Intended for licensed healthcare professionals located in Sweden.
Efficacy
The efficacy of PEMAZYRE® (pemigatinib) was investigated in the FIGHT–202 clinical study (N=108)1
FIGHT–202 was a multicentre, open-label, single-arm study to evaluate the efficacy and safety of PEMAZYRE in previously treated patients with locally advanced/metastatic or surgically unresectable cholangiocarcinoma (CCA).1
The efficacy population consisted of 108 patients (107 patients with intrahepatic disease) whose disease had progressed after at least 1 prior therapy and who had fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement, as determined by the test performed at a central laboratory.1
Patients received PEMAZYRE in 21-day cycles consisting of 13.5 mg once-daily oral dosing for 14 days, followed by 7 days off therapy. PEMAZYRE was administered until disease progression or unacceptable toxicity.1
The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR), as determined by an independent review committee according to RECIST v1.1.1
Efficacy results1,2a
ORR
(primary endpoint)1
37
%(95% confidence interval [CI]:
27.94–46.86%)1
Complete response = 2.8%1
Partial response = 34.3%1
Median DOR1
9.13
MONTHS
(95% CI: 6.01–14.49 months)1b
Kaplan-Meier estimates of DOR:1
- 3 months, 100.0%
(95% CI: 100.0–100.0%) - 6 months, 67.8%
(95% CI: 50.4–80.3%) - 9 months, 50.5%
(95% CI: 33.3–65.4%) - 12 months, 41.2%
(95% CI: 24.8–56.8%)
Median time to response1
2.69
MONTHS
(range, 0.7-16.6 months)1
aData taken from Table 5 of the Summary of Product Characteristics1 and adapted by Incyte.
b95% CI was calculated using the Brookmeyer and Crowley method.1
Best percentage change from baseline in target lesion size for individual patients with FGFR2 fusions or rearrangements2
Tumour response was assessed by independent review. Coloured bars indicate confirmed responses assessed by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Dotted lines indicate the cutoff for partial response (defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters) and progressive disease (defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study).2,3
aPatient had a decrease in target lesion size but was not evaluable for response using RECIST.2
Figure reprinted from Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 May; 21(5):671–84. Copyright © 2020 with permission from Elsevier Ltd. All rights reserved.
1. PEMAZYRE® (pemigatinib). Summary of Product Characteristics: Section 5.1 on www.fass.se (data cutoff: 08 July 2021).
2. Abou-Alfa GK, Sahai V, Hollebecque A, Vaccaro G, Melisi D, Al-Rajabi R, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020 May; 21(5):671–84 (data cutoff: 22 March 2019).
3. Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan; 45(2):228–47.
Baseline demographics1
The median age
was 55.5 years
(range, 26–77 years);
23.1% were
≥65 years of age.
95.4%
95.4% of patients had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 (42.6%) or 1 (52.8%).
All patients had at least 1 prior line of systemic therapy, 27.8% had 2 prior lines of therapy and 12.0% had 3 or more prior lines of therapy.
96.0%
96.0% of patients had received prior platinum-based therapy, including 78.0% with prior gemcitabine/cisplatin.
Local representative: John Eriksson, Key Account Manager | Email: jeriksson@incyte.com | Phone: +46 73 440 88 12
