Through the Adaura trial AstraZeneca’s Tagrisso made history in EGFR-mutated lung cancer treatment, gaining approval in the adjuvant setting, and now Roche could do the same in another targeted NSCLC niche. The Swiss group’s ALK inhibitor Alecensa was this morning said to have succeeded in the phase 3 Alina study, scoring a “statistically significant and clinically meaningful” benefit versus platinum chemo on its primary endpoint of disease-free survival at an interim analysis. Roche, which now aims to file the data with regulators, boasted of this having been a first for any ALK inhibitor in early NSCLC. Indeed, the relatively low-profile Alina study is one of few even to test such a theory. Only 14 trials are testing ALK inhibitors in adjuvant or neoajuvant NSCLC, according to OncologyPipeline, of which just three aren't academic-initiated. Perhaps the most important is Xcovery/Betta’s BTP-42338 study of ensartinib, reading out in 2025 but enrolling a slightly different window of patients than Alina by histology. The elephant in the room is that ALK-mutated NSCLC represents a relatively small market niche: roughly 5% of lung adenocarcinoma is thought to be driven by this mutation, versus 15% for EGFR.Trials of ALK inhibitors in perioperative ALK-positive NSCLCProjectCompanyTrialSetting/histologyDataAlecensaRocheAlina*^Adjuvant stage IB-IIIA, vs Pt chemoToplined positive for DFSNautika-1**Adjuvant stage II-IIIBEnds Mar 2024AlneoNeoadjuvant stage IIIEnded May 2023EnsartinibXcovery/ BettaBTP-42338*^Adjuvant stage II-IIIB, vs placeboEnds Jun 2025BD-EN-IV006Adjuvant stage IB-IIIAEnds Feb 2027BD-EN-IV005 Adjuvant stage II-IIIAStatus unclearChiCTR2300070192Adjuvant stage II-IIIBTrial ongoingBD-EN-IV0012Neoadjuvant stage IIA-IIIBEnds Dec 2023XalkoriPfizerNCT02201992*Adjuvant stage IB-IIIA, vs observationEnds May 2026NCT03088930Neoadjuvant stage IA-IIIATerminated for low recruitmentZykadiaNovartisSakulaNeoadjuvant stage II/IIIORR 100%, but just 7 pts enrolled (395 screened, of whom 15 were ALK+ve)AlulnbrigTakedaNCT05361564Neoadjuvant stage I-IIIAStatus unclearIruplinalkibQiluWX0593-IIT-001Neoadjuvant stage IB-IIIANot yet enrollingLorbrenaPfizerLorinNeoadjuvant + adjuvant stage IIIEnds Dec 2024Notes: *phase 3 trial, all others are phase 2; ^company-sponsored trial, all others are academic; **also tests Rozlytrek. Source: OncologyPipeline.
Through the Adaura trial AstraZeneca’s Tagrisso made history in EGFR-mutated lung cancer treatment, gaining approval in the adjuvant setting, and now Roche could do the same in another targeted NSCLC niche. The Swiss group’s ALK inhibitor Alecensa was this morning said to have succeeded in the phase 3 Alina study, scoring a “statistically significant and clinically meaningful” benefit versus platinum chemo on its primary endpoint of disease-free survival at an interim analysis. Roche, which now aims to file the data with regulators, boasted of this having been a first for any ALK inhibitor in early NSCLC. Indeed, the relatively low-profile Alina study is one of few even to test such a theory. Only 14 trials are testing ALK inhibitors in adjuvant or neoajuvant NSCLC, according to OncologyPipeline, of which just three aren't academic-initiated. Perhaps the most important is Xcovery/Betta’s BTP-42338 study of ensartinib, reading out in 2025 but enrolling a slightly different window of patients than Alina by histology. The elephant in the room is that ALK-mutated NSCLC represents a relatively small market niche: roughly 5% of lung adenocarcinoma is thought to be driven by this mutation, versus 15% for EGFR.
Trials of ALK inhibitors in perioperative ALK-positive NSCLC
