Celgene Announces Data from Ongoing Blood Cancer Studies

Celgene Corporation (NASDAQ: CELG) today announced that data from the TRANSCEND CLL 004 and TRANSCEND NHL 001 trials studying the investigational anti-CD19 chimeric antigen receptor (CAR) T-cell therapy lisocabtagene maraleucel (liso-cel; JCAR017) in patients with B-cell blood cancers were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Updated results from the ongoing, open-label multicenter phase 1/2 TRANSCEND CLL 004 study (Abstract #7501) of liso-cel in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) were presented in an oral presentation today. The data included safety and efficacy findings from 23 patients who received liso-cel infusion at one of two dose levels: 50 × 10⁶ or 100 × 10⁶ total CAR-positive T cells following lymphodepleting chemotherapy. All patients had been previously treated with ibrutinib, and more than half had received prior venetoclax. The median number of lines of prior therapy was five and 83% of patients had high-risk cytogenetic features.

In the study, 22 of 23 patients were evaluable for response. The best overall response rate was 82% (18/22), with 46% (10/22) of patients achieving complete remission with or without complete blood count recovery (CR/CRi). Of 20 patients evaluable for minimal residual disease (MRD), 75% (15/20) achieved undetectable MRD (uMRD) by blood measures (sensitivity, 10^-4) and 65% (13/20) achieved uMRD by bone marrow measures (sensitivity, 10^-4). Responses have been durable, with 83% of patients (5/6) who were in CR/CRi at six months post liso-cel infusion showing ongoing response.

“For patients who have failed the current standard of care treatments for CLL, such as ibrutinib and venetoclax, there is a need for additional treatment options,” said lead study investigator Tanya Siddiqi, M.D., City of Hope National Medical Center. “I am highly encouraged by this early data showing manageable toxicity and promising clinical activity in a heavily pretreated patient population with high-risk CLL. In this preliminary analysis, clinical responses are rapid, deep and durable when assessed by clinical and MRD criteria. We look forward to further investigation of liso-cel in CLL patients who have relapsed from or have become refractory to currently available treatment options.”

https://www.biospace.com/article/releases/celgene-announces-data-from-ongoing-studies-of-liso-cel-in-patients-with-difficult-to-treat-blood-cancers-at-asco-2019/