GU Cancers 2026 | IMPROEV: induction-maintenance strategy in metastatic UC
Pooja Ghatalia, MD, Fox Chase Cancer Center, Philadelphia, PA, provides an overview of the IMPROEV trial (NCT07221942), which assesses a novel induction-maintenance approach for patients with previously untreated metastatic urothelial carcinoma (UC). This single-arm Phase II study evaluates enfortumab vedotin plus pembrolizumab induction followed by pembrolizumab maintenance, aiming to maintain efficacy while minimizing cumulative toxicity, particularly peripheral neuropathy. This interview took place at the 2026 ASCO GU Cancers Symposium in San Francisco, CA.
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Transcript
We have received funding through the Department of Defense to conduct a Phase II single-arm trial called IMPROEV. And in this trial, we are including patients with metastatic or locally advanced urothelial carcinoma who have not previously received systemic therapy. And patients will be receiving six cycles of induction with enfortumab-vedotin and pembrolizumab. Patients who have a CR or a PR will be discontinuing enfortumab-vedotin and will be continuing maintenance pembrolizumab for up to two years...
We have received funding through the Department of Defense to conduct a Phase II single-arm trial called IMPROEV. And in this trial, we are including patients with metastatic or locally advanced urothelial carcinoma who have not previously received systemic therapy. And patients will be receiving six cycles of induction with enfortumab-vedotin and pembrolizumab. Patients who have a CR or a PR will be discontinuing enfortumab-vedotin and will be continuing maintenance pembrolizumab for up to two years. And the primary endpoint of this study is 18-month progression-free survival. So sort of the rationale and background for doing this study is that we know that enfortumab-vedotin and pembrolizumab are very efficacious regimens. But we do know in clinical practice that administering these drugs until a patient is not able to tolerate it due to toxicity is not a very feasible option clinically because patients have a lot of neuropathy and other toxicities, more from enfortumab-vedotin, which leads to drug discontinuations. And some of the toxicities do not resolve over time, for example, the peripheral neuropathy. But we also have data available from numerous trials, including EV-201 single-arm phase two trials, EV-201 cohorts one and two, as well as with EV-302 data, and also with phase two single-arm EV-pembrolizumab trials, where patients who discontinue enfortumab-vedotin, possibly due to toxicity, continue to experience disease control beyond discontinuation. And based on that and also some of the pharmacokinetic data that was presented earlier with enfortumab-vedotin, we think that providing patients an opportunity to discontinue enfortumab-vedotin after an induction dose of EV and pembrolizumab may be a worthwhile strategy. We have also completed a pilot study looking at the same, which also has an EV monotherapy arm, and we don’t have the final results available yet, but this IMPROVE trial is basically a step up from after completing that pilot trial.
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