b"A first in uHCC: The ONLY approved 1L IO regimenNEWwith 4-year OS data from a Phase III study1-3,5-9 4-YEARDATAPRIMARY ANALYSIS: STATISTICALLY SUPERIOR OS1,2REACH BEYOND 22 % REDUCTION IN RISK of death with IMFINZI + IMJUDO vs sorafenibHR=0.78 (95% CI, 0.66-0.92); P=0.0035with IMFINZI + IMJUDO 16.4 months mOS with IMFINZI + IMJUDO VS 13.8 months mOS with sorafenib(95% CI, 14.2-19.6)(95% CI, 12.3-16.1) The HR is based on the stratified Cox proportional hazard model. The P value is based on a stratified log-rank test and a Lan-DeMets alpha spending function with O'Brien-Flemingtype boundary and the actual number of events observed. The boundary for declaring statistical significance for IMFINZI + IMJUDO vs sorafenib was 0.0398. Median duration of follow-up was 33.2 months (range, 31.7-34.5) for IMFINZI + IMJUDO and 32.2 months (range, 30.4-33.7) for sorafenib. Data cutoff: August 27, 20211.-3NEW4-YEAR EXPLORATORY ANALYSIS: OS RATES5 1 IN 4FOR THE FIRST-LINE TREATMENT OF ADULTS WITH UNRESECTABLE HCC1-3 1.0 1.5 years ALIVE AT 4 YEARS0.8 48.7 % 2 years 3 years0.6 41.5 % 40.5 % % 4 yearsNCCNNational Comprehensive Cancer Network (NCCN) Category 1, Preferred of OS Probability 0.4 32.6 19.8 % 25.2% 30.7 %CATEGORY 1, Durvalumab (IMFINZI) + tremelimumab-actl (IMJUDO) is an NCCN Category 1, preferred first-line15.1 %PREFERRED systemic treatment option for unresectable HCC4 * 0.2 Events (n/N, %)Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Hepatocellular Carcinoma V.1.2023. National ComprehensiveIMFINZI + IMJUDO (291/393, 74.0%)Cancer Network, Inc. 2023. All rights reserved. Accessed March 13, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. Sorafenib (316/389, 81.2%)*In patients who are not transplant candidates.4 0.0NCCN 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. 0 6 12 18 24 30 36 42 48 54 60See the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for detailed recommendations, including other preferred treatment options.4 Time fromrandomization(months)Number of patients at riskIMFINZI + IMJUDO 393 308 235 190 158 131 103 88 54 19 0Study design: HIMALAYA was a large, Phase III, randomized, open-label, global study of patients with previously untreated unresectable HCC. 1171 patients wereSorafenib 389 283 211 155 121 83 64 50 28 9 1randomized to 1 of 3 arms: IMFINZI + IMJUDO, 1 dose of IMJUDO (300 mg) + IMFINZI (1500 mg Q4W) (n=393), IMFINZI monotherapy, an unapproved regimen for unresectable HCC (1500 mg Q4W) (n=389), or sorafenib (400 mg PO BID) (n=389). All treatments were given until disease progression or unacceptable toxicity.At the time of the 4-year analysis, mOS was 16.4 months (95% CI, 14.2-19.6) with IMFINZI + IMJUDO and 13.8 months (95% CI, 12.3-16.1) with sorafenibPatients in all arms could continue to receive treatment after evidence of disease progression if, in the investigator's opinion, they were still benefiting from treatment(HR=0.78 [95% CI, 0.67-0.92]); not formally tested for statistical significance. OS data maturity across the IMFINZI + IMJUDO and sorafenib arms was 78%. -and continued to meet inclusion and exclusion criteria. The primary endpoint of the study was overall survival for IMFINZI + IMJUDO vs sorafenib. At the 4-yearData cutoff: January 23, 2023.exploratory analysis, overall survival rates at 18, 24, 36, and 48 months were exploratory endpoints and not formally tested for statistical significance.1-3,5The HIMALAYA study included an additional arm of therapy: The IMJUDO 75-mg + IMFINZI arm (n=153) was closed following a preplanned analysis of a Phase II study. Results from this arm are not reported in this material, and this dosing regimen is not approved for use.3 Estimates of OS rates calculated using Kaplan-Meier technique. OS rates at 18, 24, 36, and 48 months were exploratory endpoints and were not formally tested for statistical significance3,5Indication: In the exploratory analysis, median duration of follow-up was 49.1 months (range, 47.0-50.2) for IMFINZI + IMJUDO and IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular47.3 months (range, 45.1-49.2) for sorafenib5carcinoma (uHCC). Safety and tolerability for IMFINZI + IMJUDOIMPORTANT SAFETY INFORMATIONAt the primary analysis, serious adverse reactions occurred in 41% of patients who received IMFINZI + IMJUDO. There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl).Serious adverse reactions occurring in 1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), Severe and Fatal Immune-Mediated Adverse Reactions pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). At the 4-year exploratory analysis, serious adverse reactions occurred in 41% of patients who received IMFINZI + IMJUDO, and no Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severenew serious treatment-related safety events were reported1,2,5and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur Fatal adverse reactions occurred in 8% of patients who received IMFINZI + IMJUDO, including death (1%), in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment orhemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlyinghepatitis (0.5%)1,2immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZIExplore the updated analysis at IMFINZIhcp.com/HCCEfficacy and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if combination of IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients1L=first line; BID=twice a day; CI=confidence interval; HCC=hepatocellular carcinoma; HR=hazard ratio; IO=immuno-oncology; mOS=median overall survival; NCCN=National whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Comprehensive Cancer Network (NCCN); OS=overall survival; PO=by mouth; Q4W=every 4 weeks; uHCC=unresectable hepatocellular carcinoma.Immune-Mediated PneumonitisIMFINZI in combination with IMJUDO can cause immune-mediated pneumonitis, which may be fatal. Immune- Please see additional Important Safety Information mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) andthroughout and Brief Summary of Full Prescribing Grade 3 (0.2%) adverse reactions. Information for IMFINZI and IMJUDO on adjacent pages.US-76417_US-77669_US-77951 Imfinzi-Imjudo US Medicine - The Compendium.indd 1 12/6/23 3:45 PM"