TebentafuspKIMMTRAK
Treatment of HLA-A*02:01-positive adult patients with advanced (unresectable or metastatic) uveal melanoma.
Decisions on record
- Meeting Sep 2023 Recommended HLA-A*02:01-positive advanced uveal melanoma no PSD
- Meeting Mar 2023 Not recommended Advanced (unresectable or metastatic) human leukocyte antigen (HLA)-A*02:01-positive uveal melanoma
Access path
- TGA registered · KIMMTRAK
TGA label narrower than the PBS population
- Sep 2023Recommended · restricted
vs pembrolizumab
- PBS listing · Authority Required
From the public summary
The PBAC did not recommend tebentafusp for the treatment of HLA-A*02:01-positive adult patients with advanced (unresectable or metastatic) uveal melanoma (UM). The PBAC noted the unmet clinical need for new treatments in this setting and considered that tebentafusp was superior in terms of efficacy compared to pembrolizumab, but likely inferior in term of safety.PSD · Mar 2023
The PBAC considered that tebentafusp addressed a high and urgent unmet clinical 36PSD · Mar 2023
The submission presented a cost-utility analysis (CUA) comparing tebentafusp versus pembrolizumab. A summary of the model structure is presented in Table 9. 21PSD · Mar 2023
Outcomes LYs gained; QALYs gained Methods used to generate results Partitioned survival model Health states 3 mutually exclusive health states: pre-progression; post-progression; and death Cycle length One-week cycle Transition probabilities or The proportions of patients in each health state at each cycle are based on the OS and Allocation to health states (if PFS curves.PSD · Mar 2023
The submission described tebentafusp as superior in terms of effectiveness compared to pembrolizumab. The PBAC agreed with ESC and considered that this claim was adequately supported.PSD · Mar 2023
The submission described tebentafusp as non-inferior in terms of safety compared to pembrolizumab. The PBAC agreed with ESC and considered that this claim was not supported as tebentafusp was associated with:PSD · Mar 2023
The PBAC noted and welcomed the input from individuals (10), health care professionals (7) and organisations (6) via the Consumer Comments facility on the PBS website. The comments from individuals and health care professionals described the high clinical need for new UM treatments and the potential benefits of treatment with tebentafusp including an increased overall survival and improved quality of life.PSD · Mar 2023
The PBAC noted the advice received from the Melanoma and Skin Cancer Advocacy Network (MSCAN), Rare Cancers Australia, Australasian Ocular Melanoma Alliance (AOMA), Melanoma Patients Australia (MPA) and Ocumel Australia and New Zealand Support Group which outlined the high unmet clinical need for new UM treatments and stated that tebentafusp is a well tolerated treatment that improves prognosis and quality of life for patients.PSD · Mar 2023
Cost-effectiveness
ICER value is redacted; economic analysis section is incomplete in the provided text.
Decision context
PopulationAdults aged 18 years or older with HLA-A*02:01-positive advanced (unresectable or metastatic) uveal melanoma who have not received prior systemic therapy for metastatic disease, with ECOG performance status 0 or 1.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2023 | Recommended · restricted | pembrolizumab | — | RCT · OS |
Consumer voice
Consumer input from individuals, healthcare professionals, and patient advocacy organisations highlighted the high clinical need for new uveal melanoma treatments and reported that tebentafusp is well tolerated with benefits including increased overall survival and improved quality of life.
The comments from individuals and health care professionals described the high clinical need for new UM treatments and the potential benefits of treatment with tebentafusp including an increased overall survival and improved quality of life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naive patients with ECOG 0-1 performance status in first-line setting; TGA label has no such restrictions.