PharmaMar will present at ESGO new data on Yondelis® for gynecological cancers
  • PharmaMar will present a study on the efficacy of Yondelis® in women with ovarian cancer at the European Society of Gynecological Oncology (ESGO) congress

  • PharmaMar will organize a satellite symposium in which there will be a debate on whether quality of life of ovarian cancer patients is a key factor in the taking of decisions

Madrid, November 3rd, 2017.- PharmaMar (MSE:PHM) will announce the data obtained from a Phase IV clinical trial of its antitumor compound of marine origin, Yondelis®, during the European Society of Gynecological Oncology Congress (ESGO), that will be held from the 4th to the 7th of November in Vienna.

The Company will present abstract number#206 entitled "An observational, multicenter, prospective study of trabectedin plus PLD in patients with platinum- sensitive recurrent ovarian cancer (PSROC)", where the results will be presented of a prospective Phase IV (post approval) trial that evaluated the use of Yondelis® combined with pegylated liposomal doxorubicin (PLD) to assess Yondelis´ safety and the efficacy when it is administered to women with platinum sensitive ovarian cancer (OVA-YOND). In this study, the Company observed that patients who received trabectedin plus PLD achieved a meaningful clinical benefit and with a manageable safety profile. In this trial, we observed a median progression free survival (PFS) of 6.3 months and a median overall survival of 16.4 months among treated patients.

During this meeting, results from other Investigator Initiated Studies (IIS) or Investigator Sponsored Trial (IST), including a phase II trial of bevacizumab and trabectedin with or without carboplatin in partially platinum sensitive ovarian cancer will be presented. In this abstract, it was observed that the combination of both compounds resulted was highly effective in patients that have relapsed between 6 and 12 months after receiving platinum in first or second line. Results on safety and efficacy will be presented.

The clinical case of a patient with refractory uterine leiomyosarcoma that received

60 cycles of trabectedin permitting a reduction in tumor size that, along with a good response to trabectedin and also to surgery allowed for a prolonged control of the illness.

The first results from a survey on diagnosis and treatment of gynecological sarcomas (REGSA in Germany) which was started by various German research groups (NOGGO-AGO-ARO) for the collection of data on these types of tumors will be published.

As Dr Nadia Badri, Medical Affairs VP of PharmaMar´s Oncology Business Unit, said "we are proud to be present at this congress and to be able to share our progress with the medical community, so that it can serve as a response to the necessities of the patients that suffer from this type of gynecological tumor".

PharmaMar will also host a satellite symposium on "The key role of quality of life in the long-distance race of ovarian cancer" on Saturday, the 4th of November at 1

  1. CET at the Austria Centre, Vienna, where a debate on whether quality of life in the treatment of ovarian cancer patients is sufficiently being taken into account, through a review of the available scientific evidences and the discussion of three practical cases.

    Main studies in which trabectedin will be involved at ESGO2017:
    • An observational, multicenter, open-label study of trabectedin/PLD for the treatment of patients with platinum-sensitive recurrent ovarian cancer (#206)

      E-poster: 04.11.2017, 08:30 - 18:00 h (Ovarian Cancer). Poster:

      06.11.2017, 08:30 - 18:00 h (Ovarian Cancer II)

      Lead autor: Dr. Reichert et al. Oncology department at Westerstede, Germany.

    • Randomized, non-comparative, phase II trial of bevacicumab and trabectidin with or without carboplatin in platinum partially- sensitive recurring ovarian cancer women (IRFMN-OVA-5252 study) (#174)

      E-poster: 04.11.2017, 08:30 - 18:00 (Ovarian Cancer). Poster: 05.11.2017,

      08:30 - 18:00 (Ovarian Cancer II)

      Lead author: Dra. Nicoletta Colombo et al. Gynecological oncology at the European Oncology Institute in Milan, Italy

    • First results of the German prospective registry for gynecologial sarcomas (REGSA). A collaboration of NOGGO e.V., AGO Study Group, AGO Kommission Ovar, AGO Kommission Uterus and ARO (#145)

      E-poster: 04.11.2017, 08:30 - 18:00 (Miscellaneous) Poster: 05.11.2017,

      08:30 - 18:00 (Miscellaneous) Lead autor: Dr. L. Eckes, Germany

    • Very prolonged response to trabectedin and surgical management in refractory uterine leiomysarcoma: a case report (#EP06)

E-poster: 04.11.2017, 08:30 - 18:00 (Miscellaneous)

Lead author: Dra. Vanda Salutari et al. Gynecological Oncology Unit at the Largo Agostino Gemelli, Rome, Italy

The detailed scientific programme, with more than 70 sessions and more than 130 speakers from around the world is available at http://cmoffice.kenes.com/ka/esgo17scpr.html

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 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 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, 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 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 Contact:

Alfonso Ortín - Communications Director aortin@pharmamar.com Mobile: + 34609493127

Paula Fernández - Media Relations Manager pfalarcon@pharmamar.com Mobile: +34 638796215 Phone: +34 918466000

Investor Relations:

Phone: +34 914444500

Or please visit our website at www.pharmamar.com

Pharma Mar SA published this content on 03 November 2017 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 03 November 2017 08:18:03 UTC.

Original documenthttps://www.pharmamar.com/2017/11/03/pharmamar-will-present-at-esgo-new-data-on-yondelis-for-gynecological-cancers/

Public permalinkhttp://www.publicnow.com/view/B6A9AD9F54ABE503D04757DFAF4184EB4EEB5272