Purpose: On March 4, 2022, the US Food and Drug Administration (FDA) approved nivolumab plus platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable non-small-cell lung cancer (NSCLC). We discuss the FDA's review of the key data and regulatory considerations supporting this approval.
Patients And Methods: The approval was based on the results of CheckMate 816, an international, multiregional, active-controlled trial that randomly assigned 358 patients with resectable NSCLC, stage IB (≥4 cm) to IIIA (N2) per the American Joint Committee on Cancer seventh staging edition to receive either nivolumab plus platinum-doublet or platinum-doublet chemotherapy alone for three cycles before planned surgical resection. The major efficacy end point that supported this approval was event-free survival (EFS).
Results: At the first planned interim analysis (IA), the hazard ratio (HR) for EFS was 0.63 (95% CI, 0.45 to 0.87; = .0052; statistical significance boundary = .0262) favoring the nivolumab plus chemotherapy arm; the median EFS was 31.6 months (95% CI, 30.2 to not reached) in the nivolumab plus chemotherapy arm versus 20.8 months (95% CI, 14.0 to 26.7) in the chemotherapy-only arm. At the time of a prespecified IA for overall survival (OS), 26% of patients had died, and the HR for OS was 0.57 (95% CI, 0.38 to 0.87; = .0079; statistical significance boundary = .0033). Eighty-three percent of patients in the nivolumab-containing arm versus 75% in the chemotherapy-only arm received definitive surgery.
Conclusion: This approval, the first for any regimen for the neoadjuvant treatment of NSCLC in the United States, was supported by a statistically significant and clinically meaningful improvement in EFS with no evidence of detriment in OS or negative impact on patients' receipt and timing of surgery or surgical outcomes.
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http://dx.doi.org/10.1200/JCO.22.02509 | DOI Listing |
Gan To Kagaku Ryoho
November 2024
Dept. of Gastroenterology Gastrointestinal Oncology, National Cancer Center Hospital East.
The standard first-line treatment for unresectable advanced or recurrent gastric cancer(GC)and gastroesophageal junction cancer(GEJC)has been a platinum doublet chemotherapy. Trastuzumab with chemotherapy is the standard regimen for HER2-positive GC/GEJC. While, for HER2-negative cases, chemotherapy with or without immune checkpoint inhibitors (ICIs)such as nivolumab or pembrolizumab are regarded as the standard therapy.
View Article and Find Full Text PDFPharmacoecon Open
December 2024
Health Economics and Outcomes Research Ltd, Cardiff, UK.
Objectives: This study assessed the cost-effectiveness of nivolumab plus ipilimumab (NIVO+IPI) versus platinum-doublet chemotherapy (chemo) in untreated metastatic non-small cell lung cancer (NSCLC) using mixture-cure modelling, an approach used to analyse immuno-oncology treatments due to their underlying methods depicting delayed but durable response in some patients.
Methods: A mixture-cure economic model was developed from a US third-party payer perspective to assess the lifetime costs and benefits of NIVO+IPI versus chemo using data from Part 1 of the phase III CheckMate 227 trial with 5 years of follow-up. The model consisted of four health states: progression-free without long-term response (non-LTR), progression-free with long-term response (LTR), post-progression, and death.
Lancet Respir Med
October 2024
Service de Pneumologie, Centre Hospitalier Universitaire de Rennes, Université Rennes 1, INSERM, UMR_S 1242, Centre Eugène Marquis, Rennes, France.
Eur J Cancer
November 2024
Department of Respiratory Medicine, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan. Electronic address:
J Immunother Cancer
September 2024
Department of Radiation Oncology, Amsterdam UMC Locatie VUmc, Amsterdam, Noord-Holland, Netherlands.
Background: In non-small cell lung cancer (NSCLC), chemoradiotherapy (CRT) yields pathological complete response (pCR) rates of approximately 30%. We investigated using ipilimumab plus nivolumab (IPI-NIVO) with neoadjuvant CRT in resectable, and borderline resectable NSCLC.
Methods: This single-arm, phase-II trial enrolled operable T3-4N0-2 patients with NSCLC without oncogenic drivers.
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