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Patients with FGFR2-altered tumors who previously received immune checkpoint inhibitors (ICIs) face a significantly higher risk of skin-related side effects when treated with lirafugratinib, a new analysis finds. The risk of dermatitis, in particular, was dramatically elevated. Importantly, these side effects didn't appear to reduce the drug's cancer-fighting effectiveness.
Patients with FGFR2-altered solid tumors — most commonly cholangiocarcinoma (bile duct cancer) — who had prior exposure to immune checkpoint inhibitors (ICIs) were significantly more likely to develop mucocutaneous adverse effects (skin and mucous membrane side effects) when treated with lirafugratinib, according to a post hoc analysis of the phase 1/2 ReFocus trial presented at the 2026 ESMO Congress.
Among 385 patients treated with lirafugratinib at 70 mg once daily, 90% developed a mucocutaneous adverse effect within 90 days. Prior ICI exposure was the key differentiator — it sharply increased the risk of dermatitis and mucositis, and led to more dose reductions and interruptions. Notably, efficacy was not meaningfully impacted: response rates and progression-free survival were similar regardless of prior ICI use.
By the Numbers:
Why it matters: As ICIs become standard of care in advanced cholangiocarcinoma, understanding how prior immunotherapy shapes the safety profile of subsequent FGFR2-targeted therapy is critical. Clinicians may need to plan proactive dermatology involvement and consider prophylactic strategies when sequencing these treatments.
