Aumolertinib a win in EGFR T790M-positive advanced NSCLC

The novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) aumolertinib appears to be effective in the treatment of patients with EGFR T790M-positive advanced nonsmall cell lung carcinoma (NSCLC) following progression on first- and second-generation EGFR TKI therapy, according to data from the phase II APOLLO Registrational Trial.

APOLLO included 244 treatment-experienced patients with locally advanced or metastatic NSCLC harbouring an EGFR T790M mutation. These patients were treated with aumolertinib at 110 mg orally once-daily after progression on first- or second-generation EGFR TKI therapy.

The primary endpoint of objective response rate (ORR), as assessed by an independent central review, was 68.9 percent (95 percent confidence interval [CI], 62.6–74.6). The disease control rate was 93.4 percent (95 percent CI, 89.6–96.2), and the median duration of response was 15.1 months (95 percent CI, 12.5–16.6). Treatment yielded a median progression-free survival of 12.4 months (95 percent CI, 9.7–15.0).

Results for the 23 patients with assessable central nervous system (CNS) metastases were consistent with the overall population. The CNS-ORR was 60.9 percent (95 percent CI, 38.5–80.3), while the CNS-disease control rate was 91.3 percent (95 percent CI, 72.0–98.9). The median CNS-duration of response was 12.5 months (95 percent CI, 5.6–not reached).

Aumolertinib was well tolerated, with treatment-related adverse events (AEs) of grade 3 or higher occurring in 16.4 percent of the patients overall. The most frequent AEs were elevations in blood creatine phosphokinase level (7 percent) and alanine aminotransferase level (1.2 percent).

The drug had a relative dose density of 99.2 percent.

The findings of APOLLO served as the basis of aumolertinib’s approval for the treatment of patients positive with EGFR T790M-positive NSCLC in China.