Catequentinib hydrochloride is under clinical development by Advenchen Laboratories and currently in Phase II for Head And Neck Squamous Cell Carcinoma (HNSC). According to GlobalData, Phase II drugs for Head And Neck Squamous Cell Carcinoma (HNSC) have a 26% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Catequentinib hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Catequentinib hydrochloride overview

Catequentinib hydrochloride (AL-3818) (Focus V, AL-3818) belongs to the class of organic compounds known as diarylethers acts as antineoplastic and anti-angiogenic agent. It is formulated as capsules for oral route of administration. Focus V is indicated for the treatment of patients, who are epidermal growth factor receptor (EGFR) gene mutations or anaplastic lymphoma kinase (ALK) positive, with locally advanced or metastatic non-small cell lung cancer who have experienced at least 2 systemic chemotherapy after progression or recurrence. Focus V is indicated for the treatment of alveolar soft tissue sarcoma, clear cell sarcoma and other patients with advanced soft tissue sarcoma who have undergone at least progression or recurrence after treatment with anthracycline-containing chemotherapy. Focus V is also indicated for the treatment of small cell lung cancer patients who have undergone at least two chemotherapy regimens after treatment or relapse. Focus V is also indicated for the treatment of unresectable locally advanced or metastatic medullary thyroid cancer patients with clinical symptoms or clear disease progression. Focus V is indicated for the treatment of locally advanced or metastatic radioactive iodine refractory differentiated thyroid cancer (RAIR-DTC) which is inoperable.

Catequentinib (AL-3818) is under development for the treatment of gastrointestinal tumors including pancreatic cancer, gastric cancer and bile duct cancer, advanced or metastatic differentiated thyroid cancer, metastatic urothelial carcinoma of the bladder cancer, urethral cancer, ureter cancer, renal pelvis cancer, non clear cell renal cell carcinoma, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, neuroblastoma, recurrent or metastatic cervical cancer, recurrent high-grade glioma, head and neck squamous cell carcinoma or non-squamous cell carcinoma, recurrent glioblastoma, melanoma, metastatic urothelial carcinoma, gastrointestinal pancreatic neuroendocrine tumor, metastatic advanced or recurrent soft tissue sarcomas, non-small cell lung cancer, pheochromocytoma and paraganglioma (PPGL), small cell lung cancer, pancreatic cancer, ovarian cancer, metastatic ovarian cancer and gallbladder cancer, soft tissue sarcoma including synovial sarcoma, leiomyosarcoma, angiosarcoma, liposarcoma, alveolar soft part sarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, adipocytic tumors, fibrosarcoma, clear cell sarcoma, epithelioid sarcoma, gastric cancer including gastroesophageal junction adenocarcinoma, advanced medullary thyroid carcinoma, metastatic colorectal cancer, advanced renal cell carcinoma, esophageal squamous cell carcinoma, recurrent/metastatic nasopharyngeal carcinoma, ovarian cancer, small-cell lung cancer, metastatic hepatocellular carcinoma, undifferentiated carcinoma urothelial, non-squamous non-small cell lung cancer, peripheral T-cell lymphomas (PTCL) including non-specific peripheral T-cell lymphoma, angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), enteropathy related T-cell lymphoma (EATL), monomorphic epithelial T-cell lymphoma (meitl), intranodal and extranodal Peripheral T-cell lymphoma (PTCL, TFH), follicular T-cell lymphoma (FTCL), NK / T-cell lymphoma, primary cutaneous T-cell lymphoma, HER2- breast cancer and unclassified peripheral T-cell lymphoma. It acts by targeting VEGFR2, VEGFR3, PDGFR beta and c-Kit. It was also under development for the treatment of colon cancer, squamous cell carcinoma, serous adenocarcinoma, clear cell adenocarcinoma, transitional cell carcinoma, peritoneal cancer, fallopian tube cancer, mixed epithelial carcinoma, mucinous adenocarcinoma,  and cervical cancer.

It was also under development for solid tumors, refractory or relapsed diffuse large B-cell lymphoma, osteosarcoma, chondrosarcoma, ewing sarcoma, primitive neuroectodermal tumor, giant cell tumor of bone dedifferentiated sarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, endometrial cancer, esophageal cancer, gallbladder cancer, melanoma, metastatic pancreatic cancer, liver cancer, gastrointestinal stromal tumors, cholangiocarcinoma, oral cavity (mouth) cancer, neuroendocrine gastroenteropancreatic tumors (GEP-NET), pleomorphic liposarcoma, thymic carcinoma, recurrent/metastasis pleural mesothelioma, squamous non-small cell lung cancer.

Advenchen Laboratories overview

Advenchen Laboratories is a pharmaceutical company that offers healthcare solutions. The company conducts pharmaceutical research and develops small-molecule cancer drug discovery programs. Its pipeline products include Rivoceranib/Apatinib, AL3818, AL8326, AL2846 and AL58805. Advenchen Laboratories provides services such as producing inhibitors for the treatment of human colon cancer, liver cancer, gastric cancer and lung and breast cancer, among others. It also provides customized chemical intermediate services. The company operates in China and the US. Advenchen Laboratories is headquartered in Moorpark, California, the US.

For a complete picture of Catequentinib hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 16 July 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.