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PharmaMar shows new clinical data on Yondelis® and lurbinectedin at ESMO 2016

October 05, 2016

PharmaMar (MSE:PHM) will present the data obtained from various clinical trials carried out with its antitumoral compounds of marine origin: Yondelis® (trabectedin) and lurbinectedin (PM1183), at the European Society of Medical Oncology (ESMO) congress that will take place in Copenhagen (Denmark), from the 7th to the 11th of October.

During this congress, PharmaMar will participate at different posters sessions and/or oral presentations the latest clinical advances of these molecules. In this edition, PharmaMar will present, among others, the results of a single-agent (lurbinectedin) Phase II trial in patients with BRCA 1/2 -associated metastatic breast cancer. Moreover, the French Sarcoma Group will introduce the data from a Phase III prospective study carried out in France (T-SAR), which compares trabectedin versus the best supportive care in patients with pretreated advanced soft tissue sarcoma (ASTS).

"At this year's edition of ESMO, we will announce the latest breakthroughs obtained with lurbinectedin in different tumor types. Through the various clinical trials that PharmaMar has running, we can observe that PM1183 is effective in combination and also as single-agent. This allows us to think that we have a great molecule for the treatment of different types of solid tumors, such as breast and endometrial cancers, amongst others", as Dr. Arturo Soto, director of Clinical Development at PharmaMar´s Oncology Business Unit, explains.

The trials that will be presented during this congress are available on https://cslide.ctimeetingtech.com/library/esmo/browse/search

Highlighted studies at ESMO 2016

Yondelis® (trabectedin)
  • Results of a prospective randomized phase III T-SAR trial comparing trabectedin vs. best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS) (Abstract #1473). Conducted by The French Sarcoma Group
    Proffered paper (Oral presentation). Saturday, October 8th from 11:00 a.m. to 12:15 p.m. Brussels
    Lead author: Axel Le Cesne, MD, et al. Institut de Cancérologie Gustave Roussy, Villejuif, France

  • Update of the T-DIS randomized phase II trial: trabectedin rechallenge versus continuation in patients with advanced soft tissue sarcoma (Abstract #2368). Conducted by the French Sarcoma Group
    Poster. Monday, October 10th from 13:00 to 14:00 p.m. Hall E.
    Lead author: Nuria Kotecki, MD et al. Centre Oscar Lambret, Lille, France

Lurbinectedin (PM1183)

  • Anti-tumor activity of PM1183 (lurbinectedin) in BRCA 1/2-associated metastatic breast cancer patients: results of a single-agent phase II trial (Abstract #2333)
    Proffered paper (Oral presentation). Saturday, October 8th from 11:00 to 12:30 p.m. Vienna
    Lead author: Judith Balmaña, MD, et al. Vall d´Hebron University Hospital and Vall d´Hebron Institute of Oncology, Barcelona, Spain.

  • Phase Ib/II study to evaluate the efficacy and tolerability of PM01183 (lurbinectedin) in combination with olaparib in patients with advanced solid tumors (Abstract #3654)
    Poster. Saturday, October 8th from 13:00 a 14:00 p.m. Hall E.
    Lead author: Andrés Poveda, MD, et al. Valencia Institute of Oncology. Spain.

  • Lurbinectedin (PM01183) exhibits antitumor activity in PARP-inhibitor resistant germline BRCA PDX and lacks cross-resistance with cisplatin (Abstract # 3003)
    Proffered paper (Oral presentation). Saturday, October 8th from 11:00 to 12:30 p.m. Madrid
    Lead author: Cristina Cruz, MD, et al. Vall d´Hebron University Hospital and Vall d´Hebron Institute of Oncology, Barcelona, Spain.

  • Lurbinectedin (PM1183) plus Paclitaxel (P), Recommended Dose (RD) Expansion Results with or without the addition of Bervacizumab (Bev) in patients with selected solid tumors (Abstract #1814)
    Poster. Monday, October 10th from 13:00 to 14:00 p.m. Hall E.
    Lead author: A. Drilon, MD, et al. Memorial Sloan Kettering Cancer Centre, New York, USA.

  • Lurbinectedin (PM1183) administered once every 3 weeks in combination with capecitabine in patients with metastatic breast, colorectal or pancreatic cancer (Abstract #2310)
    Poster. Monday, October 10th from 13:00 to 14:00 p.m. Hall E.
    Lead author: T. Sauri, MD, et al. Vall d´Hebron University Hospital and Vall d´Hebron Institute of Oncology, Barcelona, Spain.

-end-
About YONDELIS® (trabectedin)

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.

About PM1183 (lurbinectedin)

PM1183 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.

About PharmaMar

Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has an important pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS® in Europe and has three other clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium and the United States. PharmaMar fully owns other companies: GENOMICA, Spain's 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.

Pharmamar

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