Phase 2 Study of Copanlisib plus Gemcitabine and Cisplatin in Advanced CCA
Preliminary results of a phase 2 study suggest that the addition of the PI3K inhibitor copanlisib to chemotherapy in the first-line setting was not associated with survival benefit in patients with advanced CCA. While chemotherapy with gemcitabine and cisplatin remains the current standard of care as first-line therapy for patients with advanced CCA, survival outcomes are suboptimal with a median OS of <1 year, underscoring the need for novel approaches to improve treatment outcomes.1 Based on the rationale that PI3K/AKT activation may increase resistance to chemotherapy, it is hypothesized that inhibiting the PI3K/AKT axis may improve outcomes.