bladder). The addition of the papillary indication could expand the potential patient population benefiting from this therapy and may allow patients to avoid the high morbidity and mortality associated with radical total cystectomy.”

The anticipated sBLA is supported by data from cohort B of the QUILT-3.032 trial (NCT03022825), which assessed Anktiva in combination with BCG in patients with histologically confirmed BCG-unresponsive high-grade Ta/T1 papillary NMIBC.²

In total, 82 patients were included in the efficacy population with a median follow-up of 20.7 months (range, 2.9 to 37.1 months). The median disease-free survival (DFS) was 19.3 months (95% CI, 7.4 to not reached). Per Kaplan Meier estimates, DFS was 55.4% (95% CI, 42% to 66.8%) at 12 months, 51.1% (95% CI, 37.6% to 63.1%) at 18 months, and 48.3% (95% CI, 34.5% to 60.7%) at 24 months.

Further, the cystectomy rate was 7% (5 of 72 patients).

Additional data showed a progression-free survival of 97.1%, 94.8%, and 88.8% at 12, 18, and 24 months, respectively. Overall survival was 98.6%, 94.3%, and 91.7% at these same time points. Disease-specific survival was 100% at 12 months and 97.7% at 24 months.

Overall, the QUILT-3.032 trial enrolled patients across 3 study cohorts. Cohorts A and C in the trial included patients with BCG-unresponsive bladder CIS with or without Ta/T1 papillary tumors who received N-803 plus BCG (cohort A) or N-803 alone (cohort C). The trial also enrolled patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC who received N-803 plus BCG (cohort B).

The study remains ongoing, with final completion anticipated for October 2028.³

Additional updates from ImmunityBio

In addition to the planned sBLA submission in the US, ImmunityBio also submitted marketing authorization applications (MAA) to regulatory authorities in the EU and UK, seeking approval of Anktiva plus BCG for patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors.⁴

The submissions to the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) were completed in December and November 2024, respectively.

“The submission of our applications to EMA and MHRA represents a significant milestone in our efforts to address this critical need and improve patient outcomes globally,” said Patrick Soon-Shiong, MD, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, in the news release.⁴

According to the company, the EMA and MHRA assessments of these applications are expected to be completed by Q4 of 2025, enabling potential approvals by 2026.

References

1. ImmunityBio provides regulatory update on anticipated FDA submissions in 2025 following meeting with the agency. News release. ImmunityBio, Inc. January 15, 2025. Accessed January 16, 2025.

2. 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

3. QUILT-3.032: A multicenter clinical trial of intravesical Bacillus Calmette-Guerin (BCG) in combination with ALT-803 (N-803) in patients with BCG unresponsive high grade non-muscle invasive bladder cancer. ClinicalTrials.gov. Last updated April 8, 2024. Accessed January 16, 2025. https://clinicaltrials.gov/study/NCT03022825

4. ImmunityBio provides regulatory update on global submission for ANKTIVA + BCG in BCG unresponsive non-muscle invasive bladder cancer with carcinoma in situ in Europe and United Kingdom. News release. January 15, 2025. Accessed January 16, 2025. https://immunitybio.com/immunitybio-provides-regulatory-update-on-global-submission-for-anktiva-bcg-in-bcg-unresponsive-non-muscle-invasive-bladder-cancer-with-carcinoma-in-situ-in-europe-and-united-kingdom/