The trial met the primary endpoint by both investigator and IRC (Independent Review Committee) assessment.
Trial results will be presented at a future medical meeting.
MADRID, Spain I March 25, 2019 I PharmaMar (PHM:MSE) today announced that its Phase II trial of lurbinectedin as a single agent for the treatment of relapsed small cell lung cancer (SCLC) has achieved its primary endpoint, by both investigator review and IRC (Independent Review Committee).
The primary endpoint of this trial was to measure the Overall Response Rate (ORR), with other secondary endpoints such as Duration of Response (DOR), Progression- Free Survival (PFS), Overall Survival (OS) and safety.
This multicenter, single arm, phase II clinical trial, involving 105 patients from 38 centers in nine different countries in Europe and the US, assessed the safety and efficacy of lurbinectedin in patients with relapsed SCLC.
The results will be submitted for presentation at a major medical meeting.
Around 15% to 20% of lung cancers are small cell, and it is one of the cancer types with the worst prognosis. The treatment of relapsed SCLC has not changed substantially in more than two decades. The last FDA approved new chemical entity in second line small cell lung cancer was topotecan, in 1996
In the lurbinectedin clinical program, the SCLC indication is currently PharmaMar’s first priority. PharmaMar completed the recruitment in July 2018 of its Phase III ATLANTIS study for the treatment of relapsed SCLC. The Company is awaiting results.
Lurbinectedin was designated an Orphan Drug by the FDA in August 2018, and a positive opinion for Orphan Drug Designation by EMA was received in January 2019 for the treatment of SCLC.
About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova Zeltia. To learn more about PharmaMar, please visit us at www.pharmamar.com
About lurbinectedin
Lurbinectedin (PM1183) 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.
SOURCE: PharmaMar
Post Views: 19
The trial met the primary endpoint by both investigator and IRC (Independent Review Committee) assessment.
Trial results will be presented at a future medical meeting.
MADRID, Spain I March 25, 2019 I PharmaMar (PHM:MSE) today announced that its Phase II trial of lurbinectedin as a single agent for the treatment of relapsed small cell lung cancer (SCLC) has achieved its primary endpoint, by both investigator review and IRC (Independent Review Committee).
The primary endpoint of this trial was to measure the Overall Response Rate (ORR), with other secondary endpoints such as Duration of Response (DOR), Progression- Free Survival (PFS), Overall Survival (OS) and safety.
This multicenter, single arm, phase II clinical trial, involving 105 patients from 38 centers in nine different countries in Europe and the US, assessed the safety and efficacy of lurbinectedin in patients with relapsed SCLC.
The results will be submitted for presentation at a major medical meeting.
Around 15% to 20% of lung cancers are small cell, and it is one of the cancer types with the worst prognosis. The treatment of relapsed SCLC has not changed substantially in more than two decades. The last FDA approved new chemical entity in second line small cell lung cancer was topotecan, in 1996
In the lurbinectedin clinical program, the SCLC indication is currently PharmaMar’s first priority. PharmaMar completed the recruitment in July 2018 of its Phase III ATLANTIS study for the treatment of relapsed SCLC. The Company is awaiting results.
Lurbinectedin was designated an Orphan Drug by the FDA in August 2018, and a positive opinion for Orphan Drug Designation by EMA was received in January 2019 for the treatment of SCLC.
About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and a chemical enterprise, Zelnova Zeltia. To learn more about PharmaMar, please visit us at www.pharmamar.com
About lurbinectedin
Lurbinectedin (PM1183) 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.
SOURCE: PharmaMar
Post Views: 19
