On January 27, 2016 Incyte Corporation (Nasdaq: INCY) reported that the Phase 2 sub-study of ruxolitinib or placebo in combination with regorafenib in patients with relapsed or refractory metastatic colorectal cancer (CRC) and high C-reactive protein (CRP) will be stopped early (Press release, Incyte, JAN 27, 2016, View Source [SID:1234508874]). The decision to stop the sub-study was made after a planned interim analysis of the high CRP subgroup demonstrated that ruxolitinib plus regorafenib did not show a sufficient level of efficacy to warrant continuation. Schedule your 30 min Free 1stOncology Demo! "We are disappointed at the outcome from this interim analysis and deeply grateful for the support and commitment of the patients participating in the study, their families, and the study investigators," said Steven Stein, M.D., Chief Medical Officer of Incyte.
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About the Study
This Phase 2 randomized, double-blind study (INCB 18424-267) of patients with relapsed or refractory metastatic CRC included an open-label, safety run-in, to confirm the safety of the ruxolitinib plus regorafenib combination in subjects with relapsed or refractory metastatic CRC as well as a randomized phase of the study. The randomized phase of the study included 2 sub-studies targeting separate populations of patients with CRC based on levels of systemic inflammation, as measured by the modified Glasgow Prognostic Score (sub-study 1 CRP >10 mg/L and sub-study 2 CRP ≤ 10 mg/L). Patients in each sub-study were randomized 1:1 to receive ruxolitinib plus regorafenib or regorafenib plus placebo.
About Ruxolitinib (Jakafi)
Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.
Ruxolitinib is not approved anywhere in the world as treatment for metastatic colorectal cancer.
Full Prescribing Information, including a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi (ruxolitinib) outside the United States.