Roche's Tecentriq cancer drug with Jazz Pharmaceuticals’s lurbinectedin has been cleared to treat patients with extensive-stage small cell lung cancer https://t.co/gasJqJGf25 ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy wit. ...

Core Insights - Roche announced positive results from the Phase III IMforte study of Tecentriq in combination with lurbinectedin for extensive-stage small cell lung cancer, showing a 46% reduction in the risk of disease progression or death and a 27% reduction in the risk of death compared to Tecentriq alone [1][6]. Study Results - The IMforte study demonstrated that the combination therapy significantly extended median overall survival (OS) to 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio (HR) of 0.73 [2][3]. - Median progression-free survival (PFS) was also improved, with 5.4 months for the combination therapy versus 2.1 months for Tecentriq alone, yielding a stratified HR of 0.54 [2][3]. Study Design - The IMforte study was a Phase III, open-label, randomized trial involving 660 patients in the induction phase and 483 patients randomized for maintenance therapy [3][4]. - Patients received four cycles of induction therapy with Tecentriq, carboplatin, and etoposide before being randomized to maintenance therapy [3]. Safety Profile - The safety profile of the combination therapy was consistent with the known safety profiles of both Tecentriq and lurbinectedin, with no new safety signals observed [1][2]. Implications for Treatment - The results from the IMforte study are considered potentially practice-changing, offering a new option for patients with extensive-stage small cell lung cancer, a group with high unmet medical needs [2][6].

Core Insights - Roche announced positive results from the Phase III IMforte study, demonstrating that the combination of Tecentriq and lurbinectedin significantly improves survival outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC) [1][5] - The combination therapy reduced the risk of disease progression or death by 46% and the risk of death by 27% compared to Tecentriq alone [1][5] - The study's findings were presented at the 2025 ASCO Annual Meeting and published in The Lancet, indicating a potential practice-changing option for a disease with high unmet medical needs [1][5] Study Details - The IMforte study is a Phase III, open-label, randomized trial involving 660 patients in the induction phase and 483 patients in the maintenance phase [2] - Patients received induction therapy with Tecentriq, carboplatin, and etoposide for four cycles before being randomized to maintenance therapy with either Tecentriq plus lurbinectedin or Tecentriq alone [2] - The primary endpoints of the study were progression-free survival (PFS) and overall survival (OS) assessed by independent review [2] Treatment Efficacy - The median overall survival for the Tecentriq plus lurbinectedin regimen was 13.2 months compared to 10.6 months for Tecentriq alone, with a stratified hazard ratio of 0.73 [1][2] - Median progression-free survival was 5.4 months for the combination therapy versus 2.1 months for Tecentriq alone, with a stratified hazard ratio of 0.54 [1][2] - No new safety signals were observed, confirming the safety profiles of both Tecentriq and lurbinectedin [1][2] About Tecentriq - Tecentriq is a monoclonal antibody that targets PD-L1, designed to enhance T cell activation against tumors [3] - It is approved for various aggressive cancer types, including small cell lung cancer and hepatocellular carcinoma, and is available in both intravenous and subcutaneous forms [4][6] Roche's Commitment - Roche is a leader in cancer immunotherapy and aims to improve patient outcomes through innovative treatments [7] - The company has a long-standing commitment to sustainability and aims to achieve net zero by 2045 [8]