Promising Results for BCG-naïve NMIBC Patients
Why are new treatment options for non-muscle invasive bladder cancer (NMIBC) crucial for patient outcomes? ImmunityBio a commercial-stage immunotherapy company, has completed enrollment in its Phase 2 clinical trial evaluating ANKTIVA® plus Bacillus Calmette-Guérin (BCG) versus BCG alone in patients with BCG-naïve NMIBC carcinoma in situ (CIS), with or without papillary tumors. The QUILT 2.005 trial, which enrolled 366 patients ahead of schedule, has shown promising interim results, suggesting that the combination therapy could significantly improve the duration of complete response compared to BCG alone.
The interim analysis, requested by the U.S. Food and Drug Administration (FDA), demonstrated that at six months, 85% of patients receiving ANKTIVA plus BCG maintained a complete response, compared with 57% of patients treated with BCG alone. At nine months, 84% of subjects in the ANKTIVA plus BCG arm maintained a complete response, compared with 52% of patients in the BCG-alone arm. These results, which reached statistical significance (p=0.0455), highlight the potential of ANKTIVA to enhance treatment efficacy without significant safety concerns.
Key Insights at a Glance
- Interim Results: 85% of patients receiving ANKTIVA plus BCG maintained a complete response at six months.
- Statistical Significance: The difference in complete response duration at nine months reached statistical significance (p=0.0455).
- Safety Profile: No significant safety concerns were reported in the interim analysis.
- Future Plans: ImmunityBio anticipates submitting a biologics license application (BLA) to the FDA by Q4 2026.
The Urgency of Improving NMIBC Treatment Outcomes
The current standard-of-care for NMIBC CIS, BCG alone, has limitations that have long been recognized by the medical community. The interim results from the QUILT 2.005 trial suggest that ANKTIVA plus BCG could address these limitations by significantly improving the duration of complete response. Dr. Christopher Pieczonka, Corporate Director of Clinical Research at U.S. Urology Partners and Global Principal Investigator of the trial, noted.
The interim results from this randomized study are encouraging and suggest that ANKTIVA plus BCG may improve the durability of response in patients with BCG-naïve NMIBC.” This improvement is crucial for patients who may not respond adequately to BCG alone, highlighting the urgent need for more effective treatment options.
A Fresh Approach to Bladder Cancer Therapy
Just as a gardener cultivates a garden by nurturing both the soil and the plants, ImmunityBio is addressing NMIBC by enhancing the body’s immune response through a combination of ANKTIVA and BCG. ANKTIVA, a first-in-class IL-15 agonist IgG1 fusion complex, activates key immune cells such as NK and CD8+ killer T cells, which are essential for fighting cancer.
By overcoming the tumor escape phase and restoring memory T cell activity, ANKTIVA aims to provide a more durable and effective treatment. Patrick Soon-Shiong, Founder, Executive Chairman, and Global Chief Scientific and Medical Officer of ImmunityBio, stated, “We are encouraged by these interim results and await the final unblinding of the completed trial. If approved, ANKTIVA plus BCG could offer a new treatment option earlier in the disease course for patients with NMIBC CIS.”
Future Outlook
ImmunityBio anticipates that additional study results will be available in the fourth quarter of 2026, which will inform the submission of a biologics license application (BLA) to the FDA by the same timeframe. The company is also addressing the ongoing shortage of TICE® BCG through its Expanded Access Program (EAP) for recombinant BCG, which is progressing and supporting patient access. The potential approval of recombinant BCG as an alternative supply source could further enhance treatment options for patients with BCG-naïve disease. As the clinical landscape continues to evolve, the focus on innovative immunotherapies like ANKTIVA is likely to play a pivotal role in improving patient outcomes.
Conclusion
The interim results from ImmunityBio’s Phase 2 trial of ANKTIVA plus BCG offer a promising new direction for the treatment of BCG-naïve NMIBC. For healthcare providers and patients, this combination therapy could provide a more effective and durable treatment option, potentially changing the standard-of-care recommendations. How is your practice preparing for this shift in bladder cancer treatment? Join the conversation in the comments below.
About ImmunityBio
ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield™ platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA® (nogapendekin alfa inbakicept).
Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy.
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