Nogapendekin Alfa/BCG Earns Israeli Approval in BCG-Unresponsive NMIBC

Nogapendekin alfa inbakicept-pmln (Anktiva) in combination with Bacillus Calmette-Guérin (BCG) has been approved in Israel for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors, according to a news release from the developer, ImmunityBio.¹ The company obtained the approval in collaboration with its partner, Rafa Laboratories Ltd.

What does the Israeli approval of nogapendekin alfa inbakicept cover?

The approval covers the same patient population as the agent’s initial FDA indication: patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors. According to ImmunityBio, the Israeli approval brings the number of global approvals for the agent to 35 countries.

The company also reported that the first patients in Europe have received nogapendekin alfa inbakicept plus BCG for BCG-unresponsive NMIBC with CIS, with or without papillary tumors.

What data support nogapendekin alfa inbakicept in BCG-unresponsive NMIBC?

The approved indication is supported by the phase 2/3 QUILT-3.032 trial (NCT03022825), an open-label, single-arm, multicenter study of nogapendekin alfa inbakicept plus BCG. Long-term results from cohort A, which enrolled 100 patients with BCG-unresponsive NMIBC with CIS, with or without papillary disease, were recently published in The Journal of Urology.²

In that analysis, the complete response (CR) rate was 71% (n = 71/100; 95% CI, 61.1%-79.6%) at a median follow-up of 25.7 months (range, 3.2-63.5). The CR rate was 80% (95% CI, 68.7%-88.6%) among patients who received induction only and 50% (95% CI, 31.3%-68.7%) among those who required reinduction. By baseline disease type, CR rates were 69% (95% CI, 57.1%-79.2%) with CIS alone, 82% (95% CI, 56.6%-96.2%) with CIS plus Ta disease, and 67% (95% CI, 29.9%-92.5%) with CIS plus T1 disease.

Among responders, the median duration of CR was 26.6 months (95% CI, 13.0-49.9; range, 0.03-53.62), and the probabilities of maintaining a CR for at least 12, 24, and 36 months were 63.8% (95% CI, 51.0%-74.1%), 52.3% (95% CI, 39.0%-64.1%), and 44.2% (95% CI, 30.3%-57.2%), respectively. Estimated cystectomy-free rates among responders were 95.5% (95% CI, 86.6%-98.5%), 90.3% (95% CI, 79.7%-95.6%), and 84.2% (95% CI, 69.6%-92.1%) at 12, 24, and 36 months, respectively, and the 36-month disease-specific survival rate was 98.2% (95% CI, 88.2%-99.8%). Progression to T2 or higher disease occurred in 4% of responders (n = 3/71).

Grade 3 treatment-related adverse events occurred in 4% of patients, with no grade 4 or 5 events reported.

What is the regulatory history of nogapendekin alfa inbakicept?

The FDA first approvednogapendekin alfa inbakicept with BCG for adult patients with BCG-unresponsive NMIBC with CIS, with or without papillary tumors, on April 22, 2024.³ On October 14, 2026, the FDA approved a supplemental biologics license application expanding the indication to adult patients with BCG-unresponsive NMIBC, including those with high-grade papillary-only tumors.⁴

The Emirates Drug Establishment in the United Arab Emirates has also authorized the expanded indication, and ImmunityBio plans to pursue additional global filings for it. The agent was previously approved for BCG-unresponsive NMIBC with CIS in the UK and Saudi Arabia and received conditional approval in the EU.

In the BCG-naive setting, cohort A of the randomized QUILT-2.005 trial met its primary end point, and ImmunityBio plans to submit a supplemental biologics license application to the FDA in the fourth quarter of 2026.

How does nogapendekin alfa inbakicept work?

Nogapendekin alfa inbakicept is an interleukin-15 (IL-15) receptor superagonist designed to activate natural killer cells and CD4- and CD8-positive T cells. In NMIBC, it is administered intravesically in combination with BCG.

References

1. ImmunityBio reports label expansion and additional global approval with Q3 2026 net product revenue of $48.7 million, up 53% year-over-year and first nine months U.S. revenue up 92% to $143.6 million. News release. ImmunityBio. November 9, 2026. Accessed November 9, 2026. https://tinyurl.com/56a5v57m
2. Chang SS, Chamie K, Seabury CA, et al. Durable responses and cystectomy avoidance with IL-15 receptor agonist NAI plus BCG in BCG-unresponsive NMIBC with carcinoma in situ ± papillary disease. J Urol. 2026;216(5):663-675. doi:10.1097/JU.0000000000005198
3. FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. FDA. April 22, 2024. Accessed November 9, 2026. https://tinyurl.com/mvwccbpw
4. FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. FDA. October 14, 2026. Accessed November 9, 2026. https://tinyurl.com/38cp583x