AACR 2023: Updated Survival Results From Phase II Trial of Pemigatinib in Advanced Cholangiocarcinoma

By: Victoria Kuhr, BA
Posted: Wednesday, May 3, 2023

Based on an update from an open-label, single-arm, multicenter phase II trial, Chinese patients with recurrent or metastatic cholangiocarcinoma and an FGFR2 fusion or rearrangement who received pemigatinib experienced a “durable” survival benefit. In the initial report from this study, the FGFR inhibitor yielded benefits in terms of objective response rate, duration of response, and progression-free survival. These updated findings from Guo-Ming Shi, MD, PhD, of Zhongshan Hospital, Fudan University, Shanghai, China, and colleagues were presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 (Abstract CT153/15).

The study recruited patients with recurrent or metastatic cholangiocarcinoma who had failed to respond to at least one prior systemic therapy. A total of 31 patients with documented FGFR2 fusion or rearrangement received 13.5 mg of pemigatinib.

The updated results focused on 30 of 31 patients. (One patient was excluded from the assessment because of inadequate FGFR2 frequency.) The median overall survival follow-up time was 25.6 months. The median overall survival was 23.9 months, with 16 of the 30 patients (53.3%) experiencing an overall survival event. The estimated overall survival rate at 12 months was 73.3%; at 18 months, it was 66.5%; and at 24 months, it was 41.4%. There were no safety signals observed during the study.

In the initial update of results, the objective response rate was 60%, the median duration of response was 8.3 months, and median progression-free survival was 9.1 months.

Disclosure: For full disclosures of the study authors, visit abstractsonline.com.

AACR Annual Meeting 2023

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