MADRID, June 4, 2018 /PRNewswire/ --
- The phase II basket trial, which began recruiting 15 patients with recurrent small-cell lung cancer, was increased to target enrolment of 100 after obtaining a positive response.
- In a total of 61 patients, an objective response has been observed in 39.3% of them, with a median duration of response of 6.2 months and a median overall survival (OS) of 12 months.
- The primary endpoint of the study is objective response rate (ORR), with other secondary endpoints, including duration of response, progression free survival, overall survival and safety profile.
PharmaMar (MCE: PHM) today announced new data on the recurrent small-cell lung cancer patients cohort of the phase II basket study with lurbinectedin as a single agent, will be presented at the American Society of Clinical Oncology (ASCO) annual meeting, being held from the 1st to the 5th of June in Chicago.
The multicenter, phase II trial is assessing the safety and efficacy of lurbinectedin in different solid tumors. Among these, small-cell lung cancer, recurrent after one chemotherapy prior line, began by recruiting 15 patients, and later increased to 100 after observing 5 responses in the first 15 patients. The primary endpoint of the study is to measure the overall response rate, also evaluating other secondary objectives such as the duration of response, progression free survival, overall survival, along with the safety profile.
PharmaMar will present the results of the 61 evaluated patients out of the 72 patients recruited so far in the abstract titled "Efficacy and safety of lurbinectedin (PM1183, Zepsyre®) in small-cell lung cancer (SCLC): results from a phase 2 study" (abstract#8570). An ORR of 39.3% was seen in these patients.
The median duration of response was 6.2 months and the median overall survival was 12 months.
With respect to the safety profile, the most common adverse event was myelosuppression: 39% of the patients' registered grade 3/4 neutropenia and 9% had febrile neutropenia. No toxic deaths have been recorded.
"The patients included in this study with small-cell lung cancer are responding favorably to the treatment with lurbinectedin as a single agent. We have observed that this molecule is active in this group of patients, however, we look forward to having more information once recruitment has finalized and we can evaluate all the patients", said Dr. Arturo Soto, Director of Clinical Development at the Oncology Business Unit of PharmaMar.
The studies that will be presented during the congress are available at http://abstracts.asco.org
Lurbinectedin is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.
Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has a 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, a 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 http://www.pharmamar.com.
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.
Alfonso Ortín - Communications Director firstname.lastname@example.org , Mobile: +34-609493127
Miguel Martínez-Cava - Digital Communication Manager email@example.com Mobile: +34-606597464, Phone: +34-918466000
Investor Relations: Phone: +34-914444500
Or please visit our website at http://www.pharmamar.com