China National Medical Products Administration grants approval of Roche?s Tecentriq in combination with chemotherapy as first-line treatment of people with extensive-stage small cell lung can
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
- This marks the first approval for a Tecentriq-based therapy in China, less than a year after the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals in this indication
- Tecentriq with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy combination approved for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
- The combination significantly improved overall survival (OS) and progression-free survival (PFS) for the first time in over 20 years
- Tecentriq in combination with carboplatin and etoposide (Arm A), or
- Placebo in combination with carboplatin and etoposide (Arm B, control arm
- Tecentriq in combination with chemotherapy helped people live significantly longer, compared with chemotherapy alone (OS=12.3 versus 10.3 months; HR=0.70, 95% CI: 0.54?0.91, p=0.0069) in the ITT population.
- The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared with chemotherapy alone (median PFS=5.2 versus 4.3 months; HR=0.77; 95% CI: 0.62?0.96, p=0.017).
- Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.
- Grade 3?4 treatment-related adverse events occurred in 56.6% of people receiving Tecentriq plus chemotherapy, compared with 56.1% of people receiving chemotherapy alone. The most common adverse reactions (=10%) in people receiving Tecentriq plus chemotherapy were low white blood cell count (neutropenia; 23%), anaemia (14%), decreased neutrophil count (14%) and thrombocytopenia (10%).