Retifanlimab
Treatment of inoperable locally recurrent or metastatic squamous cell anal carcinoma (SCAC) not previously treated with systemic chemotherapy, in combination with carboplatin and paclitaxel.
Decisions on record
- Meeting Mar 2026 Recommended Squamous cell anal carcinoma (SCAC) no PSD
- Meeting Mar 2026 Recommended Merkel cell carcinoma (MCC) no PSD
- Meeting Nov 2025 Deferred Metastatic or recurrent locally advanced Merkel cell carcinoma not amenable to curative surgery or radiation
- Meeting Nov 2025 Deferred Inoperable locally recurrent or metastatic squamous cell anal cancer with chemotherapy (carboplatin and paclitaxel), treatment-naïve
Access path
- Nov 2025Deferred
Comparator changed: avelumab → carboplatin and paclitaxel (CP)
- Nov 2025Deferred
Comparator changed: avelumab → carboplatin and paclitaxel (CP)
- Mar 2026Recommended · restricted
Comparator changed: carboplatin and paclitaxel (CP) → avelumab
- Mar 2026Recommended · restricted
Comparator changed: carboplatin and paclitaxel (CP) → avelumab
- PBS listing · Authority Required
From the public summary
7.1 The PBAC deferred making a recommendation for the listing of retifanlimab for the treatment of metastatic or recurrent, locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation. The PBAC was of a mind to recommend retifanlimab pending the provision of a positive TGA Delegate’s Overview. The PBAC 31 OFFICIALPSD · Nov 2025
OFFICIAL Public Summary Document – November 2025 PBAC Meeting did not accept the clinical claim of superiority (in terms of effectiveness and safety) versus avelumab, but accepted that retifanlimab was likely to be non-inferior to avelumab for MCC. The PBAC considered retifanlimab would be cost effective with the same cost per 4 weekly treatment cycle as avelumab.PSD · Nov 2025
6.37 The submission presented a cost-utility analysis based on the results of the MAICs of POD1UM-201 (retifanlimab) and JM200 Part B (avelumab) to estimate the cost- 18 OFFICIALPSD · Nov 2025
OFFICIAL Public Summary Document – November 2025 PBAC Meeting effectiveness of retifanlimab, with the incremental cost per quality adjusted life year (QALY) gained as the main outcome of the evaluation.PSD · Nov 2025
6.31 The submission described retifanlimab as superior in terms of effectiveness compared to avelumab.PSD · Nov 2025
6.32 The ESC considered the claim of superior efficacy was not adequately supported by the clinical evidence presented in the submission as the results of the MAICs, particularly MAIC2, were highly uncertain and unreliable as differences which may not be treatment effect modifiers such as race were included, and likely biased in favour of retifanlimab.PSD · Nov 2025
6.2 The PBAC noted and welcomed the input from individuals (4), health care professionals (7) and organisations (5) via the Consumer Comments facility on the PBS website. The PBAC noted the advice received from Rare Cancers Australia, NeuroEndocrine Cancer Australia, Melanoma & Skin Cancer Advocacy network, Melanoma and Skin Cancer Trials Limited clarifying the likely use of retifanlimab in clinical practice.PSD · Nov 2025
6.3 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the retifanlimab submission, categorising it as one of the therapies of “high priority for PBS listing” on the basis of an objective response rate (ORR) of 55% in the POD1UM-201 trial.PSD · Nov 2025
Cost-effectiveness
ICER value redacted (shown as '&&&&' in the document); Special Pricing Arrangement applies.
Decision context
PopulationAdults with inoperable locally recurrent or metastatic squamous cell anal carcinoma (SCAC) not previously treated with systemic chemotherapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | avelumab | — | Single-arm · ORR |
| Mar 2026 | Recommended · restricted | placebo + carboplatin and paclitaxel (CP) | — | RCT · PFS |
| Nov 2025 | Deferred | avelumab | — | Single-arm · ORR |
| Nov 2025 | Deferred | carboplatin and paclitaxel (CP) | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| POD1UM-201 | Ph 2 | 107 | Objective Response Rate (ORR) | completed |
| POD1UM-303 | Ph 3 | 308 | Progression-free Survival (PFS) | completed |
Consumer voice
Healthcare professionals and organisations, including people living with advanced small cell anal cancer, highlighted the clinical need for new therapies due to limited effectiveness of current chemotherapy and significant impacts on quality of life including pain, fatigue, infertility, and financial distress. Input described potential benefits of retifanlimab including improved response rates and
People living with recurrent/metastatic disease described significant impacts on quality of life, including pain, fatigue, premature menopause, infertility, financial distress, and stigma. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify first-line treatment of inoperable locally recurrent or metastatic SCAC with carboplatin and paclitaxel in adults.