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

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%)
  • 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%)
  • 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%)
  • 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.