Approval marks the sixth NSCLC indication for KEYTRUDA and builds upon Merck’s progress in earlier stages of certain cancers across our oncology portfolio

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of patients with resectable (tumors ≥4 centimeters [cm] or node positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.

The approval was based on data from the Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent, for patients with resectable stage II, IIIA or IIIB (N2) NSCLC per the American Joint Committee on Cancer eighth edition (AJCC 8th edition). In the study, the KEYTRUDA regimen demonstrated statistically significant improvements in event-free survival (EFS) and overall survival (OS), the study’s dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone. The EFS results, which were from the first interim analysis, were published in June 2023 in the New England Journal of Medicine. The detailed OS results will be presented at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, on October 20, 2023.

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, were generally similar to those occurring in patients across tumor types receiving KEYTRUDA in combination with chemotherapy.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA (pembrolizumab). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

“There remains a need for treatment options to improve outcomes for patients with earlier stages of non-small cell lung cancer,” 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 important milestone has the potential to change the current treatment paradigm for resectable non-small cell lung cancer that is greater than four centimeters or has lymph node involvement, by offering an immunotherapy-based regimen that has demonstrated statistically significant improvements in overall survival and event-free survival compared to a placebo and chemotherapy regimen.”

“KEYTRUDA continues to change the way non-small cell lung cancer is treated across earlier and metastatic disease regardless of PD-L1 expression,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “This approval marks a pivotal moment for the lung cancer community by providing certain patients with earlier stages of non-small cell lung cancer and healthcare providers with an important new treatment option.”

The approval marks the sixth NSCLC indication for KEYTRUDA. The five other indications for KEYTRUDA in NSCLC include:

1) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations;

2) in combination with carboplatin and either paclitaxel or paclitaxel protein-bound for the first-line treatment of patients with metastatic squamous NSCLC;

3) as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic;

4) as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA; and

5) as a single agent for adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

Study design

KEYNOTE-671 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT03425643) evaluating KEYTRUDA in combination with neoadjuvant chemotherapy, followed by surgery and continued adjuvant treatment with KEYTRUDA (pembrolizumab) as a single agent, versus placebo plus neoadjuvant chemotherapy, followed by resection and adjuvant placebo, in patients with resectable stage II, IIIA or IIIB (N2) NSCLC per the AJCC eighth edition. Patients were enrolled regardless of tumor PD-L1 expression. Patients with active autoimmune disease that required systemic therapy within two years of treatment, a medical condition that required immunosuppression or a history of interstitial lung disease or pneumonitis that required steroids were ineligible. Randomization was stratified by stage (II vs. III), tumor PD-L1 expression (TPS ≥50% or