Merck Data Shows Positive Outcomes For Ovarian Cancer Patients Treated With Keytruda

Merck & Co Inc MRK on Thursday said the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65), met its primary endpoint of progression-free survival (PFS) for platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers.

The study also met a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1.

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The study is evaluating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without Roche Holdings AG’s RHHBY Avastin (bevacizumab) for these patients.

The trial continues, and OS for the full study population will be evaluated at a future analysis.

The Keytruda-based regimen demonstrated a statistically significant and clinically meaningful improvement in PFS regardless of PD-L1 status compared to placebo plus chemotherapy with or without bevacizumab.

The study also showed a statistically significant and clinically meaningful improvement in OS in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) compared to placebo plus chemotherapy with or without bevacizumab.

“This marks the first time a KEYTRUDA-based regimen has shown the ability to help certain patients with platinum-resistant ovarian cancer live longer, and the first time an immune checkpoint inhibitor-based regimen has demonstrated an overall survival benefit in ovarian cancer,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.

Keytruda is not approved for ovarian cancer.

Lynparza (olaparib), jointly developed by AstraZeneca Plc AZN and Merck, has three approved ovarian cancer indications in the U.S.

In October, Merck announced that the Phase 3 KEYNOTE-689 trial of Keytruda, as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma, met its primary endpoint of event-free survival (EFS).

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