Immuno-Oncology

FDA

Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.

Pembrolizumab (Keytruda) combined with ipilimumab (Yervoy) did not improve survival and had higher rates of toxicity compared with pembrolizumab monotherapy as a first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC) who had a PD-L1 tumor proportion score (TPS) of 50% or greater, and did not harbor EGFR or ALK aberrations.

The radiographic and pathologic responses that have been seen with checkpoint inhibitors in lung cancer bodes well for the use of neoadjuvant therapy. However, the relationship between response and long-term outcomes, specifically with regard to overall survival, will have to be teased out before they become standard practice, explained David Spigel, MD.