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 NSCLCDrugTrial nameSettingStages covered Regulatory status    USEUTecentriqImpower-010AdjuvantIB-IIIAApproved Oct 2021 in PD-L1 +ve (≥1%) stage II-IIIA diseaseApproved May 2022 in PD-L1 ≥50% pts without EGFR mutant/ALK-positive NSCLCOpdivoCheckmate-816NeoadjuvantIB-IIIAApproved in Mar 2022 in stage IB-IIIA all-comersApproved Jun 2023 in PD-L1 ≥1% ptsKeytrudaKeynote-091AdjuvantIB-IIIAApproved Jan 2023 in IB-IIIA all-comersPositive CHMP opinion Sep 2023KeytrudaKeynote-671Peri-adjuvantII, IIIA & IIIBPDUFA 16 Oct 2023, based on EFSExpected by YE 2023ImfinziAegeanPeri-adjuvantIIA to "select" IIIBEFS data at AACR 2023; continuing to OS assessmentOpdivoCheckmate-77TPeri-adjuvantII-IIIBToplined positive for EFS Sep 2023TecentriqImpower-030NeoadjuvantII, IIIA or “select” IIIBTrial readout delayed to 2024/2025OpdivoAnvilAdjuvantIB-IIIAReadout 2024/2025ImfinziAdjuvant BR.31AdjuvantIB, II & IIIAReadout 2025Source: OncologyPipeline & company expectations of timing.