Vepugratinib for Bladder Cancer

(FORAGER-2 Trial)

This trial tests a new medicine, vepugratinib, as a potential cancer treatment for individuals with advanced or metastatic bladder cancer. The study aims to determine the safety and effectiveness of vepugratinib when combined with other treatments, compared to a placebo (a harmless pill with no active drug). Participants will receive either vepugratinib or a placebo, both combined with two other treatments: enfortumab vedotin and pembrolizumab. This trial suits those with advanced bladder cancer and a specific genetic change called FGFR3. Participants should not have received prior treatment for their advanced cancer. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment that could soon become widely available.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that vepugratinib was safe in earlier studies. Initial results from the FORAGER-1 study found that patients with advanced solid tumors, such as bladder cancer, tolerated this treatment well. Although vepugratinib remains under investigation, the data suggest it is generally safe when combined with other treatments like enfortumab vedotin and pembrolizumab.

Researchers are excited about Vepugratinib for bladder cancer because it offers a unique approach compared to current treatments. Unlike traditional therapies, which often involve chemotherapy or immunotherapy alone, Vepugratinib is combined with Enfortumab Vedotin (EV) and Pembrolizumab to create a powerful trio. This combination targets cancer cells more precisely by integrating an oral administration with intravenous infusions. Vepugratinib's potential to enhance the effectiveness of existing treatments makes it a promising candidate in the fight against bladder cancer.

Research has shown that vepugratinib may help treat advanced bladder cancer. One study found that about one-third of patients who took vepugratinib experienced a reduction or disappearance of their cancer. This trial will test vepugratinib in combination with enfortumab vedotin and pembrolizumab, with some participants receiving this combination. Early research suggests that vepugratinib might enhance the effectiveness of these other cancer treatments. Although survival rates for advanced bladder cancer are usually low, combining vepugratinib with these treatments offers hope for better outcomes. Overall, these early findings suggest that vepugratinib could be an important addition to bladder cancer treatment options.¹²³⁶⁷