Data from an interim analysis from the pivotal Phase 3 trial of YONDELIS in soft tissue sarcoma, SAR-3007, will be presented in an oral presentation



Similar documents
REPORT AT 30 SEPTEMBER M 2014 MILESTONES

REPORT AT 31 DECEMBER HIGHLIGHTS

REPORT AT 30 JUNE H14 HIGHLIGHTS

Marine Resources & their application to healthcare Yondelis : A successful, high-value application of marine resources

Targeting Specific Cell Signaling Pathways for the Treatment of Malignant Peritoneal Mesothelioma

Transgene Presents Additional Positive Clinical Data from Phase 2b Part of TIME Trial with TG4010 at ESMO

Nuevas tecnologías basadas en biomarcadores para oncología

IMMUNOMEDICS, INC. February Advanced Antibody-Based Therapeutics. Oncology Autoimmune Diseases

Scientific Committee Hilary Calvert UCL Cancer Institute, London, United Kingdom

Understanding CA 125 Levels A GUIDE FOR OVARIAN CANCER PATIENTS. foundationforwomenscancer.org

Daiichi Sankyo to Acquire Ambit Biosciences

REPORT AT 31 DECEMBER 2011

Preliminary Results from a Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Family (MiT) Associated Tumors

Summary of treatment benefits

Promises and challenges of developing new drugs in oncology

News Release. Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma

ALLOS THERAPEUTICS, INC ANNUAL REPORT. Building an. Oncology Franchise

STRATEGY PROGRAM NEXT LEVEL BERLIN, 9 JUNE 2016

Brigham and Women s Hospital, Boston, MA, USA; 2 Verastem, Inc., Boston, MA, USA

Adaptimmune Reports Full Fiscal Year 2015 Financial Results. - Conference call to be held today at 8:00 AM ET (1:00 PM BST) -

Houston Cancer Institute

MOLOGEN AG. Q1 Results 2015 Conference Call Dr. Matthias Schroff Chief Executive Officer. Berlin, 12 May 2015

Aeterna Zentaris. 11 th Annual Needham Healthcare Conference April 3, Committed to cure

Teva and Checkpoint Therapeutics Announce License Agreement for Oral PARP Inhibitor

Exelixis Showcases R&D Pipeline at JPMorgan Healthcare Conference

Third Quarter, 2015 Update

Principal Investigator: Valerie W. Rusch, MD, FACS, Chief, Thoracic Surgery Memorial Sloan-Kettering Cancer Center

Curriculum Vitae of Luca Gianni

Building A Focused Oncology Business

10 th EADO Congress Vilnius, 7-10 May Ipilimumab update. Michele Maio

E UROPEAN C URRICULUM V ITAE F ORMAT

Program Chairs: Robert W. Holloway, MD and Martin Martino, MD Speakers and times are subject to change

Corporate Overview. November 2015 NASDAQ: CYTR

THE VIRAL HEPATITIS CONGRESS September 2015, Kap Europa, Frankfurt, Germany THE VIRAL HEPATITIS CONGRESS. Scientific Programme

Regional Young Investigator SIC meeting. 5-6 March 2015

Promises and challenges of developing new drugs in oncology

Activity of pemetrexed in thoracic malignancies

Griffith University - Case for Support. Mesothelioma Research Program

A Letter from MabVax Therapeutics President and Chief Executive Officer

Improving Life Transforming Value. May 1 st, 2015

BNC105 PHASE II RENAL CANCER TRIAL RESULTS

Foundational Issues Related to Immunotherapy and Melanoma

Ovarian Cancer (Event Driven)

Dec. 9, 2013, 11:00 a.m. EST

[ NASDAQ: MEIP ] Bank of America Merrill Lynch Health Care Conference May 12-14, 2015

POLICY A. INDICATIONS

The Ultimate Healthcare & Biotechnology Event in Deborah Rathjen CEO & Managing Director 24 March 2010

MOLOGEN AG German Equity Forum 2015

New Advances in Cancer Treatments. March 2015

E UROPEAN CURRICULUM VITAE FORMAT

Malignant Pleural Mesothelioma - Pipeline Review, H2 2014

L Lang-Lazdunski, A Bille, S Marshall, R Lal, D Landau, J Spicer

REPORT ASCO 2002 ORLANDO : LUNG CANCER Johan F. Vansteenkiste, MD, PhD, Univ. Hospital and Leuven Lung Cancer Group

Groundbreaking Collaborative Clinical Trial Launched

Decision to Continue the Development of Tecemotide (L-BLP25) in Non-Small Cell Lung Cancer to be Announced

THE CANCER STEM CELL INHIBITORS VS-6063 AND VS-5584 EXHIBIT SYNERGISTIC ANTICANCER ACTIVITY IN PRECLINICAL MODELS OF MESOTHELIOMA

Corporate Medical Policy

Scientific Programme

Trials in Elderly Melanoma Patients (with a focus on immunotherapy)

Company presentation. 7 th European Life Science CEO Forum Zurich, 4-5 March Paolo Bassanini Business Development & IR

Free to Breathe 2015 Research Grant To Prevent or Stop Lung Cancer Metastasis. Request for Proposals

1 page Overview. CONCURRENT 1D, 1E, 1F Biology & Pathogenesis Multi-Modality Immunology 1

INSERM/ A. Bernheim. Overcoming clinical relapse in multiple myeloma by understanding and targeting the molecular causes of drug resistance

Clinical Trials for Patients with

FDA approves Rituxan/MabThera for first-line maintenance use in follicular lymphoma

Mesothelioma Paul Baas Department of Thoracic Oncology The Netherlands Cancer Institute Amsterdam

ORGANIZERS Fundación para la Investigación Médica Aplicada FIMA Clínica Universidad de Navarra CUN

Scientific Committee. Andrés Cervantes (ESMO, GEICO) Antonio González (ESMO, GEICO) Andrés Poveda (ESMO, GEICO) Jan B. Vermorken (ESMO, GEICO)

CLINICAL TRIALS SHOULD YOU PARTICIPATE? by Gwen L. Nichols, MD

Avastin (Renal Cell Carcinoma) - Analysis and Forecasts to 2022

EMD Serono Presents New Data on Rebif (Interferon beta-1a) and Multiple Sclerosis Pipeline at Joint ACTRIMS-ECTRIMS Meeting in Boston

Future Directions in Clinical Research. Karen Kelly, MD Associate Director for Clinical Research UC Davis Cancer Center

Localised Cancer Treatment. PCI Biotech. Amphinex a new product for localised cancer treatment

COMPENDIA TRANSPARENCY TRACKING FORM. Ovarian cancer, recurrent

The New Kid on the Block for Advanced Renal Cell Carcinoma

Medication Policy Manual. Topic: Alimta, pemetrexed Date of Origin: May 12, 2010

How To Use Berberine

PROSPETTIVE FUTURE NEL TRATTAMENTO. Cinzia Ortega Dipartimento di Oncologia Medica Fondazione del Piemonte per l Oncologia I.R.C.C.S.

PRODYNOV. Targeted Photodynamic Therapy of Ovarian Peritoneal Carcinomatosis ONCO-THAI. Image Assisted Laser Therapy for Oncology

Call 2014: High throughput screening of therapeutic molecules and rare diseases

Hepatitis C Glossary of Terms

Novel therapeutic approaches in multiple sclerosis Neuroprotective and remyelinating agents, the future of clinical trials in MS?

Biotech Short Profile

Report on New Patented Drugs - Alimta

Mesothelioma Applied Research Foundation

A Phase II trial with PM01183 commenced on patients with breast cancer.

Guidance for Industry

Management of Platinum-Sensitive Recurrent Ovarian Cancer

Achievements Report CURING CANCER. Of all the questions addressed to CPRIT, the toughest is: When are you going to find a cure for

How To Treat Mesothelioma With A Tumor Stem Cell Inhibitor

NCCN Non-Small Cell Lung Cancer V Update Meeting 07/09/10

Two-Year Phase III Data Presented at AAN 61st Annual Meeting Show Positive Outcome of Cladribine Tablets in Patients with Multiple Sclerosis

Malignant Mesothelioma - Pipeline Review, H2 2014

Everolimus plus exemestane for second-line endocrine treatment of oestrogen receptor positive metastatic breast cancer

Update on Clinical Trials and Foundation Funded Grants

INTRAPERITONEAL HYPERTHERMIC CHEMOTHERAPY (IPHC) FOR PERITONEAL CARCINOMATOSIS AND MALIGNANT ASCITES. INFORMATION FOR PATIENTS AND FAMILY MEMBERS

What s New in Ovarian Cancer Research? Novel Therapeutics for Ovarian Cancer

T u m o r D o r m a n c y

TABLE OF CONTENTS. Introduction...1. Chapter1 AdvancesinTreatment...2. Chapter2 MedicinesinDevelopment Chapter3 ValueandSpending...

Mesothelioma , The Patient Education Institute, Inc. ocft0101 Last reviewed: 03/21/2013 1

Transcription:

PharmaMar announces new advances in oncology at ASCO 2015 for its compounds YONDELIS and PM1183 in small cell lung cancer, soft tissue sarcoma, and mesothelioma Compelling clinical activity of PM1183 in second line, achieving 67% response rate and a progression-free survival of 4.7 months in patients with small cell lung cancer (SCLC), a type of tumor with very limited treatment alternatives Data from an interim analysis from the pivotal Phase 3 trial of YONDELIS in soft tissue sarcoma, SAR-3007, will be presented in an oral presentation Phase 2 data showcase activity of YONDELIS in malignant pleural mesothelioma, a rare form of lung cancer that is largely related to asbestos exposure and for which effective therapies are lacking Madrid, May 14, 2015: PharmaMar announces that it will present several clinical studies to showcase the data obtained in various tumor types, including SCLC, soft tissue sarcoma and mesothelioma during the 51 st American Society of Clinical Oncology meeting in Chicago (ASCO; May 29-June 2). Abstracts have been selected for oral presentation, poster discussion session and general poster presentation. The studies presented by the Company will include the first-in-class drug YONDELIS (trabectedin), and the second-generation of this class, PM1183 (lurbinectedin). PM1183 is an inhibitor of the transcriptional machinery and a DNA repair complex, which have proven to be crucial in different tumor types, including SCLC, soft tissue sarcoma and ovarian cancer. In addition, these drugs have been shown to have an effect on the tumor microenvironment by targeting tumorassociated macrophages, which is relevant for cancers such as mesothelioma and ovarian cancer, in which chronic inflammation seems to be a hallmark of the disease. PharmaMar continues to advance cancer care through the development of innovative anticancer drugs that target tumors in a way that no one is doing. We are identifying new ways to tackle the root of the disease, and our new class of drugs shows efficacy even in difficult-to-treat tumors, such as small cell lung cancer, mesothelioma and soft tissue sarcoma, says Nadia Badri, MD, VP Medical Affairs, PharmaMar. The events that will take place this year are crucial for PharmaMar as we move forward in the oncology arena, and this forum is the 1

perfect scenario to feature our clinical programs Meeting abstracts are available at http://abstracts.asco.org/ Studies highlighted at ASCO 2015 YONDELIS (trabectedin) Interim data for trabectedin in soft tissue sarcoma, as well as clinical results in mesothelioma will be presented in 4 studies in oral and poster presentations. SAR-3007: A Randomized Phase 3 Study of Trabectedin (T) or Dacarbazine (D) for the treatment of patients (pts) with Advanced Liposarcoma (LPS) or Leiomyosarcoma (LMS). (Abstract 10503) sponsored by Janssen Products Oral Abstract Session: Sarcoma Presentations (3:00 PM - 6:00 PM). Monday, Jun 1 at 4:00 PM - 4:12 PM at S504 Lead Author: George Demetri, MD et al. Dana-Farber Cancer Institute, Boston, MA, USA. OVC-3006: A Phase 3 Study of Trabectedin (T) plus Pegylated Liposomal Doxorubicin (PLD) versus PLD for Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer. (Abstract TPS5606) sponsored by Janssen Products General Poster Session: Gynecologic Cancer. Saturday, May 30 from 1:15 PM - 4:45 PM at S Hall A Poster Board 163b Lead Author: Robert L. Coleman, MD The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Activity and Safety of Trabectedin in Patients with Sarcomatoid/Biphasic Malignant Pleural Mesothelioma. (MPM) (Abstract 7561) sponsored by the Mario Negri Institute for Pharmacological Research General Poster Session: Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers. Monday, June 1 from 8:00 AM to 11:30 AM at S Hall A Poster Board 309 Lead Author: Diego Luigi Cortinovis, MD Università degli Studi di Milano- 2

Bicocca, Monza, Italy. Time to secondary resistance (TTSR) after rechallenge with trabectedin (T) in myxoid round cell liposarcoma (MRCLPS) patients. (Abstract #10566) General Poster Session: Sarcoma. Sunday, May 31 from 8:00 AM to 11:30 AM at S Hall A Poster Board 210 Lead Author: Roberta Sanfilippo, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy. PM1183 (lurbinectedin) Two PharmaMar-sponsored studies will be featured at ASCO. Data from the clinical trial of PM1183 in SCLC will be further highlighted at a Poster Discussion Session that will be followed by time for networking with panelists. Lurbinectedin (PM01183) with doxorubicin (DOX), an active treatment as second-line therapy in small cell lung cancer (SCLC). (Abstract #7509) General Poster Session: Lung Cancer-Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers. Monday, June 1 from 8:00 AM to 11:30 AM at S Hall A Poster Board 256 This poster will be discussed at the Poster Discussion Session on Monday, June 1 from 1:15 PM - 2:30 PM at E Hall D2 Lead Author: Martin Forster, MD University College Hospital, London, UK. A multicenter phase II basket clinical trial of lurbinectedin (PM01183) in selected advanced solid tumors. (Abstract #TPS2604) General Poster Session: Trial in progress - developmental Therapeutics- Clinical Pharmacology and Experimental Therapeutics. Saturday, May 30 from 8:00 AM to 11:30 AM at Poster Board 318b Lead Author: Mariano Provencio Pulla, MD PhD Hospital Universitario Puerta de Hierro, Madrid, Spain. About YONDELIS (trabectedin) YONDELIS (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. It is approved in 80 countries in North America, Europe, South America and 3

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). 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 an investigational drug from the class of inhibitors of the enzyme RNA polymerase II, which is crucially involved in transcription. By targeting transcription, the drug inhibits the expression of factors important for tumor progression, and impairs the DNA repair system called NER, thereby enhancing tumor cell killing. PM1183 (lurbinectedin) is currently being investigated in different tumor types, including a Phase 3 study for platinum-resistant ovarian cancer, a Phase 2 study for BRCA1/2-associated metastatic breast cancer and a Phase 1b study for small cell lung cancer. About PharmaMar Headquartered in Madrid, PharmaMar is the world-leading biopharmaceutical company in advancing cancer care through the discovery and development of innovative marine-derived anticancer drugs. The company has a rich pipeline of drug candidates and a robust R&D oncology program. YONDELIS is the first anticancer drug of marine origin and is commercially available in 81 countries for the treatment of advanced soft tissue sarcomas as a single-agent, and for relapsed platinum-sensitive ovarian cancer in combination with DOXIL /CAELYX. PharmaMar develops and commercializes YONDELIS in Europe and has three clinical-stage programs under development for several types of solid and hematological cancers, PM1183, plitidepsin, and PM60184. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland and the United States. To learn more about PharmaMar, please visit us at www.pharmamar.com. Disclaimer This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company. Media Inquiries: Carolina Pola Communications Director Sara García Media Relations Phone: +34 91 444 45 00 Mobile: +34 608 93 36 77 Investor Relations: Phone: +34 914444500 Or please visit our website at www.pharmamar.com and www.zeltia.com 4

5