Roche has announced that the US Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).
The approval is based on positive results from the phase 3, open-label IMForte study, sponsored by Roche and co-funded by Jazz Pharmaceuticals. The trial demonstrated that, compared with Tecentriq monotherapy, the combination reduced the overall risk of death by 27% and the risk of disease progression or death by 46%. Median progression-free survival was 5.4 months with the combination vs 2.1 months with Tecentriq alone.
Following the FDA decision, Tecentriq is now available as a maintenance treatment for adults with ES-SCLC whose disease has not progressed after first-line induction therapy with either Tecentriq or carboplatin plus etoposide (CE). This marks the first and only approved combination regimen for this indication.
“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. “This advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals…reflects our abiding commitment to improving outcomes in the hardest-to-treat cancers.”
Tecentriq, in combination with chemotherapy, received FDA approval in 2019 as the first-line treatment for adults with ES-SCLC – the first new therapy for the disease in two decades. The US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology have now been updated to include the Tecentriq and lurbinectedin combination as a preferred option for patients.