Roche could take another targeted treatment into adjuvant lung cancer
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
Project | Company | Trial | Setting/histology | Data |
---|---|---|---|---|
Alecensa | Roche | Alina*^ | Adjuvant stage IB-IIIA, vs Pt chemo | Toplined positive for DFS |
Nautika-1** | Adjuvant stage II-IIIB | Ends Mar 2024 | ||
Alneo | Neoadjuvant stage III | Ended May 2023 | ||
Ensartinib | Xcovery/ Betta | BTP-42338*^ | Adjuvant stage II-IIIB, vs placebo | Ends Jun 2025 |
BD-EN-IV006 | Adjuvant stage IB-IIIA | Ends Feb 2027 | ||
BD-EN-IV005 | Adjuvant stage II-IIIA | Status unclear | ||
ChiCTR2300070192 | Adjuvant stage II-IIIB | Trial ongoing | ||
BD-EN-IV0012 | Neoadjuvant stage IIA-IIIB | Ends Dec 2023 | ||
Xalkori | Pfizer | NCT02201992* | Adjuvant stage IB-IIIA, vs observation | Ends May 2026 |
NCT03088930 | Neoadjuvant stage IA-IIIA | Terminated for low recruitment | ||
Zykadia | Novartis | Sakula | Neoadjuvant stage II/III | ORR 100%, but just 7 pts enrolled (395 screened, of whom 15 were ALK+ve) |
Alulnbrig | Takeda | NCT05361564 | Neoadjuvant stage I-IIIA | Status unclear |
Iruplinalkib | Qilu | WX0593-IIT-001 | Neoadjuvant stage IB-IIIA | Not yet enrolling |
Lorbrena | Pfizer | Lorin | Neoadjuvant + adjuvant stage III | Ends Dec 2024 |
Notes: *phase 3 trial, all others are phase 2; ^company-sponsored trial, all others are academic; **also tests Rozlytrek. Source: OncologyPipeline.
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