Superiority of Asciminib in CML-CP Is a ‘Win-Win’ for Patients

Talha Badar, MBBS, MD, discussed the unmet needs in the treatment of chronic myeloid leukemia in chronic phase.

As part of CancerNetwork’s Face-Off video series, Talha Badar, MBBS, MD, assistant professor of oncology, Mayo Clinic, discussed unmet needs in the treatment of chronic myeloid leukemia in chronic phase (CML-CP), and how results from the phase 3 ASCEMBL study (NCT03106779) are addressing these gaps.

In the trial, investigators assessed asciminib (Scemblix) at 40 mg twice daily vs bosutinib (Bosulif) at 500 mg once daily in patients with CP-CML who had been treated with 2 or more TKIs. A total of 223 patients were randomized 2:1 to active or control therapy with a median follow-up of 14.9 months. At baseline, MCyR was observed in 29.3% of patients in the asciminib arm vs 28.9% in the bosutinib arm. After the data analysis cutoff date, treatment was ongoing in 61.8% vs 28.9% of patients, respectively, with 37.6% and 71.1% discontinuing therapy.

The 24-week MMR rate was 25.5% in the asciminib arm and 13.2% in the bosutinib arm, equating to a 12.2% difference between groups after adjusting for baseline MCyR rates (95% CI, 2.19%-22.30%; 2-sided P = .029). The cumulative incidence of MMR at week 24 was 25.0% in the asciminib arm vs 12.0% in the bosutinib arm.

Badar: The 2 ways of thinking of it, and 1 unmet need is when the disease evolved with time. With prior lines of therapy, the patient tends to develop resistance mechanism, resistant mutation, in which T315I has been the most threatening in terms of patients’ prognosis and outcome. And for those patients, we have only 2 approved oral therapies: asciminib and ponatinib [Iclusig].

There's another medication which is an IV form, which is methadone that has been used prior to advent of ponatinib. In those settings, asciminib maintains a superiority in achieving response in those group of patients who are failing prior ponatinib therapy. So the one unmet need is the patients who had multiple prior therapies, including TC15 and having TC15i mutation, how to counter that mutation how to improve outcome.

The other major unmet need is the tolerance to therapies. There are a subset of patients who don’t tolerate TKI-based therapies and, as we know, from our clinical experience asciminib tends to have a better tolerance and less side effects compared to other TKIs, which had been established and reused in clinic every day.

So if you get a therapy, which is equally or better in efficacy, and as well tolerated, that's a win-win situation.

Transcription edited for clarity.

Related Videos
Daniel G. Stover, MD, suggests that stromal tumor infiltrating lymphocytes may serve as a biomarker of immune activation and can potentially help optimize therapy with microtubule-targeting agents for patients with metastatic breast cancer.
PRGN-3005 autologous UltraCAR-T cells appear well-tolerated and decreases tumor burden in a population of patients with advanced platinum-resistant ovarian cancer.
Sara M. Tolaney, MD, MPH, discusses how, compared with antibody-drug conjugates, chemotherapy produces low response rates and disease control in the treatment of those with hormone receptor–positive, HER2-negative metastatic breast cancer.
Hope Rugo, MD, speaks to the importance of identifying patients with aromatase inhibitor–resistant, hormone receptor–positive, HER2-negative advanced breast cancer who are undergoing treatment with capivasertib/fulvestrant who may be at a high risk of developing diabetes or hyperglycemia.
Sara M. Tolaney, MD, MPH, describes the benefit of sacituzumab govitecan for patients with HER2-low metastatic breast cancer seen in the final overall survival analysis of the phase 3 TROPiCS-02 study.
An expert from Vanderbilt University Medical Center says that patients with relapsed/refractory multiple myeloma may be able to live a normal life following response to salvage treatment with bispecific monoclonal antibodies.
Andrew J. Armstrong, MD, MSc, spoke about the recent approval of olaparib plus abiraterone acetate and prednisone in patients with BRCA-mutant metastatic castration-resistant prostate cancer.
For clinicians practicing in the community, constant communication and education from those in institutions may help to produce the best quality of care for patients with multiple myeloma.
Ashley E. Rosko, MD, specializes in multidisciplinary care for elderly patients with multiple myeloma, and how to make treatment most accessible to them.
At first relapse, novel therapies are offered to patients with multiple myeloma at The Ohio State University Comprehensive Cancer Center-The James.