- Incyte Corporation INCY will discontinue the Phase 3 LIMBER-304 trial following the results of a pre-planned interim analysis conducted by an independent data monitoring committee (IDMC), indicating that the study is unlikely to meet the primary endpoint in the intent-to-treat patient population.
- LIMBER-304 trial assessed parsaclisib plus ruxolitinib (Jakafi) versus placebo plus ruxolitinib in adult patients with myelofibrosis who have an inadequate response to ruxolitinib monotherapy.
- The recommendation to stop the study was not due to safety.
- Related: Incyte's Oral JAK Inhibitor Shows Durable Efficacy, Safety At One Year In Skin Disorder.
- While further data review is conducted, Incyte will inform investigators of the results and work with them to appropriately conclude the study.
- Data from this study will be submitted for presentation at an upcoming scientific meeting.
- The primary endpoint of LIMBER-304 was the proportion of patients achieving a targeted reduction in spleen volume.
- William Blair writes that the trial discontinuation represents the first setback in Incyte’s Jakafi lifecycle extension program (LIMBER), with an to generate fixed-dose combinations of Jakafi with drugs with additional mechanisms of action to extend patent expiration beyond year-end 2028
- The analyst said it highlighted reservations about the parsaclisib combination multiple times in the past based on the initial data from the Phase 2 study in which spleen responses were at the lower end of those reported across multiple other trials investigating Jakafi combinations in inadequate responders to Jakafi monotherapy.
- The analyst also writes that while investor expectations in the parsaclisib program have been very low, the failure underpins some investor concerns on the level of R&D expenses given recent productivity.
- Price Action: INCY shares are down 2.94% at $75.28 on the last check Monday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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