Novartis' Scemblix Shows Superior, Long-term Efficacy In 96-week Follow-up Trial

(RTTNews) - Novartis (NVS) Tuesday announced longer-term follow-up data from the Phase III ASCEMBL trial for patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase previously treated with two or more tyrosine kinase inhibitors.

In this analysis, the proportion of patients in the Scemblix (asciminib) arm who achieved a major molecular response at 96 weeks was more than double that in the Bosulif (bosutinib) arm, substantially increasing from previous analyses.

Additionally, the probability of maintaining MMR for at least 72 weeks for patients treated with Scemblix was 96.7%, reflecting long-term durability of efficacy.

Despite longer duration of exposure for patients in the Scemblix arm - with a median of 23.7 months vs. 7.0 months for patients in the Bosulif arm - the updated 96-week analysis showed the proportion of patients treated with Scemblix who discontinued treatment due to adverse events (AEs) continued to be more than three times lower than those treated with Bosulif.

No new on-treatment deaths were reported since the primary analysis at 24 weeks.

"In a chronic cancer where resistance can develop to many of the existing therapies, or where patients can have their quality of life negatively impacted by treatment side effects over time, it's encouraging to see sustained and increasing efficacy with consistent adequate tolerability for patients treated with Scemblix in the longer term," said Jorge E. Cortes, MD, Director, Georgia Cancer Center, Augusta University. "This 96-week data shows the potential of Scemblix and its unique mechanism of action to help change the treatment paradigm in CML."

Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket.