FDA approves Keytruda for adjuvant, neoadjuvant treatment of non-small cell lung cancer
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The FDA approved pembrolizumab plus platinum-containing chemotherapy as neoadjuvant therapy, followed by single-agent pembrolizumab as adjuvant therapy after surgery for adults with resectable non-small cell lung cancer.
The indication applies to resectable tumors 4 cm or larger or node-positive tumors.
“Keytruda continues to change the way non-small cell lung cancer is treated across earlier and metastatic disease regardless of PD-L1 expression,” Marjorie Green, MD, senior vice president and head of late-stage oncology development at Merck Research Laboratories, said in a company-issued press release. “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 health care providers with an important new treatment option.”
Pembrolizumab (Keytruda, Merck) is a PD-1 inhibitor previously approved for several NSCLC indications.
The FDA approved this latest pembrolizumab indication based on results from the double-blind KEYNOTE-671 trial. The study enrolled 786 adults with stage II, IIIA or IIIB resectable NSCLC randomly assigned to receive either neoadjuvant pembrolizumab plus chemotherapy before surgery followed by adjuvant pembrolizumab or placebo plus neoadjuvant chemotherapy before surgery followed by adjuvant placebo.
The study met both of its primary endpoints, including significant improvement in OS and investigator-assessed EFS. Median OS had not been reached as of the study’s data cut-off date in the pembrolizumab arm compared with 52.4 months among those receiving placebo (HR = 0.72; 95% CI: 0.56-0.93). Likewise, median EFS had not reached in the pembrolizumab arm compared with 17 months among those receiving placebo (HR = 0.58; 95% CI, 0.46-0.72).
The most common treatment-related adverse events reported in more than 20% of patients during the KEYNOTE-671 trial included nausea, fatigue, neutropenia, anemia, constipation, decreased appetite, decreased white blood cell count, musculoskeletal pain, rash, cough, vomiting, diarrhea and dyspnea.
“There remains a need for treatment options to improve outcomes for patients with earlier stages of non-small cell lung cancer,” Heather Wakelee, MD, 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, said in a Merck-issued press release. “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 [with] a placebo and chemotherapy regimen.”
References:
- FDA approves Keytruda (pembrolizumab) for treatment of patients with resectable (T4 cm or N+) NSCLC in combination with chemotherapy as neoadjuvant treatment, then continued as a single agent as adjuvant treatment after surgery (press release). Available at: https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-for-treatment-of-patients-with-resectable-t%e2%89%a54-cm-or-n-nsclc-in-combination-with-chemotherapy-as-neoadjuvant-treatment-then-continued-as-a-single/. Published Oct. 16, 2023. Accessed Oct. 17, 2023.
- FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer (press release). Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-adjuvant-pembrolizumab-resectable-non-small-cell-lung-cancer. Published Oct. 16, 2023. Accessed Oct. 17, 2023.
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