TECENTRIQ: Approved in Multiple Lines of Therapy
Results from the IMpower150 Study
TECENTRIQ + Avastin® (bevacizumab) + carboplatin/paclitaxel (carbo/pac) delivered superior overall survival benefit*
Additional 4.5 months of OS benefit vs Avastin + carbo/pac alone in ITT-WT patients 1,4
*Based on OS interim analysis.
- Median follow-up was ≈20 months
- Median PFS was 8.5 months with TECENTRIQ + Avastin + carbo/pac (95% CI, 7.3, 9.7) vs 7.0 months with Avastin + carbo/pac alone (95% CI, 6.3, 7.9) (HR=0.71; 95% CI, 0.59, 0.85; P=0.0002)†,‡,§
Increased survival against an established 3-drug regimen, Avastin + carbo/pac
Additional OS analyses 1
- At interim analysis, no significant OS benefit was demonstrated with TECENTRIQ + carbo/pac vs Avastin + carbo/pac (HR=0.84; 95% CI, 0.72, 1.08; P=0.204)†‡
- Exploratory analyses showed that the subset of patients in the TECENTRIQ + Avastin + carbo/pac arm who were ADA positive by Week 4 (30%) appeared to have a similar effect on OS as compared to patients who tested negative for treatment-emergent ADA by Week 4 (70%)
ADA=antidrug antibody; CI=confidence interval;
HR=hazard ratio; ITT=intent to treat; nsqNSCLC=non-squamous
non-small cell lung cancer; OS=overall survival; RECIST=Response
Evaluation Criteria In Solid Tumors; WT=wild-type.
†Stratified by the presence of liver metastases, PD-L1 expression status, and gender.
‡Based on the stratified log-rank test compared to the Avastin + carbo/pac arm.
§As determined by independent review facility per RECIST v1.1.
Prespecified exploratory subgroup analysis of OS
OS in key patient types 3
- These prespecified exploratory subgroup analyses were not powered to demonstrate statistically significant differences between treatment arms
ECOG=Eastern Cooperative Oncology Group;
IC=tumor-infiltrating immune cell; PD-L1=programmed death-ligand 1;
PS=performance status; TC=tumor cell.
‖The HR value was stratified for the ITT-WT subpopulation. All other subgroup HR values were unstratified.
In patients with liver metastases, median OS was 13.2 months with TECENTRIQ + Avastin + carbo/pac vs 9.1 months with Avastin + carbo/pac alone (HR=0.54; 95% CI, 0.33, 0.88; n=94)
Durable responses for ITT-WT patients
A majority of patients responded to TECENTRIQ + Avastin + carbo/pac vs Avastin + carbo/pac alone ¶
CR=complete response; ORR=overall response rate;
¶As determined by independent review facility per RECIST v1.1.
TECENTRIQ + Avastin + carbo/pac demonstrated durable responses vs Avastin + carbo/pac alone 1#
DoR=duration of response.
#As determined by independent review facility per RECIST v1.1.
Results from the Pivotal OAK Study
Overall survival advantage demonstrated with TECENTRIQ 1-3
1L=first line; ADA=antidrug antibody;
CI=confidence interval; HR=hazard ratio; OS=overall survival;
PD-L1=programmed death-ligand 1.
*Stratified by PD-L1 expression in tumor-inflitrating immune cells, the number of prior chemotherapy regimens, and histology.
†Based on the stratified log-rank test.
- The Kaplan-Meier curves separated starting at approximately 3 months
Additional OS analyses 1
- In an interim analysis of all 1225 patients, median OS was 13.3 months with TECENTRIQ (95% CI, 11.3, 14.9) vs 9.8 months with docetaxel (95% CI, 8.9, 11.3) (HR=0.79; 95% CI, 0.69, 0.91; P=0.0013)*†
- Exploratory analyses showed that the subset of patients who were ADA positive by Week 4 (21%) appeared to have less efficacy (effect on OS) as compared to patients who tested negative for treatment-emergent ADA by Week 4 (79%). ADA-positive patients by Week 4 appeared to have similar OS compared to docetaxel-treated patients
Select Important Safety Information
Serious and sometimes fatal adverse reactions occurred with TECENTRIQ treatment. Warnings and precautions include immune-mediated serious adverse reactions, including pneumonitis, hepatitis, colitis, endocrinopathies, and other immune-mediated adverse reactions. Other warnings and precautions include infections, infusion-related reactions, and embryo-fetal toxicity.
Prespecified exploratory subgroup analysis
Forest plot of overall survival in select patient subgroups 1,2
IC=tumor-infiltrating immune cell; ITT=intent to
treat; TC=tumor cell.
HR values were stratified for the ITT and TC or IC ≥1% subgroups. All other subgroup HR values were unstratified.
TECENTRIQ delivered enduring response
Greater than 16 months median DoR with TECENTRIQ 1
DoR=duration of response; NE=not estimable; ORR=overall response rate; PFS=progression-free survival.
Response rates and progression-free survival were similar between TECENTRIQ and docetaxel 1
- ORR was 14% with TECENTRIQ (95% CI, 11%, 17%) (58/425) vs 13% with docetaxel (95% CI, 10%, 17%) (57/425)
- Median PFS was 2.8 months with TECENTRIQ
(95% CI, 2.6, 3.0) vs 4.0 months with docetaxel (95% CI, 3.3, 4.2)
(HR=0.95; 95% CI, 0.82, 1.10)