Observed Differences of Select ARs Between TECENTRIQ + Avastin® (bevacizumab) vs Sorafenib
ARs occurring at a frequency of ≥10% in patients in either arm and ≥5% difference between arms 1,3*
1L=first line; ALT=alanine aminotransferase;
AR=adverse reaction; mHCC=metastatic hepatocellular carcinoma;
PPE=palmar-plantar erythrodysesthesia.
*Graded per National
Cancer Institute Common Terminology Criteria for Adverse Events
version 4.0 (NCI CTCAE v4.0).
†Includes fatigue and asthenia.
Consider how certain ARs can impact your 1L unresectable or mHCC
patients
- Treatment-related grade 3 to 4 ARs were 36% with TECENTRIQ +
Avastin vs 46% with sorafenib 1,7
-
The most common grade 3
to 4 ARs (≥2%) were hypertension, proteinuria,
infusion-related reaction, and fatigue/asthenia
-
The most common grade 3
to 4 ARs (≥2%) were hypertension, proteinuria,
infusion-related reaction, and fatigue/asthenia
Established safety profile
Additional ARs occurring at a frequency of ≥10% in patients receiving TECENTRIQ + Avastin 1
Additional safety data reported in IMbrave150 1,3
- The proportion of patients experiencing grade 3 to 4 bleed
rates was 6.4% with TECENTRIQ + Avastin and 5.8% with sorafenib
- The majority of bleeding/hemorrhage AEs were grade 1 to 2
- 4.6% of patients who were treated with
TECENTRIQ + Avastin experienced fatal ARs. The most common ARs
leading to death were gastrointestinal and esophageal varices
hemorrhage (1.2%) and infections (1.2%)
- Serious ARs
occurred in 38% of patients treated with TECENTRIQ + Avastin
- The most frequent (≥2%) were gastrointestinal hemorrhage
(7%), infections (6%), and pyrexia (2.1%)
- The most frequent (≥2%) were gastrointestinal hemorrhage
(7%), infections (6%), and pyrexia (2.1%)
- ARs leading to discontinuation of TECENTRIQ occurred in 9%
of patients in the TECENTRIQ + Avastin arm vs 10% with
sorafenib
- The most common ARs leading to
discontinuation of TECENTRIQ were hemorrhages (1.2%), including
gastrointestinal, subarachnoid, and pulmonary hemorrhages;
increased transaminases or bilirubin (1.2%); infusion-related
reaction/cytokine release syndrome (0.9%); and autoimmune
hepatitis (0.6%)
- The most common ARs leading to
discontinuation of TECENTRIQ were hemorrhages (1.2%), including
gastrointestinal, subarachnoid, and pulmonary hemorrhages;
increased transaminases or bilirubin (1.2%); infusion-related
reaction/cytokine release syndrome (0.9%); and autoimmune
hepatitis (0.6%)
- ARs leading to
interruption of TECENTRIQ + Avastin occurred in 41% of
patients
- The most common (≥2%) were liver function
laboratory abnormalities including increased transaminases,
bilirubin, or alkaline phosphatate (8%); infections (6%);
gastrointestinal hemorrhages (3.6%); thrombocytopenia/decreased
platelet count (3.6%); hyperthyroidism (2.7%); and pyrexia
(2.1%)
- The most common (≥2%) were liver function
laboratory abnormalities including increased transaminases,
bilirubin, or alkaline phosphatate (8%); infections (6%);
gastrointestinal hemorrhages (3.6%); thrombocytopenia/decreased
platelet count (3.6%); hyperthyroidism (2.7%); and pyrexia
(2.1%)
- Immune-related ARs requiring
systemic corticosteroid therapy occurred in 12% of patients in the
TECENTRIQ + Avastin arm
AE=adverse event; AR=adverse reaction.
Laboratory abnormalities worsening from baseline occurring in ≥20% of patients receiving TECENTRIQ + Avastin 1
Each test incidence is based on the number of
patients who had both baseline and at least one on-study laboratory
measurement available: TECENTRIQ plus bevacizumab (222-323) and
sorafenib (90-153).
AST=aspartate aminotransferase.