2 Clarke Drive
Suite 100
Cranbury, NJ 08512
© 2025 MJH Life Sciences™ and OncLive - Clinical Oncology News, Cancer Expert Insights. All rights reserved.
The EMA recommended conditional marketing authorization for nogapendekin alfa inbakicept plus BCG in BCG-unresponsive NMIBC with CIS.
The European Medicines Agency has recommended conditional marketing authorization for nogapendekin alfa inbakicept-pmln (Anktiva) in combination with BCG for the treatment of patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS).1
The recommendation was supported by data from the phase 2/3 QUILT-3.032 trial (NCT03022825). Findings presented at the 2025 American Urological Association Annual Meeting showed that among patients with NMIBC CIS with or with papillary disease treated in cohort A (n = 100), nogapendekin alfa inbakicept plus BCG yielded a complete response (CR) rate of 71% (95% CI, 61.1%-79.6%) and a median duration of CR (DOCR) of 53+ months.2 The duration of response (DOR) was at least 12 months in 60% of responders.
Additionally, 96%, 90%, and 84% of patients were cystectomy free at 12, 24, and 36 months, respectively. The 12-, 24-, and 36-month disease-free survival (DFS) rates were 100%, 99%, and 99%, respectively.
“Nogapendekin alfa inbakicept represents an important evolution in the treatment of NMIBC CIS, strengthening the immune response and improving the durability of BCG,” Patrick Soon-Shiong, founder, executive chairman and global chief scientific and medical officer of ImmunityBio, stated in a news release. “Hundreds of patients in the United States are already experiencing the benefits of this therapy, and our goal is to make it available to patients in Europe and other parts of the world as quickly and responsibly as possible, to ensure avoidance of a radical cystectomy. We are pleased that the EMA issued this positive recommendation based on our single-arm trial and through a regulatory process that allows earlier access to [nogapendekin alfa inbakicept], when as stated in the EMA announcement, the benefit of a medicine’s immediate availability to patients outweighs the inherent risks.”
In April 2024, the FDA approved nogapendekin alfa inbakicept in combination with BCG for the treatment of adult patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors, based on data from QUILT-3.032.3
The open-label, single-arm, multicenter study enrolled patients at least 18 years of age with histologically confirmed NMIBC of transitional cell carcinoma high-grade subtype.4 Patients needed to have BCG-unresponsive CIS with or without Ta or T1 disease, and an ECOG performance status of 0 to 2 was also required.
Investigators excluded patients with recurrence of BCG-unresponsive Ta or T1 disease without CIS more than 6 months after last BCG treatment, along with those with BCG-unresponsive CIS more than 12 months after the final BCG instillation.
Enrolled patients received nogapendekin alfa inbakicept mixed with BCG and saline, which was administered intravesically once per week for 6 consecutive weeks. Following first disease assessment, patients were allowed to receive the same treatment as 3-week maintenance or as 6-week re-induction at month 3. Maintenance was allowed to be continued at months 6, 9, 12, and 18, and then again at months 24, 30, and 36.
CR rate and DFS served as the trial’s primary end points. Secondary end points included DOR and DOCR.
Findings for QUILT-3.032 showed that in cohorts A and B (n = 180), nogapendekin alfa inbakicept plus BCG led to grade 3 treatment-related adverse effects (TRAEs) in 3% of patients.2 No grade 4 or 5 TRAEs were reported.
Most TRAEs were grade 1 and 2, and they were related to intravesical instillation and consistent with BCG alone. The most common TRAEs included dysuria, pollakiuria, hematuria, and micturition urgency.
Related Content:
