Ensacove (ensartinib) / Betta Pharma - LARVOL DELTA

EFFICACY AND SAFETY OF ENSARTINIB-BASED REGIMENS IN ALK-POSITIVE LYMPHOMA: A REAL-WORLD RETROSPECTIVE STUDY (EBMT 2026) - "Among all patients, 22.2% received ensartinib alone, 22.2% received ensartinib plus R-CHOP regimen, and 55.6% received ensartinib plus other chemotherapy regimens. Ensartinib-based regimens demonstrated promising preliminary efficacy and manageable toxicity in patients with R/R ALK+ lymphoma, warranting further prospective validation."

Real-world • Real-world evidence • Retrospective data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Solid Tumor • ALK

EFFICACY AND SAFETY OF ENSARTINIB-BASED REGIMENS IN ALK-POSITIVE LYMPHOMA: A REAL-WORLD RETROSPECTIVE STUDY (EBMT 2026) - "Among all patients, 22.2% received ensartinib alone, 22.2% received ensartinib plus R-CHOP regimen, and 55.6% received ensartinib plus other chemotherapy regimens. Ensartinib-based regimens demonstrated promising preliminary efficacy and manageable toxicity in patients with R/R ALK+ lymphoma, warranting further prospective validation."

Real-world • Real-world evidence • Retrospective data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • 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

Treatment with ensartinib improves postoperative survival in a patient with stage IIB LUAD carrying a rare ALK mutation: case report. (PubMed, Open Life Sci) - "The patient recovered well and was discharged after four postoperative days. During more than four years of follow-up, long-term ensartinib therapy was associated with stable disease without recurrence, offering potential clinical insights for managing LUAD with rare ALK variants."

Journal • Oncology • ALK • TOGARAM2

Ensartinib Combined with Radiotherapy for the Treatment of Advanced Primary Pulmonary Epithelioid Inflammatory Myofibroblastic Sarcoma Harboring TPM3-ALK Fusion: A Case Report (PubMed, Zhongguo Fei Ai Za Zhi) - "The progression-free survival (PFS) exceeded 32 months, with no significant treatment-related adverse events observed. This study investigates the feasibility of combining targeted therapy with local radiotherapy, guided by genetic testing, to offer novel treatment strategies for patients with advanced primary pulmonary EIMS.."

Journal • Lung Cancer • Oncology • Sarcoma • Solid Tumor • ALK • TPM3

ECONOMIC BURDEN OF INCIDENT BRAIN METASTASES IN MEDICARE BENEFICIARIES WITH ALK+ METASTATIC NON-SMALL CELL LUNG CANCER (ISPOR 2026) - "This study quantified BM-attributable cumulative healthcare spending among US Medicare beneficiaries with ALK+ mNSCLC treated with any first-line ALK TKI. We used 100% Medicare Parts A, B, and D claims (2016-2023) to identify beneficiaries aged >66 years with a lung cancer diagnosis and no baseline BM who initiated a first-line ALK TKI (alectinib, brigatinib, ceritinib, crizotinib, ensartinib, lorlatinib). Among Medicare beneficiaries with ALK+ mNSCLC, incident BMs are associated with substantial additional healthcare costs conditional on survival."

HEOR • Medicare • Metastases • Reimbursement • US reimbursement • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of MCLA-129 in Combination With Ensartinib in Patients With Advanced Solid Tumors. (clinicaltrials.gov) - P1/2 | N=164 | Recruiting | Sponsor: Betta Pharmaceuticals Co., Ltd.

New P1/2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CLDN18 • MET

NRG-LU003: Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Dec 2025 ➔ Dec 2026

Biomarker • Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Ensartinib targeted conversion surgery for ALK-positive unresectable locally advanced non-small cell lung cancer: a case report. (PubMed, J Cardiothorac Surg) - No abstract available

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

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) (clinicaltrials.gov) - P2 | N=1376 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: May 2026 ➔ Jan 2027

Biomarker • Trial completion date • Brain Cancer • CNS Tumor • Embryonal Tumor • Ependymoma • Ewing Sarcoma • Germ Cell Tumors • Glioma • Hematological Malignancies • Hepatoblastoma • High Grade Glioma • Langerhans Cell Histiocytosis • Lymphoma • Medulloblastoma • Nephrology • Neuroblastoma • Non-Hodgkin’s Lymphoma • Oncology • Osteosarcoma • Pediatrics • Rhabdoid Tumor • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Wilms Tumor • BRAF

Efficacy and Safety of Continuing Next-Generation ALK TKIs With Chemotherapy for Advanced ALK-Positive NSCLC: A Multicenter Retrospective Study. (PubMed, J Natl Compr Canc Netw) - "Among patients who received next-generation ALK TKIs as first-line therapy, continuation of next-generation ALK TKI with PT/Pem led to longer PFS and OS than PT/Pem alone, with no unanticipated toxicities. The modest efficacy of PT/Pem-based regimens overall underscores the need for more effective therapies for TKI-refractory ALK+ NSCLC."

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

Breaking resistance barriers: ensartinib as a milestone in anaplastic lymphoma kinase-driven non-small cell lung cancer therapy. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Since the approval of crizotinib, several next-generation ALK inhibitors have been introduced, offering improved treatment outcomes. The phase III eXalt3 study, a global randomized open-label trial, compared the efficacy of ensartinib, a second-generation ALK inhibitor, with crizotinib in patients with advanced ALK-rearranged NSCLC who had not received prior ALK-targeted therapy. With superior systemic and intracranial efficacy, ensartinib stands as a promising option in precision oncology. Ongoing research into improved ALK inhibitors and novel therapeutic strategies, including immune-based approaches, is expected to further improve patient outcomes."

Journal • Review • CNS Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4

Exploratory clinical study on preserving organs in patients with stage II-III non-small cell lung cancer(The Future Star) (ChiCTR) - P4 | N=598 | Recruiting | Sponsor: Jiangsu Cancer Hospital; Jiangsu Cancer Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • PD-L1

Comparative analysis of ctDNA monitoring strategies in advanced NSCLC with MET exon 14 skipping mutations treated with ensartinib. (PubMed, NPJ Precis Oncol) - "Among the three paradigms, MET-specific monitoring provided the most favorable diagnostic performance to identify long-term responders, with a specificity of 90% and a positive predictive value of 80%. These data demonstrate that early MET-specific ctDNA clearance is a robust on-treatment biomarker for ensartinib benefit in METex14 NSCLC, while broader ctDNA profiling remains valuable for uncovering emerging resistance mechanisms."

Circulating tumor DNA • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Treating Patients With Melanoma and ALK Alterations With Ensartinib (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jan 2026 ➔ Jan 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • ALK • BRAF

Cost of managing brain metastases in ALK-positive advanced NSCLC patients receiving first-line ALK TKIs in China. (PubMed, Lung Cancer Manag) - "Limited CIR beyond 12 months existed for brigatinib and ensartinib. Results from the Asian group's CIR aligned with global trials. Due to lower BM CIR, lorlatinib showed higher BM management cost savings compared to crizotinib and alectinib in Chinese 1 L patients."

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

Comparison of the efficacy based on clinicopathological characteristics and the safety of first-line treatments for patients with advanced ALK rearrangement non-small cell lung cancer: a network meta-analysis. (PubMed, Front Oncol) - "Specifically, lorlatinib demonstrated superior efficacy in the Non-Asian subgroup (86.8%), patients without brain metastasis (84.7%), those with Eastern Cooperative Oncology Group performance status (ECOG PS) 0/1 (78.5%), males (71.2%), females (83.9%), patients aged < 65 years (74.3%), and never-smoking patients (89.7%)...Ensartinib achieved the optimal PFS in the Asian subgroup (71.8%)...Alectinib had the lowest hepatic and gastrointestinal AEs risk, while iruplinalkib had the lowest hematological AEs risk. https://www.crd.york.ac.uk/prospero/, identifier CRD42023495527."

Journal • Retrospective data • Review • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

A Multicenter, Randomized Controlled Study to Assess the Effects of Ensartinib Versus Placebo Following Chemoradiation in ALK Positive Patients With Stage III Unresectable Non-small Cell Lung Cancer (ChiCTR) - P2 | N=45 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A randomized controlled clinical study on postoperative adjuvant targeted therapy and MRD observation for stage IA non-small cell lung cancer (ChiCTR) - P4 | N=178 | Not yet recruiting | Sponsor: Beijing chest hospital capital medical university; Beijing Chest Hospital Capital Medical University

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

A single-arm, multicenter clinical study of ensartinib combined with chemotherapy as neoadjuvant therapy for ALK-positive non-small cell lung cancer (NSCLC) (TD-ENSEMBLE study) (ChiCTR) - P4 | N=20 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Air Force Medical University; The Second Affiliated Hospital of Air Force Medical University

New P4 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • 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

TD-ENSEMBLE: Neoadjuvant Therapy With Ensartinib Combined With Chemotherapy for ALK-positive Non - Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=20 | Not yet recruiting | Sponsor: Tang-Du Hospital

New P1/2 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Pulmonary nodules with explosive calcification were finally diagnosed as lung adenocarcinom: A case report. (PubMed, Medicine (Baltimore)) - "This case emphasizes that nodules with diffuse, popcorn-like calcification do not rule out the possibility of lung cancer. A comprehensive evaluation integrating multidimensional imaging features is necessary. For nodules with conflicting imaging characteristics, minimally invasive surgical resection remains valuable for diagnosis. This approach broadens our diagnostic perspective on calcified nodules, enhances clinicians' understanding of lung adenocarcinoma, and reduces the rate of misdiagnosis."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Solid Tumor • ALK

The Efficacy and Safety of Ensartinib as Adjuvant Therapy in Stage I ALK-positive NSCLC Patients With High Risk Factors [WITHDRAWN] (ESMO Asia 2025) - No abstract available

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

Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor