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Johnson & Johnson Announces Updated Results From The Investigational Phase 1b Trimm-2 Study Evaluating The Combination Of TALVEY And DARZALEX FASPRO Based Combination Shows Deep And Durable Responses In Patients With Relapsed Or Refractory Multiple...

Johnson & Johnson Announces Updated Results From The Investigational Phase 1b Trimm-2 Study Evaluating The Combination Of TALVEY And DARZALEX FASPRO Based Combination Shows Deep And Durable Responses In Patients With Relapsed Or Refractory Multiple...

强生公司宣布从Trimm-2研究的第10亿阶段获得的最新结果,评估了TALVEY和DARZALEX FASPRO联合使用的组合。基于该组合在多发性骨髓瘤复发或难治患者中显示出深层持久反应。
Benzinga ·  09/27 08:02

Johnson & Johnson Announces Updated Results From The Investigational Phase 1b Trimm-2 Study Evaluating The Combination Of TALVEY And DARZALEX FASPRO Based Combination Shows Deep And Durable Responses In Patients With Relapsed Or Refractory Multiple Myeloma

强生公司宣布了来自评估TALVEY和DARZALEX FASPRO联合应用的TRIMm-2研究的最新结果,表明该组合在复发性或难治性多发性骨髓瘤患者中显示出深层和持久的反应

Updated data show 100 percent overall response rate with 56 percent of patients achieving complete response or better with weekly dosing, supporting the combinability of the GPRC5D bispecific antibody

更新的数据显示,每周服药的患者总体反应率达到100%,其中56%的患者达到完全缓解或更好的水平,支持GPRC5D双特异性抗体的可组合性

Safety profile, including infection rates, similar to TALVEY and DARZALEX FASPRO monotherapies

安全性资料,包括感染率,与TALVEY和DARZALEX FASPRO单药疗法相似

RIO DE JANEIRO, Sept. 27, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced updated results from the investigational Phase 1b TRIMM-2 study evaluating the combination of TALVEY (talquetamab-tgvs) with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) and pomalidomide in patients with relapsed or refractory multiple myeloma that demonstrated an overall response rate (ORR) of 82 percent, further supporting the investigation of this combination. These data were featured in an oral presentation at the 2024 International Myeloma Society Annual Meeting (Abstract #OA – 01).

2024年9月27日,里约热内卢/美通社——强生公司(纽交所:JNJ)今天宣布了TRIMm-2研究的最新结果,评估了TALVEY(talquetamab-tgvs)与DARZALEX FASPRO(daratumumab和透明质酸酶-fihj)以及泼他莫单抗(pomalidomide)联合用于复发性或难治性多发性骨髓瘤患者,展示出82%的总体反应率(ORR),进一步支持这种组合疗法的研究。这些数据在2024年国际多发性骨髓瘤学会年会(摘要#OA - 01)的口头报告中展示

The results from the Phase 1b TRIMM-2 study evaluating TALVEY, the first bispecific T-cell engager to target GPRC5D, combined with DARZALEX FASPRO, the first subcutaneous anti-CD38 monoclonal antibody, and pomalidomide included patients who received at least three prior lines of therapy, including a proteasome inhibitor (PI) and immunomodulatory drug (IMiD), or were double refractory to a PI and IMiD and had not received anti-CD38 therapy in the previous 90 days.1

评估TALVEY的TRIMm-2研究结果显示,这是首个针对GPRC5D的双特异性T细胞促活剂,与DARZALEX FASPRO,首个皮下抗CD38单克隆抗体,以及泼他莫单抗联合使用。这包括接受至少三线疗法,包括蛋白酶体抑制剂(PI)和免疫调节药物(IMiD)的患者,或双重耐受PI和IMiD,且在过去90天内未接受抗CD38治疗的患者

At data cutoff, 77 patients had received TALVEY in doses of 0.4 mg/kg weekly (QW) or 0.8 mg/kg biweekly (Q2W), with step-up doses, combined with DARZALEX FASPRO and pomalidomide. In the QW arm (n=18), the overall response rate (ORR) was 100 percent, with 56 percent having a complete response (CR) or better. The Q2W arm (n=59) achieved 76 percent ORR, with 56 percent achieving CR or better. The median duration of response (DOR) in the Q2W arm was 26.4 months, and the median progression-free survival (PFS) was 20.3 months. Results showed 52 percent of patients who are anti-CD38 refractory (n=64) achieved CR or better and 70.8 percent of patients who received prior chimeric antigen receptor T cell (CAR-T) therapy (n=24) achieved CR or better. Patients who had received prior bispecific antibodies (n=29) achieved an 82.8 percent ORR.1

在截至日期,有77名患者接受了TALVEY的每周0.4mg/kg或双周0.8mg/kg的递增剂量,与DARZALEX FASPRO和泼他莫单抗联合使用。在每周剂量组(n=18)中,总体反应率(ORR)为100%,其中56%达到完全缓解(CR)或更好。双周剂量组(n=59)达到76%ORR,其中56%达到CR或更好。双周剂量组中的反应持续时间(DOR)为26.4个月,无进展生存时间(PFS)中位数为20.3个月。结果显示,64名抗CD38耐药患者中有52%达到CR或更好,24名接受过CAR-T细胞治疗的患者中有70.8%达到CR或更好,29名先前接受过双特异性抗体的患者中82.8%的ORR

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