P2, N=55, Enrolling by invitation, SWOG Cancer Research Network | Not yet recruiting --> Enrolling by invitation

Particular attention is paid to how STAMP inhibition differs from ATP-competitive TKIs in terms of selectivity, toxicity profile, and resistance patterns, and how asciminib can be positioned relative to ponatinib in later-line settings.Asciminib has established itself as an effective and generally well-tolerated option for patients with TKI-resistant or -intolerant CML and is poised to expand into earlier lines of therapy. Its ability to induce rapid and deep molecular responses with reduced off-target toxicity may have important implications for long-term disease control and future treatment-free remission (TFR) strategies. Ongoing studies will clarify its optimal sequencing, combination potential, and role in facilitating durable TFR.

P2, N=124, Completed, Novartis Pharmaceuticals | Trial completion date: Jul 2026 --> Oct 2025 | Trial primary completion date: Jul 2026 --> Oct 2025 | Active, not recruiting --> Completed

SiRNA-mediated FN1 knockdown reduced the cell's susceptibility to all generations of TKIs employed in treatment of CML, including asciminib...Clinically, deregulation of FN1 was also observed in peripheral blood cells derived from CML patients. Our data indicate that FN1 may serve as a potential therapeutic target to address TKI resistance or as a suitable biomarker for the treatment.

P=N/A, N=40, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Jul 2026 --> Dec 2026

P=N/A, N=201, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

P1/2, N=42, Not yet recruiting, Duke University | Initiation date: Nov 2025 --> Feb 2026

P1, N=12, Not yet recruiting, Washington University School of Medicine | Trial completion date: Jun 2027 --> Aug 2027

P1, N=36, Recruiting, H. Lee Moffitt Cancer Center and Research Institute

P3, N=406, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2031 --> Jan 2028

P1, N=40, Recruiting, Marlise Luskin, MD | Trial completion date: Nov 2026 --> Nov 2027 | Trial primary completion date: Nov 2025 --> Nov 2026

Additional studies evaluated the impact of strong CYP3A4 perpetrators and imatinib on a single 40 mg dose of asciminib. This PBPK model was applied in lieu of clinical pharmacology studies to support the new drug application of Scemblix® and to bridge data from 40 mg BID to the 80 mg QD and 200 mg BID dose regimens. The PBPK predictions informed the drug product label and are estimated to have replaced at least 10 clinical studies.