The Janssen Pharmaceutical Companies of
The study enrolled patients who have 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. The CARTITUDE-1 study results, premiering at the 2019
Results from the Phase 1b 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 (range, 3-18) treated with JNJ-4528 (median administered dose 0.73x106 CAR+ viable T cells/kg), with 100 percent of patients achieving a response (95 percent confidence interval [CI], 76-95) at a median six-month follow-up. The overall response rate (ORR) included 69 percent of patients achieving a complete response (CR) or better (66 percent achieving a stringent CR); 86 percent of patients achieving a very good partial response (VGPR) or better and 14 percent of patients achieving a partial response (PR). In addition, 100 percent of evaluable patients achieved early minimal residual disease (MRD)-negative disease status at day 28 post-infusion. At the six-month follow-up, 27 of 29 patients were progression-free. Based on the Phase 1b results, a recommended Phase 2 dose of 0.75x106 CAR+ viable T cells/kg was confirmed.
'These initial results from the Phase 1b portion of the CARTITUDE-1 study highlight a compelling clinical profile for JNJ-4528 in heavily pre-treated patients with relapsed or refractory multiple myeloma,' said
The most common adverse events (AEs) observed in the CARTITUDE-1 study were cytokine release syndrome (CRS) (93 percent); neutropenia (93 percent); anemia (86 percent) and thrombocytopenia (86 percent). In patients who experienced grade 3 and above AEs (25 percent), the most common were neutropenia (93 percent); thrombocytopenia (69 percent) and anemia (55 percent). A majority of patients (86 percent) experienced grade 1-2 CRS. One patient experienced grade 3 CRS and one patient died of complications from grade 5 CRS at day 99. The median onset of CRS was generally predictable at seven days (range, 2-12) post-infusion, with a median duration of four days (range, 1-60).
'We are encouraged by the overall response reported in patients receiving JNJ-4528, results that build upon the LEGEND-2 study data as reported in Chinese patients and now show promise in
JNJ-4528 is a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies.[i] LCAR-B38M identifies the investigational product in
Safety and efficacy results observed in the CARTITUDE-1 study were consistent with the LEGEND-2 study of LCAR-B38M, sponsored by Legend Biotech. In follow-up data from the LEGEND-2 study presented at ASH (Abstract #579), investigators reported the long-term response and safety profile for LCAR-B38M. Overall response rates of 88 percent were observed, with 46 percent of all-treated patients and 64 percent of the MRD-negative patients with CR remaining progression-free. The median progression-free survival (PFS) for all-treated patients was 20 months (range, 10-28); median PFS for MRD-negative patients with CR was 28 months (range, 20-31).[ii]
In a separate oral presentation (Abstract #928), data highlighting post-infusion CAR+ T cell expansion in the bone marrow and blood of patients enrolled in the CARTITUDE-1 study will be reported. While both CD4+ and CD8+ CAR+ T cells expanded in vivo, a preferential expansion of memory CD8+ CAR+ T cells was observed at peak expansion. These and other correlative studies are being conducted to better understand the immune mechanisms associated with response to JNJ-4528, and suggest that the high anti-myeloma activity of JNJ-4528 seen at a relatively low T cell dose is potentially related to its preferential and consistent in vivo expansion of CD8+ CAR+ T cells.
About CARTITUDE-1
CARTITUDE-1 (NCT03548207) is an ongoing Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of JNJ-68284528 in adults with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy or are double refractory to a PI and an 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. The primary objective of the Phase 1b portion of the study is to characterize the safety and confirm the dose of JNJ-68284528, which was informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The primary objective for the Phase 2 portion of the study is to evaluate the efficacy of JNJ-68284528 (primary endpoint: overall response rate as defined by the
About LEGEND-2
LEGEND-2 (NCT03090659) is an ongoing Phase 1/2, single-arm, open-label study being conducted at four participating hospitals in
About JNJ-68284528 (LCAR-B38M)
JNJ-68284528 (LCAR-B38M) is an investigational chimeric antigen receptor T cell (CAR-T) therapy for the treatment of patients with relapsed or refractory multiple myeloma. The design comprises a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In
On
About CAR-T and BCMA
CAR-T cells are an innovative approach to eradicating cancer cells by harnessing the power of a patient's own immune system. BCMA is a protein that is highly expressed on myeloma cells.
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.[iv],[v] Refractory cancer occurs when a patient's disease is resistant to treatment or in the case of multiple myeloma, when patients progress within 60 days of their last therapy.[vi],[vii] Relapsed cancer means the disease has returned after a period of initial, partial or complete remission.[viii] In 2018, it is estimated that 30,700 people will be diagnosed and 12,770 will die from the disease in the U.S.[ix] Most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, fatigue, calcium elevation, kidney problems or infections.[x]
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of JNJ-4528. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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