On October 23, 2018 Incyte Corporation (Nasdaq: INCY) reported that it has released updated data from its ongoing Phase 2 FIGHT-202 trial for the evaluation of pemigatinib (INCB54828), its selective inhibitor of fibroblast growth factor (FGFR), in patients with metastatic or surgically unresectable cholangiocarcinoma in an advanced stage (cancer of the bile ducts) that did not respond to at least one previous treatment (Press release, Incyte, OCT 23, 2018, View Source [SID1234530065]). In patients with translocations of FGFR2 who were followed for at least eight months, the results of the intermediate study show a global response rate (ORR) of 40 percent, the main endpoint, and a progression-free survival (PFS) average of 9.2 months, a secondary endpoint.

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These results will be presented at the European Oncology Congress (ESMO) (Free ESMO Whitepaper) 2018, which is being held in Munich, Germany, in a poster presentation on Sunday, October 21 at 12:45 p.m., Spanish Peninsular Time, at 1:45 p.m. Spanish peninsular (6:45 am East Coast time at 7:45 am East Coast time). (Location: Hall A3 – Poster Area Networking Hub, summary # 756P)

"We are delighted to share with ESMO (Free ESMO Whitepaper) the updated intermediate results of our ongoing FIGHT-202 study, which underscore the potential of pemigatinib as a new effective treatment option for patients with advanced cholangiocarcinoma who have translocations of FGFR2," Steven Stein said. MD, medical director, Incyte. "If the full data set supports this, we hope to send a new application for new drug registration to the FDA in 2019 and obtain authorization for pemigatinib as the first selective inhibitor of FGFR of its kind to treat patients with advanced cholangiocarcinoma, a disease devastating ».

Cholangiocarcinoma is a cancer that arises from bile duct cells. It is often diagnosed late (phases III and IV) and the prognosis is unfavorable. It is more common in people older than 70 years, and more in men than in women. The FGFR2 fusion genes drive the onset of the disease, which occurs almost exclusively in patients with intrahepatic cholangiocarcinoma (iCCA), a subtype of the disease, and are present in up to 20% of iCCA patients. The incidence of cholangiocarcinoma with translocation of FGFR2 is growing and it is currently estimated that there are between 2,500 and 3,000 patients in the USA. UU., Europe and Japan.

Main results of FIGHT-202

The updated data, with longer-term follow-up, of the intermediate analysis presented today in the ESMO (Free ESMO Whitepaper) (with a cut-off date of July 24, 2018) show that, in advanced / metastatic or surgically unresectable iCCA patients with translocations of FGFR2 treated with pemigatinib that were followed up for at least eight months (cohort A, n = 47), the combined overall response rate (ORR) was 40%, including 19 patients (40%) with confirmed partial response and 21 patients ( 45%) with stable disease (SD). The combined disease control rate (CRD) was 85% (40/47). In addition, mean progression-free survival (PFS) was 9.2 months and mean overall survival (OS) was 15.8 months.

FIGHT-202: global response rates (ORR), disease control rates (DCR), response durability (DOR), progression-free survival (PFS), and overall survival (OS) per cohort of patients

Pemigatinib was tolerated well. The most common adverse events during treatment (TEAE) were hyperphosphatemia (61 percent), alopecia (42 percent), diarrhea (39 percent), decreased appetite (37 percent), and fatigue (36 percent). TEAEs of grade ≥ 3 (observed in> 5 percent of patients) were hyperphosphatemia (14 percent), hyponatremia (8 percent), abdominal pain (7 percent), and arthralgia (7 percent). Five patients experienced TEAE resulting in death, none of them related to the study treatment.

"I am greatly encouraged by the intermediate results of the FIGHT-202 study, which have shown significant clinical activity and a promising preliminary prediction of progression-free survival. As a practicing physician, I am excited about the potential of pemigatinib to provide a new treatment option for my patients with advanced cholangiocarcinoma, a deadly disease, "said Antoine Hollebecque, MD, Institute of Cancérologie Gustave Roussy, Villejuif, France.

About FIGHT-202

FIGHT-202 is a multicentre open-label study (NCT02924376) that evaluates the safety and efficacy of pemigatinib (INCB54828), a selective inhibitor of fibroblast growth factor receptor (FGFR), in the clinical research phase, potent and orally developed. by Incyte, in adult patients (age ≥18 years) with advanced / metastatic or surgically unresectable cholangiocarcinoma with known fibroblast growth factor (FGFR) / FGFR alterations and who have not responded to at least one previous treatment.

Patients were included in one of these three cohorts: cohort A (translocations of FGFR2), cohort B [other genetic alterations (GA) of FGF / FGFR] or cohort C (without GA of FGF / FGFR). All patients received 13.5 mg of pemigatinib orally once a day (QD) during a 21-day cycle (two weeks with treatment / one week without treatment) until the radiological progression of the disease or a level of toxicity unacceptable.

The main endpoint of FIGHT-202 is the overall response rate (ORR) in cohort A, independently assessed according to the RECIST v1.1 criteria. Secondary endpoints include ORR in cohorts B, C and A plus B, progression free survival (PFS), overall survival (OS), durability of response (DOR), disease control rate (DCR) and security.

Recruitment for the FIGHT-202 study was conducted entirely outside of Japan, and it is planned to present updated data for the second half of 2019. For more information on FIGHT-202, visit View Source show / NCT02924376 .

About FIGHT

Phase 2 studies investigating the safety and efficacy of monotherapy with pemigatinib in various neoplasms motivated by FGFR are underway. The FIGHT clinical trial program (FIbroblast Growth factor receptor in oncology and Hematology Trials) currently comprises the FIGHT-201 study in patients with metastatic or surgically unresectable bladder cancer, including activating alterations of FGFR3; the FIGHT-202 study in patients with metastatic or surgically unresectable cholangiocarcinoma who did not respond to previous treatment, including activating translocations of FGFR2; and the FIGHT-203 study in patients with myeloproliferative neoplasms with activating translocations of FGFR1.NCT03656536 ).

About the FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFR) play an important role in the proliferation of tumor cells and in survival, migration and angiogenesis (formation of new blood vessels). The mutations, translocations and activating gene amplifications of the FGFRs are closely correlated with the development of various types of cancer.

Pemigatinib is a potent selective inhibitor of isoforms 1, 2 and 3 of FGFR that, in preclinical studies, has shown a selective pharmacological activity against cancer cells with alterations in FGFR.