Unprecedented survival in 1L unresectable or metastatic HCC 42%
REDUCTION IN THE RISK OF DEATH ACHIEVED WITH TECENTRIQ + AVASTIN VS SORAFENIB1
Coprimary endpoint: median OS was not reached with TECENTRIQ + Avastin vs 13.2 months with sorafenib (HR=0.58; 95% CI, 0.42, 0.79; P=0.0006)
Study design: IMbrave150 was a Phase III, multicenter, international, open-label, randomized trial that compared TECENTRIQ + Avastin to sorafenib in 501 patients with locally advanced unresectable and/or metastatic HCC who had not received prior systemic therapy. Patients were randomized (2:1) to receive either TECENTRIQ 1200 mg IV followed by Avastin 15 mg/kg IV on the same day q3w or 400 mg sorafenib given orally twice daily, until disease progression or unacceptable toxicity. The major efficacy outcome measures were OS and IRF-assessed PFS per RECIST v1.1 in the ITT population.1,4
IMbrave150 included patients with a range of disease characteristics, such as1,4 :
BCLC stages A, B, and C
MVI and/or EHS
ECOG PS 0 to 1
Hepatitis B, hepatitis C, and nonviral etiologies
AFP < and ≥400 ng/mL
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1L=first line; AFP=alpha-fetoprotein; BCLC=Barcelona clinic liver cancer; CI=confidence interval; ECOG=Eastern Cooperative Oncology Group; EHS=extrahepatic spread; HR=hazard ratio; IRF=independent review facility; ITT=intent to treat; IV=intravenously; LRT=locoregional therapy; MDT=multidisciplinary team; MVI=macrovascular invasion; NCCN=National Comprehensive Cancer Network; OS=overall survival; PFS=progression-free survival; PS=performance status; q3w=every 3 weeks; RECIST=Response Evaluation Criteria In Solid Tumors.
Important Safety Information (cont’d)
Immune-Mediated Pneumonitis (cont’d) • Immune-mediated pneumonitis occurred in 3% (83/2616) of patients receiving TECENTRIQ alone, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.8%), and Grade 2 (1.1%) adverse reactions. Pneumonitis led to permanent discontinuation of TECENTRIQ in 0.5% and withholding of TECENTRIQ in 1.5% of patients
• Systemic corticosteroids were required in 55% (46/83) of patients with pneumonitis. Pneumonitis resolved in 69% of the 83 patients. Of the 39 patients in whom TECENTRIQ was withheld for pneumonitis, 25 reinitiated TECENTRIQ after symptom improvement; of these, 4% had recurrence of pneumonitis
Immune-Mediated Colitis • TECENTRIQ can cause immune-mediated colitis. Colitis can present with diarrhea, abdominal pain, and lower gastrointestinal (GI) bleeding. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies
• Immune-mediated colitis occurred in 1% (26/2616) of patients receiving TECENTRIQ alone, including Grade 3 (0.5%) and Grade 2 (0.3%) adverse reactions. Colitis led to permanent discontinuation of TECENTRIQ in 0.2% and withholding of TECENTRIQ in 0.5% of patients. Systemic corticosteroids were required in 50% (13/26) of patients with colitis. Colitis resolved in 73% of the 26 patients. Of the 12 patients in whom TECENTRIQ was withheld for colitis, 8 reinitiated TECENTRIQ after symptom improvement; of these, 25% had recurrence of colitis
Immune-Mediated Hepatitis • TECENTRIQ can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1.8% (48/2616) of patients receiving TECENTRIQ alone, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.5%), and Grade 2 (0.5%) adverse reactions. Hepatitis led to permanent discontinuation of TECENTRIQ in 0.2% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 25% (12/48) of patients with hepatitis. Hepatitis resolved in 50% of the 48 patients. Of the 6 patients in whom TECENTRIQ was withheld for hepatitis, 4 reinitiated TECENTRIQ after symptom improvement; of these, none had recurrence of hepatitis
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