MD Anderson, UroGen Pharma collaborate on novel immunotherapy for NMIBC

Jason M. Broderick

The collaboration will focus on the novel combinatorial intravesical immunotherapy UGN-302 as a potential treatment for patients with high-grade non-muscle invasive bladder cancer.

The University of Texas MD Anderson Cancer Center announced that it has entered into an agreement with UroGen Pharma to study the novel combinatorial intravesical immunotherapy UGN-302 as a potential treatment for patients with high-grade non-muscle invasive bladder cancer (NMIBC).1

The investigational intravesical treatment UGN-302 combines the toll-like receptor 7/8 agonist UGN-201 with the anti–CTLA-4 antibody UGN-301. The treatment is delivered directly to the bladder using RTGel, a platform developed by UroGen.

“Immune checkpoint inhibitors have become important treatment options for many patients with bladder cancer, and we look forward to working with UroGen to advance new immunotherapy strategies with intravesical delivery,” James Allison, PhD, chair of Immunology, executive director of the immunotherapy platform and co-director of the Parker Institute for Cancer Immunotherapy at MD Anderson, stated in a press release.

“This novel delivery approach has the potential to limit the adverse events seen with systemic immunotherapy treatment while providing clinical benefit, which would represent a major advancement to patient care,” added Allison.

Under the 3-year strategic collaboration, MD Anderson and UroGen will work together on designing and carrying out clinical and nonclinical studies of UGN-302. A joint steering committee will provide oversight. Funding will be provided by UroGen.

Commenting on the collaboration in the press release, Mark Schoenberg, MD, chief medical officer of UroGen, stated, “We are pleased to enter into this collaboration with MD Anderson and its immunotherapy platform, which brings unique translational and clinical expertise in immuno-oncology. This agreement will help UroGen potentially bring next-generation immunotherapy to bladder cancer patients with a significant unmet need and limited clinical options other than bladder removal.”

In the bladder cancer treatment paradigm, UroGen previously developed mitomycin-containing reverse thermal gel, known as Jelmyto. In April 2020, the FDA approved Jelmyto as the first therapy to treat patients with low-grade upper tract urothelial carcinoma (UTUC).

The approval was based on data from the phase 3 OLYMPUS trial, which included patients from 24 academic centers in the United States and Israel. To be eligible for enrollment, adult patients had to have treatment-naïve or recurrent disease, ≥1 measurable papillary low-grade tumor ≤15 mm, and a wash urine cytology sampled from the pyelocaliceal system showing the absence of high-grade disease.

The primary analysis of trial, on which the FDA approval was based, showed that 59.2% (n = 42) of the 71-patient ITT population achieved a complete response (CR).2 Eight patients had a partial response. Additionally, 20 (58.8%) of 34 patients considered unresectable at baseline by the treating urologist achieved a CR. Data for a key study secondary outcome measure showed that 56.1% of patients who achieved a CR to Jelmyto maintained that response at 12 months.3 This translated to an 81.8% probability of maintaining a CR at the 12-month visit.

Reference

1. MD Anderson and UroGen Pharma announce strategic research collaboration to advance investigational treatment for high-grade bladder cancer. Posted online January 13, 2021. https://bit.ly/3qiRdJY. Accessed January 13, 2021.

2. Kleinmann N, Matin SF, Pierorazio PM, et al. Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial. Lancet Oncol. 2020;21(6):776-785.doi: 10.1016/S1470-2045(20)30147-9

3. Lerner S, Matin S, Kleinmann N, et al. Durability of response to chemoablative treatment of low-grade upper tract urothelial carcinoma with a mitomycin-containing reverse thermal hydrogel: Final results of the OLYMPUS trial. 2020 Society of Urologic Oncology Annual Meeting (virtual). December 3-5, 2020. Abstract 16.