Hypothesis
Adding avelumab to three cycles of neoadjuvant platinum chemotherapy would produce enough radiologic responses in resectable stage IB–IIIA NSCLC to justify a full phase 2 study.
What failed
Of 15 patients in stage 1, four had a radiologic response (one complete), fewer than the six required to continue, so the study was terminated. The regimen was tolerable (26.7% grade III/IV toxicity) without extra surgical complications.
Broken assumption
The response gains from adding checkpoint inhibitors to chemotherapy in advanced NSCLC carry over to the neoadjuvant setting.
Why
The paper reports only that adding immunotherapy did not appear to raise the response rate in this setting, and so the study failed its primary endpoint.
From the published paper: Tfayli et al. Cancer Medicine, 2020. ↗CC BY