The addition of pembrolizumab to chemotherapy as first-line treatment for patients with metastatic squamous non-small cell lung cancer improved OS and PFS, according to results of an interim analysis from the randomized phase 3 KEYNOTE-407 trial.
Pembrolizumab (Keytruda, Merck) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
In the double-blind, placebo-controlled KEYNOTE-407 trial, researchers compared pembrolizumab in combination with chemotherapy — either carboplatin-paclitaxel or nab-paclitaxel — with chemotherapy alone as first-line therapy for patients with metastatic squamous NSCLC. The study included 560 patients who had received no prior systemic therapy for advanced disease. OS and PFS served as dual primary endpoints.
As HemOnc Today previously reported, the KEYNOTE-407 trial met its secondary endpoint of overall response rate.
In the updated results released by the drug’s manufacturer, patients treated with the addition of pembrolizumab to chemotherapy demonstrated improved OS and PFS.
“As first-line treatment, Keytruda in combination with traditional chemotherapy has now demonstrated an improved survival benefit, compared to chemotherapy alone, in metastatic lung cancer patients with squamous histology,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release.
The study results will be presented during an oral presentation at the ASCO Annual Meeting.
Researchers observed no new safety signals with this combination.
Pembrolizumab already is approved for several indications in the United States, including treatment of certain patients with NSCLC, melanoma, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, gastric or gastroesophageal junction adenocarcinoma, and unresectable or metastatic microsatellite instability-high or mismatch repair-deficient cancers.