Durvalumab, Olaparib
Advanced, metastatic or recurrent endometrial cancer (dMMR population receiving durvalumab + platinum-based chemotherapy followed by maintenance durvalumab monotherapy; pMMR population receiving durvalumab + platinum-based chemotherapy followed by durvalumab + olaparib maintenance).
Decision on record
- Meeting Nov 2024 Recommended Advanced, metastatic or recurrent endometrial cancer
Access path
- Nov 2024Recommended · restricted
vs dMMR: dostarlimab + PC; pMMR: PC alone
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of durvalumab, in combination with platinum- based chemotherapy (paclitaxel + carboplatin, PC), for the treatment of deficient mismatch repair (dMMR) endometrial cancer (EC), on the basis that it should be available only under special arrangements under Section 100 (Efficient Funding of Chemotherapy). The PBAC accepted that durvalumab was non-inferior in terms of efficacy and safety compared with dostarlimab + PC.PSD · Nov 2024
7.2 The PBAC noted the comments from Rare Cancers Australia and Medical Oncology Group of Australia (MOGA) expressing their support for the submission.PSD · Nov 2024
6.62 The submission presented both a CMA (durvalumab + PC compared to dostarlimab + PC in dMMR EC) and a cost effectiveness analysis (durvalumab + PC + olaparib compared to PC in pMMR EC). CMA versus dostarlimab (dMMR)PSD · Nov 2024
6.63 Based on the results of the ITC, the submission concluded that durvalumab + PC is non- inferior in terms of efficacy and safety compared with dostarlimab + PC in dMMR EC patients. On this basis, the submission presented a CMA comparing durvalumab + PC with dostarlimab + PC in patients with dMMR EC, as outlined in Table 16. 33PSD · Nov 2024
Compared with PC alone, durvalumab + PC has: - superior efficacy; and - non-inferior safety.PSD · Nov 2024
Source: Table 1.1, p23 and Section 2.2.5, p52 of the submission.PSD · Nov 2024
6.2 The PBAC noted and welcomed the input from 3 organisations via the Consumer Comments facility on the PBS website. The PBAC noted the comment received from Royal Australian and New Zealand College of Obstetricians and Gynaecologists expressing support for listings that would help improve the affordability of medications available to women in Australia.PSD · Nov 2024
Additionally, patients who self-fund treatment experience an added financial burden.PSD · Nov 2024
Cost-effectiveness
For dMMR population, cost-minimisation analysis was used (no ICER). For pMMR population, the ICER is not explicitly stated in this public summary document.
Decision context
PopulationAdults with advanced, metastatic or recurrent endometrial cancer (either dMMR or pMMR) who have not received prior systemic therapy or whose disease progressed following adjuvant systemic therapy, with ECOG performance status 0-1, unsuitable for curative surgery or radiotherapy, and without prior PD-1/PD-L1 inhibitor treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | dMMR: dostarlimab + PC; pMMR: PC alone | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| DUO-E | Ph 3 | 805 | Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments | active not recruiting |
Consumer voice
Three organisations provided input supporting durvalumab listing, emphasizing improved affordability for women, demonstrated clinical benefits for endometrial cancer patients, and high unmet need for effective and tolerable treatment options with reduced toxicity compared to chemotherapy.
durvalumab is a targeted therapy with demonstrated clinical benefits Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naïve or adjuvant-progressive patients; TGA label does not explicitly require this treatment history.