EFS signal emerges in Keytruda head‑and‑neck trial; new diagnostic updates reported
- Merck’s Keytruda posted detailed phase 3 head-and-neck data showing perioperative benefit in KEYNOTE-689, while Labcorp said it has rolled out the FDA-approved PD-L1 test needed to guide Keytruda use in ovarian cancer. - In KEYNOTE-689, the strongest event-free survival result was in tumors with PD-L1 combined positive score of at least 10: hazard ratio 0.66, with median event-free survival 59.7 months versus 26.9 months. - The ovarian test launch follows the FDA’s February 10, 2026 approval of pembrolizumab-based treatment in platinum-resistant disease and extends biomarker-based access in a hard-to-treat setting. (fda.gov)
Keytruda’s latest oncology updates split into two tracks: longer event-free survival in resectable head-and-neck cancer, and a new U.S. diagnostic rollout for ovarian cancer patients who may qualify for the drug. (biospace.com) (prnewswire.com) Event-free survival is a clock that tracks how long patients go without recurrence, progression, or another major setback after treatment. In KEYNOTE-689, Merck tested pembrolizumab before surgery and again after surgery alongside standard radiotherapy, with or without cisplatin. (biospace.com) After a median follow-up of 38.3 months, KEYNOTE-689 cut the risk of an event by 27% in the intent-to-treat population, 30% in tumors with PD-L1 combined positive score of at least 1, and 34% in tumors with combined positive score of at least 10. (biospace.com) The median event-free survival in the highest PD-L1 subgroup was 59.7 months with Keytruda plus standard care versus 26.9 months with standard care alone. In the full study population, median event-free survival was 51.8 months versus 30.4 months. (biospace.com) Merck said KEYNOTE-689 was the first positive trial in more than 20 years for patients with resected, locally advanced head-and-neck squamous cell carcinoma. The company had first disclosed that the trial met its primary end point in October 2024 and presented fuller results in April 2025. (merck.com) (biospace.com) The ovarian-cancer update is about selection, not a new trial readout. Labcorp said on April 22, 2026 that it began nationwide U.S. availability of Agilent’s PD-L1 IHC 22C3 pharmDx, the FDA-approved companion diagnostic for identifying eligible patients. (prnewswire.com) That test is tied to the FDA’s February 10, 2026 approval of Keytruda and Keytruda Qlex plus paclitaxel, with or without bevacizumab, for adults with platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors have PD-L1 combined positive score of at least 1. (fda.gov) (merck.com) In KEYNOTE-B96, the study behind that approval, pembrolizumab reduced the risk of progression or death by 28% and the risk of death by 24% in the PD-L1-positive population, according to Merck and the FDA. The trial enrolled 643 patients, with 466 in the combined positive score of at least 1 subgroup used for the efficacy analysis. (merck.com) (fda.gov) A separate Keytruda combination in lung cancer is already moving through phase 3, but that launch was earlier this year, not this week. Merck said on January 7, 2026 that it started KANDLELIT-007, enrolling about 675 patients with KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer. (merck.com) That trial pairs oral calderasib, also known as MK-1084, with subcutaneous Keytruda Qlex and compares it with Keytruda Qlex plus pemetrexed and
