Tecentriq(atezolizumab)
Oncologyยท 1780 cited findingsยท 5 source documents
Company: Roche Holding AG โ
What the regulatory reviews say
Tecentriq (atezolizumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ. The drug received accelerated approval and a Breakthrough Therapy designation in January 2015.
In clinical trials, Tecentriq demonstrated a confirmed objective response rate (ORR) of 14.8% (95% CI: 11.1%, 19.3%) across all patients. The median duration of response (DOR) in responders was not reached. For overall survival, Tecentriq showed a median of 12.6 months compared to 9.7 months for docetaxel, with an overall survival hazard ratio of 0.69. In another study, median overall survival for Tecentriq was 13.8 months versus 9.6 months for docetaxel.
Regarding safety, Grade 3 or 4 adverse events (AEs) occurred in 40.1% of atezolizumab patients, while treatment-related Grade 3 or 4 AEs were 11.3%. Serious adverse events (SAEs) were reported in 35.2% of atezolizumab patients. Grade 5 AEs (deaths) were 4.2% for atezolizumab and 3.7% for docetaxel, with treatment-related Grade 5 AEs at 0.7% for atezolizumab and 2.2% for docetaxel.
Key figures โ cited to the source page
| Confirmed ORR (all patients) | 14.8% | GENENTECH INC โ Tecentriq FDA Summary Review (NDA/BLA 761034, p.4 |
| Median overall survival (months) | 12.6 | GENENTECH INC โ Tecentriq FDA Summary Review (NDA/BLA 761041, p.4 |
| Median overall survival (months) for docetaxel | 9.7 | GENENTECH INC โ Tecentriq FDA Summary Review (NDA/BLA 761041, p.4 |
| Overall survival hazard ratio | 0.69 | GENENTECH INC โ Tecentriq FDA Summary Review (NDA/BLA 761041, p.4 |
| Grade 3 or 4 AEs (atezolizumab) | 40.1% | Roche Holding AG โ Tecentriq EMA EPAR public assessment repo, p.166 |
| Treatment-related Grade 3 or 4 AEs (atezolizumab) | 11.3% | Roche Holding AG โ Tecentriq EMA EPAR public assessment repo, p.166 |
| SAEs (atezolizumab) | 35.2% | Roche Holding AG โ Tecentriq EMA EPAR public assessment repo, p.166 |
| Approval recommendation | accelerated approval | GENENTECH INC โ Tecentriq FDA Summary Review (NDA/BLA 761034, p.4 |
Source documents
- GENENTECH INC โ Tecentriq FDA Review (NDA/BLA 761034, 2021) (2021)
- Roche Holding AG โ Tecentriq EMA EPAR public assessment report (EMEA/H/C/004143, 2017) (2017)
- Roche Holding AG โ Tecentriq EMA EPAR variation assessment report (EMEA/H/C/004143, 2017) (2017)
- GENENTECH INC โ Tecentriq FDA Summary Review (NDA/BLA 761041, 2016) (2016)
- GENENTECH INC โ Tecentriq FDA Summary Review (NDA/BLA 761034, 2016) (2016)
Explore the full evidence
All 1780 cited findings for Tecentriq โ searchable, comparable and answerable in plain language โ are in the Oncology research library โ
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials โ values are not head-to-head comparisons). Educational reference only โ not medical or investment advice.