|The following article features coverage from the American Society of Clinical Oncology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Autologous anti-CD19 chimeric antigen receptor (CAR) T-cell (CAR-T) therapy lisocabtagene maraleucel (liso-cel) showed clinical activity and acceptable toxicity in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL), according to data from the ongoing phase 1/2 TRANSCEND CLL 004 trial. The trial results were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.1
The trial (ClinicalTrials.gov Identifier: NCT03331198) included 23 CLL or SLL patients who had progressed on or become ineligible for a Burton’s tyrosine kinase inhibitor; 9 of those patients received dose level 1 (50 × 106 CAR+ T cells) and 14 received dose level 2 (100 × 106 CAR+ T cells).
The best overall response rate was 81.8%, of which nearly half of patients (45.5%) had a complete response. Overall, 75% of patients had undetectable minimal residual disease in the blood and 65% had undetectable minimal residual disease in the marrow.
Grade 3 cytokine release syndrome (CRS) occurred in 2 of 23 patients (8.7%), both of whom received dose level 2; no grade 4 CRS was seen. Grade 3 or higher neurological events (NE) occurred in 5 of 23 patients (21.7%), 2 of whom received dose level 1 and 3 of whom received dose level 2. Grade 3 or higher tumor lysis syndrome occurred in 4 of 23 patients (17.4%), 1 of whom received dose level 1 and 3 of whom received dose level 2.
A health care resource utilization analysis of patients with relapsed/refractory non-Hodgkin lymphoma who received liso-cel on the TRANSCEND NHL 001 trial (ClinicalTrials.gov Identifier: NCT02631044) showed that costs of CRS and NE were primarily due to the cost of hospitalization and rose as grade increased. The costs varied widely, ranging from $177 for a grade 1 NE to $263,743 for concurrent CRS and NE of grade 3 or higher.2 The costs of these reactions to liso-cel in CLL or SLL have the potential to be similar.
“Liso-cel demonstrated manageable toxicities and promising clinical activities in a heavily pretreated patient population with high-risk CLL,” concluded study presenter Tanya Siddiqi, MD, City of Hope, Duarte, California. “Clinical responses are rapid. They improve over time and are deep and durable.”
The phase 2 portion of the study is currently enrolling at dose level 2.
Read more of Cancer Therapy Advisor‘s coverage of ASCO’s annual meeting by visiting the conference page.
- Siddiqi T, Dorritie KA, Soumerai JD, et al. TRANSCEND CLL 004: Minimal residual disease (MRD) negative responses after lisocabtagene maraleucel (Liso-Cel; JCAR017), a CD19-directed CAR T cell product, in patients (pts) with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). Presented at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 7501.
- Abramson JS, Siddiqi T, Garcia J, et al. Burden of cytokine release syndrome (CRS) and neurologic events (NE) in patients (Pts) with relapsed/refractory non-Hodgkin lymphoma (NHL) receiving lisocabtagene maraleucel (Liso-cel; JCAR017) in TRANSCEND NHL 001. Presented at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 6637.