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JU INSIGHT: A Phase 2 Trial of Nab-paclitaxel in Combination With Anti-PD1 Therapy in Advanced Urothelial Cancer

By: Irene Tsung, MD; Edward Green, MPH; Phillip Palmbos, MD, PhD; Zachery Sloan, MS; Zachery R. Reichert, MD, PhD; Ulka Vaishampayan, MD; David C. Smith, MD; Megan E. V. Caram, MD; Sarah Yentz, MD; Stephanie Daignault-Newton, MS; Laura Hurley, BS; Charles B. Nguyen, MD; Shawna Kraft, PharmD; Ajjai Alva, MD | Posted on: 04 Jan 2023

Tsung I, Green E, Palmbos P, et al. A phase 2 trial of nab-paclitaxel in combination with anti-PD1 therapy in advanced urothelial cancer. J Urol. 2023;209(1);121-130.

Study Need and Importance

Current first-line treatment for advanced urothelial carcinoma (aUC) is platinum-based (preferably cisplatin) combination chemotherapy. In the second-line setting, pembrolizumab immunotherapy is standard. Taxane chemotherapy had shown single-agent activity. We sought to evaluate the combination of nab-paclitaxel (NAB) and pembrolizumab in patients with cisplatin-ineligible or platinum-refractory aUC.

Figure. Waterfall plot of tumor response in patients with advanced urothelial carcinoma (N = 34).

What We Found

Of 36 response evaluable patients, the confirmed overall response rate was 50% and included 3 complete and 15 partial responses. Target lesion tumor shrinkage occurred in 30 of 36 patients during therapy (see Figure). At a median follow-up of 19.7 months, median duration of response was 4.4 months (95% CI: 4.0-8.6), median progression-free survival 6.8 months (95% CI: 4.4-not reached), and median overall survival 18.2 months (95% CI: 10.6- not reached). The starting dose of NAB was reduced due to excessive neuropathy. After the reduction in the NAB starting dose, therapy was well tolerated.

Limitations

Study limitations include small size, single site, and single-arm design. Only 4 women were enrolled, and data on tumor biomarkers (programmed death-ligand 1 and comprehensive tumor genomic profiling) were incomplete.

Interpretation for Patient Care

The landscape of treatment options for aUC continues to rapidly evolve with newer combination approaches such as antibody-drug conjugates with checkpoint inhibitors. Our study shows the combination of chemoimmunotherapy using NAB and pembrolizumab also has promising activity and can be an efficacious and feasible option for cisplatin-eligible or platinum-refractory aUC. Chemoimmunotherapy can potentially expand the repertoire of therapy options in later lines of treatment.

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