California-based ImmunityBio, Inc. announced that Papillary disease (Cohort B), the second indication of its QUILT 3.032 Phase 2/3 study of intravesical BCG plus Anktiva in patients with BCG-unresponsive high-grade NMIBC, also met its primary endpoints with disease-free survival of 57% of patients at 12 months.
To date, 73 patients have enrolled in Cohort B with a median follow-up of 17.3 months.
The Company previously reported that the primary endpoint of Cohort A, patients with CIS disease, has been met with a complete response of 72% (58/81).
Non-muscle invasive bladder cancer (NMIBC) makes up 75%-85% of all bladder cancers in the U.S.
And approximately 90% of NMIBC cases are papillary (stages Ta and T1).
The current standard of care for the high-grade papillary disease is intravesical BCG, with a 40% non-response rate.
The primary endpoint was met with a disease-free rate at 12-months of 57% (95% CI: 43.7%, 68.5%) and at 18-months, 53% (95% CI: 38.8%, 64.6%) by Kaplan-Meier analysis. Durable responses were noted in both cohorts, and the therapy resulted in significant avoidance of cystectomy.
The safety profile of Anktiva (N-803) in Cohort B was consistent with that seen in Cohort A, which was recently presented at the American Urological Association's 2021 Annual meeting, in which 0% SAEs, including 0% immune-related SAEs, were detected.
In addition, 85% of the patients were able to avoid a cystectomy. A full analysis of efficacy and safety data for both Cohorts A (CIS) and B (Papillary) has been submitted to the American Society of Clinical Oncology Genitourinary Cancer Symposium (ASCO GU) which is taking place in February 2022.
"Intravesical BCG has been the standard of care for more than 30 years for patients with non-invasive papillary tumors, yet, unfortunately, some 40% of them don't respond," said Patrick Soon-Shiong, M.D., Founder, and Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio.
"Anktiva has demonstrated strong disease control in CIS, and based on the latest data from our study, it is showing the same effect in papillary tumors."
"This gives us confidence in the potential for all BCG-unresponsive NMIBC patients to benefit from this combination therapeutic."
The U.S. Patent & Trademark Office has recently allowed ImmunityBio's patent application for a method of treating cancer, including non-muscle invasive bladder cancer, using Anktiva (N-803) in combination with Bacillus Calmette-Guerin (BCG). The new patent will extend patent life on the N-803/BCG combination therapy for bladder cancer to at least 2035.