FDA Clears Roche’s Immunotherapy Tecentriq With Lurbinectedin For First-Line Maintenance In Patients With Extensive-Stage Small Cell Lung Cancer

Roche 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 following first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin, and etoposide.

This approval represents the first and only combination therapy available for the first-line maintenance treatment of ES-SCLC, a highly aggressive form of lung cancer with historically limited treatment options. The U.S. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) have also been updated to list the regimen as a category 2A and preferred option for the maintenance treatment of patients with ES-SCLC who have completed induction therapy with Tecentriq and chemotherapy.

Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and haematology at Yale Cancer Center and Smilow Cancer Hospital, stated, “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 gives us a new tool to help to delay disease progression and extend survival.”

Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, mentioned, “The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half. We are proud to deliver this advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals, as it reflects our abiding commitment to improving outcomes in the hardest-to-treat cancers.”

The FDA’s decision is supported by results from the phase III IMforte study. The trial demonstrated that combining Tecentriq and lurbinectedin significantly improved outcomes compared to Tecentriq alone. The combination reduced the risk of disease progression or death by 46 percent and lowered the risk of death by 27 percent. After 3.2 months of induction therapy, the median overall survival with the Tecentriq and lurbinectedin regimen was 13.2 months, compared with 10.6 months for Tecentriq alone. 

Median progression-free survival, as assessed independently, was 5.4 months with the combination versus 2.1 months with Tecentriq monotherapy. The safety profile observed in the study was generally consistent with the established safety profiles of both Tecentriq and lurbinectedin.

This milestone builds upon the role of Tecentriq in the treatment of ES-SCLC. In 2019, the FDA approved Tecentriq in combination with chemotherapy for the first-line treatment of adults with ES-SCLC based on the IMpower133 study, which was the first new advance in treatment for this patient population in over two decades.