Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554.
Prescribing Information
TECENTRIQ®▼(atezolizumab) Great Britain
TECENTRIQ®▼ (atezolizumab) Northern Ireland
TECENTRIQ provides an extra first-line treatment option for patients with metastatic NSCLC and high PD-L1 expression.2–4 Compared with platinum-based chemotherapy, it can give patients the chance of:
Physicians should note that, before demonstrating a long-term survival benefit with atezolizumab, a higher proportion of patients on atezolizumab (16/107) died within 2.5 months of study randomisation, compared with 10/98 in the chemotherapy arm and as such, physicians should consider the delayed onset of atezolizumab effect before initiating first-line treatment as monotherapy in patients with NSCLC3,4
-
IMpower110 study design
- IMpower110 was a randomised, open-label, multicentre, phase III trial which assessed the efficacy and safety of TECENTRIQ compared with platinum-based chemotherapy in patients with metastatic NSCLC whose disease was
PD-L1 positive and was not EGFR-mutant or ALK-positive, and who had not previously received chemotherapy1,6
Primary endpoint1
- OS in patients without EGFR mutations or ALK translocations
- OS was tested hierarchically:
- TC3 or IC3 population (PD-L1 expression on ≥50% of tumour cells or ≥10% of tumour-infiltrating immune cells)
- TC2/3 or IC2/3 population (PD-L1 expression on ≥5% of tumour cells or tumour-infiltrating immune cells)
- TC1/2/3 or IC1/2/3 population (PD-L1 expression on ≥1% of tumour cells or tumour-infiltrating immune cells)
Key secondary endpoints1
- Investigator-assessed PFS according to RECIST, v1.1
- ORR
- DoR
- OS and investigator-assessed PFS according to RECIST, version 1.1 in prespecified subgroups with respect to PD-L1 expression (defined by the SP263 immunohistochemical assay) and blood-based tumour mutational burden
- Safety (assessed in all treated patients regardless of PD-L1 expression, EGFR or ALK status)
- IMpower110 was a randomised, open-label, multicentre, phase III trial which assessed the efficacy and safety of TECENTRIQ compared with platinum-based chemotherapy in patients with metastatic NSCLC whose disease was
-
Baseline characteristics
- Baseline characteristics were generally balanced between treatment groups1
*The TC1/2/3 or IC1/2/3 population was defined as patients with PD-L1 expression on ≥1% of tumour cells or tumour-infiltrating immune cells. The TC3 or IC3 population was defined as patients with PD-L1 expression on ≥50% of tumour cells or ≥10% of tumour-infiltrating immune cells. Both population are comprised of patients who did not have EGFR-mutant or ALK-positive disease.
†Race was reported by the patients. One patient in the TECENTRIQ TC1/2/3 or IC1/2/3 population was categorised as having multiple races (not shown).
Adapted from Herbst1
Median OS - primary endpoint. TC or IC 3 population4
15.7 months’ median follow-up (range 0–35 months).
Adapted from Herbst1
Physicians should note that, before demonstrating a long-term survival benefit with atezolizumab, a higher proportion of patients on atezolizumab (16/107) died within 2.5 months of study randomisation, compared with 10/98 in the chemotherapy arm and as such, physicians should consider the delayed onset of atezolizumab effect before initiating first-line treatment as monotherapy in patients with NSCLC3,4
In the TC/IC 3 population, 64.9% of patients treated with Tecentriq lived for at least 1-year6
15.7 months’ median follow-up (range 0–35 months).
Adapted from Herbst1 and Data on File M-GB-000033646
- The 18-month OS rate was 54.6% (95% CI: 43.4–65.7) with TECENTRIQ vs 27.3% (95% CI: 15.5–39.1) with chemotherapy5
- In the IMpower 110 trial, treatment with TECENTRIQ could continue after disease progression in patients who had a continued clinical benefit4
-
For the TC/IC3 population, PFS was 8.1 months with TECENTRIQ compared with 5.0 months with platinum-based chemotherapy¹
Median PFS – secondary endpoint1
15.7 months’ median follow-up (range 0–35 months).
Adapted from Herbst1
In the TC/IC3 population, 36.9% of patients treated with Tecentriq lived for at least 1 year without disease progression5
Landmark PFS1
15.7 months’ median follow-up (range 0–35 months).
Adapted from Herbst1
-
ORR and DoR – secondary endpoints¹
In the TC/IC3 population, TECENTRIQ achieved an objective response rate in 38.3% of patients vs 28.6% with platinum-based chemotherapy1
15.7 months’ median follow-up (range 0–35 months).
Adapted from Herbst1- At data cut-off, responses were ongoing in 68.3% of patients treated with TECENTRIQ vs 35.7% of patients with chemotherapy1
-
Patients’ overall HRQoL was sustained through to week 57 with TECENTRIQ and declined from week 42 with platinum-based chemotherapy⁶
- Patients’ overall HRQoL remained clinically stable through to week 57 of treatment with TECENTRIQ6
- Patients treated with chemotherapy experienced a clinically meaningful decline in overall HRQoL from week 42 onwards6
Mean change from baseline on the QLQ-C30 Global Health Status Scale – exploratory endpoint7
Adapted from De Marinis6
TECENTRIQ is a cost-effective treatment option for the NHS2
ALK, anaplastic lymphoma kinase; AUC, area under the curve; CI, confidence interval; DoR, duration of response; ECOG, European Cooperative Oncology Group; EGFR, epidermal growth factor receptor; HR, hazard ratio; HRQoL, health-related quality of life; NE, not estimable; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PD-L1, programmed death ligand 1; PFS, progression-free survival; PS, performance status; q3w, every 3 weeks; RECIST, Response Evaluation Criteria in Solid Tumours.
References:
- Herbst RS et al. N Engl J Med 2020; 383(14): 1328–1339.
- NICE. Atezolizumab monotherapy for untreated advanced non-small-cell lung cancer (TA705). June 2021.
- TECENTRIQ GB Summary of Product Characteristics.
- TECENTRIQ NI Summary of Product Characteristics.
- Roche. Data on File M-GB-00003364. April 2021.
- De Marinis F et al. Presented at the ASCO Annual Meeting; May 29–31, 2020. Poster #360.
- Spigel DR et al. Presented at the ESMO Congress, Barcelona, Spain; 27 September to 1 October, 2019. Oral presentation.
M-GB-00004718
Date of preparation: October 2021