Astellas and Seagen announce results of study into muscle-invasive bladder cancer

pharmafile | February 15, 2022 | News story | Medical Communications  

Astellas Pharma and Seagen announced the initial results from Cohort H of their EV-103 trial. This investigated PADDCEV (enfortumab vedotin-ejfv) as a monotherapy in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.

MIBC is a stage of bladder cancer, where the tumour spreads into the muscle of the bladder wall. Treatment for this disease typically combines cisplatin-based chemotherapy with radical cystectomy, or removal of the bladder, as well as pelvic lymph node dissection.

Results of this study, of 22 patients, showed that 36.4% had a pathologic complete response, the primary endpoint, displaying no signs of cancer upon microscopic examination of tissue cells removed during surgery. Half of all patients showed a pathological downstaging, or reduction in tumour size, a secondary endpoint of the trial.

Ahsan Arozullah, MD, MPH, Vice President, Medical Sciences-Oncology, Astellas, commented: “Neoadjuvant cisplatin-based chemotherapy, which is intended to shrink tumors prior to surgery, prolongs survival in patients with MIBC. However, up to half of these patients with MIBC are ineligible for cisplatin treatment and typically must undergo surgery without that treatment.”

“Results from EV-103 Cohort H showed that, when patients received enfortumab vedotin prior to surgery, more than one-third displayed no evidence of cancer when their bladder was removed and examined microscopically for residual tumors,” said Daniel Petrylak, MD, Yale School of Medicine Professor of Medicine (Medical Oncology) and of Urology; Co-Leader, Cancer Signaling Networks, Yale Cancer Center; and principal investigator for EV-103 Cohort H. “After treatment with enfortumab vedotin, all patients proceeded to surgery. Given there is no standard of care for neoadjuvant treatment in cisplatin-ineligible patients, these results are important and support further research.”

Lina Adams

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