In a recent study, researchers evaluated the safety and efficacy of first-line rezivertinib (BPI-7711), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in the treatment of patients with locally advanced, metastatic, or recurrent EGFR-mutated non-small cell lung cancer (NSCLC).
According to the study’s lead author, Yuankai Shi, rezivertinib demonstrated favorable efficacy and safety profiles without showing new toxicity signals in this patient population. The group’s findings were published in BMC Medicine.
Rezivertinib Treatment in EGFR-Mutated NSCLC
This phase 2a study enrolled 43 patients from June 2019 to October 2019 and had a data cutoff of December 23, 2021. Researchers administered oral rezivertinib 180 mg once daily until disease progression, unacceptable toxicity, or study withdrawal.
The primary end point was objective response rate (ORR), and other parameters assessed included disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.
At data cutoff, the ORR per blinded independent central review was 83.7% (95% CI, 69.3-93.2). While on rezivertinib treatment, a total of 40 (93.0%) patients experienced at least one treatment-related adverse event, of which 4 (9.3%) events were grade 3 or higher.
Investigators noted that OS data was not mature enough to assess, but they presented the following additional findings:
- Median DoR, 19.3 months (95% CI, 15.8-25.0)
- Median PFS, 20.7 months (95% CI, 13.8-24.8)
- Investigator-assessed PFS, 22.0 months (95% CI, 16.8-26.3)
Limitations of the study included a small sample size and a potential issue with generalizability of the findings, as the study was conducted with a fully Chinese patient population. The research team highlighted a larger, ongoing phase 3 trial comparing rezivertinib and gefitinib that could further verify their findings.
“In conclusion,” the report summarized, “in this study, rezivertinib (BPI-7711) showed promising efficacy and a favorable safety profile among the locally advanced or metastatic/recurrent NSCLC patients with EGFR mutation in the first-line setting.”
Find More Research on the Lung Cancer Resource Center