INCB050465

Drug Overview
INCB050465 (Incyte) is an oral phosphoinositide 3-kinase (PI3K) delta-specific inhibitor. The PI3K pathway has been shown to be highly active in a subset of follicular lymphoma (FL), promoting cell proliferation and survival. INCB050465 inhibits the PI3K-delta isoform with a 20,000-fold selectivity over other PI3K isoforms.

INCB050465 is being developed as a third-line option for FL patients, but the drug will face intense competition from marketed and pipeline PI3K inhibitors because of its late arrival to the market. Upon approval, there will be three other drugs that target the PI3K pathway already approved for FL: Zydelig (idelalisib; Gilead), Aliqopa (copanlisib; Bayer), and Copiktra (duvelisib; Verastem/Infinity/Yakult Honsha Co) are all approved for the third-line setting. Another PI3K inhibitor, umbralisib (TG Therapeutics), is expected to be approved shortly after INCB050465

Analyst Outlook
INCB050465 (Incyte) is a phosphoinositide 3-kinase (PI3K) inhibitor being developed as a third-line option for follicular lymphoma (FL) patients, but the drug will face intense competition from marketed and pipeline PI3K inhibitors because of its late arrival to the market. Upon approval, there will be three other drugs that target the PI3K pathway already approved for FL: Zydelig (idelalisib; Gilead), Aliqopa (copanlisib; Bayer), and Copiktra (duvelisib; Verastem/Infinity/Yakult Honsha Co) are all approved for the third-line setting. Another PI3K inhibitor, umbralisib (TG Therapeutics), is expected to be approved shortly after INCB050465. Umbralisib is being developed for previously treated patients, and will therefore experience use in the second- and third-line settings in combination with TG Therapeutics’ proprietary anti-CD20 drug ublituximab. In addition to entering a crowded drug class, INCB050465’s development appears to be restricted to the US at this time, as clinical development in the pivotal Phase II CITADELNHL trial is limited to that country. Additional trials in Europe and Japan may be necessary to support approvals in those regions. Clinical development beyond the third-line setting, as well as expanded geographic development, could help INCB050465’s commercial potential, but the drug is likely to gain limited market share compared to its class competitors.