Incyte reports results from Phase II proof-of-concept trial of ruxolitinib

21st August 2013 (Last Updated August 21st, 2013 18:30)

Incyte has reported top-line results from a Phase II proof-of-concept trial of an oral JAK1 and JAK2 inhibitor, ruxolitinib, as combination therapy with capecitabine in patients with refractory metastatic pancreatic cancer.

pancreas

Incyte has reported top-line results from a Phase II proof-of-concept trial of an oral JAK1 and JAK2 inhibitor, ruxolitinib, as combination therapy with capecitabine in patients with refractory metastatic pancreatic cancer.

According to the study data, overall survival analysis in the intent to treat population demonstrated a hazard ratio of 0.79 and a pre-specified subgroup analysis achieved a significant benefit with 0.47.

In the intent to treat population of placebo-controlled RECAP trial, a 42% of six-month survival in the ruxolitinib arm was noted compared to 11% for placebo.

While durable tumor responses were noted in patients receiving ruxolitinib, a significant improvement in body weight compared to placebo was achieved in ruxolitinib treated patients.

Incyte president and chief executive officer Dr Paul Friedman said results of the RECAP trial provide the first evidence that JAK inhibition is active in this disease and suggest a demonstrable survival benefit in a well-defined group of patients with refractory metastatic pancreatic cancer who can be identified without the development of a companion diagnostic test.

"Coupled with the overall survival benefit observed in the ongoing Phase III trials in myelofibrosis, these results solidify our belief in the therapeutic opportunity that exists for Jakafi, and provide us with an acceleration strategy to advance our JAK1 inhibitor portfolio into additional areas of unmet medical need," Friedman added.

Ruxolitinib in combination with capecitabine was generally well tolerated in the randomised, double-blind study.

Around 12% of ruxolitinib plus capecitabine patients discontinued therapy for an adverse event, compared with 20% who received capecitabine alone, according to the data.

The rates of new onset grade 3 anemia, thrombocytopenia or neutropenia were 16%, 2% and 0%, respectively, among patients receiving ruxolitinib plus capecitabine and were 2%, 3% and 2%, respectively, among patients receiving capecitabine alone, the company said.


Image: Histopathogic image of pancreatic adenocarcinoma arising in the pancreas head region. Photo: KGH.