The CHMP’s positive opinion for Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel is for the first-line treatment of metastatic NSCLC in adults.
Keytruda is an anti-PD-1 therapy, which works by increasing the ability of the body’s immune system to help detect and fight tumor cells.
It is a humanized monoclonal antibody that inhibits the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Later, it activates T lymphocytes that may affect both tumor cells and healthy cells.
The recommendation was based on data from the phase 3 Keynoet-407 trial, which recuited patients regardless of PD-L1 tumor expression status.
According to the company, the study demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) for patients taking Keytruda in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) compared with chemotherapy alone.
If approved, the treatment will become the first anti-PD-1 therapy in combination with chemotherapy for adults with metastatic squamous NSCLC in Europe.
The CHMP’s recommendation will be assessed by the European Commission to grant marketing authorization in the European Union (EU). The EC is expected to reveal the decision in the first quarter of this year.
Keynote-7 is part of Merck’s clinical development program in lung cancer, which comprises 10 Merck-sponsored phase 3 trials.
The studies are assessing Keytruda in combination with other treatments and as monotherapy, in both advanced and earlier stages of disease, as well as across different histologies and lines of treatment.
Merck Research Laboratories senior vice president and global clinical development head and chief medical officer Dr Roy Baynes said: “We are pleased by today’s positive opinion from the CHMP, which brings us one step closer to potentially expanding our lung cancer indications in Europe to include first-line combination therapy for patients with metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression.
“This is important as squamous cell carcinoma continues to be an area of unmet need, and there was a significant overall survival benefit observed in the Phase 3 KEYNOTE-407 trial.”