A phase 2 randomized study of modakafusp alfa as a single agent for patients with relapsed/refractory multiple myeloma.

Our previous phase 1/2 trial identified 2 potential phase 2 doses of modakafusp alfa for patients with relapsed/refractory multiple myeloma (RRMM): 1.5 or 3 mg/kg every 4 weeks.

我们之前进行的 1/2 期临床试验确定了两种潜在的 2 期剂量，用于治疗复发/难治性多发性骨髓瘤（RRMM）患者：每 4 周 1.5 或 3 mg/kg 的 modakafusp alfa。

The overall response rate (ORR) among 30 patients treated at 1.5 mg/kg was 43%.

在30名接受1.5 mg/kg治疗的患者中，总缓解率（ORR）为43%。

This phase 2 dose optimization study randomized 147 patients with triple-class refractory disease and ≥3 previous lines of therapy 1:1 to modakafusp alfa 120 mg (n = 71) or 240 mg (n = 75) every 4 weeks (fixed-dose equivalents of 1.5 and 3 mg/kg every 4 weeks).

这项II期剂量优化研究将147名三重耐药疾病患者和≥3次先前治疗的患者随机分为1:1，分别接受每4周120 mg（相当于每4周1.5 mg/kg）或240 mg（相当于每4周3 mg/kg）的modakafusp alfa治疗，共71例和75例。

Patients had received a median of 6 previous lines of therapy; 66% were penta-exposed and 45% had previously been exposed to anti-B-cell maturation antigen (BCMA) therapy.

患者接受了中位数为6次的先前治疗线；66%的患者接受过五种不同药物的治疗，45%的患者之前接受过抗B细胞成熟抗原（BCMA）治疗。

Modakafusp alfa development was discontinued for strategic reasons by the sponsor and the study was terminated early.

由于赞助商的战略原因，Modakafusp alfa的开发被停止，研究提前终止。

At median follow-up of 7.3 and 7.6 months in the 120- and 240-mg arms, ORRs were 32% and 41%, and median progression-free survivalwas 4.1 and 5.3 months, respectively.

在120mg和240mg组的中位随访时间分别为7.3个月和7.6个月时，客观缓解率(ORR)分别为32%和41%，无进展生存期(median progression-free survival)中位数分别为4.1个月和5.3个月。

ORRs were higher in patients who had not received previous BCMA therapy (46% vs 29%).

在未接受过BCMA治疗的患者中，客观缓解率(ORR)更高（46%对比29%）。

The most common treatment-related adverse events (TEAEs) in the 120- and 240-mg arms were thrombocytopenia (75% and 84%; grade ≥3, 55% and 61%; respectively) and neutropenia (68% and 73%; grade ≥3, 56% and 68%; respectively); 90% and 96% of patients, respectively, experienced grade ≥3 TEAEs; 39% and 44%, respectively, experienced serious TEAEs.

在120毫克和240毫克剂量组中，最常见的治疗相关不良事件（TEAEs）是血小板减少症（分别占75%和84%；3级或以上占55%和61%）和中性粒细胞减少症（分别占68%和73%；3级或以上占56%和68%）；分别有90%和96%的患者经历了3级或以上的TEAEs；分别有39%和44%的患者经历了严重的TEAEs。

Our results confirm the efficacy of single-agent modakafusp alfa for patients with RRMM.

我们的结果证实了单药modakafusp alfa对于复发/难治性多发性骨髓瘤（RRMM）患者的疗效。

This trial was registered at www.clinicaltrials.gov as #NCT03215030.

这项试验已在www.clinicaltrials.gov上注册，注册号为#NCT03215030。