An ongoing trial is examining Calquence in older or frail patients with chronic lymphocytic leukemia — a group that is typically left out of clinical trials.
There were no unexpected safety signals observed with Calquence (acalabrutinib) treatment for older and/or frail patients with chronic lymphocytic leukemia (CLL), according to findings from the ongoing, phase 2 CLL-FRAIL trial, which were presented at the 2023 European Hematology Association Congress.
“Although representing roughly 20% of the general CLL population, older patients remain underrepresented in clinical trials,” the authors wrote in their poster presented at the meeting.
The study involved 30 patients with CLL who were 80 years or older (median age, 82) and/or had a score of 3 or higher on the FRAIL score — a nine-point scale used to determine frailty in patients. Scores of 3 or higher indicate some level of frailty, with a score of 3 representing patients who are managing well with their disease, but are not regularly active, while a score of 9 indicates that a person is terminally ill. Twenty-five patients had an ECOG score of 1 or higher, indicating that they had some degree of difficulty performing daily tasks.
Twenty-six patients did not have a TP53 mutation, while 3 had a TP53 deletion or mutation and 1 patient had TP53 status missing. Additionally, 19 patients (63.3%) harbored an IgHV mutation and 11 (36.7%) did not.
“Patient characteristics show a representative cohort for this age group (that is) usually exempt from clinical trials,” the researchers wrote.
Nineteen patients (63%) did not receive previous treatment. In patients who did receive prior therapy, the most common regimen was chemoimmunotherapy, which was given to 73% of pretreated patients. Other prior regimens, each of which were given to 9% of previously treated patients included: Imbruvica (ibrutinib) plus Gazyva (obintuzumab) and Venclexta (venetoclax); Bendeka (bendamustine) plus Imbruvica and Kesimpta (ofatumumab); and Gazyva plus Venclexta.
At the time of data collection on Nov. 24, 2022, patients were on treatment for an average of eight months, and 21 patients (70%) remained on therapy. Among patients who stopped treatment with Calquence, the most common reason was side effects (five patients; 56%). During treatment exposure, two patients (22%) died and another two withdrew consent to participate in the study.
All patients experienced at least one side effect of any severity, with a pooled count of side effects totaling 200 — 35 (18%) of these were grade 3 or higher. Fifteen side effect instances were severe, of which eight (53%) were deemed to be related to the treatment. Two patients (6%) experienced atrial fibrillation of grade 2, while two others experienced grade 3 atrial fibrillation. Two patients who had both prior high blood pressure and atrial fibrillation experienced cardiac failure.
In total, four patients (13%) died, and among these deaths one (25%) was related to treatment with Calquence. The others causes of death were infection (one bacterial and two COVID-19–related pneumonia) and concomitant disease.
“This first interim analysis of an ongoing phase 2 study evaluating treatment with (Calquence) in very old and/or frail patients with CLL did not show unexpected safety signals in comparison to prior published data,” the authors concluded.
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