trialsTrialActive

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

A phase 3 trial of Imatinib, Nilotinib, Bosutinib, Dasatinib and Asciminib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.

Also called: ASC4FIRST

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP is a phase 3 interventional study registered as NCT04971226 by Novartis Pharmaceuticals, with 405 participants enrolled, started 2021-10-06 and due to reach its primary completion in 2023-11-28. Interventions recorded: Imatinib, Nilotinib, Bosutinib, Dasatinib and Asciminib. Results have been posted on the registry.

Setting

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Phase

Phase 3

Sponsor

Novartis Pharmaceuticals

Registry

Started

2021-10-06

Reported

2025

Enrolled

405 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

405 enrolled

Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKIprimaryother endpoint

Asciminib (All Asciminib ): 136 participants; Investigator Selected TKI (All Comparators): 100 participants.

The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
These results apply to the people the trial enrolled: A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

405 enrolled.

Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKIprimary

· p <0.001

Download

Figures from the ClinicalTrials.gov results section (first posted 2025-03-10), not from a publication

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKIprimary	Asciminib (All Asciminib )	201	136 participants	-	<0.001	link
	Investigator Selected TKI (All Comparators)	204	100 participants	-	<0.001	link

Connected

Similar pages

cancers

Chronic myeloid leukaemia (CML)Chronic myeloid leukaemia, chronic phase

technologies

Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule allosteric ABL1 inhibitor (STAMP)

Asciminib · Scemblix

ApprovedSmall-molecule BCR-ABL1/SRC TKI

Bosutinib · Bosulif

ApprovedSmall-molecule kinase inhibitor (BCR::ABL1, SRC)

Dasatinib · Sprycel

ApprovedSmall-molecule kinase inhibitor (BCR-ABL, KIT, PDGFRA)

Imatinib · Gleevec

ApprovedSmall-molecule BCR-ABL1 TKI (second generation)

Nilotinib · Tasigna

companies

Advanced Accelerator Applications (Novartis)Novartis