Incyte Corporation (INCY - Free Report) has initiated a phase III study onits selective fibroblast growth factor receptor (FGFR) inhibitor, pemigatinib (INCB54828), in comparison with gemcitabine and cisplatin chemotherapy as a first-line therapy for patients with metastatic or surgically unresectable cholangiocarcinoma (bile duct cancer), who have activating FGFR2 rearrangements.
Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration, and angiogenesis (the formation of new blood vessels).
Shares of the company have rallied 27.4% year to date compared with the industry’s growth of 1.2%.
The company initiated FIGHT-302, the first phase III study on pemigatinib, and is planning to enroll about 432 adult patients with cholangiocarcinoma to test the safety and efficacy of the candidate. Patients, who are randomized to receive the investigational FGFR inhibitor, will receive continuous daily, oral therapy of 13.5 mg pemigatinib, whereas patients in the chemotherapy arm will receive 1000 mg/m2 of gemcitabine plus 25 mg/m2 of cisplatin, both administered on days 1 and 8 in every 3-week cycle for up to 8 cycles.
The primary endpoint of FIGHT-302 is progression free survival (PFS) across both groups, assessed by independent review. Secondary endpoints include overall response rate (ORR), overall survival (OS), duration of response (DOR), disease control rate (DCR), and safety and quality of life impact.
Per the company, FIGHT-302 will add to the growing body of evidence demonstrating the candidate’s potential as a safe and effective treatment for patients with cholangiocarcinoma with known FGFR2 rearrangements.
The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) trial program includes several ongoing studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies. Currently, the program is comprised of the recently initiated FIGHT-302 study, and three phase II studies.
Incyte’s pipeline is highly encouraging, with several candidates in early-to-mid-stage development. The pipeline includes both targeted therapies and immune therapies that are being developed in oncology and outside oncology. The company is evaluating itacitinib in patients with treatment-naïve graft-versus-host disease in the GRAVITAS program.
Incyte has two major agreements with Novartis AG (NVS - Free Report) and Eli Lilly and Company (LLY - Free Report) . The 2009 agreement with Novartis includes Jakafi (excluding topical formulations). Per the agreement, the company is marketing Jakafi in the United States, while Novartis is responsible for the same outside the country.
The deal with Eli Lilly gives the company exclusive worldwide development and commercialization rights to Olumiant. However, Incyte has elected to not participate in the development of Olumiant in order to reallocate capital, over time, to other promising internal projects. Nevertheless, it will continue to receive royalties on global net sales of Olumiant, pursuant to the terms of its agreement with Lilly.
Zacks Rank & Stock to Consider
Incyte currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Anika Therapeutics Inc. (ANIK - Free Report) carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Anika’s earnings per share estimates have moved up from $1.22 to $1.28 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.
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