Novartis reports Phase III study results of INC424

13th December 2011 (Last Updated December 13th, 2011 18:30)

Novartis has presented the supplementary results from two pivotal Phase III trials investigating its INC424 (ruxolitinib) drug, a Janus kinase (JAK) inhibitor that is used to treat patients with myelofibrosis.

Novartis headquarters

Novartis has presented the supplementary results from two pivotal Phase III trials investigating its INC424 (ruxolitinib) drug, a Janus kinase (JAK) inhibitor that is used to treat patients with myelofibrosis.

The drug candidate INC424 is an oral inhibitor of the JAK1 and JAK2 tyrosine kinases, and is being evaluated in primary myelofibrosis as well as post-polycythemia vera myelofibrosis (PPV-MF), post-essential thrombocythemia myelofibrosis (PET-MF) and polycythemia vera (PV).

A post-hoc analysis from the COntrolled MyeloFibrosis (COMFORT-II) study, along with ORal JAK Inhibitor Therapy study, evaluated patient-reported health-related quality of life (HRQoL) measures for INC424 compared with the best available therapy (BAT).

The COMFORT-II study reported a considerable improvement in HRQoL and myelofibrosis symptoms compared with the baseline for patients receiving INC424, while patients receiving BAT remained the same or worsened.

The second Phase III, COMFORT-I study investigated INC424 in symptom improvement and spleen volume reduction, as well as overall survival, and showed that patients receiving INC424 had higher response rates based on reductions in spleen volume and Total Symptom Score (TSS) versus the placebo.

In the study, the TSS assessed variations in symptoms, including abdominal discomfort, pain under the ribs on the left side, early satiety, itching, night sweats and bone or muscle pain.

Lead investigator of COMFORT-II study Claire Harrison said data from large Phase III studies supports the ability of INC424 in treating associated symptoms of myelofibrosis, potentially representing a major advance.

Novartis Oncology president Hervé Hoppenot said the data emphasise the dramatic effect INC424 has on improving the overall quality of life of patients suffering from this debilitating blood cancer.

"We are committed to developing innovative therapies to address this unmet patient need and further support our ongoing research in myelofibrosis and other myeloproliferative neoplasms," Hoppenot said.

The INC424 drug also demonstrated an overall survival advantage, which was determined using the Kaplan-Meier method, improvement in Global Health Status/QoL and in symptoms measured by the FACT-Lym symptom subscale over the placebo.

Caption: Novartis headquarters in Basel, Switzerland.