(San Diego, Calif.--September 9, 2024, 10:05 a.m.) -- The epidermal growth factor receptor tyrosine kinase inhibitor aumolertinib demonstrated improved progression-free survival compared to placebo without any significant new adverse reactions, according to data from the POLESTAR study presented today at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer.
Consolidation therapy with durvalumab is established as the standard of care for patients who do not experience disease progression following concurrent chemoradiotherapy. However, it is unknown what the specific benefit is of consolidation immunotherapy for patients with EGFR-mutant non-small cell lung cancer.
To address this, Dr. Xiangjiao Meng of the Shandong Cancer Hospital and Institute, Shandong First Medical University, China and colleagues randomized 147 patients -- 94 received aumolertinib and 53 were given a placebo. To be included in the trial, patients had EGFRm (Ex19del or L858R) unresectable stage III NSCLC and had not progressed after cCRT/sequential CRT (sCRT). The primary endpoint was progression-free survival and secondary endpoints included overall survival, other efficacy endpoints and safety.
Median follow-up was 16.36 months (range 0-33.2) for patients treated with aumolertinib and 13.93 months for those who received a placebo.
Dr. Meng and his colleagues found that patients in the aumolertinib arm had a longer progression-free survival than patients randomized to the placebo group. Median PFS by BICR was 30.4 months for patients treated with aumolertinib compared with 3.8 months for patients in the placebo group (HR 0.200, p<0.0001).
Dr. Meng reported that median overall survival (9.8% maturity for aumolertinib and 6.0% maturity for placebo) were not reached in either group. All causality adverse events were reported in 98% vs 89% patients, with radiation pneumonitis reported in 45% in aumolertinib compared to 30% for placebo. The most common ≥ Grade 3 treatment-related adverse event was blood creatine phosphokinase increased, 6.4% vs 0% for aumolertinib and placebo.
"These findings suggest that aumolertinib may represent a novel treatment option as maintenance therapy for patients with unresectable stage III EGFRm NSCLC after the CRT," said Dr. Meng.
About the IASLC:
The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association's membership includes more than 10,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies. Visit www.iaslc.org
