Picture EBD Group BioPharm America 2021 Digital BPA2021 650x80
Document › Details

PharmaMar S.A.. (3/25/19). "Press Release: PharmaMar Announces Positive Results in Its Lurbinectedin Monotherapy Trial for Small Cell Lung Cancer". Madrid.

Region Region EUR(WEST)+AM(NORTH)
Organisation Organisation PharmaMar S.A. (MSE: PHM)
  Group PharmaMar (Group)
Products Product lurbinectedin (PM1183)
  Product 2 clinical research
Person Person Ortín, Alfonso (PharmaMar 201705 Communications Director)

> 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.

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), ProgressionFree 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.

Legal warning

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

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

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.

Media Contact:

Alfonso Ortín – Communications Director Mobile: +34 609493127
Miguel Martínez-Cava – Digital Communication Manager Mobile: +34 606597464
Phone: +34 918466000
Investor Relations: Phone: +34 914444500

Or please visit our website at

Record changed: 2019-04-16


Picture [iito] Made Without Love 650x80px

More documents for PharmaMar (Group)

To subscribe to our free, monthly newsletter for the European life sciences, please send an e-mail to and simply fill the subject line with the word »LSE Newsletter«

Find more infos about advertising at [iito] web portals in our media flyer [iito] in a Nutshell [PDF file]


Picture [iito] Back into Ad 650x80px

» top