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Indication statement: IMFINZI in combination with tremelimumab is indicated for the first-line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).5,6
Could STRIDE 3 and 6-year long-term overall survival (OS) data redefine your uHCC treatment options?1–3
The STRIDE regimen is based on data from the HIMALAYA trial, designed to evaluate STRIDE as a first-line (1L) treatment for advanced or unresectable HCC. The HIMALAYA trial through exploratory analysis, offers the longest planned follow-up Phase III study in uHCC to date.1,2
Patients with oesophageal varices were included in the study, except those with active or prior documented gastrointestinal bleeding within 12 months before study entry.1
*Time from the first documentation of a response until date of progression, death or last evaluable RECIST v1.1 assessment.
*Total patient count is reflective of an additional arm of therapy: The T75 + IMFINZI arm (n=153) was closed following a pre-planned analysis of a Phase II study. Patients randomised to this arm could continue treatment following arm closure. Results from this arm are not reported in this material and this dosing regimen is not approved for use. Overall, 1171 randomised patients wereincluded in the final analysis3,4
†Treatment continued until disease progression. Patients with progressive disease who, in the investigator’s opinion, continued to benefit from treatment and met the criteria for treatment in the setting of progressive disease could continue treatment.
‡Not currently indicated for HCC on the licenses in the UK.
The HIMALAYA trial included a heterogeneous population representative of patients with HCC worldwide.1,7
Baseline demographics and clinical characteristics in the ITT population were generally well-balanced across treatment arms. Median age and sex distribution were comparable across treatment arms, with most patients being male and a similar distribution across Asia (excluding Japan) and other global regions.1
Baseline disease characteristics were comparable between treatment arms, with a predominance of advanced disease (BCLC stage C) and similar rates of BCLC stage B, macrovascular invasion, and extrahepatic spread.
Adapted from Abou-Alfa et al. 2022
† Includes Brazil, Canada, France, Germany, Italy, Japan, Russia, Spain, Ukraine, and the United States.
‡ The ECOG performance status scale ranges from 0 to 5, with higher numbers corresponding to greater disability.
§ The Child-Pugh classification of liver disease severity is determined by the degree of ascites, serum concentrations of bilirubin and albumin, prothrombin time, and degree of encephalopathy and classified as follows: class A (well-compensated disease), score of 5 to 6; class B (significant functional compromise), score of 7 to 9; and class C (decompensated disease), score of 10 to 15.
**Baseline PD-L1 results were not available for patients who were randomly assigned but not treated. PD-L1 expression level was based on the tumorand immune cell positivity score method as PD-L1 positive ($1%) or PD-L1 negative (,1%)
*As characterised by positive hepatitis B surface antigen HBsAg], detectable HBV DNA,
or hepatitis B core antibodies [anti-HBc Ab]).
Note: HBV-positive patients must remain on antiviral therapy for the study duration and mustcontinue therapy for 6 months after the last dose
of study medication.
†Characterised by the presence of detectable HCV RNA or anti-HCV antibody upon enrolment (management of this disease is per local institutional practice).
‡Defined as any ascites requiring non-pharmacologic intervention (e.g, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥2 months are eligible.
At primary analysis, STRIDE met its primary endpoint by demonstrating a statistically significant improvement in OS in the intention-to-treat (ITT) population. 3-year OS rates were 30.7% with STRIDE vs 20.2% with sorafenib.1
The STRIDE regimen significantly improved OS versus sorafenib, with longer median OS (16.4 vs 13.8 months) and a reduced risk of death (HR 0.78; p=0.0035).1
Adapted from Abou-Alfa et al. 2022
*Based on Lan-DeMets alpha spending function with O’Brien-Fleming-type boundary and the actual number of events observed, the boundary for declaring statistical significance for STRIDE vs. sorafenib was 0.0398.5,6
OS rates at 5 years (60 months) were exploratory endpoints; although not tested for statistical significance, differences in benefit for STRIDE were observed at this timepoint, consistent with prior timepoints.2
ARR at 60 months: 10.2% [HR: 0.76, 95% CI, 0.65-0.89; p=0.0008. p-value is numerical]2
Key secondary endpoints included an investigator-assessed objective response rate (ORR), mean duration of response (DoR), and median time to response.1
Median PFS at the primary analysis was 3.78 months (95% CI: 3.68-5.32) with STRIDE vs. 4.07 months (95% CI:3.75-5.49) with sorafenib.1
Graph adapted from Abou-Alfa et al. 2022
Investigator-assessed ORR (RECIST v1.1) was higher with the STRIDE regimen vs sorafenib (20.1% vs 5.1%) in the ITT population (not formally tested for statistical significance).1
[Data cut-off date: 27th August 2021]
Median DoR was longer with the STRIDE regimen than with sorafenib (22.34 months vs 18.43 months) in the ITT population (not formally tested for statistical significance).1
[Data cut-off date: 27th August 2021]*
*Time from the first documentation of a response until date of progression, death or last evaluable RECIST v1.1 assessment.
Median time to response was faster with the STRIDE regimen than with sorafenib (2.17 vs 3.78 months) in the ITT population (not formally tested for statistical significance).1
[Data cut-off date: 27th August 2021]†
†Time from randomisation to first confirmed response according to RECIST v1.1 assessment.
Exploratory analyses from the HIMALAYA trial evaluated long-term OS across key patient subgroups.2,8,9
At 6-year follow up, the STRIDE regimen demonstrated a sustained OS benefit compared to sorafenib in patients with uHCC.8
6-year (72-month) OS was 17.1% with STRIDE vs. 8.9% with sorafenib [HR: 0.76, 95% CI, 0.65–0.89]*†, which was consistent with the primary OS analysis.‡8
This exploratory six-year OS analysis was not formally tested for statistical significance
Data cut-off: 03 March 2025
* OS HRs and corresponding 95% CIs were calculated using a Cox proportional hazards model stratified by treatment,aetiology of liver disease (HBV vs. HCV vs. others), ECOG PS (0 vs. 1), and MVI (yes vs. no).
† Median OS and PFS were calculated using the Kaplan-Meier technique, with 95% CIs being calculated using a profilelikelihood approach.
‡ Median duration of follow-up in all censored participants was 71.28 (6.18–85.03) months with STRIDE and 38.31 (0.03–83.29) months with sorafenib.
OS rates at 6-years were exploratory endpoints; although not tested for statistical significance, difference in OS rates for the STRIDE regimen vs sorafenib were observed at this timepoint, consistent with prior timepoints.2,8
The following exploratory analyses present OS outcomes with the STRIDE regimen versus sorafenib according to ALBI (albumin-bilirubin) grade, reflecting liver function at baseline.9
The OS rates with STRIDE vs sorafenib were maintained in patients with ALBI grade 1 liver function.9
Median OS was longer with STRIDE than with sorafenib (23.4 vs 19.0 months), with a consistent reduction in the risk of death (HR 0.79) in this exploratory subgroup analysis.9
†OS HRs and CIs were calculated using a Cox proportional hazards model adjusting for treatment, aetiology, ECOG performance status, and macrovascular invasion.
[Data cut-off: 27th August, 2021]
OS rates were observed in the STRIDE and sorafenib groups in patients with ALBI grade 2/3 liver function.
In this exploratory analysis, median OS was longer with STRIDE than with sorafenib (11.3 vs 9.7 months), with a consistent reduction in the risk of death (HR 0.83).
†OS HRs and 95% CIs were calculated using a Cox proportional hazards model adjusting for treatment, etiology,ECOG performance status, and MVI.9
Due to small sample size, outcomes for the ALBI grade 3 subgroup (IMFINZI + IMJUDO, n=1; sorafenib, n=1) were combined with the ALBI grade 2 subgroup.9
Data cutoff: August 27, 2021.
Patients with cardiovascular or metabolic comorbidities experienced similar OS outcomes at 36 and 48 months with STRIDE compared with those without comorbidities.2
At both 36 and 48 months, OS was numerically higher with the STRIDE regimen versus sorafenib in patients with cardiovascular (32.9% vs 18.7% at 36 months; 28.0% vs 15.1% at 48 months) and metabolic comorbidities (25.7% vs 21.1% at 36 months; 20.4% vs 15.9% at 48 months).2
[Data cut-off date: 23rd January 2023]
This analysis was not formally tested for statistical significance
Table adapted from Rimassa L, et al. ESMO 20242
The STRIDE regimen offers a generally well-tolerated treatment option.1–3
Fewer treatment-related adverse events (TRAEs) were observed with STRIDE vs sorafenib: STRIDE n=294 (75.8%) vs sorafenib n=317 (84.8%)1
The most common adverse events reported in the STRIDE group (n=388) were rash (22.4%), pruritus (22.9%), diarrhoea(26.5%), hypothyroidism (12.1%), and fatigue (17%).1
TRAEs led to discontinuation in 13.7% (n=53) of patients treated with STRIDE vs 16.8% (n=23) with sorafenib.1
No new serious TRAEs occurred after the primary analysis for STRIDE.2
The majority of immune-mediated adverse events (imAEs) in the STRIDE arm that occurred (35.8%; n = 139/388) were of low grade (Grade 1 or 2) and generally manageable per treatment guidelines.1,3
| Any grade | Grade ≥3 | |
| STRIDE N=388 | 35.8% (n=139) | 12.6% (n=49) |
| Sorafenib N=374 | 8.0% (n=30) | 2.4% (n=9) |
Adapted from Abou-Alfa GK, et al. NEJM Evid. 2022.
Within the safety analysis set of the HIMALAYA study, the median duration of treatment for IMFINZI + IMJUDO (n=388) was 5.5 months (range, 0.4-42.7) and 4.1 months (range, 0.1-38.6) for sorafenib (n=374).
STRIDE is associated with imAEs, and various imAEs are special warnings for IMFINZI and IMJUDO. Routine monitoring of patients for signs and symptoms is advised.5,6
Please refer to the IMFINZI and IMJUDO SmPC’s for further information and guidance.
For patients who experienced an imAE with the STRIDE regimen, most imAEs occurred within the first 3 months of treatment (exploratory analysis).3
Most imAEs resolved with a median time to resolution of <60 days with appropriate management strategies.3
Adapted from Lau G, et al., 2023
The percentage of patients with an event is the number of patients who experienced ≥1 imAE at each time interval divided by the number of patients who experienced ≥1 imAE at any time; includes first imAE only, regardless of grade. Data cutoff:August 27, 2021.
The IMJUDO patient alert card is available to patients and carers to help them understand the risk of imAEs.
Please ensure all patients starting their first dose of IMJUDO (tremelimumab) are provided with a patient alert card to ensure they understand the risk of imAEs of this regimen.
GB-74004 | May 2026
Adverse events should be reported. Reporting forms and information can be found at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling 0800 783 0033.
This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.
GB-74216| DOP : February 2026
