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Novartis presents INC424 Phase III study results

Novartis' investigational drug compound, INC424 (ruxolitinib), a Janus kinase (JAK) inhibitor, has been found effective in treating patients with myelofibrosis during the two pivotal Phase III trials.

INC424, an oral inhibitor of the JAK1 and JAK2 tyrosine kinases, 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).

The COntrolled MyeloFibrosis (COMFORT-II) study, that evaluated patient-reported health-related quality of life (HRQoL) measures for INC424 compared to best available therapy (BAT), reported a considerable improvement in HRQoL and myelofibrosis symptoms in patients receiving INC424.

The second Phase III, COMFORT-I study demonstrated that INC424 improved symptoms, overall survival rate, and showed higher response rates based on reductions in spleen volume and Total Symptom Score (TSS) compared to placebo.

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 added.