RAHWAY, N.J. – Merck & Co., Inc., a global healthcare leader, announced positive results from its Phase 3 KEYNOTE-B96 trial, which could potentially lead to a new treatment option for patients with platinum-resistant recurrent ovarian cancer. The trial met its primary endpoint of progression-free survival (PFS) and a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1.
The KEYTRUDA (pembrolizumab) regimen, combined with chemotherapy (paclitaxel) and possibly bevacizumab, demonstrated a statistically significant improvement in PFS across all patients and in OS for patients with PD-L1-expressing tumors. The safety profile was consistent with previous studies, with no new safety concerns identified. Detailed results are expected to be presented at an upcoming medical meeting and will be submitted to regulatory authorities worldwide. With annual revenue of $63.9 billion and a robust research pipeline, Merck continues to demonstrate its commitment to innovation in healthcare.
This marks the first instance of a KEYTRUDA-based regimen showing an overall survival benefit for this patient group in a clinical trial. Dr. Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, highlighted the significance of the findings, noting that they contribute to the evidence supporting KEYTRUDA’s potential across various gynecological cancers, particularly in treating challenging forms of ovarian cancer.
Currently, KEYTRUDA is not approved for the treatment of ovarian cancer, but it has multiple approved indications in the United States for other cancers, including melanoma, non-small cell lung cancer, and cervical cancer, among others.
Merck is actively researching treatment options for breast and gynecologic cancers and has over 20 clinical trials involving more than 18,000 patients worldwide. The company’s research efforts are focused on advancing standards of care and developing new treatment combinations.
The KEYNOTE-B96 trial, also known as ENGOT-ov65, is sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups. The trial enrolled an estimated 643 patients, randomizing them to receive either the KEYTRUDA regimen or placebo plus chemotherapy, with or without bevacizumab.
Ovarian cancer is a leading cause of cancer death among women, with an estimated 324,603 new cases and approximately 206,956 deaths globally in 2022. In the U.S., approximately 20,890 new cases and about 12,730 deaths are expected in 2025. The primary goal of first-line treatment is to delay disease progression and achieve long-term remission.
This news is based on a press release statement from Merck & Co., Inc.
In other recent news, Merck & Co., Inc. reported its first-quarter 2025 earnings, surpassing analyst expectations with earnings per share (EPS) of $2.22, compared to the forecasted $2.14. The company also exceeded revenue forecasts, reporting $15.5 billion in revenue against a projected $15.3 billion. Despite these positive results, Merck is facing challenges with its Gardasil vaccine, particularly in China, where sales have significantly impacted overall revenues. Citi analysts downgraded Merck’s stock from Buy to Neutral, citing growth challenges and a slower-than-expected pipeline progression. The firm also cut the price target from $115 to $84, expressing concerns about the upcoming loss of exclusivity for Keytruda in 2028. Meanwhile, Guggenheim Securities maintained a Buy rating on Merck, though it adjusted the price target from $115 to $108 following the company’s robust first-quarter performance. The firm attributed the positive results to increased revenues and lower taxes, despite rising costs in certain areas. Additionally, President Donald Trump is expected to announce an initiative to tie government drug costs to lower prices abroad, potentially impacting Merck and other pharmaceutical companies.
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