TECENTRIQ® (atezolizumab) logo

NOW APPROVED for first-line (1L) unresectable or metastatic hepatocellular carcinoma (HCC)

TECENTRIQ® (atezolizumab) logo
 

TECENTRIQ, in combination with bevacizumab, is indicated
for the treatment of patients with unresectable or
metastatic HCC who have not received prior systemic
therapy1

 
TECENTRIQ® (atezolizumab) logo
TECENTRIQ® (atezolizumab) logo

Atezolizumab (TECENTRIQ) + bevacizumab (Avastin®) is a preferred immunotherapy option (Category 2A) for the first-line (1L) treatment of patients with unresectable or metastatic HCC (Child-Pugh Class A) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)2*

TECENTRIQ® (atezolizumab) logo
TECENTRIQ® (atezolizumab) logo
 
* NCCN makes no warranties of any kind whatsoever regarding their content, use, or application, and disclaims any responsibility for their application or use in any way. See the NCCN Guidelines® for detailed recommendations.
 
Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
 
Click here for full TECENTRIQ Prescribing Information.
 
Click here for full Avastin Prescribing Information.
 
Please see Important Safety Information below.
 
Click here for the full TECENTRIQ HCC efficacy and safety profile and for additional information
 
 
 
STUDY DESIGN1
The IMbrave150 trial was a Phase III, multicenter, international, open-label, randomized trial in patients with locally advanced unresectable and/or metastatic HCC (N=501) who have not received prior systemic therapy. The major efficacy outcomes were OS and IRF-assessed PFS per RECIST v1.1.
Patients received IV infusions of TECENTRIQ 1200 mg q3w and Avastin® (bevacizumab) 15 mg/kg q3w on Day 1 of each 21-day cycle. Sorafenib was administered orally, 400 mg BID, on Days 1-21 of each 21-day cycle until disease progression or unacceptable toxicity.
Abbreviations: BID, twice daily; IRF, independent review facility; IV, intravenous; OS, overall survival; PFS, progression-free survival; q3w, every 3 weeks; RECIST, Response Evaluation Criteria In Solid Tumors.
EFFICACY
 
The first Phase III trial to show a significant improvement in median OS (co-primary endpoint) vs sorafenib1
 
 
TECENTRIQ + Avastin demonstrated a statistically significant 42% improvement in median OS vs sorafenib
 
TECENTRIQ OS data vs sorafenib OS data
 
Exploratory analyses showed that the subset of patients (20%) who were positive for ADA by Week 6 appeared to have reduced efficacy as compared to patients (80%) who tested negative for treatment-emergent ADA by Week 6. However, the analyses were inconclusive due to the low number of events in ADA subgroups
 
Abbreviations: ADA, anti-drug antibodies; CI, confidence interval; HR, hazard ratio; NE, not estimable.
 
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.
 
See below for additional Important Safety Information.
 
Co-primary endpoint: PFS1
 
 
TECENTRIQ + Avastin demonstrated a statistically significant 2.5-month improvement in median PFS vs sorafenib
 
TECENTRIQ PFS data vs sorafenib PFS data
 
TECENTRIQ + Avastin demonstrated the potential for a complete response1
 
 
TECENTRIQ and sorafenib objective response rate
TECENTRIQ + Avastin demonstrated a CR in approximately 7% of patients vs 0% with sorafenib
ORR as assessed by HCC mRECIST was seen in 33% of patients
in the TECENTRIQ + Avastin arm (n=112/336; 95% CI, 28, 39) vs
13% of patients in the sorafenib arm (n=21/165; 95% CI, 8, 19)‡||
CR: 11% vs 18%
PR: 22% vs 11%
Per independent radiology review.
§ Assessed by IRF per RECIST v1.1.
|| Confirmed responses.
SAFETY
Observed differences of select ARs between
TECENTRIQ + Avastin vs sorafenib1,3
 
ARs occurring at a frequency of ≥10% in patients in either arm
and ≥5% difference between arms1,3¶
Select ARs for TECENTRIQ + Avastin and sorafenib
 
Treatment-related grade 3 to 4 ARs were 36% with
TECENTRIQ + Avastin vs 46% with sorafenib1,3
The most common grade 3 to 4 ARs (≥2%) were
hypertension, proteinuria, infusion-related reaction, and
fatigue/asthenia
 
Graded per National Cancer Institute Common Terminology Criteria
for Adverse Events version 4.0 (NCI CTCAE v4.0).
 
# Includes fatigue and asthenia.
 
Abbreviations: ALT, alanine aminotransferase; AR, adverse reaction;
PPE, palmar-plantar erythrodysesthesia.
 
Additional ARs occurring at a frequency of ≥10%
in patients receiving TECENTRIQ + Avastin1
 
 
AR profile for TECENTRIQ + Avastin and sorafenib
 
Graded per National Cancer Institute Common Terminology Criteria
for Adverse Events version 4.0 (NCI CTCAE v4.0).
 
# Includes fatigue and asthenia.
 
DOSING
 
TECENTRIQ + Avastin offers a same-day
dosing schedule1
 
 
A combination therapy with consistent, q3w infusions
 
HCC dosing: 1200 mg TECENTRIQ + 15 mg/kg Avastin q3w
 
Dosing information for Avastin is based on the IMbrave150 trial; TECENTRIQ was administered q3w in IMbrave150. Visualization of vials is illustrative and does not represent actual vial usage.
 
TECENTRIQ administration
 
TECENTRIQ should be administered first, followed by Avastin
 
Administer the initial infusion of TECENTRIQ over 60 minutes; if the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes
 
If Avastin is discontinued, TECENTRIQ can be administered as 840 mg q2w, as 1200 mg q3w, or as 1680 mg q4w. Refer to the TECENTRIQ Prescribing Information for dosage modification criteria
 
Do not administer TECENTRIQ as an IV push or bolus
 
Do not co-administer other drugs through the same IV line
 
Avastin administration
 
Administer Avastin as an IV infusion
 
First infusion of Avastin: Administer infusion over 90 minutes
 
Subsequent infusions: Administer second infusion over 60 minutes if first infusion is tolerated. Administer all subsequent infusions over 30 minutes if second infusion over 60 minutes is tolerated
 
Refer to the Avastin Prescribing Information for Avastin dosage modifications for specific adverse reactions. No dose reductions for Avastin are recommended
Abbreviations: q2w, every 2 weeks; q4w, every 4 weeks.
Select Important Safety Information for Avastin
An evaluation for the presence of varices is recommended within 6 months of initiation of Avastin in patients with HCC
 
There is lack of clinical data to support the safety of Avastin in patients with history of risk of variceal bleeding
 
 
Important Safety Information
Serious Adverse Reactions
Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.
Immune-Mediated Pneumonitis
  Immune-mediated pneumonitis or interstitial lung disease, including fatal cases, have occurred with TECENTRIQ treatment
 
  In clinical studies of TECENTRIQ as a single agent, 2.5% of patients developed pneumonitis, including Grade 3 (0.6%), Grade 4 (0.1%), and Grade 5 (<0.1%) events
 
  Monitor patients for signs and symptoms of pneumonitis. Evaluate patients with suspected pneumonitis with radiographic imaging. Administer corticosteroids followed by a taper. Withhold TECENTRIQ for Grade 2 and permanently discontinue for Grade 3 or 4 pneumonitis
 
Immune-Mediated Hepatitis
 
  Liver test abnormalities and immune-mediated hepatitis, including fatal cases, have occurred with TECENTRIQ treatment
 
  In clinical studies of TECENTRIQ as a single agent, hepatitis occurred in 9% of patients, including Grade 3 (2.3%), Grade 4 (0.6%), and Grade 5 (<0.1%) events
 
  Monitor patients for signs and symptoms of hepatitis, during and after discontinuation of TECENTRIQ, including clinical chemistry monitoring. Administer corticosteroids followed by a taper for immune-mediated hepatitis. Withhold TECENTRIQ for AST or ALT elevations more than 3 and up to 8 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal. Permanently discontinue TECENTRIQ for AST or ALT elevations more than 8 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal
 
Immune-Mediated Colitis
 
  Immune-mediated diarrhea or colitis have occurred with TECENTRIQ treatment
 
  In clinical studies of TECENTRIQ as a single agent, diarrhea or colitis occurred in 20% of patients, including Grade 3 (1.4%) events
 
  Monitor patients for signs and symptoms of diarrhea or colitis. Withhold TECENTRIQ for Grade 2 or 3 and permanently discontinue for Grade 4 diarrhea or colitis
 
Immune-Mediated Endocrinopathies
 
  TECENTRIQ can cause immune-mediated endocrinopathies, including thyroid disorders; adrenal insufficiency; type 1 diabetes mellitus, including diabetic ketoacidosis; and hypophysitis/hypopituitarism
 
  Withhold TECENTRIQ for Grades 2 to 4 endocrinopathies
 
  Thyroid Disorders
 
  -   In clinical studies of TECENTRIQ as a single agent, hypothyroidism occurred in 4.6% of patients and hyperthyroidism occurred in 1.6% of patients
 
  -   Monitor thyroid function prior to and during treatment with TECENTRIQ. Initiate hormone replacement therapy or medical management of hyperthyroidism as clinically indicated
 
  Adrenal Insufficiency
 
  -   In clinical studies of TECENTRIQ as a single agent, adrenal insufficiency occurred in 0.4% of patients, including Grade 3 (<0.1%) events
 
  -   Monitor patients for clinical signs and symptoms of adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate corticosteroids and hormone replacement therapy as clinically indicated
 
  Type 1 Diabetes Mellitus
 
  -   In clinical studies of TECENTRIQ as a single agent, type 1 diabetes mellitus occurred in <0.1% of patients
 
  -   Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated
 
  Hypophysitis
 
  -   In clinical studies of TECENTRIQ as a single agent, Grade 2 hypophysitis occurred in <0.1% of patients
 
  -   For Grades 2 to 4 hypophysitis, initiate corticosteroids and hormone replacement therapy as clinically indicated
 
Other Immune-Mediated Adverse Reactions
 
  TECENTRIQ can cause severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system
 
  In clinical studies of TECENTRIQ as a single agent or were reported in other products in this class, the immune-mediated adverse reactions occurring at an incidence of <1% were cardiac, dermatologic, gastrointestinal, general, hematological, musculoskeletal, neurological, ophthalmological, renal, and vascular
 
  For suspected Grade 2 immune-mediated adverse reactions, exclude other causes and initiate corticosteroids as clinically indicated. For severe (Grade 3 or 4) adverse reactions, withhold TECENTRIQ and administer corticosteroids. Permanently discontinue TECENTRIQ for Grade 4 immune-mediated adverse reactions involving a major organ
 
  Evaluate for Vogt-Koyanagi-Harada syndrome if uveitis occurs in combination with other immune-mediated adverse reactions
 
Infections
 
  TECENTRIQ can cause severe infections including fatal cases
 
  In clinical studies of TECENTRIQ as a single agent, infections occurred in 42% of patients, including Grade 3 (8.7%), Grade 4 (1.5%), and Grade 5 (1%) events
 
  Monitor patients for signs and symptoms of infection. For Grade 3 or higher infections, withhold TECENTRIQ and resume once clinically stable
 
Infusion-Related Reactions
 
  TECENTRIQ can cause severe or life-threatening infusion-related reactions
 
  In clinical studies of TECENTRIQ as a single agent, infusion-related reactions occurred in 1.3% of patients, including Grade 3 (0.2%) events
 
  Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2 infusion-related reactions. Permanently discontinue TECENTRIQ in patients with Grade 3 or 4 infusion-related reactions
 
Embryo-Fetal Toxicity
 
  Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ. Advise females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose
 
Nursing Mothers/Fertility
 
  Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose
 
  Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment
 
Most Common Adverse Reactions
 
The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with bevacizumab for HCC were hypertension (30%), fatigue/asthenia (26%), and proteinuria (20%).
 
You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.
 
Please see full Prescribing Information for additional Important Safety Information.
 
References: 1. TECENTRIQ Prescribing Information. Genentech, Inc.
2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers. V.3.2020.
© National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed June 1, 2020. To view the most recent and complete version of the guidelines, go online to www.NCCN.org. 3. Finn RS, Qin S, Ikeda M, et al. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020;382(20):1894-1905.
 
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