Roche slips further behind in perioperative lung cancer

Though Roche’s Tecentriq became the first ever anti-PD-(L)1 drug to be approved in perioperative lung cancer, the company has managed to lose this headstart. Merck & Co’s Keytruda trumped Tecentriq with an all-comers label in the adjuvant setting (Tecentriq’s label was limited to PD-L1 expressers), Bristol Myers Squibb’s Opdivo was first with a neoadjuvant approval, and now Opdivo threatens to add adjuvant use to its label, after the Checkmate-77T study was on Friday toplined positive for event-free survival. Keytruda presents a further threat, with success in the neoadjuvant Keynote-671 trial leading to a US filing on which the FDA is to decide by 16 October. And AstraZeneca’s Imfinzi has scored in the neoadjuvant Aegean trial, which featured at a plenary session of this year’s AACR. It is unclear whether Astra has filed these data with regulators, and Aegean is continuing to OS readout. Meanwhile, Roche’s Impower-030 trial, in a similar setting to Keynote-671 and Aegean, was initially due to yield data in 2021, but in February Roche said it was continuing to 2024, suggesting that interim analysis had failed to show a sufficiently positive effect; Impower-030’s clinicaltrials.gov entry now shows a primary completion date of January 2025. 

Key anti-PD-(L)1 MAb studies in perioperative NSCLC

Notes: *also has an adjuvant stage; **also has a neoadjuvant stage. EFS=event-free survival; pCR=pathological complete response; DFS=disease-free survival. Source: OncologyPipeline & company expectations of timing.