Date: 2017-09-11
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2017 Congress
Company: Merck&Co (USA - NJ)
Product: Keytruda® (pembrolizumab)
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor/immunotherapy product. Keytruda® (pembrolizumab - MK-3475) is an highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, pembrolizumab enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. Pembrolizumab is being evaluated across more than 30 types of cancers, as monotherapy and in combination. It has received a Breakthrough Therapy designation for advanced melanoma, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy. In November 2015, the FDA has granted Breakthrough Therapy Designation to Keytruda® for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer.
Disease:
Disease: recurrent or metastatic head and neck squamous cell carcinoma
Therapeutic
area: Cancer - Oncology
Country: Australia, Belgium, Canada, France, Germany, Hungary, Ireland, Italy, Republic of Korea, Lithuania, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Russian Federation, Spain, Sweden, Switzerland, UK, USA
Trial
details:
- The KEYNOTE-040 trial is a global, open-label, phase 3 study which included patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) after a platinum-based chemotherapy. This is a study of pembrolizumab (MK-3475, Keytruda®) versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer (HNSCC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment. The primary study hypothesis is that pembrolizumab treatment prolongs overall survival when compared to standard treatment. (NCT02252042)
Latest
news:
- • On September 11, 2017, Dr. Ezra Cohen, from the University of California, San Diego Moores Cancer Center, in La Jolla, California, presented results of the Keynote-040 trial at the ESMO 2017 Congress in Madrid. The trial evaluated Keytruda®) (pembrolizumab) versus standard treatment (methotrexate, docetaxel or cetuximab) for the treatment of recurrent or metastatic head and neck squamous cell cancer after a platinum-based chemotherapy. Patients were randomised to receive either pembrolizumab (n=247) or standard of care (SOC) treatment (n=248), which was the investigator’s choice of either methotrexate, docetaxel, or cetuximab.
- The study did not meet its primary endpoint. Median overall survival (OS) was only marginally higher in the pembrolizumab compared to standard treatment arm (8.4 versus 7.1 months, hazard ratio [HR] 0.81 95% CI 0.66-0.99, P= .0204), however for a subset of patients who had PD-L1-expressing tumours, pembrolizumab was associated with dramatic and significantly improved outcomes. Specifically, among patients with PD-L1-expression in more than 1% of all cells in their tumour, median OS was 8.7 months with pembrolizumab versus 7.1 months with standard treatments (HR 0.75; 95% CI 0.59-0.95, P=.0078), and among patients with PD-L1-expression in more than 50% of their cancer cells, median OS was 11.6 versus 7.9 months respectively (HR 0.54; 95% CI 0.35-0.82, P=.0017). Compared to the other treatments, pembrolizumab measured up well in terms of side-effects.
- Although the 19% improvement in overall survival among patients treated with pembrolizumab did not meet the prespecified difference for statistical significance, it was nevertheless a clinically meaningful difference for this population who only lived seven to eight months, on average, after initiating treatment, said lead investigator Dr. Ezra Cohen, from the University of California, San Diego Moores Cancer Center, in La Jolla, California.
Is
general: Yes
