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Phase 3 Study Met Dual Primary Endpoints in Patients With High-Risk Early-Stage Triple-Negative Breast Cancer

May 13, 2021 • 1:36 pm CDT
(Vax Before Cancer)

New Jersey-based Merck announced positive results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, combined with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent (adjuvant) treatment after surgery.

Merck confirmed that on May 13, 2021, KEYNOTE-522 met its dual primary endpoint of event-free survival (EFS) to treat patients with high-risk early-stage triple-negative breast cancer (TNBC).

Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), neoadjuvant KEYTRUDA plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy showed a statistically significant and clinically meaningful improvement in EFS compared with neoadjuvant chemotherapy alone.

As previously communicated, KEYNOTE-522 met its other dual primary endpoint of pathological complete response (pCR). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified.

“KEYTRUDA is the first immunotherapy to show positive results for event-free survival in patients with high-risk early-stage TNBC, a particularly aggressive form of breast cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press statement. 

“The improvement in pathological complete response rates initially observed following pre-operative treatment was encouraging, and now that we are seeing the data mature after four years to include a statistically significant improvement in event-free survival, we look forward to working with the FDA and other global authorities to bring this new option to patients as quickly as possible."

"We are grateful to the study participants who are critical to our efforts to advance potential treatment options for patients with TNBC.”

An analysis of pCR from KEYNOTE-522 was presented at the European Society for Medical Oncology 2019 Congress and published in the New England Journal of Medicine.

Triple-negative breast cancer is an aggressive type of breast cancer that characteristically has a high recurrence rate within the first five years after diagnosis, says Merck.

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