The United States Food and Drug Administration (FDA) has approved yet another combination treatment with Merck & Co’s (MSD) Keytruda (pembrolizumab) for treating non-small cell lung cancer (NSCLC).

As per the latest label expansion, Keytruda, an anti-programmed death receptor-1 (PD-1) therapy, can now be used in conjunction with platinum-containing chemotherapy as a neoadjuvant treatment. This can then be followed by single-agent Keytruda treatment in the adjuvant setting after surgery for some patients that meet the criteria for tumour size and characteristics.

The FDA approval was based on results from the Phase III KEYNOTE-671 (NCT03425643) study, a randomised, double-blind, placebo-controlled clinical trial evaluating the efficacy of the combination treatment for resectable, stage II, IIIA or IIIB (N2) NSCLC as determined by the American Joint Committee on Cancer (AJCC) eighth edition. PD-L1 expression was not a patient prerequisite for KEYNOTE-671 study qualification.

The results made a splash at this year’s American Society of Clinical Oncology meeting, but it remains unclear if the treatment is required in both neoadjuvant and adjuvant settings.

In the study, 797 patients were randomly assigned to treatment groups at a 1:1 ratio.

The Keytruda treatment group received a combination of 200 mg neoadjuvant Keytruda and 75 mg/m2 cisplatin every three weeks prior to surgery. Following surgery, patients were treated with single-agent 200 mg Keytruda administered every three weeks for up to 13 cycles. The intervention for the placebo group was consistent with the same timeline, instead combining cisplatin with neoadjuvant placebo before surgery and continuing placebo treatment following operation.

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The study met its co-primary endpoints of overall survival (OS) and investigator-assessed event free survival (EFS). Secondary endpoints laid out by the study were also fulfilled.

Following the announcement, MSD’s senior vice president and head of late-stage oncology, global clinical development, Marjorie Green, said, “Keytruda continues to change the way non-small cell lung cancer is treated across earlier and metastatic disease regardless of PD-L1 expression.”

The global NSCLC drug market is highly competitive, with GlobalData estimating its value to exceed $1bn by 2025. With their latest FDA approval, Keytruda is approved to treat six different NSCLC settings. Other drug development giants such as Bristol Myers Squibb, AstraZeneca, and Merck KGaA each have their share of the immuno-oncology market. 

GlobalData is the parent company of Pharmaceutical Technology.

Last month, BMS announced that its Phase III CheckMate-77T trial studying neoadjuvant Opdivo (nivolumab)/chemotherapy followed by adjuvant Opdivo treatment for NSCLC met its primary endpoint of EFS.

This content was updated on 25 January 2024