Merck's Keytruda (pembrolizumab) has received approval from China's National Medical Products Administration (NMPA) for the treatment of certain early-stage non-small cell lung cancer (NSCLC). This approval expands Keytruda's use to earlier stages of NSCLC, marking its fourth indication for this type of cancer in China. The decision follows the U.S. approval in October 2023, which was based on the KEYNOTE-671 study results.
The approval specifically covers the use of Keytruda in combination with platinum-containing chemotherapy as a neoadjuvant treatment, followed by Keytruda monotherapy as adjuvant treatment post-surgery, for patients with resectable stage II, IIIA, or IIIB NSCLC. This therapeutic approach demonstrated a significant improvement in overall survival for these patients in the KEYNOTE-671 trial.
KEYNOTE-671 Trial Results
The KEYNOTE-671 trial revealed that Keytruda plus chemotherapy in the neoadjuvant setting, followed by Keytruda as monotherapy after surgical resection, reduced the risk of death by 28% (HR=0.72 [95% CI, 0.56-0.93]; one-sided p=0.0103) and improved event-free survival by 42% (HR=0.58 [95% CI, 0.46-0.72]; p<0.0001) compared to the chemotherapy-placebo regimen. The median overall survival was not reached in the Keytruda-based regimen group, while it was 52.4 months (95% CI, 45.7-NR) in the chemotherapy-placebo group. Adverse reactions were consistent with those observed in other tumors treated with Keytruda in combination with chemotherapy.
Clinical Significance
Dr. Heather Wakelee, principal investigator for the KEYNOTE-671 study, emphasized the importance of this approval for patients with resectable NSCLC in China, where lung cancer is the leading cause of cancer death. Anna Van Acker, Senior Vice President of MSD and President of MSD in China, highlighted the company's commitment to addressing unmet medical needs in earlier stages of NSCLC by introducing this new treatment option in China.
Lung Cancer Burden in China
Lung cancer is the leading cause of cancer death globally, with China experiencing over one million new cases and approximately 733,200 deaths in 2022. The five-year survival rate for lung cancer in China is only 19.7%, underscoring the urgency for improved treatment options. This approval aligns with the Healthy China 2030 Planning Outline, which aims to increase the overall five-year cancer survival rate to 46.6%.
About Keytruda
Keytruda is an anti-PD-1 therapy that enhances the immune system's ability to detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes. Merck has an extensive immuno-oncology clinical research program with over 1,600 trials studying Keytruda across various cancers and treatment settings.
Trial Design
KEYNOTE-671 is a randomized, double-blind Phase 3 trial evaluating Keytruda in combination with neoadjuvant chemotherapy, followed by surgery and continued adjuvant treatment with Keytruda as a single agent, versus placebo plus neoadjuvant chemotherapy, followed by resection and adjuvant placebo, in patients with resectable stage II, IIIA or IIIB NSCLC. The trial enrolled 797 patients who were randomly assigned (1:1) to receive either Keytruda (200 mg intravenously every three weeks) plus chemotherapy or placebo plus chemotherapy.
