Cohort H of the phase 1b/2 EV-103 trial enrolled patients with MIBC who were eligible for surgical treatment but ineligible for cisplatin-based chemotherapy.
Enfortumab vedotin-ejfv (Padcev, Seagen Inc. and Astellas Pharma Inc.) showed promise as a monotherapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy in a recent trial.
The initial results from cohort H of the EV-103 trial investigating the treatment in this patient population will be announced at the 2022 ASCO Genitourinary Cancers Symposium on February 18.
MIBC is a stage of bladder cancer in which the tumor spreads into the muscle of the bladder wall. Standard treatment for MIBC is typically cisplatin-based chemotherapy combined with radical cystectomy, or removal of the bladder, as well as pelvic lymph node dissection. Cohort H of the phase 1b/2 EV-103 trial enrolled patients with MIBC who were eligible for surgical treatment but ineligible for cisplatin-based chemotherapy. Patients were administered 3 cycles of neoadjuvant enfortumab vedotin on days 1 and 8 of every 3-week cycle.
Results from the preliminary analysis of 22 patients showed that 36.4% had a pathologic complete response, which was the primary endpoint of the trial, and displayed no signs of cancer during an examination of tissue cells removed during surgery. Half of the patients experienced a reduction in tumor size, a secondary endpoint of the trial.
All the patients underwent surgery and no surgeries were delayed following treatment with enfortumab vedotin. The most common adverse events were fatigue, alopecia, dysgeusia, diarrhea, nausea, peripheral sensory neuropathy, dry eye, and rash maculo-papular, which was consistent with the known safety profile of enfortumab vedotin, according to the study.
“The initial findings from EV-103 Cohort H are encouraging, and we look forward to learning more from the Phase 3 studies evaluating enfortumab vedotin in muscle-invasive bladder cancer in combination with the anti-PD-1 therapy pembrolizumab,” said Marjorie Green, MD, senior vice president and Head of Late-Stage Development at Seagen, in a press release.
In addition to this trial, enfortumab vedotin is being examined as a monotherapy and in combination with other therapies in clinical trials across lines of treatment and stages of bladder cancer.
Seagen and Astellas Announce Initial Results of PADCEV® (enfortumab vedotin-ejfv) in Patients With Muscle-Invasive Bladder Cancer Not Eligible for Cisplatin Chemotherapy. BusinessWire. February 14, 2022. Accessed February 16, 2022. https://www.businesswire.com/news/home/20220214005193/en