ALK inhibitors(Anaplastic lymphoma kinase inhibitors), ROS1 inhibitors(Proto-oncogene tyrosine-protein kinase ROS inhibitors), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

ALK positive Non-Small Cell Lung CancerSmall Cell Lung Cancer

Inactive Indication

Advanced Malignant Solid Neoplasmmetastatic non-small cell lung cancerReactive oxygen species 1 positive non-small cell lung cancer

Originator Organization

Xcovery, Inc.

Active Organization

Xcovery Holding, Inc.

Betta Pharmaceuticals Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (17 Nov 2020),

ALK positive Non-Small Cell Lung Cancer

RegulationPriority Review (CN), Conditional marketing approval (CN)

Structure

Molecular FormulaC26H27Cl2FN6O3

InChIKeyGLYMPHUVMRFTFV-QLFBSQMISA-N

CAS Registry1370651-20-9

Clinical Trials associated with Ensartinib Hydrochloride

ChiCTR2300070192 / SuspendedPhase 2IIT

Efficacy and safety of adjuvant therapy of ensartinib in ALK-positive stage II-IIIB non-small cell lung cancer:a prospective, multicenter, single-arm phase II trial

Start Date01 May 2023

Sponsor / Collaborator-

NCT05665283 / CompletedPhase 1

A Randomized Open Label Crossover Single Dose Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers Under Fasted Conditions

This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules manufactured by two different processes.

Start Date29 Nov 2022

Sponsor / Collaborator

Xcovery Holding, Inc.

NCT05380024 / RecruitingPhase 2IIT

A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer

This is a Phase II, single-Arm, prospective study of neoadjuvant Ensartinib for the treatment of patients with ALK positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer

Start Date17 Aug 2022

Sponsor / Collaborator-

100 Clinical Results associated with Ensartinib Hydrochloride

100 Translational Medicine associated with Ensartinib Hydrochloride

100 Patents (Medical) associated with Ensartinib Hydrochloride

Literatures (Medical) associated with Ensartinib Hydrochloride

01 Dec 2023·Seminars in neurology

Management of Brain Metastases: A Review of Novel Therapies

Review

Author: Khosla, Atulya Aman ; Bellur, Shreyas ; Kotecha, Rupesh ; Ozair, Ahmad ; Ahluwalia, Manmeet S ; McDermott, Michael W

Abstract:

Brain metastases (BMs) represent the most common intracranial tumors in adults, and most commonly originate from lung, followed by breast, melanoma, kidney, and colorectal cancer. Management of BM is individualized based on the size and number of brain metastases, the extent of extracranial disease, the primary tumor subtype, neurological symptoms, and prior lines of therapy. Until recently, treatment strategies were limited to local therapies, like surgical resection and radiotherapy, the latter in the form of whole-brain radiotherapy or stereotactic radiosurgery. The next generation of local strategies includes laser interstitial thermal therapy, magnetic hyperthermic therapy, post-resection brachytherapy, and focused ultrasound. New targeted therapies and immunotherapies with documented intracranial activity have transformed clinical outcomes. Novel systemic therapies with intracranial utility include new anaplastic lymphoma kinase inhibitors like brigatinib and ensartinib; selective “rearranged during transfection” inhibitors like selpercatinib and pralsetinib; B-raf proto-oncogene inhibitors like encorafenib and vemurafenib; Kirsten rat sarcoma viral oncogene inhibitors like sotorasib and adagrasib; ROS1 gene rearrangement (ROS1) inhibitors, anti-neurotrophic tyrosine receptor kinase agents like larotrectinib and entrectinib; anti-human epidermal growth factor receptor 2/epidermal growth factor receptor exon 20 agent like poziotinib; and antibody–drug conjugates like trastuzumab-emtansine and trastuzumab-deruxtecan. This review highlights the modern multidisciplinary management of BM, emphasizing the integration of systemic and local therapies.

01 Dec 2023·Lung cancer management

A retrospective study of ensartinib-treated ALK-positive locally advanced or metastatic NSCLC patients in China

Article

Author: Yang, Min ; Yuan, Xiaobin ; Ji, Dong ; Shen, Zhilin ; Wang, Yang ; Yun, Yu ; Ma, Yongbin ; Wu, Pengxiang ; Ding, Lieming ; Chen, Hui

Aim: This retrospective study aimed to assess the efficacy and safety of ensartinib in Chinese patients with ALK-positive advanced NSCLC in real-world clinical practice. Methods: Clinical data from ALK-positive NSCLC patients treated with ensartinib in China were collected and analyzed. Efficacy end points included objective response rate and progression-free survival. Safety profiles were also evaluated. Results: A total of 682 patients were included in this study. The study demonstrated promising efficacy with an objective response rate of 54.0%, and the median progression-free survival was not estimable. Ensartinib exhibited a manageable safety profile with treatment-related adverse events (TRAEs) consistent with prior clinical trials. The most common TRAE was rash (21.1%) and no TRAE led to death. Conclusion: Ensartinib is active and well tolerated for ALK-positive NSCLC patients in real-world clinical settings.

01 Nov 2023·Cancer genetics

Identification of a novel RSRC1-ALK (R6: A20) fusion using next-generation sequencing technique

Article

Author: Wang, Jipeng ; Chen, Sheng ; Zhang, Zhujian ; Xia, Jingjing

Non-small-cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) fusion showed promising responses to ALK tyrosine kinase inhibitors (TKIs). In this study, fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), next generation sequencing (NGS) and Sanger sequencing were performed to identify the presence of ALK fusion, to investigate whether the patient may benefit from TKI therapy. Postoperative pathological analysis indicated invasive adenocarcinoma with mainly mucinous type and partial micropapillary type in left lower lung. Minimally invasive adenocarcinoma was seen in left upper lung, with mainly acinar type. NGS detected a novel RSRC1-ALK (R6: A20) fusion in left lower lobe sample, which was presented as the fusion of exon 6 of RSRC1 and exon 20 of ALK gene. Sanger sequencing validated the fusion. Break rearrangement signal of ALK gene was detected in 80% of tumor cells. Immunohistochemistry showed ALK positive expression in lung. For the treatment, the patient received ensartinib hydrochloride with a dose of 225 mg per day. He was in a state of progression-free survival for at least 24 months in follow-up with no complications. NGS can be used for exploring treatment options for NSCLC patients with ALK fusion.

News (Medical) associated with Ensartinib Hydrochloride

06 Jun 2024

·www.biospace.com

Dr. Giovanni Selvaggi, Who Has Brought Several Oncology Drugs to Market, Joins CEL-SCI as Clinical Advisor

Dr. Selvaggi was instrumental in the development and approval of lung cancer drugs Zykadia for Novartis and Opdivo for Bristol Myers Squibb CEL-SCI’s Multikine immunotherapy improves the 5-year survival of head and neck cancer patients to 73% compared to 45% in controls and cuts the 5-year risk of death by 50% FDA has given CEL-SCI the go-ahead to commence a confirmatory Registration Study for Multikine for the target population in head and neck cancer Dr. Selvaggi will be supporting CEL-SCI to bring Multikine to patients through a confirmatory registrational path that has been agreed with regulatory authorities and that has a potential for cure VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced Dr. Giovanni Selvaggi, an oncology key opinion leader instrumental in successfully bringing several drugs to market has joined CEL-SCI as a Clinical Advisor. Dr. Selvaggi joins CEL-SCI as the Company recently received its go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer. This press release features multimedia. View the full release here: (Graphic: Business Wire) Multikine is the first investigational pre-surgical cancer drug in newly diagnosed head and neck cancer. Multikine is a copy of the pro-inflammatory cytokine immune response human bodies produce every day and is designed to empower a person’s intact immune system cells to attack their own cancer. Patients are treated with Multikine right after diagnosis, before any other standard of care treatment (surgery and radiation therapy) since that is when the immune system is strongest. There is robust safety and efficacy data from 750 patients who have been treated with Multikine. Based on the following efficacy data, the FDA has agreed to CEL-SCI’s 212-person Registration Study to confirm the findings for regulatory approval: No safety signals vs standard of care 73% survival for Multikine vs 45% in the control arm at 5 years Statistically significant p = 0.0015 5-year risk of death cut in half from 55% to 27% (Hazard ratio = 0.35 (95% CIs [0.19, 0.66]) More detailed results may be viewed here: LINK Dr. Selvaggi is a US-based drug developer, cancer researcher, and strategic advisor to big pharma and early-to-late stage biotech companies. He is currently Chief Medical Officer at Xcovery Holdings, where he manages an ongoing New Drug Application with the FDA for ensartinib, an ALK-TKI for non-small cell lung cancer (NSCLC). He is also a Clinical Consultant to Tubulis GmBH for a first-in-class ADC program in solid tumors, and Clinical Strategy Senior Advisor to Alira Health. He formerly served as Medical Director, Cancer Immunotherapy, in the MAGE-A3 lung cancer vaccine program at GSK. Later, Dr. Selvaggi played an instrumental role in the successful development and approval of ceritinib (Zykadia) in ALK-translocated NSCLC at Novartis. At Oncolytics he was VP of Clinical Development. Most recently, Dr. Selvaggi was part of the immunotherapy team at Bristol-Myers Squibb, serving as a program lead in thoracic malignancies, with a focus on SCLC and mesothelioma, leading to the approval of nivolumab (Opdivo) in third line small cell lung cancer. Dr. Selvaggi received his medical degree at the University of Torino School of Medicine, in Torino, Italy, and served as staff physician of thoracic oncology at the University Hospital in Torino, participating in several clinical trials in lung cancer and mesothelioma over a span of 20 years. Dr. Selvaggi commented, “Multikine is a first in class immunotherapy that has demonstrated to meaningfully and safely prolong survival in a selected orphan population of newly diagnosed head and neck cancer. The importance of tackling cancer at the earliest stages to guarantee the most relevant impact in patients’ lives is undeniable, especially in head and neck cancer which has no approved therapeutic options before surgery. I am fully committed to supporting CEL-SCI leadership to bring this asset to patients through an expedited registrational path that has been agreed with regulatory authorities and that has a potential for cure.” “Dr. Selvaggi has a passion for bringing cancer drugs to market to save lives and lead clinical research toward a cure for cancer. We are excited to have him join CEL-SCI as a Clinical Advisor at this pivotal point for Multikine which is set to commence a confirmatory FDA Registration Study,” stated CEL-SCI CEO, Geert Kersten. “The data on Multikine is excellent, and as we proceed with and wrap up this final study, Dr. Selvaggi’s experience and successful track record in navigating late-stage development, clinical trials, and the regulatory approval process will be hugely valuable for us.” Dr. Selvaggi joins several other top-tier physician consultants and head and neck cancer key opinion leaders who are advisors to CEL-SCI. About CEL-SCI Corporation CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. View source version on businesswire.com: Contacts Gavin de Windt CEL-SCI Corporation (703) 506-9460 Source: CEL-SCI Corporation Smart Multimedia Gallery Photo (Graphic: Business Wire) Logo View this news release and multimedia online at:

ImmunotherapyVaccineExecutive ChangeOrphan DrugClinical Study

13 Mar 2024

·www.businesswire.com

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

MIAMI--( BUSINESS WIRE )-- Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC). The filing is based on the results of the eXalt3, a randomized global phase III study designed to evaluate the efficacy and safety of ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC. The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024. “The FDA’s acceptance of this NDA represents a key milestone for Xcovery in its mission to bring ensartinib as a novel and distinct first-line therapeutic option to ALK-positive NSCLC patients,” said Giovanni Selvaggi, M.D., Chief Medical Officer of Xcovery. “We will continue to work closely with the agency during the review period. This achievement is a testament to our patient-centric vision and has been made possible by the dedication and skills of the entire Xcovery team and stakeholders, with the constant support of the patients, their families and investigators in our clinical trials globally.” Ensartinib is a next generation ALK inhibitor jointly developed by Xcovery and Betta Pharmaceuticals. In the clinical trials, the drug has demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile. The results of the eXalt3 were originally published in JAMA Oncology in September 2021. About Xcovery Xcovery is a pharmaceutical company working to improve the lives of patients with cancer by discovering and developing small molecules that precisely target cancer growth mechanisms. Xcovery is developing a pipeline of drugs targeting a wide range of advanced solid tumors with a focus on lung cancer. For more information, visit www.xcovery.com. Forward‐Looking Statements This press release contains forward‐looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.

NDAPhase 3Priority ReviewClinical Result

04 Sep 2023

·www.outsourcing-pharma.com

Roche’s Alecensa smashes phase 3 as adjuvant therapy for lung cancer

Lung cancer is one of the leading causes of cancer deaths globally, with NSCLC being one of the most common forms of the disease. Additionally, many early lung cancer cases recur after surgery, despite modern treatment approaches including adjuvant chemotherapy and immunotherapy. Alecensa is a small molecule drug designed to block variations of the protein anaplastic lymphoma kinase (ALK), which occur in around 5% of NSCLC cases . The drug is already approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for ALK-positive, metastatic NSCLC. Roche is aiming to develop the drug in earlier stages of the disease as an adjuvant therapy following surgical removal of the tumor. In the trial, dubbed ALINA, Alecensa was compared with platinum-based chemotherapy in 257 patients with resected ALK-positive NSCLC. According to a pre-planned interim analysis, Alecensa’s improvement in disease-free survival met the trial’s primary endpoint, though the overall survival results were not ready to call. Roche also found no unexpected safety findings in the trial. “Alecensa has transformed outcomes for people with advanced ALK-positive NSCLC, and now these strong results provide evidence for the first time that this medicine could also play a pivotal role in early-stage disease where there is significant unmet need,” said Roche’s chief medical officer and head of global product development, Levi Garraway, in a public statement. “If approved, Alecensa has the potential to treat cancer before it has spread in a setting where treatment can increase the chances of cure, which is our ultimate goal at Roche. We look forward to sharing these data with regulatory authorities in hopes of bringing this to patients as quickly as possible.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); Alecensa is one of several ALK inhibitors in the cancer treatment market. The first to be approved by the FDA for metastatic NSCLC was crizotinib in 2011. And other ALK inhibitors such as Pfizer's lorlatinib and Betta Pharmaceuticals’ ensartinib have emerged since Alecensa was first approved in 2015. If its development as an adjuvant proceeds to plan, Alecensa could become the first approved ALK inhibitor for early-stage ALK-positive lung cancer. While ALK inhibitors can be effective treatments for NSCLC, the cancer can develop resistance to these drugs . This is leading to the development of treatment combinations with other therapies to prevent resistance. For example, Alecensa showed promise in combination with the antibody drug bevacizumab in a phase 2 trial in patients with advanced ALK-positive NSCLC.

Clinical ResultDrug ApprovalPhase 3ImmunotherapyPhase 2

100 Deals associated with Ensartinib Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D11356	-	L01XE	DB14860

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
ALK positive Non-Small Cell Lung Cancer	CN	Betta Pharmaceuticals Co., Ltd.	17 Nov 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Reactive oxygen species 1 positive non-small cell lung cancer	Phase 2	CN	Betta Pharmaceuticals Co., Ltd.	29 May 2018
Advanced Malignant Solid Neoplasm	Phase 2	US	Xcovery Holding, Inc.	01 Jun 2012
Lung Cancer	Phase 1	CN	Betta Pharmaceuticals Co., Ltd.	11 Jun 2018
Small Cell Lung Cancer	Phase 1	CN	Betta Pharmaceuticals Co., Ltd.	07 Mar 2017
metastatic non-small cell lung cancer	Phase 1	CN	Betta Pharmaceuticals Co., Ltd.	06 Mar 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03215693 (Literature) Manual	Phase 2	ALK positive Non-Small Cell Lung Cancer TP53 Mutation \| ALK Positive	180	Ensartinib 225 mg	idbwtonrcn(brdqlvsaae) = qpofevfgqc hmmkgfbwpq (rmudjapkek, 29.3-53.2) View more	Positive	29 Feb 2024
NCT03753685 (ESMO2023) Manual	Phase 2	ALK positive Non-Small Cell Lung Cancer First line \| Second line ALK Fusion	14	Ensartinib	dfzagwvokr(cotrtwkovi) = buqakvirzy tofqeglbfr (iazjgftpih, 41.9 - 91.6) View more	Positive	23 Oct 2023
NCT02959619 (Pubmed)	Phase 1	ALK positive Non-Small Cell Lung Cancer	48	Ensartinib	ezwryxxcuq(ejdxonalus) = 4.2% udzowpilgd (zxxhwgttln ) View more	-	01 Dec 2022
WCLC2022	Not Applicable	-	-	Crizotinib	kljnjjdxmc(dtxuckliyq) = attyfvacez mvltpqdouq (kzzdazbzcv )	-	06 Aug 2022
				Alectinib	kljnjjdxmc(dtxuckliyq) = srgwgorxpd mvltpqdouq (kzzdazbzcv )
NCT03215693 (WCLC2022)	Phase 2	-	-	Ensartinib (ALK Fusion Subtype Variant 1 (V1))	twquqvobfl(uohyzucvwn) = acayaghnxr jkynbccuuf (ndqboyscrk ) View more	-	06 Aug 2022
				Ensartinib (ALK Fusion Subtype Variant 3 (V3))	twquqvobfl(uohyzucvwn) = asysizcggt jkynbccuuf (ndqboyscrk ) View more
NCT03608007 (Pubmed) Manual	Phase 2	Reactive oxygen species 1 positive non-small cell lung cancer ROS1 Positive	59	Ensartinib	ufpbcmocjt(fxbozqxxpu) = lnovztpuma ooxeitbfxr (dwqyknfyky, 13.8 - 44.1) View more	Positive	01 Nov 2021
NCT02767804 (eXalt3, Pubmed \| JAMA Oncol) Manual	Phase 3	ALK positive Non-Small Cell Lung Cancer First line ALK Positive	290	Ensartinib Hydrochloride	gsjfsgoeif(xayfnjqxsb) = llpmwmrhcl raeevgupmf (mvfelicoqj ) View more	Superior	01 Nov 2021
				Crizotinib	gsjfsgoeif(xayfnjqxsb) = inzvqmihof raeevgupmf (mvfelicoqj ) View more
WCLC2021	Not Applicable	-	178	Ensartinib (ALK-EML4 V1 subtype)	wskyrplfkf(yvphnzhpes) = yaoxsltwht bddftoiufs (yqvtdyyhrx )	-	08 Sep 2021
				Ensartinib (ALK-EML4 V3 subtype)	wskyrplfkf(yvphnzhpes) = jhzvlzhefo bddftoiufs (yqvtdyyhrx )
NCT02767804 (eXalt3, WCLC2021)	Phase 3	ALK positive Lung Cancer First line	290	Ensartinib	aziprbqgec(vetdxhitme) = febdfptdqn yrxcyzgjys (elkikyfnhe )	-	28 Jan 2021
				Crizotinib	aziprbqgec(vetdxhitme) = skfvfxgbsq yrxcyzgjys (elkikyfnhe )
NCT03804541 (Pubmed \| Cancer Chemother Pharmacol)	Phase 1	-	6	Ensartinib 200 mg/100 μCi	rgsgotkmgj(gbvrpmiwgo) = eobokjavlb cfcqzvffii (qlhivzxruf ) View more	-	01 Dec 2020

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