ESMO Quick Takes: Padcev- Keytruda combo sets new standard in urothelial cancer

The combination of antibody-drug conjugate Padcev enfortumab vedotin, from Seagen Inc. (NASDAQ:SGEN) and Astellas Pharma Inc. (Tokyo:4503), and PD-1 inhibitor Keytruda pembrolizumab, from Merck & Co. Inc. (NYSE:MRK), appears on track to become the standard of care in untreated locally advanced or metastatic urothelial cancer after new data showed the combination nearly doubled survival. In the 886-patient Phase III EV-302/KEYNOTE-A39 study, the combination increased progression-free survival (PFS) to 12.5 months vs. the 6.3 months observed in the platinum-based chemotherapy control arm (HR=0.45). The combination also nearly doubled overall survival (OS) to 31.5 months from 16.1 months (HR=0.47). The Padcev-Keytruda combo had a favorable safety profile, with 55.9% of patients experiencing grade 3 or higher adverse events compared with 69.5% in the control arm. The data will be presented Sunday at ESMO Congress 2023.

Additional data released ahead of ESMO that could lead to a change in standard of care are the results from the Phase III ALINA study of ALK inhibitor Alecensa alectinib from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY). The ALINA findings suggest use of Alecensa for adjuvant treatment of ALK-positive non-small cell lung cancer (NSCLC) could spare patients from chemotherapy during early-stage disease. The trial, which enrolled patients with stage IB-IIIA ALK-positive NSCLC, showed that a 600 mg twice-daily oral dose of Alecensa, administered for up to 24 months after complete resection, increased disease-free survival (DFS) over chemotherapy standard of care by 76% (HR=0.24). Over 93% of patients in the experimental treatment arm achieved 24-month DFS compared with about 63% in the chemotherapy control arm. ...