Merck Announces Significant Efficacy of Pembrolizumab Combined with Chemotherapy in Early-Stage Triple-Negative Breast Cancer from Phase 3 KEYNOTE-522 Trial
Oct 01, 2019 10:26
CST Updated
10:26
Merck Group
Pharmaceutical R&D Developer
Merck, also known as MSD, today announced key neoadjuvant therapy in early-stage triple-negativeBreast Cancer(TNBC) Results from the Phase 3 KEYNOTE-522 trial. This trial evaluated Merck’s neoadjuvant regimen: the anti-PD-1 therapy KEYTRUDA in combination with chemotherapy. This regimen consisted of neoadjuvant KEYTRUDA plus chemotherapy, followed by adjuvant KEYTRUDA monotherapy (the KEYTRUDA regimen). The comparator regimen consisted of neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy–placebo regimen). Today, interim results from the first randomized trial of anti-PD-1 therapy in the neoadjuvant/adjuvant setting for triple-negative breast cancer (TNBC) will be presented at the European MedicalTumorpresented at the 2019 European Society for Medical Oncology (ESMO) Congress.
In the neoadjuvant setting, KEYTRUDA in combination with chemotherapy (n = 401) significantly increased the pathological complete response (pCR) rate compared with chemotherapy alone (n = 201) in patients with early-stage triple-negative breast cancer (TNBC), from 51.2% with neoadjuvant chemotherapy to 64.8% with neoadjuvant KEYTRUDA plus chemotherapy (P = 0.00055). Pathological complete response, one of the dual primary endpoints, was defined as ypT0/Tis ypN0 (i.e., no residual invasive cancer in the breast and lymph nodes). Investigators observed improvements with the addition of KEYTRUDA to neoadjuvant chemotherapy regardless of patients’ PD-L1 expression status. After a median follow-up of 15.5 months, analysis of the other dual primary endpoint, event-free survival (EFS), demonstrated that the KEYTRUDA regimen reduced the risk of neoadjuvant progression and adjuvant recurrence by 37% compared with the chemotherapy–placebo regimen (HR = 0.63 [95% CI, 0.43–0.93]). The safety profile of KEYTRUDA in combination with chemotherapy in KEYNOTE-522 was consistent with that observed in previous studies.
Dr. Roger M. Perlmutter, President of Merck Research Laboratories, stated: “This innovative trial is the first to combine neoadjuvant therapy with adjuvant KEYTRUDA for the treatment of patients with early-stage triple-negative breast cancer (TNBC). The KEYNOTE-522 study results reported today are encouraging and have the potential to changeDiagnosis"Therapeutic Approaches for Patients with Triple-Negative Breast Cancer (TNBC)."
Dr. Peter Schmid, Director of the Experimental Cancer Medicine Center at the Barts Cancer Institute, said: “As a specialist in TNBCTumor“...ologist, in the neoadjuvant setting, KEYTRUDA in combination with chemotherapy significantly improved the pCR rate, and the positive trend in event-free survival is highly encouraging. There is an urgent need for new treatment regimens that can increase the pCR rate in this patient population.”
As previously announced, KEYTRUDA plus chemotherapy was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the neoadjuvant treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC), based on data from the Phase 1b KEYNOTE-173 and Phase 2 I-SPY2 trials.FDABTD was granted; the trial demonstrated that neoadjuvant KEYTRUDA in combination with chemotherapy elicited encouraging anti-TumorActivity.
Hayley Dineen, Executive Director of the Triple Negative Breast Cancer Foundation, stated, “These findings from the KEYNOTE-522 trial are exciting for the TNBC community, which has a particular need for scientific advancements. We are committed to supporting patients with TNBC, and we are pleased to see new data on early-stage treatment approaches.”
As previously announced, Merck plans to share early interim analysis data from KEYNOTE-522 with regulatory authorities. The company will continue to develop a robust clinical development program for KEYTRUDA in breast cancer, which includes multiple internal studies and external collaborative trials, such as KEYNOTE-355 and KEYNOTE-242. (Bioon\Bioon.com)
Original source:Merck Official Website