FDA expands Keytruda approval for first-line NSCLC treatment

Cancer drug Keytruda can now be used as a first-line treatment for patients with stage three non-small cell lung cancer (NSCLC), whose treatment options are limited.

The US Food and Drug Administration (FDA) has approved Merck & Co’s Keytruda (pembrolizumab) for patients who cannot have surgery or definitive chemoradiation, or who have metastatic NSCLC with a PD-L1, or certain genetic mutations.

Dr Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories, said: “This expanded first-line indication now makes Keytruda monotherapy an option for more patients with non-small cell lung cancer, including those for whom combination therapy may not be appropriate.”

The expanded use approval is based on results from a phase 3 trial, in which overall survival (OS) was sequentially tested as part of a pre-specified analysis plan.

When used as a monotherapy, Keytruda demonstrated a statistically significant improvement in OS compared with chemotherapy alone in certain patients.

The randomised trial, which involved 1,274 patients, showed that the frontline treatment resulted in a median overall survival (OS) of 16.7 months, compared with 12.1 months with standard chemotherapy in patients who had advanced or metastatic NSCLC and a tumour proportion score (TPS) of ≥1%.

Patients in the trial either received 200 mg of Keytruda intravenously every three weeks or were given a carboplatin-containing regimen with either Alimta (pemetrexed) or Taxol (paclitaxel).

Dr Gilberto Lopes, associate director for global oncology at the Sylvester Comprehensive Cancer Center at the University of Miami, said: “As a practicing oncologist, having additional options available for patients is important in the rapidly evolving treatment landscape for lung cancer, which remains the leading cause of cancer death in the United States.”

Keytruda, a humanised monoclonal antibody, is a programmed death-ligand 1 (PD-L1) inhibitor. Such drugs are immune checkpoint inhibitors that work by blocking PD-1 and PD-L1 proteins. They disrupt the cancer cells’ signals, exposing them to the body’s immune T-cells for attack.

Keytruda was the first anti-PD-1 therapy in metastatic NSCLC approved in a first-line setting for use as a combination therapy or as monotherapy.

Last month, AstraZeneca won NICE’s backing for its cancer immunotherapy Imfinzi for NSCLC, with the drug made available via the Cancer Drugs Fund for now.

Imfinzi, also a PD-L1 inhibitor was made available on the NHS in England immediately for people with locally-advanced NSCLC who can’t be treated with surgery and who have already had platinum-based chemotherapy plus concurrent radiation therapy.