Novel Therapeutic Approaches to Target FGFR2 Mutations in Cholangiocarcinoma

Mitesh J. Borad, MD, discusses the design and methodology of the ReFocus trial, updated efficacy and safety data for RLY-4008 in the dose-escalation study, and how selective FGFR2 inhibition has the potential to shift the treatment landscape in cholangiocarcinoma.

Mitesh Borad, MD, key findings from the phase 1/2 ReFocus trial in FGFR2-altered cholangiocarcinoma.

The FGFR2 inhibitor RLY-4008 generated early evidence of efficacy in patients with cholangiocarcinoma harboring FGFR2 fusions, according to findings from the phase 1/2 ReFocus trial, which were presented at the 2023 ASCO Annual Meeting.

R. Kate (Katie) Kelley, MD, discusses unmet needs and treatment challenges within the current standard-of-care for patients with cholangiocarcinoma.

Richard Kim, MD, discusses the investigation of RLY-4008 for the treatment of patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

R. Kate Kelley, MD, details the ongoing investigation of RLY-4008 for patients with advanced cholangiocarcinoma harboring FGFR2 fusions or rearrangements, other ongoing investigations in cholangiocarcinoma, and the importance of molecular testing to drive treatment decisions in this population.

James Harding, MD, discusses the rationale for targeting FGFR2 in patients with cholangiocarcinoma and biliary tract cancers.

Suneel Kamath, MD, discusses the prevalence of FGFR2 fusions or rearrangements in cholangiocarcinoma.

Suneel Kamath, MD, discusses the current challenges of treating patients with cholangiocarcinoma, the need for more tolerable therapies in this population, and how the significant ORRs and impressive safety profile seen so far with RLY-4008 in the ReFocus trial are indicative of this agent’s efficacy and durability in FGFR2-rearranged cholangiocarcinoma.

Lipika Goyal, MD, discusses the potential for RLY-4008, an agent under exploration in patients with cholangiocarcinoma harboring an FGFR2 rearrangement or fusion.

Investigators hope to add RLY-4008, the first highly selective FGFR2 inhibitor, to the growing arsenal of treatment options for patients with cholangiocarcinoma.

Mitesh Borad, MD, discusses the next steps for investigating RLY-4008 in cholangiocarcinoma harboring FGFR2 fusion or rearrangement.

Alison Schram, MD, discusses the efficacy and safety of RLY-4008 in patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.

High response rates and encouraging durability support RLY-4008 as a transformative treatment option for patients with FGFR inhibitor–naïve cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.