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Thomas Flaig, MD


ASCO GU 2024: Updated Trial Data Support Immunotherapy Combination in Some Urothelial Carcinomas

By: Celeste L. Dixon
Posted: Tuesday, February 6, 2024

The outcomes of subgroup analyses of the phase III EV-302/KEYNOTE-A39 trial continue to support the first-line potential of the antibody-drug conjugate enfortumab vedotin-ejfv plus the PD-1 inhibitor pembrolizumab as a new standard of care for previously untreated, locally advanced metastatic urothelial carcinoma. At the 2024 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract LBA530), Michiel Simon Van Der Heijden, MD, PhD, of the Netherlands Cancer Institute, Amsterdam, and colleagues reported that survival benefits with this combination, compared with chemotherapy, were consistent across select prespecified subgroups, including those historically associated with a poor prognosis. Specifically, enfortumab vedotin plus pembrolizumab extended progression-free and overall survival in subgroups by race, cisplatin eligibility, PD-L1 expression, metastatic site, liver involvement, and renal function.

For median overall survival, the hazard ratios favoring enfortumab vedotin plus pembrolizumab in the subgroups follow: 0.47 (White race); 0.46 (other race); 0.47 (metastatic disease site, visceral metastases); 0.46 (metastatic disease site, lymph nodes alone); 0.51 (renal function, normal); 0.44 (renal function, mild impairment); and 0.50 (renal function, moderate/severe impairment).

As previously reported, in the overall patient population, “enfortumab vedotin plus pembrolizumab demonstrated a statistically significant and clinically meaningful benefit compared with platinum-based chemotherapy for the dual primary endpoints of progression-free survival (P < .00001) and overall survival (P < .00001),” stated Dr. Van Der Heijden and co-investigators.

This open-label, global study included 886 patients. They were randomly assigned about equally between the two first-line treatments, regardless of cisplatin eligibility or PD-L1 expression status, and baseline patient and disease characteristics were balanced between the treatment arms.

Patients were on 3-week treatment cycles. Those in the chemotherapy arm received gemcitabine with cisplatin or carboplatin; those in the experimental arm received enfortumab vedotin intravenously on days 1 and 8 (1.25 mg/kg) and 200 mg of pembrolizumab intravenously on day 1.

Disclosure: For full disclosures of the study authors, visit

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