Astrazeneca makes a splash in neoadjuvant lung

Bristol Myers Squibb got there first, but Astrazeneca might not be too far behind. The UK group today touted the success of its PD-L1 inhibitor Imfinzi in neoadjuvant non-small cell lung cancer in the Aegean trial – on one of its co-primary endpoints at least. Astra said adding Imfinzi on top of chemo statistically significantly improved pathologic complete response (pCR). However, it will be important for the study also to hit on event-free survival; the recent approval of Bristol’s rival Opdivo plus chemo in neoadjuvant NSCLC was based on both endpoints. For now, Astra is not giving detailed data, but investors will want to see how Imfinzi stacks up against Opdivo. Notably, the studies enrolled slightly different patient populations. Astra says it will await EFS results before presenting the full data, so Asco 2023 is a potential venue. Next up in neoadjuvant NSCLC will be Roche’s Impower-030 trial of Tecentriq – this has EFS as primary and pCR as a secondary endpoint, according to clinicaltrials.gov. Neoadjuvant disease is a smaller opportunity than adjuvant NSCLC, where Tecentriq currently has the edge.

Selected 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;
EFS 31.6mth vs 20.8mth, pCR 24% vs 2.2% for Opdivo + chemo vs chemo alone respectively
Stage II-IIIB; 2023-24 readout
Imfinzi Aegean Mermaid-1
Stage II-III; hit on pCR Jun 2022; continuing to EFS assessment Stage II-III; 2024 readout
Tecentriq Impower-030* Impower-010
Stage II, IIIA & "select IIIB"; readout delayed from 2021 to 2022 FDA approved in PD-L1 +ve (≥1%) stage II-IIIA disease, 15 Oct 2021
Keytruda Keynote-671* Keynote-091 (Pearls)
Stage II, IIIA & resectable IIIB; 2024 readout At interim, positive on DFS in stage IB-IIIA all-comers but not in ≥50% PD-L1 expressers
*Also has an adjuvant stage. Source: clinicaltrials.gov & company expectations of timing.

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