By Fineline Cube 
Roche (SWX: ROG, OTCMKTS: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved the PD‑L1 antibody Tecentriq (atezolizumab) and its hyaluronidase‑conjugated version, Tecentriq Hybreza, in combination with the chemotherapeutic lurbinectedin (Zepzelca) for maintenance therapy of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC) who remain progression‑free after first‑line induction with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide (CE).
First‑In‑Class Maintenance Regimen for a High‑Risk Disease
This FDA decision marks the first and only approved combination therapy for first‑line maintenance treatment of ES‑SCLC—a disease historically limited by short survival and few therapeutic options. The pivotal Phase 3 IMforte study underpins the approval, demonstrating that the Tecentriq‑lurbinectedin regimen reduced the risk of disease progression or death by 46 % and the risk of death by 27 % versus Tecentriq maintenance alone.
Key Efficacy Milestones
After 3.2 months of induction therapy, median overall survival (OS) for the Tecentriq‑plus‑lurbinectedin cohort was 13.2 months compared with 10.6 months for Tecentriq alone. Independent‑assessment median progression‑free survival (PFS) reached 5.4 months versus 2.1 months, respectively. Safety profiles remained consistent with the known characteristics of both Tecentriq and lurbinectedin, reinforcing the regimen’s clinical viability.
Market Implications
Roche’s approval expands its portfolio in the rapidly evolving lung‑cancer landscape, positioning the company to capture a larger share of the maintenance‑therapy market for ES‑SCLC. The combination therapy’s superior efficacy metrics may translate into a competitive advantage as oncologists seek durable disease control for high‑grade SCLC patients.-Fineline Info & Tech