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.

Key anti-PD-(L)1 MAb studies in perioperative NSCLC
  Neoadjuvant NSCLC Adjuvant NSCLC
Opdivo Checkmate-816 Checkmate-77T
 FDA approved in stage IB-IIIA all-comers, 4 Mar 2022; Stage II-IIIB; 2023-24 readout
EFS 31.6mth vs 20.8mth, pCR 24% vs 2.2% for Opdivo + chemo vs chemo alone respectively
Keytruda Keynote-671* Keynote-091 (Pearls)
Stage II, IIIA & resectable IIIB; hit on EFS & pCR Mar 2023; continuing to OS assessment; filed, with 16 Oct 2023 Pdufa date FDA approved in IB-IIIA all-comers, 27 Jan 2023
DFS 58.7mth vs 34.9mth in all-comers, but not significant in ≥50% PD-L1 expressers
Imfinzi Aegean* Mermaid-1
Stage IIA to "select" IIIB; hit on pCR Jun 2022, and on EFS Mar 2023; continuing to OS assessment Stage II-III; 2024 readout
Tecentriq Impower-030* Impower-010
Stage II, IIIA & "select IIIB"; readout delayed from 2021 to 2022 to 2024 FDA approved in PD-L1 +ve (≥1%) stage II-IIIA disease, 15 Oct 2021
DFS NR vs 35.3mth in PD-L1 expressers
Notes: *also has an adjuvant stage; EFS=event-free survival; pCR=pathological complete response; DFS=disease-free survival. Source: & company expectations of timing.

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