LurbinectedinZEPZELCA
First-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with atezolizumab for patients who have not progressed on or after first-line induction therapy with atezolizumab, a platinum-based antineoplastic drug, and etoposide.
Decision on record
- Meeting Nov 2025 Not recommended Extensive-stage small cell lung cancer – maintenance treatment after induction therapy
Access path
- TGA registered · ZEPZELCA
TGA label narrower than the PBS population
- Nov 2025Recommended · restricted
vs atezolizumab monotherapy
- PBS listing · Authority Required
From the public summary
7.1 The PBAC did not recommend lurbinectedin, in combination with atezolizumab, for first-line maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC) in patients who have not progressed on or after first line induction therapy with atezolizumab, a platinum-based antineoplastic drug, and etoposide for listing on the PBS.PSD · Nov 2025
7.2 The PBAC considered that the primary reason for this outcome was the economic evaluation. The PBAC considered that the base case ICER of $115,000 to < $135,000 per quality adjusted life year (QALY) presented in the submission was high and likely underestimated.PSD · Nov 2025
6.35 The submission presented a stepped economic evaluation of lurbinectedin plus atezolizumab versus atezolizumab monotherapy as first-line maintenance treatment of ES-SCLC for patients who have not progressed following first-line induction therapy with atezolizumab, carboplatin and etoposide. The economic evaluation was based on the results of the IMforte trial, with additional modelled data.PSD · Nov 2025
6.37 Table 7 summarises the key components of the economic evaluation.PSD · Nov 2025
6.30 The submission described lurbinectedin plus atezolizumab as superior in terms of efficacy and inferior in terms of safety, compared to atezolizumab, as maintenance therapy in patients with ES-SCLC that has not progressed on or after first-line induction therapy with atezolizumab, a platinum-based antineoplastic drug, and etoposide.PSD · Nov 2025
6.31 The evaluation noted the following issues for consideration:PSD · Nov 2025
6.65 The submission stated that the sponsor is willing to enter into a risk sharing arrangement (RSA) for lurbinectedin in ES-SCLC. The submission noted that an RSA is currently in place for atezolizumab in ES-SCLC induction and maintenance therapy, with a cost-effectiveness-based expenditure cap (paragraphs 5.15 to 5.19 and 6.11, atezolizumab PSD, November 2019 PBAC meeting). For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2025
Cost-effectiveness
ICER value is redacted (represented as '****' in document)
Decision context
PopulationAdults with extensive-stage small cell lung cancer who have not progressed after first-line induction therapy with atezolizumab, a platinum-based antineoplastic drug, and etoposide, with ECOG PS 0-1; excludes patients with central nervous system metastases.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended · restricted | atezolizumab monotherapy | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| IMforte | Ph 3 | 660 | Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (… | active not recruiting |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to ECOG PS 0-1 and excludes CNS metastases; TGA label includes all extensive-stage SCLC patients without these performance or CNS restrictions.