Early results appear promising for frontline asciminib in patients with chronic phase chronic myeloid leukemia (CML-CP), according to a presentation at the 2022 ASH Annual Meeting.
Asciminib produced an early molecular response rate of 92% and was “remarkably well tolerated,” according to study presenter David T. Yeung, MBBS, PhD, of the South Australian Health and Medical Research Institute in Adelaide, Australia.
Dr Yeung and colleagues are evaluating frontline asciminib in the ongoing phase 2 ALLG CML13 trial. Dr Yeung presented an interim analysis of the trial at the meeting.
At the data cutoff, 98 patients with CML-CP were enrolled. The median age was 57 (range, 19-88) years, 38% of patients were women, and 78.9% were Caucasian.
All patients started on asciminib at 40 mg twice daily. They could continue receiving that dose if they had an optimal response (defined as BCR-ABL1 transcript levels ≤10% at 3 months, ≤1% at 6 months, ≤0.1% at 12 months, and ≤0.01% at 18 months).
Patients with treatment failure (defined as BCR-ABL1 transcript levels >10% at 3-6 months and >1% at 12-18 months) could receive asciminib in combination with nilotinib, dasatinib, or imatinib (at the physician’s discretion). Patients with BCR-ABL1 transcript levels in between the “response” and “failure” levels could receive asciminib at 80 mg twice daily.
The median follow-up was 11 months. At 3 months, molecular response data were available for 76 patients. The rate of early molecular response was 92%, the rate of molecular response 2 was 84%, the rate of major molecular response was 47%, and the rate of molecular response 4 was 13%.
There were a total of 10 treatment discontinuations. Three patients had resistant disease, 1 withdrew consent, 1 was lost to follow-up, and the rest discontinued due to adverse events.
Grade 3-4 adverse events included neutropenia (6.5%), thrombocytopenia (5.4%), anemia (2.2%), increased lipase levels (6.5%), increased liver enzymes (1%), infection (1%), abdominal pain (1%), and pulmonary embolism (1%).
“I think the data suggest this is a very promising approach frontline, both in terms of its safety and of its efficacy, but clearly we need longer follow-up to determine that,” Dr Yeung said.
Disclosures: This research was supported by Novartis Pharmaceuticals. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Yeung DT, Shanmuganathan N, Reynolds J, et al. Early and deep molecular responses achieved with frontline asciminib in chronic phase CML – interim results from ALLG CML13 Ascend-CM. Presented at ASH 2022. December 10-13, 2022. Abstract 79.