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Imfinzi (durvalumab) UK Prescribing Information
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  • Home | DUO-E (Imfinzi (durvalumab) & Lynparza (olaparib))
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Efficacy and safety| DUO-E (Imfinzi (durvalumab) & Lynparza (olaparib))

Clinical trials

 

The Imfinzi + Lynparza regimen offers a PFS of 15 months (vs 9.7 months in placebo arm) for advanced and recurrent pMMR endometrial cancer (P-value not tested)

DUO-E study design Efficacy Safety

DUO-E is a global, randomised, double-blind, Phase III study investigating the efficacy and safety of the addition of IMFINZI (durvalumab) followed by IMFINZI® (durvalumab) with or without LYNPARZA® (olaparib) to carboplatin and paclitaxel for newly diagnosed advanced/recurrent endometrial cancer across all histologies, including carcinosarcomas (except sarcomas).

DUO-E study design1

overview of study design of DUO-E

Patients were stratified by 3 key factors1

details about stratification factors in DUO-E details about stratification factors in DUO-E
details about stratification factors in DUO-E

detailed table on patient population in each arm in DUO-E

EFFICACY

Imfinzi® + Lynparza® Regimen

pMMR prespecified exploratory subgroup analysis1,2

 PFS KM curve for Imfinzi + lynparza regimen in pMMR arEC

Adapted from Westin SN, et al; 2024

'PFS  outcome across pMMR arEC subgroups

OS in patients with pMMR arEC (80% of ITT population)

'OS KM curve on Imfinzi + lynparza regimen in pMMR arEC

Duration of response in patients with pMMR arEC

'duration of response KM curve on Imfinzi + lynparza regimen in pMMR arEC

ORR in patients with pMMR arEC

'Objective repsonse rate KM curve on Imfinzi + lynparza regimen in pMMR arEC

Imfinzi Regimen

dMMR prespecified exploratory subgroup analysis

Broadening horizons for your dMMR arEC patients with more time progression-free (p-value not tested)

' PFS KM curve for Imfinzi regimen in dMMR arEC

Adapted from Westin SN, et al; 2024.

OS in patients with dMMR arEC (20% of ITT population)

'OS KM curve on Imfinzi regimen in dMMR arEC

Duration of response in patients with dMMR arEC

'duration of response KM curve on Imfinzi regimen in dMMR arEC

ORR in patients with pMMR arEC

'Objective repsonse rate KM curve on Imfinzi regimen in dMMR arEC

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Safety Profile

The IMFINZI® + CP with or without LYNPARZA® regimens were generally well tolerated and adverse events remain consistent with the established safety profiles of the individual components.

'safety profile of regimens across all study arms, induction and maintenance phase

Adverse events of special interest

Immune-mediated adverse reactions are special warnings for Imfinzi. MDS/AML and pneumonitis are special warnings for Lynparza. Pure red cell aplasia and autoimmune haemolytic anaemia are special warnings for the Lynparza and Imfinzi regimen. Please refer to the relevant Summary of Product Characteristics before prescribing to help minimise the risks associated with the use of the combination

 

No cases of myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML)1

'table on adverse events of special interest for Imfinzi and Lynparza

* MDS/AML and new primary malignancies include AEs from first dose of investigational product (durvalumab/placebo or olaparib/placebo) until the end of the study (includes cases reported beyond the safety follow-up period). †Excludes one event of basal cell carcinoma. ‡Grouped term; includes pneumonitis, bronchiolitis and interstitial lung disease.

PRCA and/or AIHA have been reported with the LYNPARZA® + IMFINZI® Regimen
In the DUO-E study:

  • PRCA: three (1.6%) cases (Grade 3) with LYNPARZA® + IMFINZI® Regimen,§no cases with IMFINZI® Regimen or CP alone
  • AIHA: two (<1%) cases with LYNPARZA® + IMFINZI® Regimen, one (<1%) case with IMFINZI® Regimen (all Grade 3)

AE, adverse events; AIHA, autoimmune haemolytic anaemia; AML, acute myeloid leukaemia; CP, carboplatin/paclitaxel; MDS, myelodysplastic syndrome; PRCA, pure red cell aplasia.

§During maintenance phase or the follow-up period; one patient discontinued study treatment.3

'short overview of efficacy and safety of Imfinzi(+lynparza) regimen for arEC cancer

Comparable rates of AE-related discontinuation to CP alone

comparable-rate-one
comparable-rate-two
comparable-rate-three
comparable-rate-four

Both regimens generally well tolerated, with comparable rates of AE-related discontinuation to CP aline (ITT data)1

24.4% patients on IMFINZI® + LYNPARZA® discontinued treatment due to AEs (vs 18.6% on CP alone)
20.9% patients on IMFINZI® discontinued treatment due to AEs (vs 18.6% on CP alone)

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

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Abbreviations:

CP: Carboplatin & Paclitaxel, arEC: advanced and recurrent endometrial cancer, d/pMMR: deficient/proficient mismatch repair, mPFS: median progression free survival, HR: Hazard Ratio, AE: adverse event, ORR: Objective response rate, HRR: homologous recombination repair, ITT: intention to treat

  1. Westin SN et al. J Clin Oncol 2024;42:283–299.
  2. Chon HS, et al. SGO Annual Meeting on Women’s Cancer 16–18 March 2024. San Diego, USA. Oral presentation.
  3. IMFINZI® (durvalumab) Summary of Product Characteristics.
  4. Baurain J-F, et al. SGO Annual Meeting on Women’s Cancer 16–18 March 2024. San Diego, USA. Oral presentation.
  5. Westin SN et al. J Clin Oncol 2024;42:283–29. Supplementary appendix.
Indication
  • IMFINZI in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by treatment with:
    • IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)
    • IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).
  • Lynparza in combination with durvalumab is indicated for the maintenance treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair proficient (pMMR) whose disease has not progressed on first-line treatment with durvalumab in combination with carboplatin and paclitaxel.

GB-68805 | DOP: September 2025

Adverse events should be reported. Reporting forms and information can be found at 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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