China Approves Keytruda + Chemo for NSCLC
Keytruda ( pembrolizumab) Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC)
“While there have been several advances in the treatment of metastatic lung cancer over the past decade, lung cancer continues to be the leading cause of cancer death in China,” said Dr. Heather Wakelee, principal investigator for KEYNOTE-671, thoracic medical oncologist and professor of medicine at Stanford University and past president of the International Association for the Study of Lung Cancer (IASLC). “This approval represents an important moment for certain patients with resectable NSCLC in China, providing a new option that has been shown in the KEYNOTE-671 study to significantly improve overall survival in these patients.”
In October 2023, Keytruda in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment for patients with stage II, IIIA or IIIB NSCLC was approved in the U.S. based on results from the KEYNOTE-671 trial.Keytruda plus chemotherapy in the neoadjuvant setting followed by Keytruda as monotherapy after surgical resection significantly improved overall survival (OS), reducing the risk of death by 28% (HR=0.72 [95% CI, 0.56-0.93]; one-sided p=0.0103) in patients with NSCLC, regardless of PD-L1 expression, versus placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection. For patients who received the Keytruda-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen. The Keytruda-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 42% (HR=0.58 [95% CI, 0.46-0.72]; p<0.0001) compared to the chemotherapy-placebo regimen. Adverse reactions occurring in patients with resectable NSCLC receiving Keytruda in combination with platinum-containing chemotherapy, given as neoadjuvant treatment and continued as single agent adjuvant treatment after surgery, were generally similar to those occurring in patients across tumor types receiving Keytruda in combination with chemotherapy.
This milestone builds on the momentum for worldwide approvals for Keytruda in the perioperative setting for certain patients with earlier stages of NSCLC, including the European Union and Japan.
“This approval marks Keytruda 's fourth lung cancer indication in China, embarking on a new journey of treating certain patients with earlier stage non-small cell lung cancer,” said Anna Van Acker, Senior Vice President of MSD and President of MSD in China. Keytruda has established an important role in immunotherapy for advanced NSCLC with its three previously approved indications in China, but there are still significant unmet medical needs for certain patients with earlier stage NSCLC, as lung cancer remains China's leading cause of cancer incidence and mortality. We are thrilled to introduce this new treatment option and remain committed to advancing innovation to help more Chinese patients.”
About the KEYNOTE-671 study design; KEYNOTE-671 is a randomized, double-blind Phase III trial (ClinicalTrials.gov, NCT03425643 ) 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 (T3-4N2) NSCLC (per the eight edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual). The trial’s dual primary endpoints are EFS, per RECIST v1.1 by investigator assessment, and OS. Key secondary endpoints include pathologic complete response (pCR) and major pathological response (mPR).
The study enrolled 797 patients who were randomly assigned (1:1) to receive either: 1.Keytruda (200 mg intravenously [IV] every three weeks [Q3W]) plus chemotherapy (cisplatin [75 mg/m2 , IV; given on Day 1 of each cycle] and either gemcitabine [1,000 mg/m2 , IV; given on Days 1 and 8 of each cycle] or pemetrexed [500 mg/m2 , IV; given on Day 1 of each cycle]) for up to four cycles as neoadjuvant therapy prior to surgery. Within 4-12 weeks following surgery, Keytruda (200 mg) was administered every three weeks for up to 13 cycles, or;
- 2. Placebo (saline IV Q3W) plus chemotherapy (cisplatin [75 mg/m2 , IV; given on Day 1 of each cycle] and either gemcitabine [1,000 mg/m2 , IV; given on Days 1 and 8 of each cycle] or pemetrexed [500 mg/m2 , IV; given on Day 1 of each cycle]) for up to four cycles as neoadjuvant therapy prior to surgery. Within 4‑12 weeks following surgery, placebo was administered every three weeks for up to 13 cycles
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