Educational content on VJOncology is intended for healthcare professionals only. By visiting this website and accessing this information you confirm that you are a healthcare professional.

Share this video  

ESMO 2025 | Dose-optimization of LY3866288 for FGFR3-mutated solid tumors in FORAGER-1

Guru Sonpavde, MD, AdventHealth Cancer Institute, Orlando, FL, reviews the Phase I FORAGER-1 study (NCT05614739), which evaluated LY3866288, a selective FGFR3 inhibitor, in patients with FGFR3-altered advanced solid tumors, predominantly metastatic urothelial cancer. LY3866288 demonstrated a manageable safety profile and promising antitumor activity, including in patients with prior FGFR-targeted therapy, supporting further clinical development, especially in the first-line space. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.

Transcript

Right, so FORAGER-1 looked at a drug called vepugratinib . This is a specific FGFR3 oral tyrosine kinase inhibitor. So this was LOXO-435, known as formerly. And so basically this drug was looked at in patients with advanced urothelial carcinoma who were pre-treated and had an FGFR3 activating mutation or fusion. So the bottom line is this drug given in this early phase 1/1b cohort was active with a response rate around 35% in around 35 patients and so the activity was preserved compared to across different studies compared to erdafitinib, which is already approved in this patient population...

Right, so FORAGER-1 looked at a drug called vepugratinib . This is a specific FGFR3 oral tyrosine kinase inhibitor. So this was LOXO-435, known as formerly. And so basically this drug was looked at in patients with advanced urothelial carcinoma who were pre-treated and had an FGFR3 activating mutation or fusion. So the bottom line is this drug given in this early phase 1/1b cohort was active with a response rate around 35% in around 35 patients and so the activity was preserved compared to across different studies compared to erdafitinib, which is already approved in this patient population. However, the benefit here was that being a specific FGFR3 inhibitor, the toxicity profile appeared more tolerable, again, compared across different studies. So, we believe that this could be an incremental benefit. Now, one of the other interesting findings in this study was there were expansion cohorts and preliminary presentation of a handful of patients, five patients, who had received EV pembrolizumab and also had the LOXO-435, vepugratinib added to these patients with FGFR3 activating mutations or fusions. So preliminarily, this combination was feasible. We need more data for sure. And there was activity seen in four out of these five patients having a response. So it’s very exciting that this triplet in this patient population might give us a big increment in the first-line space if they’re also eligible for EV pembrolizumab.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.

Read more...