Lurbinectedin is under clinical development by Pharma Mar and currently in Phase III for Leiomyosarcoma. According to GlobalData, Phase III drugs for Leiomyosarcoma have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Lurbinectedin’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

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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.

Lurbinectedin overview

Lurbinectedin (Zepzelca) is a synthetic tetrahydropyrrolo [4, 3, 2-de] quinolin-8(1H)-one alkaloid analogue with potential anti-neoplastic activity. It is formulated as lyophilised powder for solution for intravenous route of administration. Zepzelca is indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

Lurbinectedin (PM-01183) is under development for the treatment of neuroendocrine gastroenteropancreatic tumors (GEP-NET), advanced or metastatic soft-tissue sarcoma, advanced or metastatic leiomyosarcoma, unresectable non-small cell lung cancer, malignant pleural mesothelioma, small cell lung cancer, HER2 positive metastatic breast cancer, metastatic colorectal cancer, gastric cancer, endometrial cancer, triple-negative breast cancer (TNBC), leukemias, neuroendocrine tumors, relapsed or primary refractory non-M3 acute myeloid leukemia, chronic myeloid leukemia, esophageal cancer, large cell neuroendocrine carcinoma of the lung, pancreatic adenocarcinoma, relapsed/refractory myelodysplastic syndrome, metastatic biliary tract carcinoma, head and neck carcinoma, relapsed or refractoryacute lymphocytic leukemia, germ cell cancer, soft tissue sarcoma, human epidermal growth factor receptor 2 negative breast cancer (HER2- breast cancer), mesothelioma, glioblastoma, Ewing family of tumors, advanced solid tumors, metastatic pancreatic cancer, prostatic small cell and neuroendocrine carcinoma (SC/NEPC), metastatic urothelial cell carcinoma, synovial sarcoma, soft tissue sarcoma of extremity, trunk or retroperitoneum, myxoid liposarcoma and neuroendocrine gastroenteropancreatic tumors. It is administered intravenously as a solution concentrate. It is a synthetic alkaloid which targets RNA polymerase II. It was also under development for the treatment of epithelial ovarian cancer peritoneal cancer, fallopian tube cancer, metastatic pancreatic cancer, hepatocellular carcinoma, bone cancer and bladder cancer.

Pharma Mar overview

Pharma Mar discovers, develops and markets marine-derived drugs to treat cancer. The company’s marketed products include Yondelis (trabectedin) an antitumor agent indicated for the treatment of soft tissue sarcoma and relapsed ovarian cancer in combination with doxorubicin HCl liposome injection; Aplidin (plitidepsin), an anticancer agent for the treatment of multiple myeloma; and Zepzelca (lurbinectedin) for small cell lung cancer. Pharma Mar offers in vitro diagnostic products used for detection of virus and bacteria in respiratory infections and human papilloma virus genotypes, among others. It also offers kits used for diagnosis of influenza A and B and respiratory syncytial virus. Its development pipeline includes PM14 for solid tumors, among others. It also develops RNAi candidates for the treatment of retina diseases. The company has subsidiaries in Germany, Italy, France, Switzerland, the UK, and the US, among others. Pharma Mar is headquartered in Madrid, Spain.

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

This content was updated on 20 May 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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.