Drs Baljevic and Cortes Preview Upcoming Studies and Emerging Data From ASH 2024

I look forward to seeing the [data for] single-agent daratumumab in smouldering multiple myeloma, with long-term follow-up results. I have the privilege of presenting a couple of different abstracts with some colleagues around the country.”

Muhamed Baljevic, MD, FACP, hematologist, medical oncologist; associate professor, medicine, Division of Hematology Oncology; director, Plasma Cell Disorders Research; director, Vanderbilt Amyloidosis Multidisciplinary Program, Vanderbilt-Ingram Cancer Center, shares key studies in multiple myeloma that will be presented at the 2024 ASH Annual Meeting.

Among these highly-anticipated trials is the randomized, phase 3 AQUILA study (NCT03301220), which evaluated daratumumab (Darzalex) monotherapy vs active monitoring in patients with high-risk smoldering multiple myeloma. Primary results from the study are expected to inform future management strategies in this patient population. These long-term follow-up data are crucial for understanding the efficacy of single-agent daratumumab in delaying disease progression, Baljevic emphasizes.

Baljevic will also present updated results from the phase 1b/2 STOMP trial (NCT02343042). The dataset will comprise cohorts that received weekly 40 mg or 60 mg doses of selinexor (Xpovio) plus pomalidomide (Pomalyst) and dexamethasone.

We are going to be presenting an update at the 2024 ASH Annual Meeting. We're going to be presenting the 96 weeks data. That's going to be very important in terms of efficacy and safety.

Jorge Cortes, MD, director of the Georgia Cancer Center at Augusta University, also previewed the 96-week data update from the phase 3 ASC4FIRST trial (NCT04971226) evaluating asciminib (Scemblix) in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP).

This update, which will be presented at the meeting, will focus on the efficacy and safety of asciminib compared with investigator-selected TKIs as frontline therapy.

On October 29, 2024, the FDA granted accelerated approval to asciminib, a first-in-class STAMP inhibitor targeting the ABL myristoyl pocket, based on data from the phase 3 ASC4FIRST trial. Previously reported data from the study showed that patients treated with asciminib (n = 201) experienced a 48-week major molecular response (MMR) rate of 68% (95% CI, 61%-74%) vs 49% (95% CI, 42%-56%) in those treated with investigator’s choice of TKI (n = 204). These included imatinib (Gleevec), nilotinib (Tasigna), dasatinib (Sprycel), or bosutinib (Bosulif; difference, 19%; 95% CI, 10%-28%; P < .001).

Cortes notes that this update will provide insights into the long-term efficacy and safety profile of asciminib as a frontline therapy for newly diagnosed CML-CP. He concludes that the FDA approval of asciminib represents a pivotal step towards improving patient outcomes and cure rates for this disease.