MedPath

Novartis' Scemblix Shows Sustained Efficacy in Chronic Myeloid Leukemia at 96 Weeks

• Scemblix (asciminib) demonstrates favorable safety and tolerability compared to investigator-selected tyrosine kinase inhibitors in newly diagnosed chronic myeloid leukemia. • Interim results from the Phase 2 ASC2ESCALATE trial show efficacy and safety of asciminib in CML patients after one prior tyrosine kinase inhibitor. • The Phase 3 ASC4OPT study indicates high efficacy and favorable tolerability of asciminib at different dosages in CML patients previously treated with multiple TKIs.

Novartis presented new 96-week results from the Phase III ASC4FIRST trial of Scemblix® (asciminib) in first-line Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition.
The data reinforce the potential of Scemblix as a treatment option for patients with CML-CP. Jeff Legos, Executive Vice President, Global Head of Oncology Development, Novartis, stated the company's commitment to prioritizing research in areas of greatest medical need and focusing on earlier stages of disease to change the treatment paradigm for people who require additional treatment options.

ASC4FIRST Trial

The ASC4FIRST trial is a Phase III study evaluating the efficacy and safety of asciminib compared to investigator-selected tyrosine kinase inhibitors (IS TKI) in newly diagnosed CML-CP patients. The longer-term 96-week results build upon the 48-week data that led to recent FDA approval.
Abstract #475 highlights that asciminib demonstrates favorable safety and tolerability compared with each investigator-selected tyrosine kinase inhibitor (IS TKI) in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) in the pivotal Phase 3 ASC4FIRST study.

ASC2ESCALATE Trial

Interim results from the Phase 2 ASC2ESCALATE trial, Abstract #479, showcase the efficacy and safety of asciminib in chronic myeloid leukemia in chronic phase (CML-CP) in the cohort of patients (Pts) after 1 prior tyrosine kinase inhibitor (TKI).

ASC4OPT Study

Primary analysis from the ASC4OPT Study, Abstract #4526, indicates that asciminib shows high efficacy and favorable tolerability at 80 mg once daily and 40 mg twice daily in patients with chronic phase chronic myelogenous leukemia previously treated with 2 or more tyrosine kinase inhibitors.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Scemblix Demonstrates Superior Efficacy Over TKIs in First-Line CML Treatment: 96-Week ASC4FIRST Trial Results

Scemblix (asciminib) shows significantly higher major molecular response (MMR) rate compared to investigator-selected tyrosine kinase inhibitors (TKIs) at 96 weeks in newly diagnosed chronic myeloid leukemia (CML) patients.
The ASC4FIRST trial demonstrates a favorable safety profile for Scemblix, with fewer discontinuations due to adverse events compared to TKIs.

Novartis' Scemblix Shows Promising 96-Week Data in First-Line CML Treatment

Scemblix (asciminib) demonstrates favorable safety and tolerability compared to investigator-selected TKIs in newly diagnosed CML-CP patients.
The ASC4FIRST Phase III study's 96-week results support Scemblix as a potential first-line treatment option for chronic myeloid leukemia.

Novartis Highlights Extended Scemblix Data in CML and Kisqali Results in Early Breast Cancer at ASH and SABCS

Scemblix (asciminib) demonstrates favorable safety and tolerability in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) patients after 96 weeks, based on the Phase 3 ASC4FIRST study.
A late-breaking 4-year analysis of Kisqali (ribociclib) from the Phase III NATALEE trial shows distant disease-free survival benefits in key subgroups with HR+/HER2- early breast cancer.

Novartis Highlights Scemblix and Kisqali Data at ASH and SABCS

Scemblix demonstrated favorable safety and tolerability in newly diagnosed chronic myeloid leukemia patients in the ASC4FIRST Phase III study.
Kisqali showed promising distant disease-free survival across key subgroups in HR+/HER2- early breast cancer from the Phase III NATALEE trial.

Scemblix (asciminib) Receives FDA Approval as First-Line Treatment for Chronic Myeloid Leukemia

The FDA has granted accelerated approval to Scemblix (asciminib) for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
ASC4FIRST Phase III trial data showed Scemblix achieved superior major molecular response rates (MMR) compared to standard of care tyrosine kinase inhibitors (TKIs).

FDA Approves Novartis' Scemblix as First-Line Treatment for Chronic Myeloid Leukemia

The FDA has granted accelerated approval to Scemblix (asciminib) for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
Scemblix demonstrated superior major molecular response (MMR) rates at week 48 compared to standard of care tyrosine kinase inhibitors (TKIs) in the Phase III ASC4FIRST trial.

Novartis' Scemblix Demonstrates Superior Efficacy in Newly Diagnosed CML Patients

The Phase III ASC4FIRST trial showed Scemblix achieved a 67.7% major molecular response (MMR) rate at week 48, significantly outperforming standard-of-care TKIs.
Scemblix demonstrated a favorable safety profile with fewer Grade 3 or worse adverse events compared to standard-of-care treatments like imatinib.

Novartis Highlights New Data on Kisqali, Iptacopan, and Scemblix at SABCS and ASH

Final analysis of the NATALEE trial showed Kisqali (ribociclib) significantly improved invasive disease-free survival in HR+/HER2- early breast cancer patients.
APPLY-PNH trial data demonstrated iptacopan monotherapy's sustained efficacy and safety in anti-C5-treated PNH patients with persistent anemia over 48 weeks.

Scemblix Receives Positive CHMP Opinion for CML Treatment After TKI Failure

The CHMP has recommended marketing authorization for Scemblix (asciminib) for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP).
The recommendation targets adult patients who have previously been treated with two or more tyrosine kinase inhibitors (TKIs).

Scemblix Receives Positive CHMP Opinion for CML Treatment After TKI Failure

The CHMP has recommended Scemblix (asciminib) for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP) in adults after two or more tyrosine kinase inhibitors (TKIs).
Phase III ASCEMBL trial data showed Scemblix nearly doubled the major molecular response rate compared to bosutinib (25.5% vs. 13.2%) at 24 weeks.

Reference News

[1]
Novartis highlights new 96-week results from Phase III Scemblix® ASC4FIRST trial at ASH ...
uk.finance.yahoo.com · Nov 25, 2024

Novartis to present over 65 abstracts at ASH and SABCS, including 96-week Scemblix results and 4-year Kisqali analysis, ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy