Aumseqa

Aumseqa is proposed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations, and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. The EMA granted a paediatric waiver for Aumseqa. The regulatory procedure started on 1 December 2022.

In efficacy studies, Aumseqa demonstrated a median Progression-Free Survival (PFS) of 19.12 months, compared to 9.72 months for its comparator. The PFS Hazard Ratio for male subjects was 0.528, with a p-value of < 0.05. At 12 months, the PFS for Aumseqa was 69.56%, compared to 45.65% for the comparator. The median follow-up time for PFS was 20.50 months for Aumseqa and 20.70 months for the comparator.

Regarding safety, 25.2% of deaths in the aumolertinib arm were due to study discontinuation, compared to 32.1% in the gefitinib arm. Interstitial lung disease of any grade requires permanent discontinuation of Aumseqa. For QTc interval prolongation, specific actions are recommended, including withholding Aumseqa for up to 2 weeks depending on the severity. There have been 162 total post-marketing reports, with 344 total post-marketing events, of which 225 (65.4%) were non-serious.