Merck?s KEYTRUDA (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Pathological Complete Response (pCR) in Pivotal Phase 3 KEYNOTE-522 Trial in Patients with Triple-Neg
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
KEYTRUDA is the First Anti-PD-1 Therapy to Demonstrate a Statistically Significant Improvement in pCR Rates as Neoadjuvant Therapy for TNBC Regardless of PD-L1 Status
Data to be Presented at an Upcoming Medical Congress and Discussed with Regulatory Authorities
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck?s anti-PD-1 therapy, in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status. A pathological complete response or pCR is defined as a lack of all signs of cancer in tissue samples analyzed following completion of neoadjuvant therapy and definitive surgery. Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual-primary endpoint of event-free survival (EFS), per the trial design. The safety profile of KEYTRUDA in this trial was consistent with previously reported studies; no new safety signals were identified.
?These findings from this innovatively designed trial with KEYTRUDA mark the first time an anti-PD-1 therapy plus chemotherapy has demonstrated a statistically significant improvement in pathological complete response rate as a neoadjuvant, or pre-surgical, segment of treatment for triple-negative breast cancer,? said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. ?TNBC is an aggressive malignancy with a high rate of recurrence within the first five years of diagnosis. We are encouraged by these results and plan to discuss these data with health authorities and to present these findings at an upcoming medical congress.?
The KEYTRUDA breast cancer clinical development program encompasses several internal and external collaborative studies, including three ongoing registration-enabling studies for TNBC (KEYNOTE-355, KEYNOTE-242, and KEYNOTE-522).
About KEYNOTE-522
KEYNOTE-522 is a Phase 3, randomized, double-blind trial (ClinicalTrials.gov, NCT03036488) investigating KEYTRUDA in combination with chemotherapy compared with placebo plus chemotherapy as neoadjuvant therapy, followed by KEYTRUDA compared with placebo as adjuvant therapy in patients with TNBC. The dual-primary endpoints are pCR and EFS. Secondary endpoints include pCR rate using alternative definitions (i.e. no invasive or noninvasive residual cancer in breast or nodes) at the time of definitive surgery, EFS in patients whose tumors express PD-L1, overall survival, safety and patient-reported outcomes.
The study enrolled 1,174 patients who were randomized 2 vs.1 to receive either:
- KEYTRUDA (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by KEYTRUDA plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles as neoadjuvant therapy prior to surgery, followed by nine cycles of KEYTRUDA (every three weeks) as adjuvant therapy post-surgery or;
- placebo (every three weeks) plus paclitaxel (weekly) and carboplatin (weekly or every three weeks) for four cycles, followed by placebo plus cyclophosphamide and either doxorubicin or epirubicin (every three weeks) for four cycles, followed by nine cycles of placebo (every three weeks) as adjuvant therapy post-surgery.
- solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or
- colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan.
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