Primary OS analysis        Updated OS analysis        Progression-free survival

Median follow-up of 8.6 months

Unprecedented Overall Survival in 1L Unresectable or mHCC

42% reduced risk of death demonstrated with TECENTRIQ + Avastin® (bevacizumab) vs sorafenib 1,3

 

  • OS was a coprimary endpoint
Additional OS analysis 1
  • Exploratory analyses showed that the subset of patients (20%) who were ADA positive by Week 6 appeared to have reduced efficacy as compared to patients (80%) who tested negative for treatment-emergent ADA by Week 6. ADA-positive patients by Week 6 appeared to have similar OS compared to sorafenib-treated patients. However, the analyses were inconclusive due to the low number of events in ADA subgroups

1L=first line; ADA=antidrug antibody; CI=confidence interval; HR=hazard ratio; mHCC=metastatic hepatocellular carcinoma; NE=not estimable; OS=overall survival.


Median follow-up of 15.6 months

Descriptive Follow-up Analysis: Numerical Improvement of 5.8 Months in Median OS

TECENTRIQ + Avastin OS data vs sorafenib 4

Landmark analyses were not powered to demonstrate statistically significant differences and no conclusions can be drawn from these analyses. The OS rates at 6, 12, and 18 months were estimated with the use of Kaplan-Meier methodology for each treatment arm.
 
The safety observed in the updated analysis was generally consistent with the safety observed in the initial analysis.

Select Important Safety Information

Serious and sometimes fatal adverse reactions occurred with TECENTRIQ treatment. Warnings and precautions include severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, dermatologic adverse reactions, nephritis and renal dysfunction, and solid organ transplant rejection. Other warnings and precautions include infusion-related reactions, complications of allogeneic HSCT, and embryo-fetal toxicity.

Please see below and the TECENTRIQ Prescribing Information for additional Important Safety Information.


Significantly Improved Progression-free Survival

TECENTRIQ + Avastin demonstrated a 41% reduction in disease progression or death vs sorafenib 1

 

  • PFS as assessed by IRF per RECIST v1.1 was a coprimary endpoint

HSCT=hematopoietic stem cell transplantation; IRF=independent review facility; PFS=progression-free survival; RECIST=Response Evaluation Criteria In Solid Tumors.

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