ZolbetuximabVyloy
First-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumours are CLDN18.2-positive.
Decisions on record
- Meeting Sep 2025 Recommended Gastric or gastroesophageal junction cancer (locally advanced/metastatic, HER2-negative, CLDN18.2-positive) first-line with chemotherapy no PSD
- Meeting Mar 2025 Deferred Gastric or gastroesophageal junction cancer, locally advanced unresectable or metastatic, HER2-negative, CLDN18.2-positive
Access path
- TGA registered · Vyloy
TGA label narrower than the PBS population
- Mar 2025Recommended · restricted
vs nivolumab in combination with fluoropyrimidine- and…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC deferred making a recommendation for the listing of zolbetuximab with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (G/GOJ) adenocarcinoma whose tumours are CLDN18.2- positive (CLDN18.2+).PSD · Mar 2025
7.2 The PBAC considered that there is a moderate clinical need for new treatments for advanced G/GOJ as there are few effective treatment options for this population and the associated prognosis is poor.PSD · Mar 2025
6.53 The submission presented a CMA comparing zolbetuximab + chemotherapy with CLDN18 testing, to nivolumab + chemotherapy with no testing, based on the claim of noninferior efficacy and safety. The CMA was based on the published price of nivolumab + chemotherapy.PSD · Mar 2025
6.54 The equi-effective doses were estimated in the submission as: 32 OFFICIALPSD · Mar 2025
chemotherapy is noninferior compared to no testing and nivolumab in combination with chemotherapy in terms of efficacy, with different but manageable safety profile Source: Table 1-1, pp25-26 of the submission.PSD · Mar 2025
Italics added during evaluation based on the Table 1, p2 of the MSAC 1767 Ratified PICO Confirmation, April 2024 PASC Meeting. 2 OFFICIALPSD · Mar 2025
6.2 The PBAC noted and welcomed the input from health care professionals (1), and organisations (3) via the Consumer Comments facility on the PBS website. The comments described the poor prognosis for the proposed population and considered it valuable to have an additional treatment option for these patients.PSD · Mar 2025
6.4 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the zolbetuximab submission, categorising it as one of the therapies of “highest priority for PBS listing” on the basis of the SPOTLIGHT trial.PSD · Mar 2025
Cost-effectiveness
Cost-minimisation analysis (CMA) submitted; no ICER calculated.
Decision context
PopulationPatients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumours (≥75% of tumour cells demonstrating moderate to strong membranous CLDN18 IHC staining) with WHO performance status no higher than 1, untreated with PD-1/PD-L1 inhibitor therapy for gastro-oesophageal cancer.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended · restricted | nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy | — | RCT · OS |
Clinical evidence
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| Immunohistochemistry testing for Claudin 18.2 (CLDN18.2) expression | Claudin 18.2 (CLDN18.2) expression | supported | 2025 |
Consumer voice
Healthcare professionals and organisations, including Rare Cancers Australia and Pancare, welcomed zolbetuximab as an additional treatment option for patients with advanced gastric cancer and poor prognosis, noting improved progression-free and overall survival compared to chemotherapy alone.
the use of zolbetuximab may provide another treatment option for this small population of patients with advanced disease and poor prognosis Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status ≤1 and excludes prior PD-1/PD-L1 inhibitor therapy; TGA label has no such restrictions.