Ensacove (ensartinib) / Betta Pharma - LARVOL DELTA

Amylase-producing lung adenocarcinoma with an anaplastic lymphoma kinase fusion mutation: a case report. (PubMed, Lab Med) - "We suggest that serum amylase may be a tumor marker that may lead to a more effective approach to the diagnosis and treatment of related diseases."

Journal • Gastroenterology • Gastrointestinal Disorder • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Shifting landscape of resistance to next-generation ALK inhibitors with evolving treatment paradigm in ALK+ lung cancer. (ASCO 2025) - "Funded by No funding sources reported Background: Next-generation (gen) ALK tyrosine kinase inhibitors (TKIs) are standard first-line (1L) therapy for patients (pts) with ALK-rearranged (ALK+) metastatic non-small cell lung cancer (mNSCLC), having supplanted crizotinib (criz)... This retrospective study included pts with ALK+ mNSCLC who received 2G ALK TKIs (alectinib, brigatinib, ceritinib, ensartinib) or 3G TKI lorlatinib (lorl) and had post-progression tissue (TBx) or liquid bx (LBx) assessed by next-generation sequencing (NGS)... In this largest analysis of post-2G/3G ALK TKI TBx/LBx to date, on-target resistance was less freq after 2G/3G TKIs in pts treated with the current paradigm (upfront 2G/3G ALK TKIs) than the past approach (2G/3G TKI after 1L criz). These findings crystallize a shifting resistance landscape and indicate an increasing role for off-target resistance with upfront 2G/3G TKIs, highlighting a need to uncover and therapeutically address off-target..."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4 • MET

Ensartinib as postoperative adjuvant therapy in patients with ALK-positive non-small cell lung cancer (NSCLC): A registered, retrospective, real-world study. (ASCO 2025) - "To our knowledge, this real-world study has the largest sample size on postoperative adjuvant therapy with ALK inhibitors. In this real-world setting, ensartinib demonstrated encouraging efficacy and well-tolerated safety profile among stage IA1-IIIB ALK-positive NSCLC, providing a potential adjuvant therapy option in this patient population."

Real-world • Real-world evidence • Retrospective data • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Ensartinib in a primary pulmonary ALK-rearranged mesenchymal neoplasm harboring a novel HMBOX1::ALK fusion: a case report and literature review. (PubMed, Front Med (Lausanne)) - "The family of ALK-rearranged mesenchymal neoplasms is expanding and ensartinib could be a potential treatment option for patients with HMBOX1::ALK. Repeated biopsy and NGS detection are critical to guide treatment selection at disease progression."

Journal • Oncology • ALK • HMBOX1 • NF2

Treatment of metastatic ALK-positive non-small cell lung cancer: indirect comparison of different ALK inhibitors using reconstructed patient data. (PubMed, Front Oncol) - "Second- and third-generation ALKi, including alectinib, brigatinib, ensartinib, envonalkib, and lorlatinib, have shown better efficacy than crizotinib. In this indirect comparison using reconstructed patient data, lorlatinib emerged as the most effective ALKi, showed the most favorable HR for PFS compared to the other ALKi, although it did not reach statistical significance versus alectinib and ensartinib. Additionally, lorlatinib showed the highest efficacy in the control of CNS progression."

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

Case Report: Ensartinib as a first-line treatment for SMARCA4-deficient and EML4-ALK non-small cell lung cancer. (PubMed, Front Oncol) - "In this report, we describe a male non-smoker diagnosed with SMARCA4-deficient, EML4-ALK non-small cell lung cancer who has been undergoing ensartinib targeted therapy for 3 months, resulting in a significant partial response. We also propose that, from a signaling perspective, the presence of SMARCA4 deficiency may influence the sensitivity of EML4-ALK NSCLC to targeted therapy, highlighting the need for further investigation into the underlying mechanisms and the exploration of novel therapeutic approaches."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EML4 • SMARCA4

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) | N=2316 ➔ 1376 | Trial completion date: Jun 2025 ➔ May 2026 | Trial primary completion date: Jun 2025 ➔ Mar 2025

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

Case Report: Clinical response of ensartinib for inflammatory myofibroblastic tumor of the urinary bladder with multiple metastases and TPM4-ALK fusion. (PubMed, Front Oncol) - "Ensartinib may provide a new therapeutic direction with promising efficacy and an acceptable safety profile for IMTUB with ALK fusion. Further clinical investigation is needed to identify its efficacy and safety."

Journal • Bladder Cancer • Oncology • Solid Tumor • ALK • TPM4

UPLIFT: Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations (clinicaltrials.gov) - P3 | N=270 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Guangzhou Medical University

IO biomarker • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Clinical practice guideline on anaplastic lymphoma kinase-tyrosine kinase inhibitors for non-small cell lung cancer (2025 edition) (PubMed, Zhonghua Zhong Liu Za Zhi) - "As of December 31, 2024, eight ALK-TKIs, including crizotinib, ceritinib, alectinib, ensartinib, brigatinib, lorlatinib, iruplinalkib, and invonalkib have garnered approval from the China National Medical Products Administration (NMPA) (Ranking according to the approval time for marketing by NMPA), providing targeted treatment agents for ALK-positive NSCLC patients. To standardize the application of ALK-TKIs, The Chinese Association for Clinical Oncologists and the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care has organized experts to compile the "Clinical practice guideline on anaplastic lymphoma kinase-tyrosine kinase inhibitors for non-small cell lung cancer (2025 edition)". This guideline provides recommendations in four aspects, encompassing ALK fusion testing, ALK-TKI targeted therapy, ALK-TKI adverse events management, and patient post-treatment follow-up, thus serving as a valuable..."

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

Properties of FDA-approved small molecule protein kinase inhibitors: a 2025 update. (PubMed, Pharmacol Res) - "Seven drugs (abrocitinib, baricitinib, deucravacitinib, deuruxolitinib, ritlecitinib, tofacitinib, upadacitinib) are prescribed for the management of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis)...The following four drugs received FDA approval in 2024 - deuruxolitinib (alopecia areata), ensartinib and lazertinib (non-small cell lung cancer), and tovorafenib (pediatric glioma) while mirdametinib was approved in 2025 for the treatment of type I neurofibromatosis (von Recklinghausen disease). Apart from netarsudil, temsirolimus, and trilaciclib, the approved protein kinase blockers are orally bioavailable. This article summarizes the physicochemical properties of all 85 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 39 of the 85..."

FDA event • Journal • Review • Alopecia • Atopic Dermatitis • Brain Cancer • Chronic Myeloid Leukemia • CNS Tumor • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Glioma • Hematological Malignancies • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Leukemia • Lung Cancer • Neurofibromatosis • Non Small Cell Lung Cancer • Oncology • Pediatrics • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Ulcerative Colitis • MAP2K1

The efficacy and safety of Ensartinib as adjuvant therapy in stage I ALK-positive NSCLC patients with high risk factors (ChiCTR) - P=N/A | N=40 | Not yet recruiting | Sponsor: Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital

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

Acute renal injury induced by ensartinib in a lung adenocarcinoma patient treated with sequential ALK inhibitors: A case report and literature review. (PubMed, Clin Nephrol) - "This case underscores the uncommon adverse effect of ALK-targeting therapy, specifically regarding acute renal failure induced by ensartinib. We recommend conducting a renal biopsy to ascertain the presence of drug-induced nephrotoxicity. An accurate diagnosis and timely intervention can prevent the deterioration of renal function."

Journal • Review • Acute Kidney Injury • Glomerulonephritis • IgA Nephropathy • Lung Adenocarcinoma • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Renal Disease • Solid Tumor • ALK

A Recurrent Small Cell Lung Carcinoma Harboring an EML4-ALK Fusion Mutation with Sustained Response to Ensartinib: A Case Report. (PubMed, Curr Oncol) - "The ALK-TKI may be a new treatment option for these patients. This article provides a therapeutic reference."

Journal • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • ALK • EML4

Ensartinib as a neoadjuvant therapy for stage IIIA non-small cell lung cancer patients with EML4-ALK fusion: a case report and literature review. (PubMed, Front Oncol) - "Nevertheless, clinical trials can be conducted in the future to validate our results. Moreover, we performed multiple immunofluorescence staining analyses on samples before and after neoadjuvant therapy, observed and compared the changes in the expression of relevant immune cells (CD8+ T cells, macrophages, PD-1, and PD-L1), and performed a simple analysis."

IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CD8 • EML4 • PD-1 • PD-L1

Ensartinib for EML4-ALK-positive lung adenocarcinoma with comorbid mutations in TP53, EGFR, and ERBB2: a case report. (PubMed, Front Oncol) - "This case demonstrates the potential for ensartinib in the treatment of EML4-ALK+ lung adenocarcinoma with multiple gene mutations. Further investigation through clinical trials is needed to evaluate the safety and efficacy of this targeted therapy."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • EML4 • HER-2 • TP53

Ensartinib for advanced or metastatic non-small-cell lung cancer with MET exon 14 skipping mutations (EMBRACE): a multi-center, single-arm, phase 2 trial. (PubMed, EClinicalMedicine) - P2 | "Ensartinib has a promising anti-tumor activity and manageable safety in previously treated patients with METex14 positive lung cancer. This work was supported by the National Natural Science Foundation of China [82370028, 82422001] and the CSCO-MET Aberrant Solid Tumor Research Grant [Y-2022METAZMS-0066]."

IO biomarker • Journal • P2 data • Dermatology • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor • ALK • MET

Ensartinib (Ensacove) for non-small cell lung cancer. (PubMed, Med Lett Drugs Ther) - No abstract available

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

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=2316 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Sep 2027 ➔ Jun 2025 | Trial primary completion date: Sep 2027 ➔ Jun 2025

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

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 2025 ➔ Jan 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

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

Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Fujian Medical University Union Hospital

New P4 trial • Real-world evidence • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Evaluate the Efficacy and Safety of Ensartinib Combined with Radiotherapy in ALK-Rearranged Non-Small Cell Lung Cancer Patients with Brain Metastases: A Prospective, Multi-center, Single-arm, Phase II Trial (ChiCTR) - P2 | N=20 | Recruiting | Sponsor: The Second Affiliated Hospital of Chongqing Medical University; The Second Affiliated Hospital of Chongqing Medical University

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

A multicenter real-world clinical study on the efficacy and safety of Ensartinib as neoadjuvant treatment for anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) patients. (ChiCTR) - P=N/A | N=100 | Sponsor: Harbin Medical University Cancer Hospital; Harbin Medical University Cancer Hospital

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

Mapping the evolution and frontiers of Translational Lung Cancer Research: a bibliometric analysis and literature review. (PubMed, Transl Lung Cancer Res) - "Future research directions in TLCR might focus on first-line treatment, ensartinib, and advanced data analysis methods such as the Kyoto Encyclopedia of Genes and Genomes (KEGG) to revolutionize lung cancer research and practice. In conclusion, this study underscores TLCR's significant contributions to lung cancer research and provides valuable insights into its evolution and future directions."

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

Adjuvant Treatment of ALK-positive Non-small Cell Lung Cancer with Ensartinib Guided by MRD (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Peking University Cancer Hospital & Institute

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