PharmaMar Showcases New Data for YONDELIS® and PM1183 in Soft Tissue Sarcoma and Solid Tumors at ECCO 2015

MADRID, September 14, 2015 /PRNewswire/ --

• Final OS and subgroup analysis of the pivotal study SAR-3007 
  
• First interim results of the Y-IMAGE prospective study showing real-world data for trabectedin in advanced soft tissue sarcoma (STS) 
  
• Clinical data of trabectedin in translocated-related sarcomas, and in advanced leiomyosarcomas and liposarcomas  
  
• Early clinical studies of PM1183 in combination with paclitaxel or cisplatin show a synergistic activity  

PharmaMar announces that it will show new data from clinical pivotal studies as well as real-life data from prospective non-interventional studies to highlight the role of YONDELIS^® (trabectedin) in STS, during the 18th ECCO - 40th ESMO European Cancer Congress, Vienna, 25 - 29 September 2015 (ECC 2015). This congress is the leading European forum for oncologists to keep abreast of practice-changing scientific studies and learning the most innovative approaches for cancer patient management. The abstracts have been selected for oral presentation and general poster presentation, and will feature data from the first-in-class drug YONDELIS^® (trabectedin), and the transcription inhibitor PM1183 (lurbinectedin).

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"Being part of this important oncology platform, as it is the European Cancer Congress, allows us to add to the clinical cancer community. We are glad we can present both clinical and real-life data for our compounds that will help clinicians and researchers, as they continue to seek new therapeutic avenues and improved treatments", says Nadia Badri, MD, VP Medical Affairs, PharmaMar. "PharmaMar is not only witnessing a major change in treatment approaches, but also contributing to this ongoing transformation."

Meeting abstracts are available at https://www.europeancancercongress.org/en  

Studies highlighted at ECC 2015 

YONDELIS^® (trabectedin) 

Final results for trabectedin in STS, as well as real-world data from a large prospective phase IV study in this same tumor type will be showcased in 4 studies in oral and poster presentations. In addition, the role of trabectedin in the tumor microenvironment and its effect on tumor-associated macrophages will be highlighted during a special session.

• Final overall survival (OS) analysis of the randomized phase 3 study of trabectedin (T) or dacarbazine (D) for the treatment of patients (pts) with advanced leiomyosarcoma (LMS) or liposarcoma (LPS). (Abstract #3403) - sponsored by Janssen Products 

Oral presentation: Sarcoma - Soft Tissue. Saturday, Sep 26 from 11:25 - 11:35 at LEHAR 3

Lead Author: Shreyaskumar Patel, MD, Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

• Trabectedin and M2 macrophages. 

Special Session oral presentation: Targeted Therapies of Sarcomas. Saturday, Sep 26 from 15:15 - 11:25 at LEHAR 3

Speaker: Maurizio D'Incalci, MD PhD, Department of Oncology, IRCCS Institute for Pharmacological Research 'Mario Negri', Florence, Italy.

• A non-interventional, multicenter, prospective phase IV study of trabectedin in patients with advanced soft tissue sarcoma (STS): the first interim analysis of Y-IMAGE study. (Abstract #3435) 

Poster Session: Sarcoma - Soft Tissue and Bone. Saturday, Sep 26 from 16:15 - 18:45 at Hall C Poster Board P300

Lead Author: Nicolas Penel, MD PhD, Department of Medical Oncology, Centre Oscar Lambret, France.

• Final results of a randomized phase II study comparing trabectedin and best supportive care (BSC) in patients with translocation-related sarcomas (TRS). (Abstract #3445A) - sponsored by Taiho Pharmaceutical 

Poster Session: Sarcoma - Soft Tissue and Bone. Saturday, Sep 26 from 16:15 - 18:45 at Hall C Poster Board P310A

Lead Author: Toshiyuki Kunisada, MD, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan

• Efficacy and safety of trabectedin (T) or dacarbazine (D) for treatment of patients (pts) with advanced leiomyosarcoma (LMS) or liposarcoma (LPS) after prior chemotherapy. (Abstract #3436) - sponsored by Janssen Products 

Poster Session: Sarcoma - Soft Tissue and Bone. Saturday, Sep 26 from 16:15 - 18:45 at Hall C Poster Board P301

Lead Author: George Demetri, MD, Dana-Farber Cancer Institute, Boston, MA, USA.

• Efficacy and safety of trabectedin (T) or dacarbazine (D) in an elderly patient subgroup (≥65 years) with advanced leiomyosarcoma (LMS) or liposarcoma (LPS) after prior chemotherapy (Abstract #1321) - sponsored by Janssen Products 

Poster Session: Cancer in the Elderly. Sunday, Sep 27 from 16:15 - 18:45 at Hall C Poster Board P108

Lead Author: Margaret Von Mehren, MD, Sarcoma Oncology Physician Director, Fox Chase Cancer Center and Temple University, Philadelphia, PA, USA.

• Drugs acting on ovarian cancer cells and tumor microenvironment 

Scientific symposium: Biology-based Selected Drugs in Ovarian Cancer Treatment. Monday, Sep 28 from 17:40 - 18:00 at Hall A2

Speaker: Maurizio D'Incalci, MD PhD, Department of Oncology, IRCCS Institute for Pharmacological Research 'Mario Negri', Florence, Italy.

PM1183 (lurbinectedin) 

At ECC 2015, there will be two PharmaMar-sponsored studies presented in poster sessions for the role of PM1183 in advanced solid tumors.

• Phase I study of lurbinectedin (PM01183) in combination with cisplatin (C) with or without aprepitant (Ap) in patients (pts) with advanced solid tumors. (Abstract #316) 

Poster Session: Early Drug Development. Sunday, Sep 27 from 16:45 to 18:45 at Hall C Poster Board P127

Lead Author: Martin Forster, MD University College Hospital, London, UK.

• Lurbinectedin (PM01183) in combination with paclitaxel (P) in patients (pts) with advanced solid. (Abstract #335) 

Poster Session: Early Drug Development. Sunday, Sep 27 from 16:45 to 18:45 at Hall C Poster Board P146

Lead Author: Elena Garralda, MD Spanish National Cancer Research Center (CNIO), Madrid, Spain.

PM60184  

• Phase I, Open-label, Dose-escalating Clinical and Pharmacokinetic Study of the Novel Antimicrotubulin Agent PM060184 administered over 10 Minutes on Days 1-3 and 15-17 every 28 days to Patients with Advanced Malignant Solid Tumors. (Abstract 

Poster Session: Early Drug Development (TUBULIN-INTERACTING AGENTS). Sunday, Sep 27 from 16:45 - 18:45 at Hall C Poster Board P172

Lead Author: Manuel Hidalgo, MD, PhD, Spanish National Cancer Research Center (CNIO), Madrid, Spain.

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SOURCE PharmaMar