Keytruda Has Favorable Results in Adjuvant NSCLC Treatment, a First in Stage 1b-3a

In an interim analysis from a phase 3 trial of Keytruda, the use of the immunotherapy drug was associated with significantly improved disease-free survival in patients with non-small cell lung cancer.

In a phase 3 trial, treatment with Keytruda (pembrolizumab) showed significant improvement in patients with stage 1b-3a non-small cell lung cancer (NSCLC) as an adjuvant treatment following surgical resection (lobectomy or pneumonectomy), regardless of PD-L1 expression.

The KEYNOTE-091 trial met one of its main goals of disease-free survival (DFS), defined as the amount of time that a patient lives with no evidence of disease on scans following surgery.

The researchers randomized patients to receive Keytruda — an anti-PD-1 immunotherapy —intravenously to patients in 200 milligram infusions every three weeks for one year or at a maximum of 18 doses. The other group of patients in the trial received a placebo treatment at the same numbers of time/doses. There were 1,177 patients enrolled in the trial randomly assigned to either treatment group, and they were treated with or without chemotherapy.

“Surgery is widely considered the first and most important intervention for most patients with early-stage non-small cell lung cancer; however, an estimated 43% of those who undergo surgery will see their disease return,” said co-principal investigator Mary O’Brien of The Royal Marsden, NHS Foundation Trust and Imperial College in London in a news release. “Data from KEYNOTE-091 suggest adjuvant Keytruda reduced the risk of disease recurrence or death after surgery in the overall population of patients with stage 1b-3a non-small cell lung cancer.”

The researchers plan to continue analyzing DFS in patients whose tumors express high levels of PD-L1, the protein that Keytruda targets to help alert the immune system to attack the cancer. They will also analyze overall survival — or the amount of time that a patient survives starting from the time of study entry/treatment initiation.

The interim analysis results also demonstrated a safety profile consistent with that reported in previous studies for Keytruda.

“Globally, lung cancer is the leading cause of cancer death, and it remains critically important to detect and treat lung cancer early,” said Dr. Luis Paz-Ares, chair of the Medical Oncology Department at Hospital Universitario Doce de Octubre in Madrid, and co-principal investigator, in the news release.

“The goal of adjuvant treatment is to lower the risk of cancer returning after surgery. By moving Keytruda into earlier stages of non-small cell lung cancer, we may be able to reduce the risk of disease recurrence after surgery for patients with stage 1b-3a non-small cell lung cancer.”

It was also noted that these results are a first for Keytruda in terms of adjuvant treatment for patients with stage 1b-3a NSCLC.

“Keytruda has become foundational in the treatment of metastatic non-small cell lung cancer, and we continue to advance research to explore its potential to help fight cancer earlier,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer of Merck Research Laboratories, in the release.

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