Alecensa gets its first-mover adjuvant label
After Roche followed through on its promise to deliver “unprecedented” data with Alecensa in adjuvant ALK-positive NSCLC the FDA has upheld its end of the bargain, yesterday approving the drug for this use a month before its 22 May PDUFA date. The move, based on the Alina trial that featured in last year’s ESMO late-breaker, makes Alecensa the first ALK inhibitor available for perioperative use, specifically in stage IB to IIIA NSCLC that’s been resected and is positive for ALK. This gives Alecensa first-mover advantage in a perioperative targeted lung cancer niche, and a surprising finding is how little competitor activity there is here: Xcovery/Betta’s ensartinib and Pfizer’s Xalkori are the only other ALK inhibitors being tested in phase 3 in adjuvant NSCLC, but the latter’s trial, Alchemist, is academic-sponsored. There’s more activity in the neoadjuvant setting, though Alecensa’s own Alneo trial is a phase 2, and the ALK space overall is being shaken up by next-generation approaches.
Phase 3 studies of ALK inhibitors in adjuvant NSCLC
| Trial | Drug | Setting | Design | Data |
|---|---|---|---|---|
| Alina (US approved setting) | Alecensa (Roche) | Stage IB-IIIA | Vs platinum chemo | Disease-free survival HR=0.24 (same in ITT as in stage II-IIIA subgroup) |
| BTP-42338 | Ensartinib (Xcovery/Betta) | Stage II-IIIA | Vs placebo | Readout expected mid-2025 (enrolment completed Sep 2023) |
| Alchemist* | Xalkori (Pfizer) | Stage IB-IIIA | Vs observation | Primary completion 2036 (earlier 2022) |
Note: *investigator sponsored. Source: OncologyPipeline.
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