Amivantamab And Lazertinib
First-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with evidence of activating epidermal growth factor receptor mutation (EGFRm), specifically exon 19 deletions or exon 21 L858R substitution mutations.
Decision on record
- Meeting Mar 2025 Not recommended Non-small cell lung cancer (NSCLC) with EGFR mutation, locally advanced or metastatic
From the public summary
7.1 The PBAC did not recommend the Section 100 (Efficient Funding of Chemotherapy Program) Authority Required listing of amivantamab and a General Schedule Authority Required listing for lazertinib used in combination for the first line treatment of patients with epidermal growth factor receptor mutated (EGFRm) locally advanced or metastatic (Stage IIIB-IV) non-small cell lung cancer (NSCLC).PSD · Mar 2025
7.2 The PBAC considered the primary reason for this outcome was due to the economic analysis provided in the submission. The PBAC also noted that the clinical place in therapy of A+L in EGFRm NSCLC (specifically exon 19 deletions or exon 21 L858R substitution) relative to osimertinib monotherapy and osimertinib in combination with chemotherapy required further consideration due to concerns regardingPSD · Mar 2025
6.40 The submission presented a stepped economic cost-effectiveness and cost-utility analysis, based on the direct randomised trial, MARIPOSA. A cost-utility analysis was appropriate given that the clinical claim of superior effectiveness was reasonable. The economic evaluation compared A+L with osimertinib for the first-line treatment of patients diagnosed de novo with locally advanced/metastatic EGFRm NSCLC.PSD · Mar 2025
6.41 The submission used a 15-year time horizon. The evaluation considered that this was not reasonable and may overestimate A+L benefits. The MARIPOSA trial had a median follow-up of 37.8 months in the December 2024 CCO (reported in the PSCR),PSD · Mar 2025
6.32 The submission claimed that treatment with A+L was superior in efficacy, in terms of PFS and OS, and inferior but manageable in safety compared to osimertinib. 26PSD · Mar 2025
6.33 The clinical efficacy claim was supported by statistically significant and clinically meaningful observed improvements in PFS (HR=0.70 [95% CI: 0.58, 0.85], p=0.0002) and OS (HR=0.77 [95% CI: 0.61, 0.96], p=0.02) for A+L patients compared to osimertinib; however, the ESC agreed with the evaluation that the magnitude of the OS benefit remains uncertain given that:PSD · Mar 2025
6.3 Rare Cancers Australia stated that the NSCLC patient population is faced with significant physical, psychological and financial challenges. The organisation stated that A+L has shown strong clinical results, with many patients reporting that their disease progression has slowed or halted.PSD · Mar 2025
6.4 Lung Foundation Australia wrote in support of A+L being listed on the PBS for NSCLC with EGFRm, noting the health, financial and social cost of lung cancer in patients who currently have low survival rates and limited treatment options available.PSD · Mar 2025
Cost-effectiveness
ICER value redacted or not stated in the provided text excerpt; the document appears truncated at section 3.7.
Decision context
PopulationAdult patients with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, treatment-naive or intolerant to prior EGFR-TKIs in the advanced/metastatic setting, WHO performance status ≤2.
Risk sharingSpecial Pricing Arrangement (SPA) applies to both amivantamab vial and lazertinib pack. ACM advised prophylactic anticoagulation for at least the first 4 months of therapy with ongoing anticoagulation at clinician discretion due to venous thromboembolism (VTE) risk.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Not recommended | osimertinib | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| MARIPOSA | Ph 3 | 1,074 | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors … | active not recruiting |
Consumer voice
Consumer input from 74 individuals, 3 healthcare professionals, and 3 organisations emphasised the high disease burden of NSCLC, variable effectiveness of existing treatments, and strong support for A+L access. Patients and carers highlighted that A+L could provide better symptom control and quality of life, though some experienced side effects; cost was identified as a significant access barrier.
Rare Cancers Australia stated that the NSCLC patient population is faced with significant physical, psychological and financial challenges. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naive or TKI-intolerant patients with WHO PS ≤2; TGA label has no such eligibility criteria.