PharmaMar presents positive results from a Phase II study of PM1183 in Ewing's sarcomaNovember 13, 2017
In abstract #2768194 entitled "Efficacy and safety of lurbinectedin (PM1183) in Ewing Sarcoma: results from a Phase 2 study" the efficacy and safety results from the Phase II basket trial were presented, in which a group of patients with this type of advanced sarcoma, that hadn´t received more than 2 prior chemotherapeutic treatment in metastatic disease, were included. The study is ongoing, although the cohort of patients with Ewing´s sarcoma has now closed.
At the moment of this abstract, 25 patients with Ewing´s sarcoma were enrolled. The observed disease control rate (overall response, partial response and stabilization of the disease) was 60%, including partial responses in 12% of cases, and a stabilization of the disease in the 48% of cases. The observed median duration of response was 2.9 months and 3 months of median progression free survival was reached.
The study showed that adverse effects were generally related to myelosuppression, which were reported to be manageable with dose adjustments. No treatment withdrawals due to toxicity or toxic deaths occurred. The patients with Ewing´s sarcoma have a poor outcome. The authors of the abstract would like to highlight that new therapeutic agents with different mechanism of action are needed, as in the case of lurbinectedin, which has exhibited a favorable safety and tolerability profile as a single agent in pre-treated patients with advanced Ewing´s sarcoma.
Main studies presented at CTOS
- A matching indirect adjusted comparison of trabectedin and pazopanib for the treatment of advanced, metastatic, leiomyosarcomas. Sponsored by Janssen Research & Development, LLC. And PharmaMar. Lead author: Robin Jones et al.
- SAR-3007: Efficacy and safety of trabectedin, when administered as Inpatient vs. Outpatient Site of Care. Sponsored by Janssen Research & Development, LLC. Lead author: Robin Jones et al.
- SAR-3007: Genomic Characterization of Uterine Leiomyosarcoma Patients to Define Exploratory Biomarkers in the Phase III Randomized Trial of Trabectedin versus Dacarbazine. Sponsored by Janssen Research & Development, LLC. Lead author: Gurpreet Kapoor et al.
- SAR-3007: Efficacy and Safety of Trabectedin in an Elderly Patient Subgroup ??65 years? with Advanced Leiomyosarcoma ?LMS? or Liposarcoma ?LPS? from the Expanded Access Program ?EAP? Sponsored by Janssen Research & Development, LLC. Lead author: Robin Jones et al.
- SAR-3002: Efficacy and Safety of Patients Treated Long?Term with Trabectedin ?T? on the Expanded Access Program: A Retrospective Analysis Sponsored by Janssen Research & Development, LLC. Lead author: Elizabeth Davis et al.
YONDELIS® (trabectedin) is a multimodal, synthetically produced antitumor agent, originally derived from the sea squirt, Ecteinascidia turbinata. The drug exerts its activity by targeting the transcriptional machinery and impairing DNA repair. It is approved in close 80 countries in North America, Europe, South America and Asia for the treatment of advanced soft tissue sarcomas as a single-agent and for relapsed ovarian cancer in combination with DOXIL®/CAELYX® (doxorubicin HCl liposome injection) in the European Union. Under a licensing agreement with PharmaMar, Janssen Products, L.P. has the rights to develop and sell YONDELIS® globally except in Europe, where PharmaMar holds the rights, and in Japan, where PharmaMar has granted a license to Taiho Pharmaceuticals.
Lurbinectedin is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III study for small cell lung cancer.
Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has other clinical-stage programs under development for several types of solid and hematological cancers, Zepsyr® (PM1183), plitidepsin, PM184 and PM14. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, a leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us at http://www.pharmamar.com.
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A team from the Spanish National Cancer Research Centre (CNIO) has optimized a system capable of generating a cellular model of Ewing sarcoma.
A University of Colorado Cancer Center study published in the journal Oncogene pinpoints a protein that may be essential to Ewing's sarcoma metastasis -- when researchers knocked down the protein KDM3A in Ewing's sarcoma tumor cells, one of a family known as Jumonji proteins, they also inhibited the cancer's metastatic ability.
Patients with a type of advanced malignant cancer of the arms or legs have typically faced amputation of the afflicted limb as the only treatment option.
IDIBELL researchers describe the Ewing's sarcoma (ES) methylation profile for the first time.
Researchers at Mayo Clinic Center for Individualized Medicine have discovered a potential cause and a promising new treatment for inflammatory myofibroblastic tumors, a rare soft tissue cancer that does not respond to radiation or chemotherapy.
Medical researchers at Indiana University have found evidence for a link between prostate cancer, which affects millions of men age 50 and older, and Ewing's sarcoma, a rare form of cancer that affects children and young adults.
Neoadjuvant chemotherapy with an anthracycline plus ifosfamide was associated with significant survival gains in patients with soft tissue sarcoma of the trunk or extremities who are at high-risk of recurrence, in an interim analysis that led to the early discontinuation of a trial presented today at the ESMO 2016 Congress in Copenhagen.
In a landmark multi-country study, Australian researchers have transformed our understanding of the genes that affect our risk of cancer.
An existing cancer immunotherapy drug reduces tumor size in some types of rare connective tissue cancers, called sarcomas, report researchers at the University of Pittsburgh Cancer Institute.
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