Outcomes With Immunotherapy for Metastatic NSCLC: An FDA Pooled Analysis

By: Victoria Kuhr, MS
Posted: Thursday, April 25, 2024

Bernardo Haddock Lobo Goulart, MD, of the U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, and colleagues observed moderate correlations of overall response rate and progression-free survival with overall survival at the trial level for first-line immune checkpoint inhibitor–based regimens in patients with metastatic non–small cell lung cancer (NSCLC). Additionally, these findings, which were published in The Lancet Oncology, included a patient-level analysis suggesting that Response Evaluation Criteria in Solid Tumors (RECIST) responses were associated with longer overall survival in patients with NSCLC treated with first-line immune checkpoint inhibitor–based regimens in randomized trials.

“The present analysis supports the importance of a reasonably mature evaluation of overall survival when evaluating progression-free survival and overall response rate results in first-line immune checkpoint inhibitor–based regimens for metastatic NSCLC,” said the study authors.

The researchers conducted a pooled analysis of first-line randomized trials submitted to the FDA from June 2016 to March 2021. Patients with metastatic squamous and nonsquamous NSCLC were included. Eligible trials evaluated at least one immune checkpoint inhibitor in the experimental group vs chemotherapy in the control group.

This pooled analysis included a total of 13 trials with 9,285 patients; it evaluated the use of immune checkpoint inhibitors alone or in combination with chemotherapy vs chemotherapy with or without bevacizumab. At the trial level, the R² was 0.61 for correlation of overall response rate with overall survival and 0.70 for correlation of progression-free survival with overall survival. Correlations ranged from weak to moderate when the study authors assessed subgroups by PD-L1 expression and were consistent across trials evaluating immune checkpoint inhibitors alone or in combination with chemotherapy. At the patient level, responders had longer overall survival rates than did nonresponders. Among responders, overall survival was longer in patients enrolled in experimental groups than in control groups.

Disclosure: The study authors reported no conflicts of interest.

The Lancet Oncology

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