Efficacy

Efficacy of Copiktra (duvelisib) in Leukemia

Copiktra (duvelisib) is a kinase inhibitor specifically approved for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or follicular lymphoma (FL) after at least two prior therapies. Its efficacy in CLL and SLL was evaluated in a randomized, multicenter, open-label, phase 3 study. The study demonstrated a statistically significant improvement in progression-free survival (PFS) when compared to the comparator arm. Patients treated with Copiktra showed a median PFS of 13.3 months versus 9.9 months in the comparator arm, which consisted of ofatumumab treatment.

For patients with relapsed or refractory CLL or SLL, Copiktra has shown a clinically meaningful benefit. However, it is important to note that the safety and efficacy of Copiktra for the treatment of patients with CLL or SLL who have not received at least two prior systemic therapies have not been established. Additionally, the use of Copiktra comes with a boxed warning for serious toxicities such as infections, diarrhea or colitis, cutaneous reactions, and pneumonitis.

Efficacy of Elzonris (tagraxofusp-erzs) in Leukemia

Elzonris (tagraxofusp-erzs) is a CD123-directed cytotoxin and the first approved treatment for blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare form of leukemia. The efficacy of Elzonris in BPDCN was primarily shown in a multicenter, open-label, single-arm clinical trial. In this trial, patients with BPDCN, including treatment-naive and previously treated patients, were administered Elzonris. The trial demonstrated a combined complete response (CR) and clinical complete response (CRc) rate of 54%, with some patients achieving a CR/CRc with a duration ranging from 3 to over 12 months.

Elzonris has not been studied in patients with other forms of leukemia and its use is specifically indicated for BPDCN. The safety and efficacy of Elzonris for the treatment of other types of leukemia have not been established. As with many cancer treatments, Elzonris carries a risk for serious side effects, including capillary leak syndrome, which can be life-threatening if not properly managed. It is essential for healthcare providers to carefully monitor patients receiving Elzonris for signs and symptoms of capillary leak syndrome and other potential toxicities.