Genentech, part of the Roche Group, announced that the U.S. Food and Drug Administration has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab with hyaluronidase-tqjs) combined with lurbinectedin (Zepzelca) as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not worsened following first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin, and etoposide. This approval represents the first combination therapy authorized specifically for first-line maintenance in ES-SCLC, a form of cancer known for its aggressive nature and limited treatment options. The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology have updated their recommendations to include this regimen as a preferred and category 2A option for maintenance after induction therapy involving Tecentriq and chemotherapy.
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Dr. Roy Herbst, Deputy Director and Chief of Medical Oncology and Hematology at Yale Cancer Center and Smilow Cancer Hospital, acknowledged the uncertainty patients and families face after initial treatment due to the high chance of relapse. He described the combination of Tecentriq and Zepzelca as an important new option that proactively improves progression-free and overall survival in patients who have not progressed after standard induction therapy. Dr. Herbst suggested that this approval could transform the way this difficult cancer is managed, providing clinicians with a tool to delay progression and extend patient survival.
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Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, emphasized that the combination reduced the risk of disease progression or death by almost 50 percent. He expressed pride in delivering this advancement to the small cell lung cancer community alongside Jazz Pharmaceuticals and highlighted the company’s ongoing commitment to improving outcomes for hard-to-treat cancers.
The FDA decision was based on results from the Phase III IMforte clinical trial, which demonstrated that adding lurbinectedin to Tecentriq lowered the risk of disease progression or death by 46 percent and decreased the risk of death by 27 percent compared to Tecentriq maintenance alone. After a median of 3.2 months of induction therapy, overall survival reached 13.2 months with the combination versus 10.6 months with Tecentriq by itself. Progression-free survival assessed independently was 5.4 months compared to 2.1 months, showing significant improvement. The safety profile observed was consistent with known effects of both drugs.
This approval builds on Tecentriq’s existing role in treating ES-SCLC. In 2019, the FDA first approved Tecentriq with chemotherapy for frontline ES-SCLC treatment based on the IMpower133 study. That approval was the first new treatment option for this disease in over twenty years.
The NCCN guidelines include a disclaimer noting they make no warranties about their content or how it is applied and are not responsible for its use.
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