Merck’s Keytruda, Chemotherapy Helps High-Risk Breast Cancer
The estimated three-year event-free survival rates for patients with high-risk breast cancer were 84.5 percent in the Keytruda group and 76.8 percent in the chemotherapy-placebo group.
Merck recently announced that Keytruda, combined with chemotherapy and followed by Keytruda as monotherapy, prolonged event-free survival compared to chemotherapy followed by placebo in patients with high-risk early-stage triple-negative breast cancer.
The Phase 3 KEYNOTE-522 trial, published in the New England Journal of Medicine, showed that the Keytruda regimen reduced the risk of events or death by 37 percent versus the chemotherapy-placebo regimen.
The estimated three-year event-free survival rates were 84.5 percent in the Keytruda group and 76.8 percent in the chemotherapy-placebo group. Notably, the safety profile of the Keytruda regimen was consistent with the known profiles of each regimen, and researchers identified no new safety concerns.
“These data, which supported the FDA approval and updates to the NCCN guidelines, establish that KEYTRUDA plus chemotherapy as neoadjuvant therapy followed by adjuvant KEYTRUDA could change clinical practice for the treatment of patients with high-risk early-stage TNBC,” Peter Schmid, MD, lead of the Centre for Experimental Cancer Medicine at Barts Cancer Institute, said in the announcement.
“KEYNOTE-522 is the first prospective randomized Phase 3 trial to show an improvement in event-free survival among patients with stage II and stage III TNBC,” Schmid continued.
In May 2021, the Phase 3 KEYNOTE-522 trial met its dual primary endpoint of event-free survival when compared with chemotherapy alone and the secondary endpoint of complete pathological response.
Keytruda is the first immunotherapy to show positive results for event-free survival in patients with high-risk early-stage triple-negative breast cancer.
Then in July, FDA approved an expanded label for Keytruda as a monotherapy for patients with locally advanced cutaneous squamous cell carcinoma after the drug demonstrated an objective response rate of 50 percent, including a complete response rate of 17 percent and a partial response of 33 percent in patients with locally advanced disease.
Out of 27 responding patients, 81 percent experienced a duration of six months or longer, while 37 percent had a duration of response of 12 months or longer.
Weeks later, the agency approved the combination of Keytruda and Eisai’s tyrosine kinase inhibitor, Lenvima, to treat patients with advanced endometrial carcinoma.
