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Incyte's (INCY) Itacitinib Fails in Late-Stage GVHD Study

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Shares of Incyte Corporation (INCY - Free Report) declined 10% after it announced disappointing results from a late-stage study on pipeline candidate itacitinib, (INCB039110) a novel and selective JAK1 inhibitor.

The phase III randomized, double-blind, placebo-controlled GRAVITAS-301 study was evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve (first-line) acute graft-versus-host disease (GVHD).

The primary endpoint was overall response rate (ORR) at day 28, defined as the proportion of subjects demonstrating a complete response, very good partial response, or partial response. The key secondary endpoint is non-relapse mortality (NRM) at month 6, defined as the proportion of subjects who died due to causes other than malignancy relapse.

However, the study did not meet the primary endpoint of ORR improvement at day 28 compared to placebo plus corticosteroids (74.0% vs. 66.4%, p=0.08, respectively). While itacitinib added to corticosteroids improved the ORR in patients with treatment-naïve acute GVHD, the difference observed versus placebo plus corticosteroids was not statistically significant. Additionally, there was no difference observed in NRM at month 6 between the treatment and placebo arms.

The safety profile observed in GRAVITAS-301 was consistent with that observed in previously reported studies of itacitinib in combination with corticosteroids.

The successful development of the drug for acute GVHD would have strengthened Incyte’s GVHD franchise. We note that the company’s lead drug Jakafi is approved in the United States for the treatment of steroid-refractory acute GVHD in adult and pediatric patients aged 12 years or older. Additionally, phase III REACH2 and REACH3 studies are evaluating Jakafi for steroid-refractory acute and steroid-refractory chronic GVHD, respectively, in collaboration with Novartis (NVS - Free Report) . REACH2 met its primary endpoint of superior overall response. An Independent Data Monitoring Committee (IDMC) recommended that the REACH3 trial should continue without modification following an interim efficacy and safety analysis.

Shares of the company have rallied 18.9% in the past year compared with the industry’s 3.8% growth.


Though we are pleased with Incyte’s deep pipeline, setbacks are concerning. Incyte earlier suffered a setback with epacadostat. The external Data Monitoring Committee (eDMC) review of the pivotal phase III study, ECHO-301, evaluating epacadostat in combination with Merck’s (MRK - Free Report) Keytruda in patients with unresectable or metastatic melanoma, determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to pembrolizumab monotherapy. Consequently, based on the disappointing data and the recommendation of the eDMC, Incyte stopped the study.

Zacks Rank & A Stock to Consider

Incyte currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Alexion Pharmaceuticals, Inc. (ALXN - Free Report) , which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Earnings estimates for Alexion have increased 5 cents for 2020 in the past sixty days.

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