SOUTH SAN FRANCISCO, Calif.– Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced 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) whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin, and etoposide (CE).
This marks the first and only FDA-approved combination therapy for first-line maintenance treatment of ES-SCLC, a highly aggressive cancer with limited treatment options and a high rate of relapse. The regimen has been added as a category 2A, preferred maintenance option in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®).
“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,” said Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and hematology at Yale Cancer Center and Smilow Cancer Hospital. “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. This approval may meaningfully shift how we manage this disease and offers a new tool to delay progression and extend survival.”
The approval is supported by data from the pivotal Phase III IMforte study, which demonstrated that the Tecentriq plus lurbinectedin regimen reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq maintenance alone. Median overall survival was 13.2 months versus 10.6 months (HR=0.73; 95% CI: 0.57–0.95; p=0.0174), and median progression-free survival was 5.4 months versus 2.1 months (HR=0.54; 95% CI: 0.43–0.67; p<0.0001). Safety findings were generally consistent with the known profiles of both Tecentriq and lurbinectedin.
“The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development at Genentech. “We are proud to deliver this advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals, reinforcing our commitment to improving outcomes in the most difficult-to-treat cancers.”
This approval builds on Tecentriq’s established role in ES-SCLC. In 2019, Tecentriq in combination with chemotherapy became the first new treatment in two decades for the disease, following FDA approval based on the IMpower133 study.
