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REAL-WORLD ANALYSIS: IMFINZI + GEM-CIS vs GEM-CIS

REAL-WORLD ANALYSIS CONSISTENT WITH TOPAZ-1 KEY FINDINGS2,3

Retrospective analysis was not part of TOPAZ-1 and cannot be used to draw comparative conclusions3

IMFINZI + gem-cis: Real-world benefit in OS beyond gem-cis3*
*Median overall survival 15.1 months with IMFINZI + gem-cis vs 11.1 months with gem-cis alone (HR 0.59; 95% CI 0.47–0.74; P<0.0001 descriptive only)3

Adapted from Rimini M, et al. 2024.3 At data cutoff (April 1, 2024), the median duration of follow-up was 8.5 months (95% CI 7.9–9.5), 350 patients (52.5%) discontinued the treatment due to disease progression, and 200 patients (30.0%) died. †Survival curves were estimated using the product-limit method of Kaplan-Meier, reported as median values with 95% confidence interval. ‡Confidence intervals are estimated from the visual data shown in Kaplan-Meier curves.3

REAL-WORLD GLOBAL RETROSPECTIVE ANALYSIS: Conducted to evaluate the use of first-line IMFINZI + gem-cis in patients with unresectable, locally advanced or metastatic BTCs, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer. Patients receiving IMFINZI 1500 mg Q3W for up to 8 cycles with gem-cis followed by IMFINZI 1500 mg Q4W until disease progression or unacceptable toxicity (n=666) were enrolled between 2022 and 2024 at study sites in Italy, Germany, Austria, Spain, UK, US, South Korea, China, Hong Kong, Japan and Belgium. Patients receiving gem-cis Q3W up to 8 cycles (n=213) were enrolled between 2016 and 2022 at study sites in Italy. Primary endpoint was OS.3

REAL-WORLD ANALYSIS CONSISTENT WITH TOPAZ-1 KEY FINDINGS2,3

Retrospective analysis was not part of TOPAZ-1 and cannot be used to draw comparative conclusions3

IMFINZI + gem-cis: Real-world benefit in PFS beyond gem-cis3*
*Median progression-free survival survival 8.2 months with IMFINZI + gem-cis vs 6.0 months with gem-cis alone (HR 0.57; 95% CI 0.47–0.69; P<0.0001 descriptive only)3

Adapted from Rimini M, et al. 2024.3 †Survival curves were estimated using the product-limit method of Kaplan-Meier, reported as median values with 95% confidence interval. ‡Confidence intervals are estimated from the visual data shown in Kaplan-Meier curves.3

REAL-WORLD GLOBAL RETROSPECTIVE ANALYSIS: Conducted to evaluate the use of first-line IMFINZI + gem-cis in patients with unresectable, locally advanced or metastatic BTCs, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer. Patients receiving IMFINZI 1500 mg Q3W for up to 8 cycles with gem-cis followed by IMFINZI 1500 mg Q4W until disease progression or unacceptable toxicity (n=666) were enrolled between 2022 and 2024 at study sites in Italy, Germany, Austria, Spain, UK, US, South Korea, China, Hong Kong, Japan and Belgium. Patients receiving gem-cis Q3W up to 8 cycles (n=213) were enrolled between 2016 and 2022 at study sites in Italy. Primary endpoint was OS.3

WITHIN THE REAL-WORLD ANALYSIS, ORR WAS 32.6% WITH IMFINZI + GEM-CIS AND 25.6% WITH GEM-CIS (not significant)3

Disease control rate was higher with IMFINZI + gem-cis vs gem-cis alone: 77.8% vs 59.2%, P<0.000001. Disease control rate was defined as the proportion of patients who achieved ORR or stable disease3

Real-world analysis: IMFINZI + gem-cis response to treatment3

By investigator assessment. Adapted from Rimini M, et al 2024.3

REAL-WORLD GLOBAL RETROSPECTIVE ANALYSIS: Conducted to evaluate the use of first-line IMFINZI + gem-cis in patients with unresectable, locally advanced or metastatic BTCs, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer. Patients receiving IMFINZI 1500 mg Q3W for up to 8 cycles with gem-cis followed by IMFINZI 1500 mg Q4W until disease progression or unacceptable toxicity (n=666) were enrolled between 2022 and 2024 at study sites in Italy, Germany, Austria, Spain, UK, US, South Korea, China, Hong Kong, Japan and Belgium. Patients receiving gem-cis Q3W up to 8 cycles (n=213) were enrolled between 2016 and 2022 at study sites in Italy. Primary endpoint was OS.3

REAL-WORLD SAFETY PROFILE CONSISTENT WITH THE KNOWN SAFETY PROFILE OF IMFINZI2,3

Retrospective analysis was not part of TOPAZ-1 and cannot be used to draw comparative conclusions. Most treatment-related AEs were represented by typical chemotherapy-related toxicities. All 650 patients in safety analysis had received IMFINZI + gem-cis3

Real-world analysis: IMFINZI + gem-cis response to treatment3

In patients receiving IMFINZI + gem-cis:3

  • Grade ≥3 AEs occurred in 46.6% of patients
  • Most common Grade ≥3 toxicities (observed in >5% of patients) were neutropenia (23.6%), thrombocytopenia (9.0%), leukopenia (6.8%), anaemia (6.5%), cholangitis (5.4%) Discontinuation rate due to AEs was 1.5%
  • Most common AEs (>30%) were fatigue (55.0%), neutropenia (47.7%), anaemia (46.8%), thrombocytopenia (39.2%), leukopenia (33.7%), nausea (32.8%) Treatment-related AEs leading to death were reported in 0.5% of patients none of which were related to immunotherapy
  • Most immune-mediated AEs were Grade 1 or 2
  • Grade 3/4 immune-mediated AEs occurred in 2.5% of patients

REAL-WORLD GLOBAL RETROSPECTIVE ANALYSIS: Conducted to evaluate the use of first-line IMFINZI + gem-cis in patients with unresectable, locally advanced or metastatic BTCs, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer. Patients receiving IMFINZI 1500 mg Q3W for up to 8 cycles with gem-cis followed by IMFINZI 1500 mg Q4W until disease progression or unacceptable toxicity (n=666) were enrolled between 2022 and 2024 at study sites in Italy, Germany, Austria, Spain, UK, US, South Korea, China, Hong Kong, Japan and Belgium. Patients receiving gem-cis Q3W up to 8 cycles (n=213) were enrolled between 2016 and 2022 at study sites in Italy. Primary endpoint was OS.3

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AE, adverse event; BTC, biliary tract cancer; CI, confidence interval; gem-cis, gemcitabine-cisplatin; HR, hazard ratio; mPFS, median progression-free survival; mOS, median overall survival; mo, months; ORR, overall response rate; OS, overall survival; Q3W, every 3 weeks; Q4W, every 4 weeks; RWE, real-world evidence.

References: 1. IMFINZI® Approved Product Information. 2. Oh DY et al. N Engl J Med 2022;1(8):DOI: 10.1056/EVIDoa2200015 (including Supplementary Appendix). 3. Rimini M et al. Eur J Cancer 2024;208:114199.

IMFINZI® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com.

IMFINZI
IMFINZI

PBS Information: Authority required (STREAMLINED) for NSCLC. Refer to PBS Schedule for full authority information.

PLEASE CLICK HERE TO REVIEW FULL PRODUCT INFORMATION BEFORE PRESCRIBING.
FURTHER INFORMATION AVAILABLE ON REQUEST FROM ASTRAZENECA ON 1800 805 342.

▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information.
Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

AE: adverse event; BICR: Blinded Independent Central Review; CI: confidence interval; CRT: chemoradiation therapy; HR: hazard ratio; irAE: immune-related adverse event; NSCLC: non-small cell lung cancer; OS: overall survival; PFS: progression-free survival; RECIST: Response Evaluation Criteria in Solid Tumors.

References: 1. Girard N, et al. J Thorac Oncol 2023;18:181-193. 2. Spigel DR, et al. J Clin Oncol 2022;1301-1311. 3. Antonia SJ, et al. N Engl J Med 2017;377:1919-1929. IMFINZI® is a registered trademark of the AstraZeneca group of companies. Registered user AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park, NSW 2113. https://www.astrazeneca.com.au. For Medical Information enquiries or to report an adverse event or product quality complaint: Telephone 1800 805 342 or via https://contactazmedical.astrazeneca.com or email Medical Information enquiries to medinfo.australia@astrazeneca.com. AU-15640 ASTR0828/EMBC Date of preparation: January 2023.
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