- PharmaMar will start a pivotal phase 3 trial with platinum-resistant patients to assess efficacy of PM1183 in a larger population in the first half of 2015
- The data show that PM1183 is superior compared to topotecan regarding median overall survival
Madrid, December 4, 2014: Zeltia announces today that its pharmaceutical division PharmaMar has data from a group of 33 randomized patients with platinum-resistant ovarian cancer demonstrating that PM1183 shows a significantly superior median overall survival compared to topotecan. In this multicenter Phase IIb randomized trial, platinum-resistant ovarian patients treated with PM1183 lived longer, with a median overall survival of 18.1 months, compared to topotecan, which only achieves 8.5 months. PharmaMar will launch a pivotal Phase III trial to confirm the efficacy of PM1183 in a larger population, and that is expected to be the final step before registration of PM1183 for platinum-resistant ovarian cancer.
"The pivotal trial planned for next year will hopefully confirm the effects in survival that we observe in these patients, who are in need of drugs that will reduce the risk of death and extend their lives, without posing major side effects", says Arturo Soto, Director of Clinical Development, PharmaMar.
The Phase IIb trial consisted of a first stage, single arm approach to assess efficacy of PM1183 in platinum-resistant ovarian cancer patients, followed by a second stage, in which patients were randomized to be treated with PM01183 or topotecan as control group.
Results presented at the American Society of Clinical Oncology (ASCO) earlier this year showed a significant improvement in the other secondary endpoint, progression-free survival, as well as in the overall response rate, which was the primary endpoint1. The results found now for the overall survival of patients with platinum-resistant ovarian cancer treated with PM1183 add to the clinical benefit, measured as 70% of overall responses and stable disease, previously observed. The manageable safety profile previously described for these patients has not changed.
About ovarian cancer
It is estimated that about 240,000 cases will be diagnosed worldwide and about 150,000 women will die of ovarian cancer. Among gynaecological malignancies, it is the second most common cancer and the one causing more deaths2. Most patients with ovarian cancer have late-stage disease, in which the cancer has spread, at the moment of diagnosis3. Debulking surgery to remove most of the tumor is usually followed by chemotherapy; however, about 80% of women will relapse after treatment with platinum or a taxane4 and they may benefit from other therapeutic alternatives5.
PharmaMar is a biopharmaceutical subsidiary of Grupo Zeltia; it is a world leader in discovering, developing and marketing marine-based drugs to treat cancer. Yondelis® is the first marine-based antitumour drug. PharmaMar has four other compounds in clinical development: Aplidin®, PM01183 and PM060184. PharmaMar also has a rich pipeline of pre-clinical candidates and a major R&D program.
Zeltia S.A. is a world-leading biopharmaceutical company specialized in the development of marine-based drugs for use in oncology. Grupo Zeltia consists mainly of the following companies: PharmaMar, the world-leading biotechnology company in advancing cancer care through the discovery and development of innovative marine-derived medicines; Genómica, Spain's leading company in molecular diagnostics based on DNA analysis; and Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi).
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.
For more information:
PharmaMar: +34 608 93 36 77
Grupo Zeltia: +34 914444500
1. J Clin Oncol 32:5s, 2014 (suppl; abstr 5505)
2. Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.
4. Ann Oncol (2013) 24 (suppl 10):x69-x76.doi: 10.1093/annonc/mdt475