Merck shares data from phase 3 trial of Keytruda for TNBC treatment

Betsy Goodfellow | May 29, 2024 | News story | Medical Communications |  Merck, Oncology, breast cancer, clinical trial, keytruda 

Merck, known as MSD outside of the US and Canada, has announced results from the phase 3 KEYNOTE-522 trial, which evaluated Keytruda (pembrolizumab) for the pre-operative (neoadjuvant) and single agent after surgery (adjuvant) treatment of high-risk early-stage triple-negative breast cancer (TNBC), in combination with chemotherapy.

At a pre-specified interim analysis, the drug demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to pre-operative chemotherapy.

The drug’s safety profile remained consistent with that observed in previous trials, with no new safety signals being observed.

The company intends to present full results at an upcoming medical meeting as well as sharing them with the relevant regulatory authorities.

Dr Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, commented: “This is a significant milestone, as it is the first time an immunotherapy-based regimen has demonstrated a statistically significant overall survival benefit compared to chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer. To have achieved overall survival from this landmark study is highly encouraging and builds upon the positive pathological complete response and event-free survival results that led to approvals for this regimen around the world.”

Betsy Goodfellow