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PharmaMar announces data presentations: Yondelis® and lurbinectedin at ASCO

Pharmamar

  • Yondelis®: oral presentation of a comparative study in soft tissue sarcoma (T-SAR) between trabectedin versus best supportive care; and, a study in combination with immunotherapy.

  • Lurbinectedin: the clinical advances made in Small Cell Lung Cancer, Ewing´s sarcoma, and breast cancer.

  • Plitidepsin: overall survival data from the ADMYRE study in patients with relapsed/refractory multiple myeloma.

Madrid, 17th of May, 2018.- During the Congress of the American Society of Clinical Oncology (ASCO) that will be held form the 1st to the 5th of June in Chicago (USA), PharmaMar will present the data obtained from various clinical studies of the molecules Yondelis ®, lurbinectedin (PM1183) and plitidepsin.

Two studies carried out with Yondelis® (trabectedin) will be presented, including an oral presentation by the French Sarcoma Group on the results of aprospective phase III study comparing trabectedin versus best supportive care in patients with soft tissue sarcoma. And the design of the phase I/II safety and efficacy study using the triple combination of trabectedin, ipilimumab and nivolumab for the first line treatment of soft tissue sarcoma.

PharmaMar will also have data for lurbinectedin (PM1183), presenting the clinical advances made in indications such as Ewing´s sarcoma, breast cancer and small-cell lung cancer, which is currently in a pivotal phase III clinical trial called ATLANTIS that should complete recruitment in Q3.

The studies that will be presented during the meeting are available at http://abstracts.asco.org

Studies highlighted at ASCO 2018

Lurbinectedin

Lurbinectedin is a compound under clinical investigation which is an inhibitor of the RNA polymerase II enzyme which is essential for the transcription process. It's inhibition suppresses tumor growth, and results in tumor death. The antitumor efficacy of PM1183 is being investigated in various types of solid tumors.

  • Efficacy and safety of lurbinectedin (PM1183) in Ewing sarcoma: Final results from a phase 2 study. (Abstract #11519)
    Poster Board: #264. Saturday, June 2. 15:00 to 16:15. Hall A
    Discussed at the Poster Discussion Sessuon on Satuday, June 2, from 15:00 to 16:15 at S404
    Lead author: Vivek Subbiah, MD. The University of Texas MD Anderson Cancer Center

  • Antitumor activity of PM1183 (lurbinectedin) in combination with capecitabine in metastatic breast cancer patients: results from a Phase I trial. (Abstract #1072)
    Poster board: #153. Saturday, June 2. 8:00 a.m. to 11:30 a.m. Hall A.
    Lead author: Ahmad Awada, MD, PhD. Medical oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles

  • Efficacy and safety of lurbinectedin (PM1183) in small cell lung cancer (SCLC): Results from a phase 2 study. (Abstract #8570)
    Poster board: #176. Sunday, June 3. 8:00 a.m to 11:30. Hall A.
    Lead author: Jose Manuel Trigo Perez, MD. Hospital Virgen de la Victoria, Spain.

  • ATLANTIS: Global, randomized phase III study of lurbinectedin (L) with doxorubicin (DOX) vs. CAV or topotecan (T)in small-cell lung cancer after platinum therapy. (Abstract #TPS8587)
    Poster board: #189b. Sunday, June 3. 8:00 a.m to 11:30. Hall A.
    Lead author: Anna F. Farago, MD, PhD. Massachusetts General Hospital

  • Phase I trial of lurbinectedin (PM1183) in Japanese patients with advanced tumors: results of the dose escalation part. (Abstract #2551)
    Poster board: #377. Monday, June 4. 8:00 a.m. to 11:30. Hall A
    Lead author: Shunji Takahashi, MD. Cancer Institute Hospital of JFCR

Yondelis® (trabectedin)

Trabectedin is a novel, 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.

  • Whole exome sequencing (WES) od metastatic leiomyosarcoma (LMS) and liposarcoma (LPS) and correlation of genomic aberrations with clinical outcomes in the phase III randomized trial of trabectedin (T) vs. dacarbazine (D). (Abstract #11513)
    Poster board: #258. Saturday, June 2. 15:00 to 16:15. Hall A
    Lead author: Gurpreet Kapoor. Scientific Operations, LabConnect LLC.

  • Multi-institutional European phase I/II trial of trabectedin plus radiotherapy in metastatic soft tissue sarcoma (STS) patients. A Collaborative Spanish (GEIS), Italian (ISG) and French (FSG) Sarcoma Groups study. (Abstract #11544)
    Poster board: #289. Saturday, June 2. 15:00 to 16:15. Hall A
    Lead author: Javier Martin Broto MD, PhD. Hospital Universitario Virgen del Rocio, Instituto de Investigación Biomédica, Universidad de Sevilla, Spain.

  • Impact of pathological stratification of advanced well differentiated/dedifferentiated (WD/DD) liposarcoma (LPS) on the response to trabectedin (T). (Abstract #11566)
    Poster board: #311. Saturday, June 2. 15:00 to 16:15. Hall A
    Lead author: Roberta Sanfilippo, MD. Departamento de Oncología Médica, Fondazione IRCCS Istituto Nazionale dei Tumori

  • Phase 1/2 study of safety/efficacy using trabectedin, ipilimumab and nivolumab triple therapy as first line of treatment of advanced soft tissue sarcoma. (Abstract #TPS11591)
    Poster board: #333b. Saturday, June 2. 15:00 to 16:15. Hall A
    Lead author: Erlinda Maria Gordon, MD. Sarcoma Oncology Center

  • Results of a prospective randomized phase III T-SAR trial comparing trabectedin (T) vs best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS): A French Sarcoma Group (FSG) trial. (Abstract #11508)
    Oral sesión. Monday, June 4. 8:00 a.m. to 11:00. S100a
    Lead author: Axel Le Cesne, MD. Gustave Roussy Cancer Campus

Plitidepsin

  • Overall survival (OS) results of randomized phase III study (ADMYRE trial) of plitidepsin and dexamethasone (DXM) vs. DXM alone in patients with relapsed/refractory multiple myeloma (RRMM): Evaluation of the crossover impact. (Abstract #8018)
    Poster board: #27. Monday, June 4. 8:00 to 11:30. Hall A
    Discussed ta the poster discussion session on Monday, June 4, 15:00 to 16:15 at E450
    Lead autor: Javier Gómez, PharmaMar

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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 lurbinectedin

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.

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 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, Zepsyre® (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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