Keytruda May Be Equipped to Be a First-Line Lung Cancer Treatment

Findings from the KEYNOTE-024 clinical trial will be presented at the European Society of Medical Oncology.

Positive results from a new study suggest that Keytruda (pembrolizumab) may become a first-line treatment option for patients with advanced lung cancer and high PD-L1 expression.

Keytruda is a humanized monoclonal antibody that inhibits the interaction between PD-1 and its ligands (PD-L1, PD-L2).

Included in the phase 3 KEYNOTE-024 clinical trial were 305 treatment-naïve patients with squamous and non-squamous non-small cell lung cancer whose tumors expressed high levels of PD-L1. Patients were randomized to receive Keytruda or a platinum-based chemotherapy regimen.

“These data from KEYNOTE-024 demonstrate the potential of Keytruda to change the way non-small cell lung cancer is currently treated,” said lead author Martin Reck, MD, PhD. “This provides additional evidence that testing for PD-L1 levels should become standard in lung cancer at first diagnosis to guide treatment decisions.”

The primary endpoint was progression-free survival and the secondary endpoints were safety, overall survival, and objective response rate. Scientists found a 40% increase in survival among patients receiving Keytruda compared with chemotherapy.

Keytruda was able to extend progression-free survival by 4 months, meeting the primary endpoint. They also found that overall survival was prolonged, as 80% of patients treated with Keytruda were alive at 6 months, compared with 72% receiving chemotherapy, according to the study.

The overall response rate for patients taking Keytruda was 44.8%, which included 6 complete responses. The overall response rate for patients receiving chemotherapy was 27.8%, including 1 complete response, Merck reported.

The safety profile was consistent, and the most common adverse events were diarrhea, fatigue, and pyrexia. Keytruda is currently indicated for patients with unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC), and recurrent or metastatic hear and neck squamous cell carcinoma.

The drug has also been granted breakthrough status for patients with advanced melanoma, non-small cell lung cancer in previously treated patients, microsatellite instability, high metastatic colorectal cancer, and relapsed or refractory classical Hodgkin Lymphoma.

“This data will completely change the management of patients with advanced NSCLC. All endpoints of efficacy and tolerability favored treatment with pembrolizumab, suggesting it should become 1 standard of care for first line treatment of patients with advanced NSCLC and high PD-L1 expression. This is primarily an opportunity for patients without oncogenic alterations. More information is needed for those with alterations,” Dr Reck said. “This is a landmark trial for the 30% of patients with advanced NSCLC who are high expressers of PD-L1. The new treatment algorithm should include upfront testing for PD-L1 expression to identify patients who will benefit from first line treatment with pembrolizumab.”