Copiktra was approved in 2018 based on the benefit-risk evaluation of data available at the time from the DUO trial for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least two prior lines of therapy. The DUO trial was a phase 3, randomized, open-label trial that evaluated Copiktra versus the monoclonal antibody ofatumumab in 319 patients with relapsed or refractory CLL or SLL who received at least one prior line of therapy. The primary endpoint was progression-free survival. At the time of initial approval, the overall survival information was limited, and FDA required the drug manufacturer, Secura Bio, to submit the final analysis of overall survival at 5 years in the trial to enable us to evaluate Copiktra’s long-term safety.

With a median of 63 months follow-up, the final overall survival results showed a possible increased risk of death with Copiktra, with a hazard ratio of 1.09 (95% confidence interval [CI] 0.79, 1.51) (see Table 1 below). Among the subpopulation of patients receiving at least two prior lines of therapy – the FDA approved use – the hazard ratio was 1.06 (95% CI 0.71, 1.58). In addition to the risk of death, the incidence of deaths due to adverse events, serious adverse events, Grade ≥3 adverse events, and treatment modifications due to adverse events were higher among patients receiving Copiktra.

Table 1. Summary of Final Overall Survival (OS) Data in the DUO Trial, ITT population

NE=not estimable; HR=hazard ratio; CI=confidence interval.