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
ICER dropped $95,000 → $75,000 (-21%)
- Mar 2026Recommended · restricted
ICER dropped $95,000 → $75,000 (-21%)
- 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 · Mar 2026
7.2 The PBAC considered there is a small unmet clinical need for the first line treatment of metastatic MCC, noting there are currently other treatment options including avelumab and chemotherapy. The PBAC noted that the listing of retifanlimab may improve access for rural and regional patients given its less frequent and faster administration compared with avelumab.PSD · Mar 2026
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 · Mar 2026
6.38 However, the ESC considered the presented clinical evidence was insufficient to support a claim of superiority for retifanlimab versus avelumab, and therefore the presented cost-utility analysis was not reasonable or informative.PSD · Mar 2026
6.31 The submission described retifanlimab as superior in terms of effectiveness compared to avelumab.PSD · Mar 2026
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 · Mar 2026
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 · Mar 2026
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 · Mar 2026
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 | $55k–75k | Single-arm · ORR |
| Mar 2026 | Recommended · restricted | placebo + carboplatin and paclitaxel (CP) | $75k–95k | RCT · PFS |
| Nov 2025 | Deferred | avelumab | — | Single-arm · ORR |
| Nov 2025 | Deferred | carboplatin and paclitaxel (CP) | $75k–95k | 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.