Ghassan K. Abou-Alfa, MD, discusses the questions that remain with infigratinib in advanced cholangiocarcinoma with FGFR2 gene fusions/translocations.
Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the questions that remain with infigratinib (BGJ398) in advanced cholangiocarcinoma with FGFR2 gene fusions/translocations.
In the multicenter, open-label, randomized, phase 3 PROOF trial, patients with previously untreated advanced, metastatic, or inoperable cholangiocarcinoma with FGFR2gene fusions were enrolled. Those enrolled were randomized 2:1 to receive oral infigratinib or intravenous standard gemcitabine plus cisplatin. The data are not yet available, but it is important to discuss the future impact of the trial, says Abou-Alfa.
The field will have to see whether the drug works, says Abou-Alfa. Investigators will measure efficacy by overall survival and progression-free survival, as well as response rates, which will help the field understand the proper sequencing of therapy. At the moment, pemigatinib (Pemazyre) is an FDA-approved drug on the market for patients with FGFR2-altered cholangiocarcinoma, data for which were published in Lancet Oncology, adds Abou-Alfa.
Pemigatinib is not necessarily available as a first-line therapy, says Abou-Alfa. As such, it is important to think about the PROOF study in terms of not only efficacy of infigratinib versus gemcitabine/cisplatin, but also in terms of sequencing. Notably, pemigatinib is also being evaluated in another study versus gemcitabine/cisplatin, concludes Abou-Alfa.