Merck gets USFDA priority review for 2 applications for Keytruda, Keytruda Qlex in combo with Padcev for bladder cancer
Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 7, 2026, marking the first concurrent review of both KEYTRUDA and KEYTRUDA QLEX for the same novel indication.
“New options for muscle-invasive bladder cancer are vital — patients who are ineligible for chemotherapy have not seen a treatment advance beyond surgery in decades,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “With the FDA’s priority review, we are one step closer to offering KEYTRUDA or KEYTRUDA QLEX plus Padcev as a potential treatment option to these patients with MIBC who are ineligible for cisplatin-containing chemotherapy and have such high unmet medical need.”
The sBLAs are based on data from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. Results, which were presented at the recent European Society for Medical Oncology (ESMO) Congress, showed that after a median follow-up of 25.6 months, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the trial’s primary endpoint, reducing the risk of EFS events by 60% (HR=0.40 [95% CI, 0.28-0.57]; p<0.0001) versus surgery (radical cystectomy) alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy. Median EFS was not reached [NR] (95% CI, 37.3-NR) for the KEYTRUDA plus Padcev regimen versus 15.7 months (95% CI, 10.3-20.5) for surgery alone.
KEYTRUDA plus Padcev also demonstrated a statistically significant and clinically meaningful improvement in key secondary endpoints of overall survival (OS) and pathologic complete response (pCR) rate. KEYTRUDA plus Padcev reduced the risk of death by 50% (HR=0.50 [95% CI, 0.33-0.74]; p=0.0002) versus surgery. The pCR rate increased from 8.6% in patients treated with surgery alone (n=15/174) to 57.1% in patients treated with perioperative KEYTRUDA plus Padcev (n=97/170), an estimated increase of 48.3 percentage points (95% CI, 39.5-56.5; p<0.000001).
KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world based on results from the Phase 3 KEYNOTE-A39 trial, also known as EV-302. KEYTRUDA as a monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).
Four additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic disease. Three of these studies are in MIBC including KEYNOTE-B15 (NCT04700124), which is also known as EV-304 and is being conducted in collaboration with Pfizer and Astellas, KEYNOTE-866 (NCT03924856) and KEYNOTE-992 (NCT04241185). KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in the Phase 3 KEYNOTE-676 (NCT03711032) trial.
