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.
Basics
QUILT-3.032/NCT0302285 – single-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.
Results
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.
About OncoDaily
OncoDaily was founded in 2023. It is a US-based oncology media platform, which features the latest news, insights, and patient stories from the world of oncology. Within a short period of time it became one of the leading oncology media platforms globally.
OncoDaily gathers content from various sources, including social media posts from renowned oncologists from all over the world, news from oncology societies and cancer centers, patient and survivor stories, and career-related information for professionals.
The mission of OncoDaily is to empower patients, survivors, and professionals with the knowledge and inspiration they need to fight cancer. The motto of OncoDaily is “Cancer doesn’t take a day off – neither do we”.
-
ESMO 2024 Congress
September 13-17, 2024
-
ASCO Annual Meeting
May 30 - June 4, 2024
-
Yvonne Award 2024
May 31, 2024
-
OncoThon 2024, Online
Feb. 15, 2024
-
Global Summit on War & Cancer 2023, Online
Dec. 14-16, 2023