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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). • Phase III ASCEMBL study data showed Scemblix nearly doubled major molecular response rates compared to Bosulif, with lower discontinuation rates. • Scemblix, if approved, will be the first CML treatment specifically targeting the ABL myristoyl pocket, offering a new option for TKI-resistant patients.

Novartis' Scemblix (asciminib) has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending marketing authorization for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) in adult patients who have been previously treated with two or more tyrosine kinase inhibitors (TKIs). The European Commission is expected to make a decision in the coming months.
The CHMP's positive opinion was based on data from the pivotal Phase III ASCEMBL study. The study evaluated Scemblix in patients who had failed two or more prior TKIs. Results demonstrated a near doubling of the major molecular response (MMR) rate for patients treated with Scemblix compared to those treated with Bosulif. The discontinuation rate due to adverse reactions was more than three times lower in the Scemblix arm at 24 weeks of treatment.

Novel STAMP Inhibitor

If approved in Europe, Scemblix will be the first CML treatment that works by specifically targeting the ABL myristoyl pocket, also known as a STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor. This distinctive mechanism of action could provide a new treatment option for CML patients who have experienced intolerance or inadequate response to at least two prior TKI treatments.

Prior Approvals and Current Landscape

The FDA granted accelerated approval to Scemblix for treating adult patients with Ph+ CML-CP, previously treated with two or more TKIs, in October 2021. This approval underscores the need for alternative treatment options for patients who develop resistance or intolerance to existing TKI therapies. CML is a rare myeloproliferative neoplasm characterized by the presence of the Philadelphia chromosome, resulting in the BCR-ABL1 fusion protein, a constitutively active tyrosine kinase that drives leukemic cell proliferation.

Cosentyx Expansion

In a separate announcement, Novartis reported that the EC has approved Cosentyx (secukinumab) for use alone or with methotrexate in juvenile idiopathic arthritis, specifically enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients aged six years and above who have not responded adequately to or cannot tolerate conventional therapy. This approval was based on data from the Phase III JUNIPERA study, which demonstrated a significantly longer time to flare in patients treated with Cosentyx versus placebo in pediatric patients with ERA and JPsA.
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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 (NVS) Gets Positive CHMP Opinion for Scemblix in CML
finance.yahoo.com · Jun 27, 2022

Novartis AG announced a positive CHMP opinion recommending marketing authorization for Scemblix (asciminib) for Ph+ CML-...

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