Posted: Monday, March 14, 2022
According to phase I/II study findings presented in Clinical Cancer Research, a 300-mg dose of the EGFR tyrosine kinase inhibitor (TKI) abivertinib given twice daily may result in favorable clinical efficacy with manageable side effects for patients with EGFR T790M–mutant non–small cell lung cancer (NSCLC). Yi-Long Wu, MD, of the Guangdong Lung Cancer Institute at the Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China, and colleagues further confirmed the positive clinical outcomes of abivertinib for patients with EGFR T790M–resistant mutations.
“Whether the clinical benefits to abivertinib can be expanded in patients with EGFR TKI–naive advanced NSCLC will be evaluated in a randomized trial in comparison with gefitinib,” the authors wrote.
In this trial to establish the recommended phase II dose in phase I and evaluate the safety and efficacy of abivertinib in patients with EGFR T790M–mutant NSCLC, the authors enrolled 367 Chinese patients. In phase I, patients received from 50 to 300 mg of abivertinib twice daily continually for 28-day cycles. The recommended phase II dose of 300 mg twice daily was used during phase II in continual 21-day cycles. During this phase, 227 patients received the recommended phase II dose, for a median treatment duration of 24.6 weeks.
Among 209 response-evaluable patients, the confirmed overall response rate was 52.2%, and the disease control rate was 88.0%. The median duration of response for these patients was 8.5 months, with a progression-free survival of 7.5 months. Patients had a median overall survival of 24.9 months.
Including the entire pool of patients in phase II, all 227 reported at least one adverse event, 220 (96.9%) of which were related to treatment. Treatment-related serious adverse events were reported in 13.7% of patients. Of the group, 10 patients (4.4%) died, although none of the deaths were determined to be treatment-related.
Disclosure: For full disclosures of the study authors, visit clincancerres.org.