Roche unveiled that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
This approval holds the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, a highly aggressive disease for which treatment options have been limited. The U.S. National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) have been updated to include the regimen as a category 2A and preferred option for maintenance treatment of people with ES-SCLC, following induction therapy with Tecentriq and CE.
The approval is based on the Phase III IMforte study, which demonstrated that this combination reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone. Median overall survival was 13.2 months for the combination therapy versus 10.6 months for Tecentriq alone, and median progression-free survival was 5.4 months versus 2.1 months, respectively.
Executive Statement
According to Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and haematology at Yale Cancer Center and Smilow Cancer Hospital, for people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse. The Tecentriq and Zepzelca combination provides a new option and a proactive approach in this setting shown to improve progression-free and overall survival in patients who haven't progressed after standard induction treatment with Tecentriq and chemotherapy. The approval may lead to a meaningful shift in how we manage this challenging disease and give them a new tool to help to delay disease progression and extend survival.
