OBJECTIVES: The proliferation of novel technologies for the diagnosis, treatment, and monitoring of cancer patients has led to a substantial increase in costs at every stage of their journey. This study aims to evaluate the suitability of new drug regimens for patients with EGFRm metastatic lung cancer in a Brazilian Oncology Care Network perspective.

METHODS: Value assessment tools in healthcare were utilized to evaluate the benefit of amivantamab plus chemotherapy for patients with metastatic lung cancer harboring EGFR mutations. The study focused on two patient groups: those with exon 19 deletion or L858R mutation who progressed after first-line therapy, based on data from the MARIPOSA-2 trial, and those with exon 20 insertion receiving first-line treatment, based on the PAPILLON trial. Additionally, metrics such as NNT-RAR and QALY were derived from published progression-free survival (PFS) and 12-month PFS.

RESULTS: Both the MARIPOSA-2 and PAPILLON trials achieved their primary endpoints, with PFS hazard ratios of 0.48 (95% CI 0.36-0.64; P<0.001) and 0.40 (95% CI 0.30-0.53; P<0.001), respectively. However, the ROB-2 assessment tool classified these trials as high risk of bias, particularly due to their open-label design. Furthermore, both trials received modest scores from ESMO (MCBS score 3) and ASCO (NHB 46.8 for MARIPOSA-2 and 43.3 for PAPILLON), with potential improvements in PAPILLON scores anticipated with longer follow-up. The NNT-RAR values were 12 for MARIPOSA-2 and 3 for PAPILLON. QALY values were calculated at 0.12 and 0.16, respectively.

CONCLUSIONS: The evaluation of amivantamab plus chemotherapy for EGFRm metastatic lung cancer within this context reveals significant limitations in the current assessment tools, such as the short follow-up duration and open-label designs of the trials. This underscores the urgent need for the development of more robust assessment methodologies to ensure reliable decision-making in the approval of cancer treatments, especially when based on interim trial data.