Mosunetuzumab Plus Polatuzumab Vedotin in Transplant-Ineligible Refractory/Relapsed Large B-Cell Lymphoma: Primary Results of the Phase III SUNMO Trial.

The combination of mosunetuzumab, a T-cell-engaging bispecific antibody, and polatuzumab vedotin, an antibody-drug conjugate (Mosun-Pola), represents a novel fixed-duration outpatient therapy.

Mosunetuzumab（一种T细胞双特异性抗体）和polatuzumab vedotin（一种抗体药物偶联物，Mosun-Pola）的联合使用，代表了一种新型的固定治疗周期的门诊治疗方案。

Methods

In the phase III SUNMO trial, patients with refractory/relapsed LBCL who were ineligible for autologous stem-cell transplant were randomly assigned (2:1) to receive Mosun-Pola or rituximab, gemcitabine, and oxaliplatin (R-GemOx).

在III期SUNMO试验中，不符合自体干细胞移植条件的难治/复发性LBCL患者被随机分配（2:1）接受Mosun-Pola或利妥昔单抗、吉西他滨和奥沙利铂（R-GemOx）治疗。

Dual primary end points were centrally assessed overall response rate (ORR) and progression-free survival(PFS).

主要终点是中央评估的总缓解率（ORR）和无进展生存期（PFS）。

Overall survivalwas a key secondary end point.

总生存是关键次要终点。

Results

A total of 208 patients were randomly assigned to receive Mosun-Pola (n = 138) or R-GemOx (n = 70).

共有208名患者被随机分配接受Mosun-Pola（n=138）或R-GemOx（n=70）。

At a median follow-up of 23.2 months, the primary analysis of SUNMO demonstrated that the median PFS was significantly longer with Mosun-Pola than with R-GemOx (11.5 months [95% CI, 5.6 to 18] v 3.8 months [95% CI, 2.9 to 4.1]; hazard ratiofor progression or death, 0.41 [95% CI, 0.3 to 0.6]; P < .0001).

在中位随访23.2个月时，SUNMO的主要分析显示，与R-GemOx相比，Mosun-Pola的中位无进展生存期显著更长（11.5个月 [95% 置信区间, 5.6至18] 对比 3.8个月 [95% 置信区间, 2.9至4.1]；进展或死亡的风险比为0.41 [95% 置信区间, 0.3至0.6]；P < .0001）。

ORR was significantly greater with Mosun-Pola versus R-GemOx (70% v 40%; P < .0001), with complete response rates of 51% and 24%, respectively.

与R-GemOx相比，Mosun-Pola的客观缓解率显著更高（70% 对比 40%；P < .0001），完全缓解率分别为51%和24%。

In the Mosun-Pola group, the rate of grade ≥2 cytokine release syndrome (CRS) and usage of tocilizumab occurred in <5% of patients and patient-reported outcomes were improved compared with R-GemOx.

在 Mosun-Pola 组中，≥2 级细胞因子释放综合征（CRS）的发生率和托珠单抗的使用发生在 <5% 的患者中，与 R-GemOx 相比，患者报告的结果有所改善。

Conclusions

Mosun-Pola demonstrated superior efficacy versus R-GemOx, with significant improvements in both ORR and PFS, and infrequent CRS events with a manageable safety profile.

Mosun-Pola 展示了优于 R-GemOx 的疗效，ORR 和 PFS 均有显著改善，且 CRS 事件发生率低，安全性可控。