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IMFINZI (durvalumab) UK Prescribing Information
IMJUDO (tremelimumab) ▼ UK Prescribing Information
Adverse Event Reporting

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Why STRIDE?

 

Find your STRIDE

with the only 1L uHCC treatment regimen with up to 5-year phase 3 long-term OS data1,2

 

(STRIDE = Single Tremelimumab Regular Interval Durvalumab)

UK Therapeutic Indications:

IMFINZI (durvalumab): IMFINZI in combination with tremelimumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).3

IMJUDO (tremelimumab): IMJUDO in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).4

5 reasons to prescribe STRIDE: The only 1L uHCC treatment regimen with up to 5-year phase 3 long-term OS data1,2

STRIDE (Single Tremelimumab Regular Interval Durvalumab) offers a dual IO regimen with a single priming dose of IMJUDO (tremelimumab) anti–CTLA-4 therapy with IMFINZI (durvalumab) anti-PD-L1 therapy, followed by IMFINZI monotherapy every four weeks to enhance the antitumour response.3-5

STRIDE met the primary endpoint of statistically significant improvement in overall survival versus sorafenib during the HIMALAYA trial*.

  • In the ITT population, OS rates were statistically significantly higher with STRIDE (30.7%) vs with Sorafenib (20.2%) at 3 years. [HR: 0.78, 96.02% CI, 0.65-0.93; P=0.0035]5

1 in 5 patients were alive at 5 years with STRIDE (19.6%) vs 1 in 10 with sorafenib (9.4%) – demonstrated in the longest planned follow up phase 3 study in uHCC so far.1

Exploratory analysis; Not formally tested for statistical significance.1

STRIDE OS improvement was observed across most subgroups, including cardiovascular and metabolic comorbidities vs sorafenib.1,6

(Exploratory analysis; OS subgroup analysis was not formally tested for statistical significance).

 

The incidence, frequency, and severity of the adverse events for STRIDE and IMFINZI were consistent with the known safety profiles of each agent, and no new safety signals were identified.5

 

The majority of imAEs that occurred in the STRIDE arm were of low grade (Grade 1 or 2).5

  • The incidence of any grade imAE was 35.8% in the STRIDE arm (n=388) vs. 8.0% in the sorafenib arm (n=374).5

Please refer to the SmPC for further information
to minimise the risks associated with the use of these medicines before making any prescribing decisions.

*HIMALAYA was a global, randomised, open-label, multi-centre, Phase III trial evaluating Imfinzi (durvalumab) monotherapy and the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab) versus sorafenib. The trial included a total of 1171 patients with unresectable hepatocellular carcinoma who had notreceived prior systemic treatment. Patients were randomly assigned to one of three treatment arms: tremelimumab (300 mg, one dose) in combination with durvalumab (1500 mg, one dose) followed by durvalumab (1500mg, every 4 weeks), durvalumab monotherapy, or sorafenib (400 mg twice daily). The primary endpoint was overall survival for STRIDE versus sorafenib. Overall survival was defined as time from date of randomisation until death from any cause.5

1L, first line; CTLA-4, cytotoxic T lymphocyte-associated protein 4; IO, immunotherapy; OS, overall survival; PD-L1, programmed death ligand 1; STRIDE, single tremelimumab regular interval durvalumab; TRAE, treatment-related adverse event; uHCC, advanced or unresectable hepatocellular carcinoma; SmPC, summary of product characteristics; HR, hazard ratio; CI, confidence interval; imAE, immune-mediated adverse event.

  1. Rimassa L, et al. Poster presented at ESMO 2024. Barcelona, Spain. Presentation #947MO.
  2. Data on file, REF-196190, AstraZeneca Pharmaceuticals LP.
  3. IMFINZI, Summary of Product Characteristics.
  4. IMJUDO, Summary of Product Characteristics.
  5. Abou-Alfa GK, et al. NEJM Evid. 2022;1(8) (including Supplementary Appendix and Protocol).
  6. Lau G, et al. Poster presented at ASCO 2023. Chicago, IL.

GB-68076 | July 2025

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.

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