Roche is losing its perioperative lung cancer lead

Roche boasted the first ever approval of a PD-(L)1 drug in perioperative lung cancer, but now looks like losing this lead. Not only did Merck & Co’s Keytruda trump it with an all-comers label in the adjuvant setting – Tecentriq’s earlier label was limited to PD-L1 expressers – Bristol Myers Squibb’s Opdivo was first with a neoadjuvant approval. This month the latter setting added two other wins, with Keytruda succeeding in the Keynote-671 trial and being filed with a 16 October Pdufa date, and Astrazeneca’s Imfinzi today scoring in the Aegean study. Meanwhile, Roche’s Impower-030 trial, in a similar setting to Keynote-671 and Aegean, is mired in delays, having initially been due to yield data in 2021. In January Cowen analysts were still expecting imminent readout, but at its fourth-quarter results call Roche quietly slipped out the fact that Impower-030 was continuing to 2024, suggesting that interim analysis had failed to show a positive effect. Astra did not confirm whether it had filed Imfinzi on the basis of Aegean, but since the trial has now hit the same endpoints as Keynote-671 this seems likely. By the end of this year, Tecentriq could have three approved competitors in neoadjuvant NSCLC.