Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma.

Daratumumab, a monoclonal antibody targeting CD38 protein, has shown survival benefit in patients with multiple myeloma.

达雷妥尤单抗，一种靶向CD38蛋白的单克隆抗体，在多发性骨髓瘤患者中显示出生存益处。

Methods

In this phase 3 trial, we randomly assigned patients with one to three previous lines of therapy to receive combination therapy with teclistamab-daratumumab or daratumumab combined with dexamethasone plus the investigator's choice of pomalidomide (DPd) or bortezomib (DVd) - the DPd or DVd group.

在这项III期试验中，我们随机分配了一至三线治疗的患者，接受teclistamab-daratumumab联合治疗或daratumumab联合地塞米松加上研究者选择的pomalidomide（DPd）或硼替佐米（DVd）-即DPd组或DVd组。

The primary end point was progression-free survival, as assessed by an independent review committee.

主要终点是独立审查委员会评估的无进展生存期。

Results

A total of 587 patients underwent randomization (291 to receive teclistamab-daratumumab and 296 to receive DPd or DVd).

共有587名患者进行了随机分组（291名接受teclistamab-daratumumab治疗，296名接受DPd或DVd治疗）。

At a median of 34.5 months, progression-free survivalwas significantly longer with teclistamab-daratumumab than with DPd or DVd.

在中位随访34.5个月时，接受teclistamab-daratumumab治疗的患者的无进展生存期显著长于接受DPd或DVd治疗的患者。

The estimated 36-month progression-free survivalwas 83.4% in the teclistamab-daratumumab group and 29.7% in the DPd or DVd group (hazard ratio, 0.17; 95% confidence interval, 0.12 to 0.23; P<0.001).

在 teclistamab-daratumumab 组中，估计的36个月无进展生存率为83.4%，而在DPd或DVd组中为29.7%（风险比，0.17；95%置信区间，0.12至0.23；P<0.001）。

More patients in the teclistamab-daratumumab group than in the DPd or DVd group had a complete response or better (81.8% vs. 32.1%), an overall response (89.0% vs. 75.3%), and minimal residual disease negativity (10-5; 58.4% vs. 17.1%) (P<0.001 for all comparisons).

在 teclistamab-daratumumab 组中，与 DPd 或 DVd 组相比，有更高比例的患者达到完全缓解或更好（81.8% 对比 32.1%），总体反应（89.0% 对比 75.3%），以及微小残留病灶阴性（10^-5；58.4% 对比 17.1%）（所有比较的 P 值均小于0.001）。

Serious adverse events occurred in 70.7% of the patients in the teclistamab-daratumumab group and in 62.4% of those in the DPd or DVd group; death from adverse events occurred in 7.1% and 5.9%, respectively.

在接受teclistamab-daratumumab治疗的患者中，有70.7%的患者出现了严重不良事件，而在DPd或DVd治疗组中，这一比例为62.4%；因不良事件导致的死亡率分别为7.1%和5.9%。

Conclusions

In patients with multiple myeloma who had received one to three previous lines of therapy, those in the teclistamab-daratumumab group had significantly longer progression-free survivalthan those in the DPd or DVd group.

在那些接受了一到三线治疗的多发性骨髓瘤患者中，接受teclistamab-daratumumab治疗的患者的无进展生存期显著长于接受DPd或DVd治疗的患者。

(Funded by Johnson & Johnson; ClinicalTrials.gov number, NCT05083169.).

(由强生公司资助; ClinicalTrials.gov 注册号, NCT05083169.)。