Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted approval for Zepzelca®? (lurbinectedin) in combination with atezolizumab (Tecentriq®?) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza®?) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with ateolizumab, carboplatin and etoposide.1 The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a fast-growing and aggressive cancer with limited treatment options. The National Comprehensive Cancer Network®?
(NCCN®?) updated the NCCN Clinical Practice Guidelines in Oncology®? (NCCN Guidelines®?) for SCLC to include the Zepzelca and atezolizumab combination as a preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizUMab reduction. The FDA approval is based on results from the Phase 3 IMforte trial (NCT05091567), which showed that the Zepzelca andAtezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone.
Following four cycles of induction therapy, from the point of randomization the median overall survival (OS) for the Zepzelca and Atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57-0.95; p=0.0174). People with a family history of lung cancer may also be at a higher risk, too.4 SCLC is the most aggressive form of lung cancer and it tends to spread quickly to other parts of the body including the brain, liver and bone.5,6 A large percentage of SCLC patients on treatment shortly achieve a response, although the cancer often returns and is usually more aggressive and resistant to regimens that were previously effective.
