July, 2024
July 2024
FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer
Apr 24, 2024, 09:13

FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

FDA, the Food and Drug Administration, approved nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience, LLC) with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.


QUILT-3.032/NCT0302285single-arm, multicenter, open-label Phase II/III trial

  • Population – BCG-unresponsive, high-risk NMIBC with CIS with or without Ta/T1 papillary disease following transurethral resection
  • Study size – 77 patients
  • Arms – BCG+N-803 and N-803 alone
  • Primary outcome measures – 1/ 60 Months complete response of CIS (with or without Ta/T1 papillary disease) patients at any time; 2/ Disease-Free Rate at 12 months since first study treatment
  • Secondary outcome measures – duration of complete response; disease-free survival; complete response rate and disease-free rate at 6-9-12-18-24 months.


CR rate – 62% (95% CI: 51, 73) – 58% of patients with CR had a DOR ≥ 12 months and 40% had a DOR ≥ 24 months.

The most common adverse reactions (≥15%), including laboratory test abnormalities, were increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia.

IL-15 Superagonist NAI in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer
Authors: Karim Chamie, Sam S. Chang, Eugene Kramolowsky, Mark L. Gonzalgo, Piyush Kumar Agarwal, Jeffrey C. Bassett, Marc Bjurlin, Michael L. Cher, William Clark, Barrett E. Cowan, Richard David, Evan Goldfischer, Khurshid Guru, Mark W. Jalkut, Samuel D. Kaffenberger, Jed Kaminetsky, Aaron E. Katz, Alec S. Koo, Wade J. Sexton, Sergei N. Tikhonenkov, Edouard J. Trabulsi, Andrew F. Trainer, Patricia Spilman, Megan Huang, Paul Bhar, Sharif A. Taha, Lennie Sender, Sandeep Reddy, and Patrick Soon-Shiong.

Quality of life in QUILT 3.032 study: Patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) receiving IL-15RαFc superagonist N-803 plus BCG
Authors: Karim Chamie, Sam S. Chang, Eugene V. Kramolowsky, Mark L. Gonzalgo, Stanislav Lechpammer, Sandeep K. Reddy, and Patrick Soon-Shiong.

Read further on the FDA website.

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