FDA Approves Roche’s Tecentriq and Lurbinectedin Combo as First Maintenance Therapy for Advanced Small Cell Lung Cancer

Roche has announced that the U.S. Food and Drug Administration (FDA) has approved the combination of Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) with lurbinectedin (Zepzelca®) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following first-line induction therapy with Tecentriq and chemotherapy.

This marks the first and only FDA-approved combination therapy for maintenance treatment in ES-SCLC, offering a new approach for a highly aggressive cancer with historically limited treatment options.

“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 Dr. Roy Herbst, Deputy Director at Yale Cancer Center. “This combination provides a proactive option that improves both progression-free and overall survival, and may shift how we manage this difficult disease.”

The approval is based on the Phase III IMforte trial, which demonstrated that the Tecentriq-lurbinectedin combination reduced the risk of disease progression or death by 46%, and the risk of death by 27%, compared to Tecentriq alone. Median progression-free survival was 5.4 months versus 2.1 months, and median overall survival was 13.2 months compared to 10.6 months with Tecentriq monotherapy. Safety findings were consistent with previously known profiles for both drugs.

“This approval reflects our commitment to addressing the most difficult-to-treat cancers,” said Levi Garraway, Chief Medical Officer at Roche. “By combining Tecentriq with lurbinectedin, we’re helping to extend survival for patients who previously had few options after induction therapy.”

The National Comprehensive Cancer Network (NCCN) has updated its guidelines to include the regimen as a Category 2A, preferred option for maintenance treatment following induction with Tecentriq and carboplatin-etoposide chemotherapy.

This approval builds on Tecentriq’s role in ES-SCLC treatment. In 2019, it became the first immunotherapy approved for first-line use in this cancer in two decades, based on results from the IMpower133 trial.

Roche developed Tecentriq in partnership with Jazz Pharmaceuticals, which markets lurbinectedin. The newly approved combination could reshape the standard of care for a patient group with limited long-term survival prospects.