Commentary

Video

Dr Sharma on the Role of Enfortumab Vedotin Plus Pembrolizumab in Bladder Cancer

Janaki Neela Sharma, MD, discusses how data from EV-302 further defined the role of frontline enfortumab vedotin plus pembrolizumab in bladder cancer.

“EV-302 read out [in 2023]... [Data from this study] led to the eventual full FDA approval of [treatment with enfortumab vedotin plus pembrolizumab] in patients with bladder cancer in the frontline [setting].”

Janaki Neela Sharma, MD, assistant professor, clinical medicine, Genitourinary Medical Oncology, University of Miami Health Systems, discusses how data from the randomized, open-label, phase 3 EV-302/KEYNOTE-A39 trial (NCT04223856) further defined the role of frontline enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) in patients with advanced urothelial cancer, irrespective of cisplatin eligibility.

This study included a broad population of patients with previously untreated metastatic bladder cancer, comparing the combination therapy against the standard chemotherapy regimen of gemcitabine and cisplatin, Sharma begins. The findings from EV-302 ultimately supported the FDA’s full approval of enfortumab vedotin plus pembrolizumab for the first-line treatment of patients with locally advanced or metastatic urothelial cancer in December 2023, she reports.

The EV-302 trial demonstrated a significant overall survival (OS) benefit with the use of the combination therapy, Sharma continues. The median OS was 31.5 months (95% CI, 25.4-not reached) for patients treated with enfortumab vedotin plus pembrolizumab compared with 16.1 months (95% CI, 13.9-18.3) for patients who received standard-of-care chemotherapy (HR, 0.47; 95% CI, 0.38-0.58;P < .001), she states. Importantly, the OS advantage was consistent across cisplatin-eligible and cisplatin-ineligible patients, as highlighted by a preplanned subgroup analysis, Sharma notes, adding that this uniform survival benefit underscores the broad applicability of the combination therapy, regardless of a patient’s ability to tolerate cisplatin.

The overall response rate (ORR) data further emphasized the effectiveness of enfortumab vedotin plus pembrolizumab, Sharma expands. Patients who received the combination achieved a confirmed ORR of 67.7% (95% CI, 63.1%-72.1%),significantly surpassing the 44.4% (95% CI, 39.7%-49.2%) ORR observed with standard chemotherapy, she says. These robust response rates, coupled with improved survival outcomes, establish enfortumab vedotin plus pembrolizumab as a highly effective frontline treatment option for patients with advanced urothelial cancer, offering new hope for improved treatment outcomes across diverse patient populations, Sharma concludes.

Related Videos
Matthew P. Deek, MD
Peter Schmid, MD, PhD, FRCP, discusses updated KEYNOTE-522 data showing that pembrolizumab plus chemotherapy improves EFS in early-stage TNBC.
1 expert in this video
1 expert in this video
Guru P. Sonpavde, MD
David Rimm, MD, PhD
Suneel Kamath, MD
Kathleen N. Moore, MD, MS
Shaji Kumar, MD
Karine Tawagi, MD,