Public Release: 

Real-life study for YONDELIS® in sarcoma show comparable or better efficacy than clinical trials

Outcomes from 885 patients with soft-tissue sarcoma at 25 French centers were analyzed

Pharmamar

  • The study using 885 patients from the RetrospectYon database suggests that treatment with YONDELIS® (trabectedin) can be optimized when given earlier, as second-line therapy, in patients who are likely to obtain clinical benefit

  • The study reinforces the efficacy of this drug in multiple types of soft-tissue sarcoma and supports that long-term treatment delays disease progression

  • Even in heavily pretreated patients, the efficacy of YONDELIS® (trabectedin) was similar or improved compared to historical controls

Madrid, February 26, 2015 - PharmaMar announced that the European Journal of Cancer published online data from a large retrospective study with soft-tissue sarcoma (STS) patients carried out at 25 French centers confirming that in routine practice YONDELIS® (trabectedin) shows comparable or better clinical outcomes than those observed in clinical trials . The results add to previous evidence from other studies with trabectedin , including the compassionate expanded access program of 1895 patients with incurable disease , demonstrating that response and disease control rates are higher than expected. The authors describe that long-term treatment of multiple types of STS patients without progressive disease delayed progression and improved survival compared to those who stopped it after six cycles, as recently suggested in the T-DIS studyiii. In this routine real-life scenario, the median progression-free survival (PFS) and overall survival (OS) were 4.4 and 12.2 months, respectively after a median follow-up of 22 month. Of the 304 patients who achieved non-progressive disease after six cycles, 227 continued receiving trabectedin and obtained significant superior PFS (11.7 versus 7.6 months) and OS (24.9 versus 16.9 months) than those who did not. The recent study reinforces an approach of early administration of YONDELIS® (trabectedin) to optimize its efficacy as second-line treatment in patients that will probably benefit from this drug. Despite the limitations of the study, the investigators emphasize that this clinical strategy may achieve longer disease control without compromising the safety profile of the treatment, given that a third of the patients received more 6 or more cycles of the drug and were able to tolerate longer treatments.

"Harnessing real-world data from patients who do not progress after finishing 6 cycles, we provide the rationale to strongly consider treating these patients until disease progression given the improvement in survival" says lead investigator Axel Le Cesne, MD, Department of Medicine, Institut Gustave Roussy, France. "This not only further confirms the results of the prospective phase II trial T-DIS, but it also adds value from clinical practice where we find patients with multiple types of soft-tissue sarcoma"

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About Soft Tissue Sarcoma

Soft tissue sarcomas are a rare type of cancer originating in the soft tissues that connect, and support other body structures, such as muscle, fat, and blood vessels, among others . In the U.S., nearly 12,000 people will be diagnosed with STS and approximately 4,870 are expected to die of this cancer in 2015 . Only 16% of patients with disease that has already spread will achieve a 5-year survival.

About PharmaMar

PharmaMar is a world leader in the discovery and development of marine-based anticancer drugs with a rich pipeline of drug candidates and a strong R&D program. PharmaMar, which is headquartered in Madrid, is a subsidiary of Zeltia, S.A., which has been listed on the Spanish Stock Exchange since 1963 (MSE: ZEL) and on Spain's Electronic Market since 1998. 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.

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Le Cesne A. European Journal of Cancer. http://www.ejcancer.com/article/S0959-8049(15)00014-3/abstract

Demetri GD et al. Journal of Clinical Oncology. http://jco.ascopubs.org/content/27/25/4188

Le Cesne A et al. The Lancet Oncology. http://dx.doi.org/10.1016/S1470-2045(15)70031-8

Samuels BL et al. Annals of Oncology. http://annonc.oxfordjournals.org/content/24/6/1703

American Cancer Society. What is a soft tissue sarcoma? Available at: http://www.cancer.org/cancer/sarcoma-adultsofttissuecancer/detailedguide/sarcoma-adult-soft-tissue-cancer-soft-tissue-sarcoma

General information about adult soft tissue sarcoma. Available at:. http://www.cancer.gov/cancertopics/pdq/treatment/adult-soft-tissue-sarcoma/HealthProfessional

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