Merck hits another Keynote in perioperative lung
Merck & Co’s Keytruda had already hit on one co-primary endpoint of its (neo)adjuvant non-small cell lung cancer trial, Keynote-671. Now the company has said the study met its other co-primary measure, overall survival – marking the first time a PD-(L)1 inhibitor has shown a survival benefit. No data are yet available but investors won’t have long to wait, with results slated for the ESMO meeting this month. Before that, though, Keytruda is facing a US approval decision by 16 October for the new perioperative use, based on improvement in event-free survival. Keynote-671 involved Keytruda plus chemo before surgery (neoadjuvant), followed by resection and single-agent Keytruda afterwards (adjuvant). The checkpoint inhibitor players have been duelling in the perioperative space, with Bristol Myers Squibb recently announcing a win in its rival (neo)adjuvant trial CheckMate-77T; data from that study are also due at ESMO. However, Roche, once a leader in this setting, has fallen behind, with its neoadjuvant Impower-030 study delayed.
Key anti-PD-(L)1 MAb studies in perioperative NSCLC
| Drug | Trial name | Setting | Stages covered | Regulatory status | |
|---|---|---|---|---|---|
| US | EU | ||||
| Tecentriq | Impower-010 | Adjuvant | IB-IIIA | Approved Oct 2021 in PD-L1 +ve (≥1%) stage II-IIIA disease | Approved May 2022 in PD-L1 ≥50% pts without EGFR mutant/ALK-positive NSCLC |
| Opdivo | Checkmate-816 | Neoadjuvant | IB-IIIA | Approved in Mar 2022 in stage IB-IIIA all-comers | Approved Jun 2023 in PD-L1 ≥1% pts |
| Keytruda | Keynote-091 | Adjuvant | IB-IIIA | Approved Jan 2023 in IB-IIIA all-comers | Positive CHMP opinion Sep 2023 |
| Keytruda | Keynote-671 | Peri-adjuvant | II, IIIA & IIIB | PDUFA 16 Oct 2023, based on EFS | Expected by YE 2023 |
| Imfinzi | Aegean | Peri-adjuvant | IIA to "select" IIIB | EFS data at AACR 2023; continuing to OS assessment | |
| Opdivo | Checkmate-77T | Peri-adjuvant | II-IIIB | Toplined positive for EFS Sep 2023 | |
| Tecentriq | Impower-030 | Neoadjuvant | II, IIIA or “select” IIIB | Trial readout delayed to 2024/2025 | |
| Opdivo | Anvil | Adjuvant | IB-IIIA | Readout 2024/2025 | |
| Imfinzi | Adjuvant BR.31 | Adjuvant | IB, II & IIIA | Readout 2025 | |
Source: OncologyPipeline & company expectations of timing.
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