Abstract 145P
Background
Fruquintinib(F) is an orally available VEGFR inhibitor that is highly selective for VEGFR-1,2 and 3. In the phase Ⅱ and Ⅲ trials, F has been shown an improved progression-free survival(PFS) compared to placebo and a manageable safety profile with advanced NSCLC. This study aimed to investigate the efficacy and safety of F plus PD-1 inhibitor sintilimab(S) and platinum-based chemotherapy(chemo) as the first-line treatment for advanced naive EGFR- and ALK-negative nsq-NSCLC.
Methods
This single-arm, open-label, phase Ⅱ study (NCT04956146) consists of a safety lead-in phase(Part 1) and dose expansion phase(Part 2). In Part 1 the F taken orally at 5 mg (2 weeks on/ 1 weeks off, Q3W) plus S (200mg, iv, d1,Q3W) and chemo(Q3W). After 4∼6 cycles followed by maintenance therapy with F(RP2D) plus S and pemetrexed or not. DLT was observed for 1 cycle. The primary objective of Part 1 is to assess the safety and confirm the RP2D of F. The primary objective of Part 2 is to estimate the PFS and the secondary endpoints including ORR, DCR, OS, and safety.
Results
From February 2022 to September 2022, 15 pts were enrolled. Median age was 66, male 93.3%, ECOG PS 0 66.7%, adenocarcinoma 80%. No DLTs were reported in Part 1. The dose of F (5mg, 2 weeks on/ 1 weeks off, Q3W) was established as the RP2D. Of 9 evaluable pts, ORR and DCR were 66.7% and 100%(6 partial response and 3 stable disease). Median PFS was not reached yet. The most common treatment-emergent adverse events (TEAEs) (Total; Grade ≥3) were Alanine aminotransferase increased (100%; 7.7%), hypoalbuminaemia (100%; 0), Aspartate aminotransferase increased (92.3%; 0), White blood cell count decreased (84.6%; 38.5%) and Gamma-glutamyltransferase increased (84.6%, 23.1%).
Conclusions
This finding showed promising efficacy for fruquintinib combined with sintilimab and chemo in pts with advanced NSCLC as first-line treatment with a manageable safety profile. These findings support fruquintinib plus sintilimab and chemo as a potential new first-line treatment option for unresectable or metastatic advanced naive EGFR- and ALK-negative nsq-NSCLC.
Clinical trial identification
NCT04956146 Release date: February 2, 2022.
Legal entity responsible for the study
The First Affiliated Hospital with Nanjing Medical University.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.