New CAR-T therapy works well, with relief in 94% of patients
New CAR-T therapy works well, with relief in 94% of patients
December 12, 2017 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, Celgene and bluebird bio announced the results of a phase 1 clinical trial at the annual meeting of the American College of Hematology (ASH). This trial evaluated the safety and efficacy of anti-B cell mature antigen (BCMA) CAR-T cell therapy bb2121 in patients with advanced relapsed/refractory multiple myeloma.
Bb2121 is a CAR-T therapy developed by bluebird for advanced relapsing/refractory multiple myeloma. It has not been approved yet, but it has received the FDA-issued breakthrough therapy certification and the European Medicines Agency (EMA). PRIME qualification granted.
The efficacy and safety of bb2121 was confirmed in clinical trials. This ongoing phase 1 study, CRB-401, evaluated the initial safety and efficacy of bb2121 in 21 patients with relapsed/refractory multiple myeloma and determined the recommended dose for phase 2 trials. These patients were first treated with a pretreatment regimen of cyclophosphamide and fludarabine followed by infusion of increasing doses of bb2121 anti-BCMA CAR-T cells. These CAR-T cells are produced by each patient's own blood cells and then modified using a proprietary lentiviral vector encoding anti-BCMA CAR. The current results show:
• Median follow-up time is 40 weeks (range: 6.6-69)
• 94% (17/18) patients achieved objective relief
• 89% (16/18) patients achieve at least one very good partial response (VGPR)
• 56% (10/18) patients achieved complete remission (CR, N=7), or unrecognized complete remission (N=3)
• Nine of the 10 patients who underwent minimal residual disease (MRD) status assessment were MRD negative
• Median progression-free survival (PFS) has not been achieved in the effective dose group, with PFS at 8 and 9 months being 81% and 71%, respectively.
• Three patients who have achieved remission during dose escalation subsequently develop disease progression
In terms of safety, the main side effect is cytokine release syndrome (CRS). In the dose escalation phase, 71% (15/21) of the patients experienced CRS, mostly at grade 1 or 2, and 2 patients at grade 3, with remission after treatment.
“Celgene has a long-term commitment to treating patients with multiple myeloma and has conducted extensive research on this deadly blood cancer,†said Nadim Ahmed, president of Helenology and Oncology at Celgene. “Looking ahead, we think BCMA is the disease. Important targets, we believe that bb2121 may have a significant impact on the treatment and outcome of these patients."
â–² Dr. David Davidson, Chief Medical Officer of bluebird bio (Source: bluebird bio official website)
“More and more bb2121 clinical data is building a compelling story that further supports the importance of the unique features of the therapy,†said Dr. Dave Davidson, chief medical officer of bluebird bio. “In the relapsed and refractory patient population The response obtained, coupled with good safety, enhances the potential role of bb2121 as a breakthrough CAR-T therapy in multiple myeloma."
"In the patient population after multiple treatments, it is very promising to see these reactions after a single treatment with bb2121. We hope that CAR-T therapy and bb2121 can be an important treatment for multiple myeloma, and the disease remains It’s terrible and incurable,†said Dr. James Kochenderfer, principal investigator of the study, Cancer Research Center at the National Cancer Institute.
We expect this new treatment to bring new hopes for treatment to these complex multiple myeloma patients.
Reference materials:
[1] bluebird, Celgene Tout 'Unheard of' Early-Stage Multiple Myeloma Data
[2] bluebird bio official website
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