Innovent Biologics has presented overall survival (OS) data from a Phase ll trial of Pemazyre (pemigatinib) in Chinese patients diagnosed with advanced cholangiocarcinoma (CCA).
The open-label, multi-centre, single-arm Phase ll trial has been designed to assess the efficacy and safety of pemigatinib in Chinese patients.
It includes patients with unresectable, advanced/recurrent or metastatic CCA with FGFR2 fusion/rearrangement that failed to previous systemic therapy.
As of the study data cut-off date of 28 December 2022, 31 subjects with known FGFR2 fusion or arrangement were included.
The subjects were given pemigatinib 13.5mg QD on a two weeks on/one week off basis until disease progression, intolerable toxicity, consent withdrawal or physician decision.
The newly revealed results showed that out of 30 efficacy evaluable participants, the median follow-up was 25.6 months.
Among those patients, the median OS was 23.9 months and 16 OS events were reported.
The trial’s estimated OS rates at 12 months, 18 months and 24 months were 73.3%, 66.5% and 41.4%, respectively.
As reported earlier, no clinically or statistically important differences in safety results with extended follow up of the trial were observed.
Pemigatinib is a selective fibroblast growth factor receptor (FGFR) inhibitor.
Innovent senior vice-president Dr Hui Zhou said: “This bridging study aimed to evaluate and validate the efficacy and safety of pemigatinib in Chinese patients with recurrent or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, and previously efficacy and safety data was presented at the ESMO Congress 2021.
“These updated OS results demonstrate the encouraging and durable survival benefit of pemigatinib in Chinese patients.
“Pemigatinib provides an important treatment option for eligible Chinese cholangiocarcinoma patients. Innovent has an ongoing Phase lll study of pemigatinib as first line therapy for cholangiocarcinoma.”