Roche bags USFDA nod for Tecentriq plus lurbinectedin for extensive-stage small cell lung cancer

This is a 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.

“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 haematology 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 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.”

“The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “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 approval is based on results from the phase III IMforte study, which showed that the Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. Following 3.2 months of induction therapy, the median overall survival (OS) for the Tecentriq plus lurbinectedin regimen was 13.2 months versus 10.6 months for Tecentriq alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival (PFS) by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54; 95% CI: 0.43–0.67; p<0.0001). Safety was generally consistent with the known safety profiles of Tecentriq and lurbinectedin.

The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals.

The approval builds on Tecentriq’s established role in 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 at the time was the first new treatment option in two decades for this patient population.