Treatment with aumolertinib was associated with prolonged survival in patients with advanced non-small cell lung cancer.
Compared to treatment with Iressa (gefitinib), aumolertinib demonstrated longer progression-free survival and was associated with less side effects in patients with advanced non-small cell lung cancer, according to study findings.
“Based on these results, we will pursue discussions with global regulatory authorities; we anticipate our development approach with facilitate a markedly less costly global access pricing structure,” said Shun Lu, from the Shanghai Lung Cancer Center, Shanghai Chest Hospital at Shanghai Jiao Tong University in China, during a presentation of the data at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.
Aumolertinib — an irreversible epidermal growth receptor factory (EGFR) tyrosine kinase inhibitor (TKI) — has already received regulatory approval in China for use in patients with EGFR-mutated non-small cell lung cancer when disease has progressed and has favorable pharmacologic properties that inhibit EGFR-sensitizing and resisting mutations.
The safety and efficacy of treatment with aumolertinib compared to Iressa was assessed in 429 patients across China who had previously untreated metastatic or locally advanced non-small cell lung cancer and whose disease expressed EGFR exon-19 deletion or L858R mutations.
Patients were randomly assigned to receive either aumolertinib, once per day at 110 mg (214 patients; median age, 59 years), or Iressa, once per day at 250 mg (215 patients; median age, 62 years). Measuring progression-free survival (time during and after treatment when the patient lives without disease progression) was the main goal of the study. Additional goals included investigating overall survival (time from diagnosis or treatment start when patients are alive), objective response rate (rate of a measurable response to the treatment), duration of response (length of time a tumor continues to respond to treatment without the cancer or tumor spreading) and safety.
Median progression free survival was significantly prolonged with aumolertinib at a median of 19.3 months compared with Iressa at 9.9 moths. Median duration of response followed a similar trend and was also significantly prolonged by treatment with aumolertinib at 18.1 months compared with Iressa at 8.3 months. Objective response rate was 73.8% with aumolertinib and 72.1% with gefitinib. And median overall survival was not yet reached.
Although patients in the aumolertinib group received treatment significantly longer than those in the Iressa group (463 days versus 254 days), they were less likely to experience side effects such as rash, diarrhea and liver damage/disease.
The most common side effects included liver damage, (63 patients in the aumolertinib group vs. 120 patients in the Iressa group), liver disease (64 patients vs. 116 patients, rash (50 patients vs. 89 patients), diarrhea (35 patients vs. 77 patients) and stress or injury to the muscle tissue, heart, or brain (76 patients vs. 20 patients).
Further research involving aumolertinib in combination with chemotherapy and other therapies in an adjuvant setting in resected EGFR-mutated non-small cell lung cancer are either ongoing or planned, according to Lu.
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