On Tuesday, Merck & Co. Inc. (NYSE:MRK) released topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
In this study, Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), given before and after surgery (radical cystectomy), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, as well as overall survival (OS) and pathologic complete response (pCR) rate, key secondary endpoints, compared to surgery (radical cystectomy) alone.
The trial, evaluating Merck’s Keytruda plus Padcev, was conducted in collaboration with Pfizer Inc. (NYSE:PFE) (previously Seagen) and Astellas Pharma Inc. (OTC:ALPMF) (OTC:ALPMY).
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The trial continues to evaluate the secondary EFS, OS, and pCR rate endpoints for neoadjuvant and adjuvant Keytruda versus surgery alone as they mature.
The safety profile of Keytruda plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination.
The companies plan to share these results with regulatory authorities worldwide and present the data at an upcoming medical meeting.
Keytruda plus Padcev is approved for adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan, and several other countries.
Keytruda as monotherapy is also approved in the U.S., EU, Japan, and other countries for certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).
Five additional Phase 3 studies are currently evaluating Keytruda across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive, and metastatic.
Three of these studies are in MIBC, including KEYNOTE-866, KEYNOTE-992, and KEYNOTE-B15, which is also known as EV-304 and is being conducted in collaboration with Pfizer and Astellas.
Keytruda is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in the Phase 3 KEYNOTE-676 trial, and as adjuvant treatment for localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma in the KEYNOTE-123 trial.
In July, Pfizer and Astellas Pharma released topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating Xtandi (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence (BCR) at high risk for metastasis.
For patients treated with Xtandi plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS.
There was a favorable trend in results towards improved OS for patients treated with Xtandi monotherapy versus placebo plus leuprolide; however, the difference did not reach statistical significance.
Price Action: MRK stock is up 0.50% at $80.43, and PFE stock is up 0.12% at $24.61 at last check Tuesday.
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