DostarlimabJemperli
Treatment of primary advanced or first recurrent mismatch repair proficient (pMMR) endometrial cancer in combination with carboplatin and paclitaxel, in patients unsuitable for curative surgical resection or radiotherapy.
Decisions on record
- Meeting May 2025 Not recommended Primary advanced or first recurrent pMMR endometrial cancer
- Meeting Nov 2023 Recommended Primary advanced or first recurrent endometrial cancer (mismatch repair deficient)
- Meeting Mar 2023 Noted Endometrial cancer; recurrent or advanced mismatch repair deficient endometrial cancer
- Meeting Nov 2022 Not recommended Recurrent or advanced mismatch repair deficient endometrial cancer no PSD
- Meeting Mar 2022 Not recommended Endometrial cancer
Access path
- TGA registered · Jemperli
TGA label narrower than the PBS population
- Mar 2022Not recommended
vs Standard of care (SoC) comprising single-agent chemotherapy…
- ↻ resubmittedMar 2023Recommended · restricted
Comparator changed: Standard of care (SoC) comprising single-agent chemotherapy…
- Nov 2023Recommended · restricted
Comparator changed: Standard of care comprising single-agent chemotherapy and…
- May 2025Not recommended
Comparator changed: carboplatin-paclitaxel (chemotherapy alone) → carboplatin and…
From the public summary
7.1 The PBAC did not recommend the listing of dostarlimab (DOS) in combination with carboplatin and paclitaxel (CP) for the treatment of primary advanced or first recurrent (A/R) mismatch repair proficient (pMMR) endometrial cancer (EC).PSD · May 2025
7.2 The PBAC noted there was support from clinicians and consumer groups for dostarlimab to be used in the pMMR population, with MOGA providing strong support for its PBS listing, considering it high priority. The PBAC noted the TGA Delegate had concluded there was sufficient evidence to establish efficacy for dostarlimab plus carboplatin-paclitaxel followed by dostarlimab in the treatment of adult patients with primary advanced or recurrent pMMR EC.PSD · May 2025
6.45 The resubmission presented a stepped economic evaluation based on the RUBY trial.PSD · May 2025
The type of economic evaluation presented was a cost-utility analysis (CUA). The ESC considered a CUA would be reasonable, if the clinical claim was supported by PBAC.PSD · May 2025
6.39 The resubmission described that, in patients with primary advanced or first recurrent pMMR EC, DOS+CP was superior in terms of effectiveness compared with CP alone, based on the pMMR subgroup results of RUBY. The resubmission claimed that DOS+CP was inferior to CP alone but had a manageable safety profile based on the all-comer results of RUBY.PSD · May 2025
6.40 The therapeutic conclusion of superior effectiveness was not adequately supported by the evidence presented the resubmission and may not be applicable to the Australian population because:PSD · May 2025
6.3 Inherited Cancers Australia described the need for new treatments due to increasing incidence of endometrial cancer over the past 20 years. Further it noted that chemotherapy and its side effects are difficult for patients to manage. The PBAC noted that the input by Inherited Cancers incorrectly suggested data established improved overall survival in the pMMR subgroup.PSD · May 2025
6.4 Rare Cancers Australia described how patients are often diagnosed at a later stage which worsens their prognosis and noted that many patients report experiencing physical, emotional, social and financial strain from the disease. It was also noted that surgical treatment heavily affects quality of life and is associated with extensive recovery time.PSD · May 2025
Cost-effectiveness
ICER value is redacted/commercially sensitive; the document states the nominal ICER is similar to the November 2023 submission for dMMR but is not numerically disclosed.
Decision context
PopulationAdults with primary advanced or first recurrent pMMR endometrial cancer unsuitable for curative surgical resection or radiotherapy, either treatment-naïve or with recurrence/progression >6 months after prior neoadjuvant/adjuvant systemic therapy, and no prior PD-1/PD-L1 inhibitor treatment, with ECOG performance status ≤1.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2025 | Not recommended | carboplatin and paclitaxel alone | — | RCT · OS |
| Nov 2023 | Recommended · restricted | carboplatin-paclitaxel (chemotherapy alone) | — | RCT · OS |
| Mar 2023 | Recommended · restricted | Standard of care comprising single-agent chemotherapy and platinum-based chemotherapy | — | Single-arm · ORR |
| Mar 2022 | Not recommended | Standard of care (SoC) comprising single-agent chemotherapy (doxorubicin, paclitaxel) and platinum-based chemotherapy (c | — | Single-arm · ORR |
Clinical evidence
Consumer voice
Rare Cancers Australia highlighted the burden of multiple medical appointments and financial hardship for self-funding patients, emphasizing unmet need for more effective and less toxic treatment options. The Medical Oncology Group of Australia strongly supported dostarlimab as a highest-priority PBS listing based on clinical trial evidence.
patients living with endometrial cancer currently undergo a range of examinations, medical appointments and fertility treatments, and patients who self-fund treatment experience an added financial burden Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to pMMR only, first recurrence, surgical/radiation unsuitability, and specific prior therapy eligibility criteria not in TGA label.