- Incyte is gearing up for a Jakafi label expansion, announcing Thursday plans to submit the bone marrow drug to treat graft-versus-host disease in the third quarter.
- The decision came packaged with positive topline results from a pivotal Phase 2 study that's testing Jakafi combined with corticosteroids in patients who have acute GVHD and are steroid-refractory. At day 28, patients in the single-cohort study showed an overall response rate of 55%. A majority also experienced the treatment-emergent adverse events of anemia, low platelet counts and low neutrophil counts.
- Jakafi has thus far gained approval for two types of bone marrow disease. It joined the blockbuster club in 2017, with net revenue increasing 33% year over year to $1.13 billion.
Allogeneic stem cell transplants have long been a valuable treatment option for blood cancer patients. The therapy is not without drawbacks, though, and one of the biggest is GVHD.
GVHD arises when immune cells in the stem cell transplant attack the patient's body like they would infections and bacteria. The disease has two types, acute and chronic, both of which can lead to organ damage and death. Between 30% and 70% of patients who receive an allogeneic stem cell transplant will develop some form of GVHD, according to the Leukemia and Lymphoma Society (LLS).
So far, there are very few treatments for GVHD. The first to secure Food and Drug Administration approval for the chronic form actually came less than a year ago, when AbbVie and Johnson & Johnson's Imbruvica (ibrutinib) got the go-ahead for patients who failed one or more prior therapies.
Incyte is looking to join that short list, though in the acute setting.
The biotech was clearly pleased with the early pivotal trial data, as were others. Gwen Nichols, chief medical officer at LLS, called the greater than 50% overall response rate "pretty promising," and noted too that Jakafi could prove an important medicine given the lack of treatments for steroid-refractory patients.
That "doesn't mean it's a cure, but if you can keep [GVHD] under control, often times it will improve," she told BioPharma Dive.
A Jakafi label expansion would be welcome news for Incyte after what's been quite a turbulent second quarter. The failure of ECHO-301, a closely watched study that paired the biotech's IDO inhibitor epacadostat with Merck & Co.'s Keytruda (pembrolizumab), crushed Incyte shares in mid-April.
In another gut punch, the blockbuster potential for Incyte and Eli Lilly's rheumatoid arthritis drug Olumiant (baricitinib) all but shattered when it received a very narrow FDA approval.
What's more, Incyte separately disclosed on June 21 that it's ending a clinical trial testing the company's investigational phosphatidylinositol 3-kinase-delta inhibitor in patients with diffuse large B cell lymphoma because the drug didn't meet defined response rate criteria. Incyte plans to continue evaluating the drug across several other cancers, including non-Hodgkin lymphoma and mantle cell lymphoma.
Incyte stock was up 1% to $74.18 per share at market's open Thursday. Year-to-date, however, shares are down 22%.