Blood Vessel

CAR-T therapies by BMS and Janssen reported successful

Bristol-Myers Squibb logoCAR-T therapies that are being developed by Bristol Myers Squibb and Janssen have all hit targets in early-mid-stage trials. Increasing hopes of new treatment options for difficult to treat blood cancers.

Johnson & Johnson’s Janssen unveiled initial results from the Phase Ib/II CARTITUDE-1 study assessing the efficacy and safety of JNJ-68284528 (JNJ-4528) – an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy – in treating relapsed or refractory multiple myeloma.

The study enrolled patients who had already received at least three prior lines of therapy or are double refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD); have received a PI, IMiD and an anti-CD38 antibody; and who progressed on or within 12 months of their last line of therapy.

Results from the Phase Ib portion of the CARTITUDE-1 study showed “early and deep responses” among patients (n=29) with a median of five prior multiple myeloma treatment regimens treated with JNJ-4528, with 100 percent of patients achieving a response at a median six-month follow-up, the firm said.

The overall response rate (ORR) included 69% of patients achieving a complete response (CR) or better; 86% of patients achieving a very good partial response (VGPR) or better; and 14% of patients achieving a partial response (PR).

The results “highlight a compelling clinical profile” for the treatment in this setting, said Deepu Madduri, assistant professor of Medicine, Haematology and Medical Oncology, Tisch Cancer Institute at Mount Sinai, New York, and principal study investigator.

US regulators have granted JNJ-4528 a breakthrough designation in the US based on the data.

Elsewhere, Bristol-Myers Squibb’s CAR-T cell therapy liso-cel (lisocabtagene maraleucel) showed promise across two trials involving patients with blood cancers.

The studies included an evaluation of liso-cel in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (TRANSCEND CLL 004); and a study in second-line patients with relapsed or refractory large B-cell non-Hodgkin’s lymphoma (NHL) patients who were ineligible for high-dose chemotherapy and hematopoietic stem cell transplant (PILOT).

Among 20 patients evaluable for minimal residual disease (MRD), the majority achieved undetectable MRD in the blood (75%) and bone marrow (65%) by next-generation sequencing, the firms noted.

“As we continue to evaluate liso-cel in important new disease settings and areas of unmet medical need, we are encouraged to see the early results from these studies,” said Stanley Frankel, senior vice president, Cellular Therapy Development for BMS.

Data from all studies were presented at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.

Source: PharmaTimes