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Merck Reports European Commission Approval Of Its KEYTRUDA Plus Chemo

First Immunotherapy-Based Regimen Approved in Europe for These Patients With Persistent, Recurrent or Metastatic Cervical Cancer Approval Based on Overall Survival Benefit Demonstrated in Phase 3 KEYNOTE-826

Benzinga · 04/29/2022 06:31

First Immunotherapy-Based Regimen Approved in Europe for These Patients With Persistent, Recurrent or Metastatic Cervical Cancer

Approval Based on Overall Survival Benefit Demonstrated in Phase 3 KEYNOTE-826 Trial

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). This approval is based on results from the Phase 3 KEYNOTE-826 trial, in which KEYTRUDA plus chemotherapy with or without bevacizumab (the KEYTRUDA regimen) demonstrated a statistically significant improvement in overall survival (OS) (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS) (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001) compared to chemotherapy with or without bevacizumab in this patient population. Additionally, more patients responded to the KEYTRUDA regimen, with an objective response rate (ORR) of 68% (95% CI, 62-74) versus 50% (95% CI, 44-56), respectively.

“After many years of limited progress in developing new treatment options for persistent, recurrent or metastatic cervical cancer, we saw notable improvements in overall survival in KEYNOTE-826, with a 36% reduction in the risk of death,” said Dr. Nicoletta Colombo, associate professor, University of Milan-Bicocca, and director, Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. “With today’s approval, healthcare providers in the EU will be able to offer certain patients with advanced cervical cancer a long-awaited immunotherapy option that has shown significant improvement in overall survival.”

“Women diagnosed with persistent, recurrent or metastatic cervical cancer often have a low survival rate,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “The EU approval of this KEYTRUDA regimen for women with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 CPS ≥1 is the first of its kind for an immunotherapy regimen in Europe and is another example of our continued commitment to delivering new therapies for patients with breast and gynecologic cancers.”

This approval allows marketing of this KEYTRUDA regimen in all 27 European Union member states plus Iceland, Lichtenstein, Norway and Northern Ireland.

Merck is rapidly expanding its extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across gynecologic cancers, including evaluating KEYTRUDA for the treatment of locally advanced cervical cancer.

Additional Data and Safety from KEYNOTE-826

  • Median OS in patients whose tumors express PD-L1 CPS ≥1 was not reached (95% CI, 19.8-not reached [NR])for the KEYTRUDA regimen versus 16.3 months (95% CI, 14.5-19.4) for the chemotherapy regimen (HR=0.64 [95% CI, 0.50-0.81]; p=0.0001).
  • Median PFS in patients whose tumors express PD-L1 CPS ≥1 was 10.4 months (95% CI, 9.7-12.3) for the KEYTRUDA regimen versus 8.2 months (95% CI, 6.3-8.5) for the chemotherapy regimen (HR=0.62 [95% CI, 0.50-0.77]; p<0.0001).
  • The ORR in patients whose tumors express PD-L1 CPS ≥1 was 68% (95% CI, 62-74), including a complete response (CR) rate of 23% and a partial response (PR) rate of 45% for patients receiving the KEYTRUDA regimen versus 50% (95% CI, 44-56), including a CR rate of 13% and a PR rate of 37% for patients receiving the chemotherapy regimen.

The safety of KEYTRUDA in combination with chemotherapy has been evaluated in 3,123 patients with non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal carcinoma, triple-negative breast cancer (TNBC) or cervical cancer receiving KEYTRUDA 200 mg, 2 mg/kg bodyweight (bw) or 10 mg/kg bw every three weeks (Q3W) in clinical studies. In this patient population, the most frequent adverse reactions were anemia (55%), nausea (54%), fatigue (38%), neutropenia (36%), constipation and alopecia (35% each), diarrhea (34%), vomiting (28%) and decreased appetite (27%). Incidences of Grades 3‑5 adverse reactions were 67% for KEYTRUDA plus chemotherapy and 66% for chemotherapy alone in patients with NSCLC; 85% for KEYTRUDA plus chemotherapy and 84% for chemotherapy plus cetuximab in patients with HNSCC; 86% for KEYTRUDA plus chemotherapy and 83% for chemotherapy alone in patients with esophageal carcinoma; 78% for KEYTRUDA plus chemotherapy and 74% for chemotherapy alone in patients with TNBC; and 82% for KEYTRUDA plus chemotherapy and 75% for chemotherapy alone in patients with cervical cancer.