And Yondelis® (Trabectedin) at ESMO 2020
Total Page:16
File Type:pdf, Size:1020Kb
PharmaMar will present data for ZepzelcaTM (lurbinectedin) and Yondelis® (trabectedin) at ESMO 2020 Results of lurbinectedin monotherapy will be presented in patients with Small Cell Lung Cancer (SCLC) that relapsed 90 and 180 days after completion of first-line chemotherapy. Results of trabectedin in combination with immunotherapy (durvalumab) in pre-treated patients with advanced Soft-Tissue Sarcomas, will be presented in an oral session. Results of trabectedin in combination with immunotherapy (nivolumab) in patients with metastatic or inoperable Soft-Tissue Sarcomas after treatment with an anthracycline, will also be presented. Madrid, 14th September, 2020. At the European Society of Medical Oncology (ESMO) Congress, which will be held virtually from 17th to 19th of September, PharmaMar (MSE:PHM) will present data on lurbinectedin in second-line SCLC patients who had received previous platinum-based chemotherapy and relapsed 90 and 180 days after its completion and therefore, being candidates for platinum re- challenge. Phase I results for lurbinectedin in Japanese patients with previously treated advanced Solid Tumours, will also be presented. Results of trabectedin in combination with immunotherapy (durvalumab) in pre- treated patients with advanced Soft-Tissue Sarcomas, will be presented at an oral session. In addition, results of Yondelis® (trabectedin) in combination with immunotherapy (nivolumab) for the treatment of Soft-Tissue Sarcoma, as well as results of trabectedin in combination with doxorubicin (PLD) for the treatment of Recurrent Ovarian Cancer, will be presented. ZepzelcaTM (lurbinectedin) The poster, titled "Activity of Lurbinectedin in Second-line SCLC Patients Candidates for Platinum Re-challenge" will present the evaluation of a subset of patients from the Phase II basket trial, conducted both in the United States and in Europe, in which 5 105 patients with SCLC who had progressed after previous platinum-based chemotherapy, participated. In the 20 patients who were platinum-sensitive and had a CTFI (Chemotherapy-Free Interval) of more than 180 days and were, therefore, candidates for platinum re- challenge according to National Comprehensive Cancer Network guidelines (NCCN), an overall survival of 16.2 months and an Overall Response Rate (ORR) of 60% were achieved. A poster on a Phase I trial of lurbinectedin in Japanese patients with advanced solid tumours will also be presented. Yondelis® (trabectedin) During this ESMO Congress, different studies carried out with Yondelis® (trabectedin) will be presented, including an oral presentation by the French Sarcoma Group on late breaking results of trabectedin in combination with durvalumab in pre-treated patients with advanced Soft-Tissue Sarcomas. Data from a non-randomised, open-label, phase II trial, assessing the efficacy and feasibility of the treatment with trabectedin in combination with nivolumab, in patients with metastatic or inoperable Soft-Tissue Sarcomas after anthracycline treatment, will be presented as a poster. Moreover, a sub-analysis of a randomised, phase III study, comparing trabectedin in combination with pegylated liposomal doxorubicin (PLD) versus PLD monotherapy, in patients with recurrent Ovarian Cancer, will also be presented as a poster. Finally, as an oral presentation, results of the InovatYon study -an international, randomised, phase III study comparing PLD with either trabectedin or carboplatinum in patients with recurrent Ovarian Cancer, progressing 6-12 months after the last platinum line– will be presented. The studies presented at the ESMO 2020 congress are available at: https://cslide.ctimeetingtech.com/library/esmo/browse/search Outstanding studies in ESMO 2020 ZepzelcaTM (lurbinectedin) 5 Activity of Lurbinectedin in Second-line SCLC Patients Candidates for Platinum Re-challenge E-Poster Display session. 17.09.2020. 09:00 - 23:59, Channel: On-Demand Main author: Subbiah V et al. Phase I study of lurbinectedin in Japanese patients with pretreated advanced tumors: Final results E-Poster Display session. 17.09.2020. 09:00 - 23:59, Channel: On-Demand Main author: Takahashi et al. Yondelis® (trabectedin) Randomized, phase III international study to evaluate whether the administration of trabectedin/PLD followed by platinum at progression could improve overall survival in comparison with a platinum-based regimen in patients with recurrent ovarian cancer and a platinum-free interval between 6-12 months Oral session. 19.09.2020. 13:26 - 13:38. Presentation number: LBA30 Main author: Nicoletta Colombo (Milan, Italy) TRAMUNE, a phase Ib study combining Trabectedin and Durvalumab: Results of the expansion cohort in patients with advanced pretreated Soft Tissue Sarcomas Oral session. 20.09.2020, 16:32 - 16:44. Presentation number: LBA67 Main author: Maud Toulmonde (Bordeaux, CEDEX, France) Treatment: trabectedin in inmunotherapy + durvalumab Subanalysis of a randomized phase 3 study comparing trabectedin and PLD vs PLD alone in patients with recurrent ovarian cancer (ROC) E-Poster Display session. 17.09.2020. 09:00 - 23:59, Channel: On-Demand Main author: Monk, Herzog, Coleman A non-randomized, open-label phase II trial evaluating efficacy and feasibility of combined treatment with trabectedin and nivolumab in 5 patients with metastatic or inoperable soft tissue sarcomas after failure of an anthracycline-containing regimen. E-Poster Display session. 17.09.2020. 09:00 - 23:59, Channel: On-Demand Main author: Pink et al. Treatment: trabectedin in inmunotherapy + nivolumab Legal warning This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction. About Yondelis® Yondelis® (trabectedin) is a novel, synthetically produced antitumor agent originally isolated from Ecteinascidia turbinata, a type of sea squirt. Yondelis® exerts its anticancer effects primarily by inhibiting active transcription, a type of gene expression on which proliferating cancer cells are particularly dependent. About lurbinectedin Lurbinectedin (ZepzelcaTM), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinacidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets. About PharmaMar Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin. PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: ZepzelcaTM (lurbinectedin, PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com. Media Contact: Alfonso Ortín – Communications Director [email protected] Mobile: +34 609493127 Miguel Martínez-Cava – Communication Manager [email protected] Mobile: +34 606597464 Álvaro Mateo - Communication Manager [email protected] Mobile: +34 650726009 Phone: +34 918466000 5 Capital Markets & Investor Relations: José Luis Moreno– Capital Markets & Investor Relations Director María Marín de la Plaza – Capital Markets & Investor Relations [email protected] Phone: +34 914444500 Or please visit our website at www.pharmamar.com 5 .