Public Release: 

Study in Lancet Oncology sheds light on YONDELIS prolonged therapy in soft-tissue sarcoma

Pharmamar

PharmaMar announces that data in The Lancet Oncology recommend continuation of YONDELIS® (trabectedin) for advanced soft-tissue sarcoma patients who have not progressed after six courses of treatment

  • Continued therapy with trabectedin in these patients significantly improved progression-free survival (PFS) compared to treatment interruption

  • The results suggest not including a drug holiday in patients with advanced soft-tissue sarcoma (STS) who benefit from trabectedin in terms of tumor control after six cycles of treatment

  • The safety profile was the same in both groups and as expected for patients treated with trabectedin

Madrid, February 12, 2015 PharmaMar announced that The Lancet Oncology published online the results from a final analysis of a randomized phase 2 trial study which found that treatment continuation with trabectedin in advanced STS patients who have not progressed after six cycles of treatment increases PFS (NCT01303096 clinical trials.gov) . The data indicate that continued treatment may be recommended for these patients, who received doxorubicin-based chemotherapy and are eligible for trabectedin, until treatment intolerance or disease given the acceptable and manageable safety profile and lack of cumulative toxicity of trabectedin .

"In the clinic, whether trabectedin should be given after six cycles in patients with advanced soft-tissue sarcoma who have not progressed during treatment was not clear, and the results of our study supports the maintenance of this therapy to achieve longer progression-free survival", points outt lead investigator of the clinical study Nicolas Penel, MD, PhD, Department of Medical Oncology, Centre Oscar Lambret, France.

The study carried out at 14 centers of the French Sarcoma Group included 178 patients with advanced STS who were treated with six cycles of trabectedin (given at a dose of 1.5 mg/m2 for 24 hours every 3 weeks). Of the 91 patients who were free of progression at the end of the treatment, 53 were then randomly assigned to continuously receive trabectedin or to drug interruption (although patients allocated to this group were allowed to restart trabectedin in case of progressive disease). The first clinical endpoint of the study was PFS after 6 months of the randomization, which was achieved by 51.9% of the patients in the continuation group versus 23.1% in the interruption group. When the PFS was measured at 12 months after randomization, a greater portion of patients in the continuation group were also progression-free compared to those who were not receiving trabectedin (33.3% versus 15.4%). This improvement in survival without progression was also supported by an increased in the median PFS, which was 7.2 months (95% CI 4.0-12.7) in the continuation group and 4.0 months (95% CI 2.5-5.5) in the interruption group.

The study also showed how continuation of treatment with trabectedin in these patients was not associated with an increase in toxicity, suggesting that the safety profile of trabectedin is maintained after more than six cycles of treatment, and that this is accompanied by an improved PFS. Patients in the continuation group received a median of 11 cycles of trabectedin in total at the cutoff date, and two patients are still on treatment.

Although the study has its limitations as it was a non-comparative phase 2 trial, the investigators underscore that more than half of the patients in this setting treated with trabectedin were free of progression after six cycles of treatment and that early interruption of the drug results in worse PFS. This study adds to the results obtained in two randomized phase 2 trials in patients with several different subtypes of STS , indicating the value of trabectedin treatment in terms of progression-free survival, and sheds light on the role of maintenance therapy in patients who benefit from trabectedin after six cycles of treatment.

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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 2015iv. Only 16% of patients with disease that has already spread will achieve a 5-year survival. Leiomyosarcoma is an aggressive type of soft tissue sarcoma that occurs in smooth muscles, such as those in the uterus, gastrointestinal tract or lining of blood vessels. Liposarcoma originates in fat cells and most commonly occurs in the thigh and abdominal cavity, though it can occur in fat cells in any part of the bodyv.

About PharmaMar and YONDELIS® (trabectedin)

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. YONDELIS® (trabectedin) is a new, multimodal, synthetically produced anti-cancer agent, and originally derived from the sea squirt. The drug prevents tumor progression through different mechanisms of action, including DNA binding to block its replication, inhibition of activated transcription and proteins involved in DNA repair, and the modulation of the tumor microenvironment. PharmaMar develops and commercializes YONDELIS® (trabectedin) in Europe, and has granted a license to Janssen Research & Development and Taiho Pharmaceutical to develop and sell the drug globally and Japan, respectively.

Disclaimer

PharmaMar, which is headquartered in Madrid (Spain), is a subsidiary of Zeltia, S.A. (Spanish stock exchange: ZEL), which has been listed on the Spanish Stock Exchange since 1963 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.

PharmaMar Media Relations:

Carolina Pola
Phone: +34 91 846 6108
Mobile: +34 608 93 36 77
Or please visit our website at http://www.pharmamar.com and http://www.zeltia.com

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

George Demetri et al. J Clin Oncol 2009; 27: 4188-96. http://jco.ascopubs.org/content/27/25/4188.long

Shunji Takahashi et al. http://meetinglibrary.asco.org/content/132813-144

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

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

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