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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 is presenting data from over 65 abstracts at the American Society of Hematology (ASH) Annual Meeting and the San Antonio Breast Cancer Symposium (SABCS), showcasing advancements in hematologic diseases and cancers.

Novartis is presenting data from more than 65 abstracts at the 66th American Society of Hematology (ASH) Annual Meeting & Exposition and the 2024 San Antonio Breast Cancer Symposium® (SABCS), showcasing advancements in research and development programs in hematologic diseases and cancers. Key presentations include updated results from the Phase III ASC4FIRST trial of Scemblix in chronic myeloid leukemia (CML) and a late-breaking analysis from the Phase III NATALEE trial of Kisqali in early breast cancer.

Scemblix (asciminib) in Chronic Myeloid Leukemia

Longer-term 96-week results from the Scemblix® ASC4FIRST Phase III study in first-line Philadelphia chromosome-positive (Ph+) CML in chronic phase (CP) are being presented. The data reinforces the favorable safety and tolerability profile of asciminib compared to investigator-selected tyrosine kinase inhibitors (TKIs) in newly diagnosed CML-CP patients. This follows the recent FDA approval of Scemblix based on the 48-week data.
Additional Scemblix data includes interim results from the Phase 2 ASC2ESCALATE trial in patients after one prior TKI, and primary analysis from the ASC4OPT study in patients previously treated with two or more TKIs. These studies further characterize the efficacy and safety of asciminib in various CML treatment settings.

Kisqali (ribociclib) in Early Breast Cancer

A late-breaking 4-year analysis of distant disease-free survival (DDFS) from the Phase III NATALEE trial of Kisqali® plus a nonsteroidal aromatase inhibitor (NSAI) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) is being presented. The analysis focuses on key subgroups and provides insights into the long-term benefits of ribociclib in this patient population.
Further Kisqali data includes the impact of ribociclib dose reduction on efficacy in HR+/HER2- EBC patients in NATALEE, risk of recurrence in real-world NATALEE- and monarchE-eligible populations, tolerability of first-line ribociclib in metastatic breast cancer, impact of body mass index on safety and efficacy of ribociclib in advanced breast cancer, and first-line ribociclib plus endocrine therapy versus combination chemotherapy in clinically aggressive HR+/HER2- advanced breast cancer.

Additional Highlights

Other notable presentations include data on ianalumab (VAY736) in primary immune thrombocytopenia, rapcabtagene autoleucel (YTB323) in relapsed/refractory diffuse large B-cell lymphoma, Fabhalta® (iptacopan) in paroxysmal nocturnal hemoglobinuria (PNH), and pelabresib (CPI-0610) in myelofibrosis.
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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' 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.

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 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 ...
novartis.com · Nov 25, 2024

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

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