{"id":62713,"date":"2026-02-27T16:06:00","date_gmt":"2026-02-27T15:06:00","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-reduced-risk-of-event-free-survival-events-by-47-and-risk-of-death-by-35-for-cisplatin-eligible-patients-with-muscle-invasive\/"},"modified":"2026-02-27T16:06:00","modified_gmt":"2026-02-27T15:06:00","slug":"keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-reduced-risk-of-event-free-survival-events-by-47-and-risk-of-death-by-35-for-cisplatin-eligible-patients-with-muscle-invasive","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/keytruda-pembrolizumab-plus-padcev-enfortumab-vedotin-ejfv-reduced-risk-of-event-free-survival-events-by-47-and-risk-of-death-by-35-for-cisplatin-eligible-patients-with-muscle-invasive\/","title":{"rendered":"KEYTRUDA\u00ae (pembrolizumab) Plus Padcev\u00ae (enfortumab vedotin-ejfv) Reduced Risk of Event-Free Survival Events by 47% and Risk of Death by 35% for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery"},"content":{"rendered":"
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\nFirst and only immunotherapy plus antibody-drug conjugate regimen, used perioperatively, to significantly extend survival for these patients<\/b><\/p>\n

\nKEYNOTE-B15 is the sixth study demonstrating overall survival with a KEYTRUDA-based regimen in an earlier-stage cancer<\/b><\/p>\n

\nLate-breaking results from the Phase 3 KEYNOTE-B15 trial were selected for the official Press Program and will be presented at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium<\/b><\/p>\n

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced KEYTRUDA\u00ae<\/sup> (pembrolizumab) plus Padcev <\/sup><\/b>\u00ae<\/sup> (enfortumab vedotin-ejfv) reduced the risk of event-free survival (EFS) events by 47% and reduced the risk of death by 35% when given before and after surgery versus neoadjuvant chemotherapy and surgery in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. These late-breaking data will be presented for the first time today during an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA630) and are included in the official ASCO GU Press Program.<\/p>\n

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\nAfter a median follow-up of 33.6 months, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant and clinically meaningful improvement in EFS, the trial\u2019s primary endpoint, reducing the risk of EFS events by 47% (HR=0.53 [95% CI, 0.41-0.70]; p<0.0001) versus neoadjuvant chemotherapy and surgery in patients with MIBC who are eligible for cisplatin-based chemotherapy. Median EFS was not reached (NR) (95% CI, NR-NR) for the KEYTRUDA plus Padcev regimen versus 48.5 months (95% CI, 43.3-NR) for neoadjuvant chemotherapy and surgery. Approximately 79.4% of patients treated with KEYTRUDA plus Padcev were alive without disease progression or recurrence versus approximately 66.2% for patients treated with neoadjuvant chemotherapy and surgery at two years.<\/p>\n

\n\u201cThese findings demonstrate the strength and consistency of KEYTRUDA plus Padcev in treating muscle-invasive bladder cancer,\u201d said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. \u201cShowing a survival benefit in cisplatin-eligible patients in the perioperative setting reinforces the potential of this combination to play a foundational role in bladder cancer care.\u201d<\/p>\n

\nKEYTRUDA 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 35% (HR=0.65 [95% CI, 0.48-0.89]; p=0.0029) versus neoadjuvant chemotherapy and surgery. Median OS was NR (95% CI, NR-NR) for either regimen. Approximately 86.9% of patients treated with KEYTRUDA plus Padcev were alive versus approximately 81.3% of patients treated with neoadjuvant chemotherapy and surgery at two years. The pCR rate increased from 32.5% in patients treated with neoadjuvant chemotherapy and surgery to 55.8% in patients treated with perioperative KEYTRUDA plus Padcev, an estimated increase of 23.4% (95% CI, 16.7-29.8; p<0.0001).<\/p>\n

\n“For almost 25 years, cisplatin-based neoadjuvant chemotherapy was the standard of care for approximately half of patients with muscle-invasive bladder cancer who were eligible to receive platinum-based treatment,\u201d said Dr. Matthew Galsky, Lillian and Howard Stratton Professor of Medicine, director of genitourinary medical oncology, Mount Sinai Tisch Cancer Center. \u201cResults from KEYNOTE-B15 further support that a perioperative approach with pembrolizumab plus enfortumab vedotin can significantly improve survival compared to neoadjuvant chemotherapy in cis-eligible patients with muscle-invasive bladder cancer \u2013 setting the stage for a new treatment standard in this disease setting.\u201d<\/p>\n

\nKEYNOTE-B15 <\/b>evaluated Merck\u2019s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), and was conducted in collaboration with Pfizer and Astellas. The companies plan to share these results with regulatory authorities worldwide for potential regulatory filings. 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. KEYTRUDA plus Padcev is also approved in the U.S. for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy. 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).<\/p>\n

\nKEYTRUDA plus Padcev has now demonstrated an OS benefit across three Phase 3 trials bladder cancer. In addition to KEYNOTE-B15, these trials include KEYNOTE-905<\/a> for the treatment of patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy and KEYNOTE-A39<\/a> for the treatment of adult patients with la\/mUC. Three additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic disease. Two of these studies are in MIBC including KEYNOTE-866 (NCT03924856<\/a>) and KEYNOTE-992 (NCT04241185<\/a>). KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in KEYNOTE-676 (NCT03711032<\/a>).<\/p>\n

\nKEYNOTE-B15 is one of six Phase 3 studies of a KEYTRUDA-based regimen in an earlier stage of cancer to demonstrate an OS benefit. It is also the 14th<\/sup> positive pivotal trial for a KEYTRUDA-based regimen in earlier-stage cancers.<\/p>\n

\nStudy design and additional data from KEYNOTE-B15\/EV-304
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<\/b>KEYNOTE-B15, also known as EV-304, is an open-label, randomized Phase 3 trial (ClinicalTrials.gov, NCT04700124<\/a>) evaluating perioperative KEYTRUDA in combination with Padcev and surgery (radical cystectomy and pelvic lymph node dissection) versus neoadjuvant chemotherapy (gemcitabine plus cisplatin) and surgery in patients with MIBC who are cisplatin-eligible. The trial enrolled 808 patients who were randomized to receive either:<\/p>\n