Novel Drug Boosts Responses to BCG Bladder Cancer Treatment

A novel treatment boosted another treatment in patients with non-muscle-invasive bladder cancer without affecting patient quality of life.

A novel “immune enhancer” improved outcomes and did not affect quality of life in patients with Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), according to findings from the ongoing phase 2/3 QUIKT 3.032 clinical trial.

Anktiva (N-803) is an interleukin-15 drug that makes patients more likely to respond to BCG therapy. In patients with prior BCG-unresponsive NMIBC (cohort A), findings showed that 71% responded to therapy (meaning that their cancer shrank or disappeared), while 89.2% were able to avoid a cystectomy (surgical removal of the bladder cancer). The average duration of complete response was 26.6 months.

Of note, approximately 80% of newly diagnosed bladder cancer cases are NMIBC. Although BCG therapy is the standard of care for patients with intermediate- or high-risk disease, nearly 40% to 50% of patients will not respond to or relapse after BCG treatment.

Findings also showed that among both cohort A and cohort B (patients with papillary disease), physical function and global health remained stable over the two-year study. Specifically, patients who achieved a complete response (meaning that all signs of their cancer disappeared) reported better physical function at month six than those who did not have a complete response.

“The self-reported stability of health and physical function over the course of the study by the participants reflect another aspect of safety and tolerability of this new combination therapy,” said Dr. Patrick Soon-Shiong, executive chairman and Global Chief Scientific and Medical Officer at ImmunityBio, the manufacturer of Anktiva, in a press release. “Taken together with the positive response rate in cohort A of over 70%, the persistence of responses and cystectomy avoidance, these (quality of life) findings suggest a favorable risk-benefit ratio for this potential new therapeutic option for patients with BCG-unresponsive bladder cancer.”

Notably, according to the release, patients in the study reported no decline in their health or urinary tract-related symptoms while participating in the trial.

“Many current therapies for bladder cancer slow disease progression but can cause debilitating side effects,” said principal investigator Dr. Karim Chamie, associate professor of Urology at UCLA. “The data from the QUILT 3.032 Quality of Life study suggest that many patients not only have a durable response but also report no decline in physical function, which is very important for these patients.”

These findings, in part, provided the basis for the Food and Drug Administration’s (FDA) October decision to accept a biologics license application for Anktiva plus BCG therapy for BCG-unresponsive bladder cancer.

READ MORE: New Agent Can Improve BCG Response, Quality of Life in Bladder Cancer

Now the FDA plans on making their approval decision on or by April 23, 2024.

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