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.

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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.

References

  1. 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.
  2. 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.