At the 2025 European Society of Medical Oncology (ESMO) Congress, held on 17 to 21 October in Berlin, Germany, results from the Phase III ELEVATE double-blind, randomized study were presented. The study evaluated Xcovery and Betta Pharmaceuticals’ tyrosine kinase inhibitor (TKI) Ensacove (ensartinib) for anaplastic lymphoma kinase (ALK)–positive stage Ib–IIIb resected non-small cell lung cancer (NSCLC) in the adjuvant setting.
At a 24-month median follow-up, disease-free survival (DFS), the study’s primary endpoint, was reached in 86.4% of patients treated with ensartinib, compared to 53.5% in the placebo control arm. Grade 3 or higher adverse events occurred in 35.8% of the treatment arm compared to 18.2% in the control. In 2024, Ensacove was US Food and Drugs Administration-approved for the treatment of metastatic ALK-positive NSCLC.
Go deeper with GlobalData
Access deeper industry intelligence
Experience unmatched clarity with a single platform that combines unique data, AI, and human expertise.
The data presented is similar to that of Roche’s Alecensa (alectinib), the current standard of care, based on the Phase III ALINA study, in which the 2-year DFS was 93.8%. The key difference between the studies is that the ELEVATE trial allowed for patients who had previously received adjuvant chemotherapy, whereas ALINA required no prior treatment. The two studies, however, demonstrate the reduced role adjuvant chemotherapy plays in earlier-stage ALK-positive NSCLC with newer TKIs entering the market.
Ensacove faces the challenge of Alecensa being first-to-market, and the widespread commercial capabilities of its sponsor, Roche. Another TKI that could eventually move into these earlier settings is Pfizer’s Lorbrena (lorlatinib), which is currently competing with Alecensa in the metastatic setting. A new-generation TKI, Nuvalent’s neladalkib, is in the ALKOVE-1 study for metastatic ALK-mutated NSCLC and could potentially be investigated in the adjuvant setting.
According to GlobalData’s analyst consensus forecast, the global market for kinase inhibitors targeting ALK-mutated NSCLC is expected to reach $5.7 billion by 2031, led by Alecensa at $2.2 billion and followed by Lorbrena at $1.5 billion. The number of NSCLC patients with ALK mutations is expected to increase, as GlobalData epidemiologists project the number of patients rising from 19,626 in 2022 to 21,705 in 2032 within the seven major markets (7MM: France, Germany, Italy, Japan, Spain, UK and the US).
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData
