JAVELIN Lung 100 Trial Evaluating Progression-Free and Overall Survival for Patients With NSCLC

Millie Das, MD, outlines the JAVELIN Lung 100 trial and shares insights on strategies and data interpretation from the trial.

Millie Das, MD: JAVELIN Lung 100 (NCT02576574) was an open-label phase 3 trial that enrolled previously untreated patients with advanced non–small cell lung cancer with PD-L1 expression levels of greater than or equal to 1%. Patients with EGFR and ALK alterations were excluded. Patients were randomized to receive avelumab, a PD-L1 inhibitor approved in the treatment of Merkel cell carcinoma, compared with platinum-based chemotherapy. The results that were reported showed no statistically significant difference in overall survival and progression-free survival. This was felt to be related to the statistical design and analysis, which had to undergo changes due to some of the decisions in changing the end points and dosing of the drug after the start of the study.

We would have expected to see efficacy for avelumab in the PD-L1–high subgroup of patients, similar to other trials with single-agent I/O [immuno-oncology] in this patient population. We saw a benefit here, but it wasn’t statistically significant and it wasn’t as pronounced, perhaps due to the statistical reasons that I mentioned. Also, in this study, 30% of the patients in the chemotherapy arm went on to receive immunotherapy, which would certainly make it difficult to tease out survival differences. Interestingly, the more frequent weekly dosing of avelumab also didn’t seem to impact the efficacy of this drug.

Transcript edited for clarity.

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