Novartis’ therapy to transform standard of care in leukaemia management

Pharma News: Novartis’ tyrosine kinase inhibitor (TKI) has been approved for listing on the Pharmaceutical Benefits Scheme (PBS) from 1st May, offering a new treatment approach for adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in chronic phase (Ph+ CML-CP) who have been previously treated with two or more TKIs.

Clinicians treating blood cancer patients with Philadelphia chromosome-positive CML have been choosing between a handful of TKIs, including Novartis’ Gleevec and Tasigna and rival drugs by Bristol Myers Squibb (Sprycel) and Pfizer (Bosulif). 

As a first-in-class STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor, Scemblix (asciminib) does not target the ATP pocket of the protein. With this unique mechanism of action, Scemblix aims to improve outcomes in patients who develop resistance or intolerance to other TKIs, according to Novartis.

“Despite major advances in CML treatments over the past two decades, many patients still struggle with treatment side effects and resistance, which can impact their quality of life and increase the risk of disease progression” said Professor Timothy Hughes, an international expert in the biology and treatment of leukaemia, Chair of the International Chronic Myeloid Leukemia Foundation (iCMLf) and Co-Theme Leader in Precision Cancer Medicine at SAHMRI in Adelaide.

The Leukaemia Foundation Chief Executive Officer, Chris Tanti, said “With the incidence of blood cancer continuing to rise, our priority is to ensure that every Australian diagnosed with blood cancer, no matter where they live or community they identify with, is able to access the best treatments and services that will not only help them to survive their blood cancer but also to live well.”

It is estimated that each year, around 330 people will be diagnosed with CML in Australia, accounting for around 0.03% of all cancers diagnosed in the country. However, the number of people affected by CML in Australia is forecast to increase fivefold to 2,130 by 2035, according to a recent report published by the Leukaemia Foundation, and the number of Australians who will lose their lives to the disease is predicted to triple.

The approval of Scemblix is based on results from the Phase III ASCEMBL trial outperforming Pfizer’s Bosulif. The proportion of patients in the Scemblix arm who achieved a major molecular response (MMR) at 96 weeks was more than double that in the Bosulif arm (37.6% vs. 15.8% [P=.001]).

Novartis Australia’s Country President, Richard Tew, said “Building on over twenty years of innovation in haematology, Novartis is proud to once again contribute, with the listing of Scemblix, to the potential transformation in the care of patients living with chronic myeloid leukaemia.”

The favourable efficacy and safety data from previous trials in patients who were treated with ≥2 prior TKIs has provided the rationale for testing Scemblix as a first-line treatment. ASC4FIRST is a Novartis-sponsored phase III randomised study of oral Scemblix versus investigator-selected TKI in patients with newly diagnosed Ph+ CML-CP.

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