This approval marks the fourth non-small cell lung cancer (NSCLC) indication and the first indication in earlier stages of NSCLC for KEYTRUDA in China
December 16, 2024 6:45 am ET--RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced KEYTRUDA, 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 3 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:
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;
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.
About lung cancer
Lung cancer is the leading cause of cancer death worldwide. In 2022, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. In China alone, there were more than one million new cases and about 733,200 deaths from lung cancer in 2022. Patients diagnosed with lung cancer in China have historically faced poor outcomes, as the five-year survival rate for patients diagnosed with lung cancer in China is only 19.7%. Improving lung cancer survival remains an important goal in China, as the Healthy China 2030 Planning Outline aims to increase cancer’s overall five-year survival rate to 46.6%. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases.
About Merck’s early-stage cancer clinical program
Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 25 ongoing registrational studies across multiple types of cancer.
About KEYTRUDA® (pembrolizumab) injection, 100 mg
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.
Merck’s focus on cancer
Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit www.merck.com/clinicaltrials.
About Merck’s research in lung cancer
Merck is advancing research aimed at transforming the way lung cancer is treated, with a goal of improving outcomes for patients affected by this deadly disease. Through nearly 200 clinical trials evaluating more than 36,000 patients around the world, Merck is at the forefront of lung cancer research. In NSCLC, KEYTRUDA has six approved U.S. indications and is approved for advanced disease in more than 95 countries. Among Merck’s research efforts are trials focused on evaluating KEYTRUDA in earlier stages of lung cancer as well as identifying new combinations and coformulations with KEYTRUDA.
About Merck
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.