Dr Feldman on the Importance of the TRANSCEND CLL 004 Trial in CLL/SLL

Tatyana Feldman, MD, hematologist, director, T Cell Lymphoma Program, John Theurer Cancer Center, Hackensack University Medical Center, discusses the importance of the phase 1/2 TRANSCEND CLL 004 trial (NCT03331198) investigating lisocabtagene maraleucel (liso-cel; Breyanzi) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

This trial holds significant importance due to the evolution of CLL treatment, Feldman begins. Although oncologists have witnessed remarkable advancements with treatment options such as BTK inhibitors and BCL-2 inhibitors, drastically altering the prognosis for patients with CLL, there has been a notable emergence of relapses among patients after long-term or even short-term treatment with these inhibitors, Feldman explains. Despite ongoing studies exploring various treatment avenues, one particularly noteworthy study is the TRANSCEND CLL 004 trial, she elucidates.

After the primary analysis findings from TRANSCEND CLL 004 were presented, at the 2023 ASH Annual Meeting, a 24-month median follow-up analysis was presented, Feldman says. The trial focused on adult patients with relapsed/refractory CLL, including a cohort of double-refractory patients who had progressed on both BTK inhibitor– and venetoclax (Venclexta)–based treatments, she reports. This population presents a considerable treatment challenge due to their notably short overall survival outcomes, Feldman adds.

Patients in the trial received liso-cel at 2 dose levels, with the second dose level being the standard for all patients, Feldman continues. The study comprised 2 cohorts: 1 encompassing all patients and another specific to venetoclax- and BTK inhibitor–pretreated patients, she concludes.

Results from the initial analysis of this research were previously disclosed, showing rapid and deep responses with the treatment. These findings played a role in the FDA's priority review of the supplemental biologics license application for liso-cel for patients with relapsed/refractory CLL or SLL. This application sought to broaden the approved use of liso-cel to encompass patients diagnosed with CLL and SLL who had previously received treatment with both a BTK inhibitor and a BCL-2 inhibitor.