Swedish pharmaceutical company Immedica Pharma AB, backed by investment firms KKR & Co. Inc. (NYSE: KKR) and Impilo, announced on Thursday that its partner, Spanish biopharmaceutical company PharmaMar, has secured MHRA approval for Zepzelca (lurbinectedin) combined with atezolizumab as first-line maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after induction therapy.
Lurbinectedin is a selective inhibitor of oncogenic transcription derived from a marine compound and targets transcriptional addiction in tumour cells and tumour-associated macrophages.
The decision is supported by Phase 3 IMforte trial data which found that the combination reduced the risk of disease progression or death by 46% and the risk of death by 27% versus atezolizumab alone. Median overall survival was 13.2 months compared with 10.6 months (HR=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival was 5.4 months versus 2.1 months (HR=0.54; 95% CI: 0.43–0.67; p
MHRA approves Zepzelca and atezolizumab as first-line maintenance therapy for ES-SCLC in the UK
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