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Dr. Siefker-Radtke on upfront erdafitinib/cetrelimab in cisplatin-ineligible urothelial cancer


“Our ultimate goal is to come up with strategies that really enhance the life expectancy and the treatment options for our patients with urothelial cancer,” says Arlene O. Siefker-Radtke, MD.

In this video, Arlene O. Siefker-Radtke, MD, professor of genitourinary medical oncology at The University of Texas MD Anderson Cancer Center, discuses the 2023 ASCO Annual Meeting Abstract, “Erdafitinib (ERDA) vs ERDA plus cetrelimab (ERDA+CET) for patients (pts) with metastatic urothelial carcinoma (mUC) and fibroblast growth factor receptor alterations (FGFRa): Final results from the phase 2 Norse study” (abstract 4504).


The clinical trial that it's my pleasure presenting at this year's ASCO meeting is the NORSE clinical trial. This clinical trial was designed to test the combination of erdafitinib with the PD-1 inhibitorcetrelimab in the frontline treatment of patients with metastatic, surgically unresectable urothelial carcinoma. This trial was designed as a randomized yet non-comparative cohort trial with erdafitinib as a single agent, and then the combination of erdafitinib with cetrelimab.

And if we look at the biology behind the design, there's been historical literature suggesting that the FGFR3 alterations are present in more immunologically cold tumors. So the goal was to see if this combination could overcome any potential immuno-resistance, or perhaps enhance the clinical activity of erdafitinib in the FGFR3-altered urothelial carcinoma population.

The results of this trial are quite promising. It was a frontline trial (no prior therapy) for patients who are ineligible for cisplatin-based chemotherapy. The treatment of these patients has long been an unmet need, with over 50% of patients not eligible for standard of care cisplatin-based regimens, so developing alternatives would be very important to enhance activity. The results appeared quite compelling. Single agent erdafitinib had an objective response rate of around 45%. The combination of erdafitinib and cetrelimabhad an objective response rate of around 55%. We also saw deeper and more durable responses with the combination. We saw nearly a 14% complete response rate with the combination treatment. This also translated to an impact in progression-free survival was single agent erdafitinib having a progression-free survival of around 5.5 months, and the combination arm having a median survival of around 11 months. The median overall survival with erdafitinib alone was around 16 months, whereas the combination had a median overall survival of around 20.8 months.

So as a result of this trial, we see that single-agent erdafitinib had similar clinical activity to what has been reported previously in the second-line treatment of urothelial carcinoma. The combination appears promising, as well. So I feel the combination is worth further study, as well. But our ultimate goal is to come up with strategies that really enhance the life expectancy and the treatment options for our urothelial cancer patients.

Transcript has been edited for clarity.

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