PharmaMar receives recommendation for the approval from the European Medicines Agency for Zepzelca® (lurbinectedin) for the treatment of extensive-stage small cell lung cancer in combination with the immunotherapy atezolizumab

The recommendation is based on the results of the IMforte Phase 3 trial, which showed a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared to atezolizumab monotherapy. Lurbinectedin has also received positive opinion for designation as orphan drug in small cell lung cancer. In Europe, around 62,000 new cases of small cell lung cancer, the most aggressive type of lung cancer characterized by rapid growth and early spread, are diagnosed each year. PharmaMar (MSE: PHM), has announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Zepzelca® (lurbinectedin) in combination with atezolizumab (Tecentriq®) as first-line maintenance therapy for adult patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after standard induction therapy. The CHMP’s positive opinion is based on data from the Phase 3 IMforte trial, sponsored by Roche in collaboration with Jazz Pharmaceuticals in which the combination of lurbinectedin and atezolizumab was associated with a 46% reduction in the risk of disease progression or death, and a 27% reduction in the risk of death compared with atezolizumab monotherapy. Dr. Luis Paz-Ares, Head of the Medical Oncology Service at the 12 de Octubre University Hospital in Madrid and principal investigator of the IMforte trial, highlights that: “This positive opinion represents a significant step forward in providing patients in Europe with access to an innovative therapy for a disease with a particularly poor prognosis. For the first time in this maintenance context, an improvement in overall survival and progression-free survival has been demonstrated, marking a milestone in the treatment of this disease. For healthcare professionals, this advancement provides a new treatment option to offer our patients.” Luis Mora, Managing Director of PharmaMar, commented: “The CHMP’s positive opinion represents a very important milestone in facilitating access for European patients to a new therapeutic option. It also represents important recognition of our Company’s commitment to research and development of innovative new compounds.” The European Commission will now decide on the marketing authorization in accordance with the established procedure. This combination is currently authorized for first-line maintenance treatment in 10 countries including the US, Switzerland, the United Arab Emirates, Oman, Uruguay, Peru, Paraguay, Ecuador, Israel and Taiwan. Following a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the EMA, lurbinectedin has been approved as an Orphan Medicinal Product for small cell lung cancer. Orphan drug designation is a status granted by the EMA to drugs intended to treat rare or uncommon diseases that affect fewer than 5 people per 10,000 inhabitants in the European Union.  Small cell lung cancer accounts for about 15% of lung cancer cases and is characterized by its aggressive behavior, and an early tendency to spread[i],[ii]. Each year, around 62,000 new cases of SCLC[iii] are diagnosed in Europe,with most patients presenting advanced disease at the time of diagnosis. [i] General information on small cell lung cancer. Small Cell Lung Cancer Treatment (PDQ®) – NCI [ii] Lung Cancer Statistics | How Common Is Lung Cancer? | American Cancer Society [iii] Cancer today. https://gco.iarc.who.int/today/en/fact-sheets-populations#regions

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