KEY TAKEAWAYS
- The POLESTAR phase III trial aimed to assess tthe efficacy and safety of aumolertinib maintenance therapy after chemoradiotherapy in patients with unresectable stage III EGFRm NSCLC.
- The primary endpoint was PFS.
- Researchers found aumolertinib significantly improved PFS over placebo, potentially becoming a new standard for stage III EGFRm NSCLC.
The standard of care (SOC) for patients with unresectable stage III non-small-cell lung cancer (NSCLC) who do not progress after concurrent chemoradiotherapy (cCRT) includes consolidation therapy with durvalumab. However, the benefit of this immunotherapy for patients with EGFR-mutant (EGFRm) NSCLC is uncertain. Aumolertinib, a third-generation EGFR tyrosine kinase inhibitor (TKI), has shown efficacy in first- and second-line treatment of EGFRm NSCLC and is approved for use in China.
J. Yu and the team aimed to investigate the efficacy and safety of aumolertinib maintenance therapy following CRT in patients with stage III, unresectable EGFRm NSCLC. This interim analysis presented the efficacy and safety data from the trial.
Patients with EGFRm (Ex19del or L858R) unresectable stage III NSCLC who had not progressed following cCRT or sequential CRT (sCRT) were randomized 2:1 to receive aumolertinib (110 mg daily orally) or placebo until disease progression as per RECIST v1.1. The primary endpoint was progression free survival (PFS) assessed by blinded independent central review (BICR). Secondary endpoints included overall survival (OS), other efficacy endpoints, and safety.
As of February 5, 2024, 147 patients were enrolled in China, with 94 assigned to aumolertinib and 53 to placebo. Baseline characteristics were well balanced. Aumolertinib significantly improved PFS compared to placebo (HR 0.20, 95% CI 0.11, 0.35; P<0.0001). Median PFS was 30.4 months for aumolertinib versus 3.8 months for placebo. PFS benefit was consistent across predefined subgroups.
The most common grade ≥ 3 treatment-related adverse event (TRAE) was increased blood creatine phosphokinase, occurring in 6.4% of aumolertinib recipients versus 0% of placebo recipients. All other grade ≥ 3 TRAEs were reported in less than 2% of patients in both groups.
Aumolertinib demonstrated significant improvement in PFS compared to placebo without new safety signals. These findings suggested that aumolertinib is a promising treatment option as maintenance therapy for patients with unresectable stage III EGFRm NSCLC after CRT.
The trial was sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.
Source: https://cattendee.abstractsonline.com/meeting/20598/presentation/3201
Clinical Trial: https://clinicaltrials.gov/study/NCT04951635
Yu J, Meng X, Ge H, et al. (2024). “Aumolertinib maintenance after chemoradiotherapy in stage III non-small-cell lung cancer: interim results of the phase III study (POLESTAR).” Presented at: World Conference on Lung Cancer (WCLC); September 8, 2024; Singapore
