Ensacove (ensartinib) / Betta Pharma - LARVOL DELTA

Alectinib versus ensartinib in Asian resected ALK-positive early-stage NSCLC: A matching-adjusted indirect comparison (ESMO 2026) - No abstract available

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Adjuvant Treatment of Postoperative ALK-positiveNSCLCwith Ensartinib Guided by MRD: A Single-Arm, Multicenter Study (Ensapilot) (IASLC-WCLC 2026) - P2, P3 | "While alectinib is currently the only approved adjuvant therapy for patients with completely resected ALK-positive NSCLC (stage IB [tumor ≥4 cm] to IIIA per the 7th edition of the AJCC staging system). Statistical analysis will utilize the Kaplan-Meier method to estimate median DFS and OS with 95% confidence intervals (CIs); time-to-event rates at specified time points will also be reported with 95% CIs. Patient enrollment commenced in March 2025 and is currently ongoing."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK

Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer: A Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "Ensartinib represents a new first-line option for patients with ALK-positive NSCLC. ClinicalTrials.gov Identifier: NCT02767804."

Clinical • Journal • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Development and Validation of a UPLC-MS/MS Method for Simultaneous Quantification of Ensartinib and Its Major Metabolite M465 in Rat Plasma and Application to Pharmacokinetic Studies. (PubMed, Drug Des Devel Ther) - "Crizotinib was used as the internal standard (IS). A sensitive, reliable, and rapid UPLC-MS/MS method was successfully developed and validated for the simultaneous determination of ensartinib and M465 in rat plasma. The method was successfully applied to a rat pharmacokinetic study and provides useful analytical support for further preclinical investigations of ensartinib and its major metabolite."

Journal • PK/PD data • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC: An Exploratory Analysis (IASLC-WCLC 2026) - "Conclusions : Ensartinib combined with anlotinib demonstrates promising antitumor activity and favorable tolerability in heavily pretreated lorlatinib-resistant ALK-positive NSCLC. These preliminary findings support further validation in larger prospective cohorts with extended follow-up."

Clinical • Hepatology • Liver Failure • Lung Cancer • Non Small Cell Lung Cancer • Small Cell Lung Cancer • Solid Tumor • ALK • TP53

Long Term Survival and Safety Analysis of Exalt3 Study: Ensartinib vs Crizotinib as First Line Regimen in ALK+ NSCLC Patients (IASLC-WCLC 2026) - P3 | "Horn L, et al. JAMA Oncol 2021; 7:1617-1625 ."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Efficacy of MET-TKI in ALK-rearranged,MET-aberrant Advanced NSCLC After Resistance to ALK-TKI (IASLC-WCLC 2026) - "Five patients received crizotinib or ensartinib, while 8 patients received alectinib/lorlatinib combined with savolitinib/vebreltinib/capmatinib. Lung cancer drug-sensitive organoids could offer personalized medication guidance. Further research is needed for further exploration in the future."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • MET

Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC: An Exploratory Analysis [Google translation] (IFENG.COM) - "The primary endpoints were ORR and DCR, and safety was assessed by treatment-related adverse events (TRAEs). Results showed that three patients achieved partial remission (ORR 42.9%) and DCR 85.7%; the incidence of TRAEs was 57.1%. Overall, the treatment was well-tolerated, with only one patient requiring dose reduction due to ≥ grade 3 skin reactions. No permanent discontinuation due to adverse events occurred."

Clinical data • Non Small Cell Lung Cancer

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Gevalka, intended for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC). (European Medicines Agency) - "Gevalka will be available as 25 mg and 100 mg capsules."

CHMP • Non Small Cell Lung Cancer

A Phase II Study of Ensartinib as Neoadjuvant Therapy for Stage II-IIIB ALK-rearranged Non-Small Cell Lung Cancer (NEOEAST) (IASLC-WCLC 2026) - P2 | "Notably, most adverse events were Grade 1 or 2 in severity, only one patient (10%) experienced a grade ≥ 3 increased transaminases. Conclusions : Although the study is still ongoing, neoadjuvant treatment with ensartinib demonstrated promising pathologic responses and was well tolerated in patients with resectable stage II-IIIB ALK+ lung adenocarcinoma."

Clinical • P2 data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Pan-RAS(on) Inhibitors RMC-6236 and GFH276 With Omeprazole or Ensartinib in KRAS-mutant Lung Cancer Cells (IASLC-WCLC 2026) - "Our previous work showed that the combination of omeprazole plus tepotinib is active in KRAS-mutant G12C and non-G12C cell lines ( Rosell et al...The H23 and A549 (sotorasib-resistant) cells were sensitive to both Pan-RAS(ON) inhibitors with higher IC 50s...Finally, pretreatment with omeprazole plus Pan-RAS inhibitors suggests a potential to delay resistance. Like crizotinib, ensartinib has activity against ALK, ROS1, and MET, and additionally targets AXL; therefore, ensartinib warrants further investigation."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • AXL • CTNNB1 • KRAS • ROS1 • SQSTM1 • STAT3

Ensartinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. (PubMed, N Engl J Med) - P3 | "Among patients with completely resected stage IB to IIIB ALK-positive NSCLC, the percentage of patients who were alive and disease-free at 24 months was significantly higher with ensartinib than with placebo. (Funded by Betta Pharmaceuticals; ELEVATE ClinicalTrials.gov number, NCT05341583.)."

Clinical • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Ensartinib as adjuvant therapy in patients (pts) with stage IB–IIIB ALK-positive (ALK+) non-small cell lung cancer (NSCLC) after complete tumor resection: The phase III randomized ELEVATE trial (ESMO 2025) - P3 | "Conclusions Adjuvant ensartinib is the first ALK inhibitor to show a statistically significant and clinically meaningful improvement in DFS in pts with stage IB-IIIB (T3N2M0) ALK-positive NSCLC after complete tumor resection and adjuvant chemotherapy. Adjuvant ensartinib provides an effective new treatment strategy for these pts."

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • ALK

Organ Preservation Exploratory Clinical Study in Stage II-III Non-Small Cell Lung Cancer (the Future Star) (IASLC-WCLC 2026) - "Cohort A: Almonertinib (110 mg once daily for 18 weeks) combined with pemetrexed and carboplatin (every 3 weeks for up to 4 cycles)...Cohort B: Ensartinib (225 mg once daily for 13 weeks) combined with pemetrexed and carboplatin (every 3 weeks for up to 4 cycles)...Cohort C: Adebrelimab (1200 mg every 3 weeks) combined with chemotherapy (nab-paclitaxel plus carboplatin for squamous histology, or pemetrexed plus carboplatin for non-squamous histology) for up to 3 cycles...The primary endpoint is event-free survival (EFS) assessed by investigators per RECIST v1.1. Secondary endpoints include disease-free survival (DFS), overall survival (OS), quality of life score, organ preservation rate, pathological complete response (pCR) rate and major pathological response (MPR) rate in the surgical arm, and safety."

Clinical • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Cost-Effectiveness Analysis of the Five First-line Treatment Regimens for ALK-positive NSCLC in China: An Economic Evaluation Based on Network Meta-Analysis. (PubMed, Value Health) - "For patients with advanced ALK-positive NSCLC in China, lorlatinib, alectinib, brigatinib, and iruplinalkib are cost-effective compared to crizotinib, with the exception of ensartinib. Among these, iruplinalkib is the most cost-effective TKI for first-line treatment, followed by lorlatinib."

HEOR • Journal • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Evolution from KRAS G12C-mutant to ALK fusion-positive stage IV lung adenocarcinoma following immune checkpoint inhibitor therapy: a case report. (PubMed, Front Oncol) - "She received first-line therapy including the ICI tislelizumab in combination with chemotherapy and bevacizumab, achieving a partial response (PR) that was maintained for approximately 12 months (from April 2024 to April 2025), before subsequent disease progression was documented 26 months after treatment initiation...The patient was switched to the ALK inhibitor ensartinib, achieving a second PR. This case provides supporting evidence consistent with the selection of a pre-existing ALK fusion clone in a KRAS-mutant lung adenocarcinoma under chemo-immunotherapy pressure. It also highlights the clinical value of re-biopsy at progression to guide subsequent targeted therapy."

Checkpoint inhibition • IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4 • KRAS • RB1 • TP53

Clinical Evaluation of Anaplastic Lymphoma Kinase (ALK) Inhibitors for the First-Line Treatment of Advanced ALK-Positive Non-Small Cell Lung Cancer Based on the 2nd Edition of China's Drug Evaluation and Selection Guideline. (PubMed, Drug Des Devel Ther) - "The final assessment result scores from highest to lowest were alectinib (78.70 points), lorlatinib (78.70 points), brigatinib (78.50 points), ensartinib (73.30 points), iruplinalkib (72.55 points), ceritinib (71.50 points), envonalkib (71.15 points), crizotinib (70.60 points). Based on the second edition of China's drug evaluation and selection guideline and combined with the clinical application characteristics of ALK inhibitors, this study performed a multidimensional scoring of eight ALK inhibitors. The evaluation results could provide a reference for medical institutions in the introduction and elimination of ALK inhibitors."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Computational design and AI-assisted discovery of anaplastic lymphoma kinase inhibitors for lung cancer treatment | Poster Board #1212 (ACS-Fall 2026) - "FDA-approved ALK tyrosine kinase inhibitors such as Alectinib, Brigatinib, Ensartinib, Crizotinib and Lorlatinib have been used in treating NSCLC...A fourth-generation ALK inhibitor, Zotizalkib or TPX-0131 has proven potent against a different ALK resistance mutations, however, its trial was withdrawn at the Phase I clinical trial...The top novel compounds predicted from the modifications will be further subjected to molecular docking and dynamics simulation to understand the binding orientation and stability of these compounds. Top leads will be synthesized, characterized and screened in vitro and in vivo as new and efficient ALK inhibitors."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Spectrofluorometric and spectrophotometric assay of anticancer drug ensartinib using ion-pair complex formation reaction with eosin Y. (PubMed, Sci Rep) - "Statistical comparison with a reported chromatographic method showed no significant difference at the 95% confidence level. The environmental impact of the developed methods was assessed using AGREE and GAPI tools, confirming their compliance with green analytical chemistry principles."

Journal • Oncology

Expert consensus on iruplinalkib for the treatment of ALK-positive non-small cell lung cancer (2026 edition) (PubMed, Zhonghua Zhong Liu Za Zhi) - "Currently, the China National Medical Products Administration (NMPA) has approved ten ALK-TKIs, including crizotinib, ceritinib, alectinib, ensartinib, brigatinib, lorlatinib, iruplinalkib, envonalkib, dirozalkib and conteltinib. This consensus provides systematic and comprehensive update of clinical research data on iruplinalkib published before June 25, 2026, based on the 2024 edition. It covers common clinical issues and provides corresponding recommendations for the use of iruplinalkib in the treatment of ALK-positive NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Groundbreaking Achievement: Study of Ensartinib as Postoperative Adjuvant Therapy Published in The New England Journal of Medicine (PRNewswire) - "In the ELEVATE study, a total of 274 patients....The results showed a 2-year disease-free survival rate of 86.4% in the ensartinib group compared with 53.5% in the placebo group, with a hazard ratio of 0.20 (95% CI: 0.11 to 0.38) in patients with stage II to IIIB NSCLC. This means that two years of adjuvant treatment with ensartinib reduces the risk of disease recurrence or death by 80%. A significant reduction in this risk was also observed in stage IB to IIIB population, with a hazard ratio of 0.20 (95% CI: 0.10 to 0.37)."

P3 data • Non Small Cell Lung Cancer

Efficacy and Safety of Ensartinib Combined With Anlotinib in Lorlatinib-Resistant ALK-Positive NSCLC (clinicaltrials.gov) - P4 | N=80 | Not yet recruiting | Sponsor: Qiming Wang

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Long-term outcomes of ALK inhibitors in metastatic ALK-positive non-small cell lung cancer: an updated indirect comparison using reconstructed patient-level data. (PubMed, Transl Lung Cancer Res) - "While second- and third-generation ALKi (including alectinib, brigatinib, ensartinib, envonalkib, and lorlatinib) have demonstrated superior efficacy compared with the first-generation inhibitor crizotinib in randomized trials, the absence of direct head-to-head comparisons limits the definition of their relative clinical benefit. This indirect comparison indicates that lorlatinib provides the most durable PFS and the strongest intracranial disease control, although ALKis are characterized by distinct toxicity profiles. In the absence of clear OS differences at present, first-line treatment selection should integrate efficacy, intracranial activity, tolerability, and emerging molecular features within a personalized therapeutic framework."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Case report: complete pathologic response to neoadjuvant ensartinib in locally advanced, ALK-positive lung squamous cell carcinoma. (PubMed, Front Oncol) - "Our case provided evidence that locally advanced, ALK-positive LSCC could benefit from neoadjuvant ensartinib, with an impressive response and favorable safety. Our findings may also extend the indications for targeted therapy to the neoadjuvant setting in locally advanced, ALK-positive, resectable LSCC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • ALK • EML4

Repurposing ALK Inhibitors as Influenza and Corona Virus Antivirals Targeting Lymphocyte Tyrosine Kinase (LTK). (PubMed, Virus Res) - "In vitro, influenza and SARS-CoV-2 viruses could be inhibited by the LTK inhibitors ceritinib, crizotinib, entrectinib, ensartinib, brigatinib, and alectinib, but not lorlatinib. Importantly, the repurposed ALK-inhibitors crizotinib, brigatinib, and ceritinib also gave some protection in mice against lethal viral challenges with influenza and SARS-CoV-2, respectively. The study highlights the potential of LTK inhibition as target for a new class of host-targeted antivirals therapeutics."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Oncology • Respiratory Diseases