2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.12A.47 Befotertinib (D-0316) Plus Icotinib as First-Line Therapy for Patients with EGFR-Mutated Advanced Non-Small-Cell Lung Cancer

EP.12A.47 Befotertinib (D-0316) Plus Icotinib as First-Line Therapy for Patients with EGFR-Mutated Advanced Non-Small-Cell Lung Cancer

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This study explores the efficacy and safety of combining befotertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), with icotinib as a first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC) harboring EGFR mutations. The aim is to overcome resistance to EGFR-TKIs, a significant therapeutic challenge. Earlier research has suggested that using both first- and third-generation TKIs could delay resistance. <br /><br />The study is a prospective, open-label, single-arm, phase II trial conducted by Tianjin Medical University General Hospital, enrolling 16 patients with EGFR-mutated advanced NSCLC. Participants, aged 18 and above, had not received any prior systemic anticancer therapy and were EGFR-sensitive mutation positive.<br /><br />Primary endpoints were a 6-week circulating tumor DNA (ctDNA) clearance rate and a 12-month progression-free survival (PFS) rate. Secondary endpoints included the objective response rate (ORR), overall survival (OS), and safety profile.<br /><br />Results indicated substantial antitumor activity and a high ctDNA clearance rate. After six weeks, nine of the ten ctDNA-positive patients achieved ctDNA clearance, reaching 100% at 12 weeks. ORR was 78.6%, and the disease control rate was 100%. Among patients with brain metastases, 85.7% attained partial responses.<br /><br />Safety data showed a well-tolerated profile with only two patients experiencing grade 2 or 3 adverse events. Liver function issues in one patient resolved with treatment, and no therapy discontinues occurred.<br /><br />These findings demonstrate that befotertinib plus icotinib offers effective and tolerable first-line therapy for EGFR-mutated advanced NSCLC, showing promising results in ctDNA clearance and response rates. Future studies could further illuminate its clinical benefits and potential for broader application.

Asset Subtitle

Fanlu Meng

Meta Tag

Speaker Fanlu Meng

Topic Metastatic Non-small Cell Lung Cancer – Targeted Therapy

Keywords

befotertinib

icotinib

EGFR-TKI

NSCLC

EGFR mutations

ctDNA clearance

progression-free survival

objective response rate

brain metastases

safety profile