The European Commission has approved nogapendekin alfa inbakicept plus BCG in BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
The European Commission has granted conditional marketing authorization to nogapendekin alfa inbakicept-mln (Anktiva) plus BCG in adult patients with BCG-unresponsive non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.1
The regulatory decision was supported by data from the phase 2/3 QUILT-3.032 trial (NCT03022825). Findings from QUILT-3.032 showed that patients who received nogapendekin alfa inbakicept plus BCG (n = 100) achieved a complete response (CR) rate of 71% (95% CI, 61%-80%); responses lasted up to 54 months and longer and were ongoing at the time of the data cutoff. The median duration of CR was 6 months (95% CI, 13.0-49.9).
“The European Commission’s authorization of [nogapendekin alfa inbakicept] in combination with BCG marks a defining moment for patients with BCG-unresponsive NMIBC CIS across Europe, who until now have had no authorized treatment and faced radical cystectomy as their only alternative,” Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer of ImmunityBio, stated in a news release.1
QUILT-3.032 was an open-label, single-arm, multicenter study that enrolled patients with BCG-unresponsive, high-grade NMIBC.4 To be eligible for enrollment, patients needed to be at least 18 years old and have an ECOG performance status of 0 to 2. Patients also had to have no resectable disease following transurethral resection; CIS was permitted.
All patients received mixed BCG and nogapendekin alfa inbakicept via intravesical instillation weekly for 6 consecutive weeks. After the first disease assessment, eligible patients received a 3-week maintenance course or a 6-week reinduction course at month 3. Eligible patients continued to receive maintenance therapy in the third treatment period at months 6, 9, 12, and 18; maintenance therapy in the fourth treatment period at months 24, 30, and 36 was also available for eligible patients.
The study’s primary end points were CR rate in cohorts A and C and disease-free rate in cohort B, respectively. Secondary end points included duration of CR as well as CR rates at 6, 9, 12, 18, and 24 months. The CR rate at any time for patients with CIS per central pathology review was also a secondary end point.
The 12-month and 24-month CR rates for responders were 66% and 42%, respectively.1 The 12-, 24-, and 36-month cystectomy-free survival rates for responders were 96%, 90%, and 84%, respectively. The 24- and 36-month disease-specific survival rates among all patients were both 99%.
In the safety population (n = 180), most treatment-related adverse effects (TRAEs) were grade 1 or 2. Grade 3 TRAEs were reported in 3% of patients; no grade 4 or 5 TRAEs occurred. The most common any-grade adverse effects included dysuria, hematuria, pollakiuria, urinary tract infection, micturition urgency, fatigue, chills, musculoskeletal pain, and pyrexia.
“With [nogapendekin alfa inbakicept] now authorized in 33 countries from the United States and United Kingdom to the European Union and Saudi Arabia, we have built the broadest global access platform for an immunotherapy in this indication. With more than 80% of treated patients preserving their bladder through 3 years of follow-up, [nogapendekin alfa inbakicept] represents a meaningful advance designed to strengthen the immune response and extend the durability of BCG,” Soon-Shiong added in the news release.
