Roche announced that FDA approved its Tecentriq(atezolizumab) and Tecentriq Hybreza combinations with Lurbinectedin (Zepzelca) for the maintenance treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease hasn’t progressed following first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide.¹ FDA’s 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.¹ The approval builds on Tecentriq’s established role in ES-SCLC, as back in 2019, FDA approved Tecentriq in combination with chemotherapy for the first-line treatment of adults with ES-SCLC. This was based on the IMpower133 study, which at the time was the first new treatment option in two decades for patients diagnosed with ES-SCLC.

“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.”

What is the IMforte Study?

IMforte is a Phase III, open-label, randomized trial evaluating the efficacy and safety of Tecentriq (atezolizumab) plus lurbinectedin, (Zepzelca) compared to Tecentriq alone as a first-line maintenance therapy solution for adults diagnosed with ES-SCLC.¹ The study’s primary endpoints consisted of independent review facility assessed progression-free survival, and overall survival from randomization into the maintenance Phase. Roche and Jazz Pharmaceuticals sponsored the trial as part of both companies’ collaborative effort to get the combination therapy approved. Patients initially received induction therapy with Tecentriq, carboplatin, and etoposide across four 21-day rotations. Patients without disease progression were then randomized one to one, set to receive maintenance therapy of either Tecentriq plus lurbinectedin or just Tecentriq, until disease progression or unacceptable toxicity.¹ The Phase III IMforte study enrolled 660 participants in its induction phase, and randomized 483 participants into its maintenance phase.

What is Tecentriq?

Tecentriq (atezolizumab)is a monoclonal antibody designed to bind with PD-L1 protein which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.¹ Through inhibitions with PD-L1, Tecentriq holds the potential to enable re-activation of T cells, while also having potential to affect normal cells.

Tecentriq is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations and is the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer, SCLC, and hepatocellular carcinoma. Tecentriq is approved in multiple countries around the world in either in combination with targeted therapies and/or chemotherapies, and or as an isolated treatment for the following:

• Various forms of metastatic NSCLC
• Certain types of metastatic urothelial cancer
• PD-L1-positive metastatic triple-negative breast cancer
• BRAF V600 mutation-positive advanced melanoma
• Alveolar soft part sarcoma

Sources

1. FDA approves Roche’s Tecentriq plus lurbinectedin as first-line maintenance therapy for extensive-stage small cell lung cancer Roche October 2, 2025 https://www.roche.com/media/releases/med-cor-2025-10-03b