TECENTRIQ: First- and Second-Line Approval Based on Pivotal
A phase III, multicenter, international, randomized, open-label,
3-arm trial in
chemotherapy-naïve patients with metastatic
Patients received IV infusions of TECENTRIQ 1200 mg, Avastin 15 mg/kg, carboplatin AUC 6, and paclitaxel 175 mg/m2 or 200 mg/m2 q3w. This study excluded patients who had a history of autoimmune disease; administration of a live, attenuated vaccine within 28 days prior to randomization; active or untreated CNS metastases; administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomization; clear tumor infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions as seen on imaging.
Efficacy data were stratified by the presence of liver metastases, PD-L1 expression status,* and gender
Coprimary endpoints 1
- Overall survival in the ITT-WT subpopulation
- Progression-free survival using RECIST v1.1 in the ITT-WT subpopulation
Key secondary endpoints 1
- Overall response rate and duration of response in the ITT-WT subpopulation
1L=first line; AUC=area under the
concentration-time curve; carbo/pac=carboplatin and paclitaxel;
CNS=central nervous system; IC=tumor-infiltrating immune cell;
ITT=intent to treat; IV=intravenous; nsqNSCLC=non-squamous non-small
cell lung cancer; PD-L1=programmed death-ligand 1; q3w=every 3
weeks; q6w=every 6 weeks; q9w=every 9 weeks; RECIST=Response
Evaluation Criteria In Solid Tumors; TC=tumor cell;
*TC ≥50% and IC ≥1% vs TC <50% and IC ≥5% vs TC <50% and IC <5%.
TECENTRIQ + Avastin (bevacizumab) + carbo/pac was evaluated across key patient types 1,3,4
ALK=anaplastic lymphoma kinase; ECOG=Eastern Cooperative Oncology Group; NSCLC=non-small cell lung cancer; PS=performance status.
- The demographics for the 696 patients in the ITT-WT subpopulation were similar to the ITT population, except for the absence of patients with EGFR- or ALK-positive NSCLC
The largest pivotal Phase III cancer immunotherapy study that enrolled previously treated metastatic NSCLC patients regardless of PD-L1 expression 1,2
Multicenter, international, randomized, open-label trial evaluating TECENTRIQ against docetaxel
- Overall survival*
- Duration of response
- Overall response rate per RECIST v1.1
- Progression-free survival per RECIST v1.1
Randomization was stratified by PD-L1 expression
in ICs, the number of prior chemotherapy regimens, and histology.
Tumor specimens were evaluated prospectively using the VENTANA PD-L1
(SP142) Assay. Patients with a history of autoimmune disease,
symptomatic or corticosteroid-dependent brain metastases, or
requiring systemic immunosuppression within 2 weeks prior to
enrollment were ineligible.
*The major efficacy outcome measure was OS in the first 850 randomized patients and in the TC or IC ≥1% PD-L1 expression subgroup. Additional efficacy outcome measures included OS in all 1225 randomized patients and in additional PD-L1 expression subgroups.
Select demographics from the OAK study 1
In the OAK study, nearly half of patients did not have PD-L1–expressing tumors
1L=first line; IC=tumor-infiltrating immune cell;
Non–PD-L1–expressing=TC and IC <1%; PD-L1 expressing=TC or IC ≥1%. 2
Baseline characteristics were generally well balanced between treatment arms 2
ALK=anaplastic lymphoma kinase; ECOG=Eastern
Cooperative Oncology Group; EGFR=epidermal growth factor receptor;
IV=intravenous; OS=overall survival; PD-L1=programmed death-ligand
1; PS=performance status; q3w=every 3 weeks; q6w=every 6 weeks;
q9w=every 9 weeks; RECIST=Response Evaluation Criteria In Solid
*Tumor tissue for 8 patients was not evaluable for TC or IC ≥1%.