Aumolertinib plus chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 19 deletion or exon 21 L858R: a phase II trial.

BACKGROUND

To evaluate the efficacy and safety of aumolertinib combined with pemetrexed and carboplatin as first-line treatment in advanced non-small-cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation (exon 19 deletion or exon 21 L858R).

METHODS

In phase II trial (NCT04646824), patients received aumolertinib 110 mg once daily plus pemetrexed (500 mg/m2) and carboplatin (area under curve = 5) once every 3 weeks for 4 cycles, followed by maintenance aumolertinib (110 mg once daily) and pemetrexed (500 mg/m2 once every 4 weeks). The primary endpoint was progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.

RESULTS

From November 2020 to October 2021, 34 patients were included for analysis. The median PFS was 28.0 months (95% CI, 18.7-36.9). The ORR was 91.2% (31/34), and the DCR was 100%. The median OS was not reached. Of 28 patients with circulating tumor DNA (ctDNA) testing, 22 (78.6%) showed clearance of EGFR mutation after 2 or 4 cycles. The median PFS was 31 months in patients with EGFR mutation clearance in ctDNA, and the ORR of them was higher than those without EGFR mutation clearance in ctDNA (90.9% vs 33.3%). The most common grade ≥ 3 treatment-related adverse event was decreased neutrophil count (22 [64.7%]).

CONCLUSION

Aumolertinib plus chemotherapy shows potential as first-line treatment for patients with EGFR-mutant advanced NSCLC, which deserves to be investigated in randomized controlled trials. CtDNA clearance may be a prognostic marker.