Patients with a hard-to-treat form of bladder cancer have gained a new guideline-backed option. The National Comprehensive Cancer Network (NCCN) has added nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG to its bladder cancer guidelines for non-muscle invasive bladder cancer (NMIBC) that no longer responds to BCG and involves papillary-only disease.
Version 1.2026 of the guidelines lists the combination as a category 2A recommendation. That widens an earlier category 2A recommendation covering BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary disease. The FDA had approved the combination for that CIS group in April 2024, based on cohort A of the QUILT-3.032 trial.
What the trial showed
The new recommendation rests on cohort B of the phase 2/3 QUILT-3.032 trial (NCT03022825), which enrolled 80 patients with high-grade papillary-only disease. Their 12-month disease-free survival was 58.2% (95% CI, 46.6%-68.2%), meeting the trial’s primary end point. At 24 and 36 months the rates were 52.1% and 38.2%.
Median follow-up was 30.2 months. Median progression-free survival, disease-specific survival and time to cystectomy had not been reached. Progression-free survival stood at 94.9%, 88.7% and 83.1% at 12, 24 and 36 months, and the rates of avoiding bladder removal were 92.2%, 87.9% and 81.8%.
Across cohorts A and B (180 patients), grade 1 or 2 treatment-related adverse effects occurred in 61%. Grade 3 events were reported in 3%. There were no grade 4 or 5 events, no treatment-related deaths and no immune-related grade 3 events.
The open-label, multicenter study enrolled adults with BCG-unresponsive high-grade Ta/T1 papillary disease and an ECOG performance status of 2 or less. Patients had their index lesions removed by transurethral resection first. Everyone received the drug at 400 μg with BCG at 50 mg, instilled into the bladder weekly for six weeks.
What comes next
ImmunityBio, the drug’s developer, resubmitted a supplemental biologics license application to the FDA in March 2026 for the papillary-only indication. Founder Patrick Soon-Shiong said the guideline change is “an important milestone” for patients who have exhausted standard BCG therapy, and that the company awaits the FDA’s review. Chief executive Richard Adcock said the update validates the growing role of immune-based therapies.
Patients weighing their options should talk to their doctor. For people whose cancer has stopped responding to BCG, the encouraging part is that more bladder-sparing choices are being studied and recognized. Consult your doctor for medical advice.
