Roche Holding AG's (OTC:RHHBY) Phase 3 SKYSCRAPER-02 study in extensive-stage small-cell lung cancer (ES-SCLC) did not meet its co-primary endpoint of progression-free survival.
- The trial evaluated the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) and chemotherapy (carboplatin and etoposide) as an initial or first-line treatment for ES-SCLC.
- The company noted that the co-primary endpoint of overall survival was not met at its interim analysis and is unlikely to reach statistical significance at the planned final analysis.
- Data suggest tiragolumab plus Tecentriq and chemotherapy was well-tolerated, and no new safety signals were identified when adding tiragolumab.
- The company will present the trial data at an upcoming medical meeting.
- ES-SCLC is a hard-to-treat disease, and Tecentriq plus chemotherapy remains a standard of care. Tecentriq was the first cancer immunotherapy to show a survival benefit in ES-SCLC (phase III IMpower133 study) and was the first approved treatment option in 20 years.
- Tiragolumab was granted FDA Breakthrough Therapy Designation in 2021 for the initial treatment of PD-L1-high metastatic non-small cell lung cancer, based on the phase II CITYSCAPE study results.
- The Phase 3 SKYSCRAPER-01 trial is currently ongoing to confirm the CITYSCAPE results.
- Price Action: RHHBY shares are down 0.06% at $50.12 during the market session on the last check Wednesday.
