Merck’s KEYTRUDA® Approved in China for Earlier-Stage NSCLC Treatment
Tuesday, December 17, 2024
Merck’s KEYTRUDA® has been approved in China by the National Medical Products Administration (NMPA) for use in combination with platinum-based chemotherapy as a neoadjuvant treatment, followed by KEYTRUDA as a single-agent adjuvant therapy after surgery.
Lung cancer is the leading cause of cancer-related deaths worldwide, with China accounting for a significant portion of cases. In 2022, more than one million new cases and over 733,000 deaths were reported in China alone.
Non-small cell lung cancer accounts for approximately 80% of lung cancer cases globally. Historically, lung cancer patients in China have experienced poor outcomes, with a five-year survival rate of just 19.7%.
The approval is for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC).
The decision was based on findings from the Phase 3 KEYNOTE-671 trial, which demonstrated that this treatment significantly improves overall survival (OS) and event-free survival (EFS) in patients compared to chemotherapy alone.
The KEYNOTE-671 trial evaluated the efficacy of KEYTRUDA alongside platinum-containing chemotherapy as a pre-surgical (neoadjuvant) therapy, followed by KEYTRUDA as a single agent after surgery (adjuvant therapy).
Patients receiving the KEYTRUDA-based regimen showed a 28% reduction in the risk of death compared to those on the placebo-chemotherapy regimen. The median overall survival for patients in the KEYTRUDA group had not yet been reached, while those in the placebo group reported a median OS of 52.4 months.
Additionally, the KEYTRUDA-based treatment reduced the risk of disease recurrence, progression, or death by 42% compared to placebo. These benefits were observed regardless of PD-L1 expression levels.
The safety profile of the KEYTRUDA-based regimen was consistent with previous studies involving its use in combination with chemotherapy across other tumour types.
This latest approval marks the fourth lung cancer indication for KEYTRUDA in China, strengthening its role in immunotherapy for NSCLC.
While advances have been made in treating advanced NSCLC, significant challenges remain for patients with earlier stages of the disease, particularly in China where lung cancer remains the most common cause of cancer-related deaths.
KEYTRUDA’s approval in China aligns with previous approvals in regions such as the United States, the European Union, and Japan, marking progress in global treatment options for earlier-stage NSCLC.
The trial’s primary endpoints were overall survival (OS) and event-free survival (EFS), with secondary endpoints including pathological complete response (pCR) and major pathological response (mPR).
Source: merck.com
