Merck's KEYNOTE-522 Phase III Trial of Keytruda in Early-Stage High-Risk Triple-Negative Breast Cancer Meets Overall Survival Primary Endpoint

May 29, 2024 07:45 CST Updated 07:45

MSD

Pharmaceutical R&D and Manufacturer

May 28,MSDAnnouncement of the KEYNOTE-522 pivotal Phase III clinical trial reaching the overall survival (OS) endpoint. In a pre-specified interim analysis conducted by the Independent Data Monitoring Committee, compared with preoperative chemotherapy alone,Keytruda(Pembrolizumab) combined with chemotherapy as neoadjuvant therapy, followed by continued monotherapy as adjuvant treatment post-surgery, can lead to statistically significant and clinically meaningful improvements in OS for patients with high-risk early-stage triple-negative breast cancer (TNBC).KeytrudaThe safety profile is consistent with previously reported study results, with no new safety signals observed.

KEYNOTE-522 is the fourth clinical trial in which Keytruda has demonstrated OS benefits in the treatment of early-stage cancer. Previously, KEYNOTE-A18 (cervical cancer), KEYNOTE-671 (non-small cell lung cancer)...Cancer), KEYNOTE-564 (Renal Cell Carcinoma) study achieved OS benefit.

Previously, MSD submitted a supplemental Biologics License Application (sBLA) to the FDA for Keytruda in the treatment of high-risk early-stage TNBC patients based on the pCR data from the KEYNOTE-522 study and interim EFS results. However, in March 2021, MSD received a Complete Response Letter from the FDA, with the FDA's Oncologic Drugs Advisory Committee voting 10:0 that approval of this indication should be reconsidered after obtaining more data from the KEYNOTE-522 study.

May 2021,KEYNOTE-522 StudyReached the second endpoint of Event-Free Survival (EFS)Primary Endpoint. In July 2021, based on this researchEFS Data, FDAApprovalKeytrudaNeoadjuvant Therapy with Preoperative Combination Chemotherapy for High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC), and Postoperative Monotherapy as Adjuvant Treatment for TNBCC. This is also the first approved immunotherapy regimen for the treatment of TNBC.

In addition,Keytruda has also been approved by the FDACombined Chemotherapy TreatmentTumors express PD-L1 (CPS≥10)Patients with locally recurrent unresectable or metastatic TNBC.

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