Christie Hospital Foundation NHS Trust, University of Manchester, Manchester, UK.
University Hospital Birmingham, Birmingham, UK.
J Eur Acad Dermatol Venereol. 2021 Nov;35(11):2225-2238. doi: 10.1111/jdv.17523. Epub 2021 Aug 20.
Mogamulizumab was compared with vorinostat in the phase 3 MAVORIC trial (NCT01728805) in 372 patients with relapsed/refractory mycosis fungoides (MF) or Sézary syndrome (SS) who had failed ≥1 prior systemic therapy. Mogamulizumab significantly prolonged progression-free survival (PFS), with a superior objective response rate (ORR) vs. vorinostat.
This post hoc analysis was performed to evaluate the effect of baseline blood tumour burden on patient response to mogamulizumab.
PFS, ORR, time to next treatment (TTNT), skin response (modified Severity-Weighted Assessment Tool [mSWAT]) and safety were assessed in patients stratified by blood classification (B0 [n = 126], B1 [n = 62], or B2 [n = 184], indicating increasing blood involvement).
Investigator-assessed PFS was longer for mogamulizumab versus vorinostat across all blood classes, significantly so for B1 and B2 patients. ORR was higher with mogamulizumab than with vorinostat in all blood classification groups and more markedly so with escalating B class (B0: 15.6% vs. 6.5%, P = 0.0549; B1: 25.8% vs. 6.5%, P = 0.2758; B2: 37.4% vs. 3.2%, P < 0.0001). TTNT was significantly longer for patients treated with mogamulizumab versus vorinostat with B1 (12.63 vs. 3.07 months; HR 0.32 [95% CI 0.16-0.67]; P = 0.0018) and B2 (13.07 vs. 3.53 months; HR 0.30 [95% CI 0.21-0.43]; P < 0.0001) blood involvement. In the mogamulizumab arm, 81 patients (43.5%) had ≥50% change in the mSWAT vs. 41 patients (22.0%) with vorinostat; mSWAT improvements with mogamulizumab occurred most often in B1 and B2 patients. Rapid, sustained reductions were seen in CD4 CD26 cell counts and CD4:CD8 ratios in mogamulizumab patients for all B classes. Treatment-emergent adverse events were less frequent overall with mogamulizumab and similar in frequency regardless of B class.
This post hoc analysis indicates greater clinical benefit with mogamulizumab vs. vorinostat in patients with MF and SS classified as having B1 and B2 blood involvement.
莫格利珠单抗在复发/难治性蕈样真菌病（MF）或塞扎里综合征（SS）患者的 3 期 MAVORIC 试验（NCT01728805）中与伏立诺他进行了比较，这些患者在接受 ≥1 次先前的系统治疗后失败。莫格利珠单抗显著延长了无进展生存期（PFS），客观缓解率（ORR）优于伏立诺他。
本事后分析旨在评估基线血液肿瘤负担对莫格利珠单抗患者反应的影响。
根据血液分类（B0 [n=126]、B1 [n=62]或 B2 [n=184]，表示血液受累程度增加）对患者进行分层，评估莫格利珠单抗与伏立诺他治疗的 PFS、ORR、下次治疗时间（TTNT）、皮肤反应（改良严重程度加权评估工具[mSWAT]）和安全性。
在所有血液分类中，与伏立诺他相比，莫格利珠单抗的研究者评估 PFS 更长，B1 和 B2 患者的 PFS 显著延长。在所有血液分类组中，莫格利珠单抗的 ORR 均高于伏立诺他，随着 B 类增加更为明显（B0：15.6% vs. 6.5%，P=0.0549；B1：25.8% vs. 6.5%，P=0.2758；B2：37.4% vs. 3.2%，P<0.0001）。与伏立诺他相比，莫格利珠单抗治疗患者的 TTNT 显著延长，B1（12.63 个月 vs. 3.07 个月；HR 0.32 [95% CI 0.16-0.67]；P=0.0018）和 B2（13.07 个月 vs. 3.53 个月；HR 0.30 [95% CI 0.21-0.43]；P<0.0001）患者的血液受累。在莫格利珠单抗组中，81 名患者（43.5%）的 mSWAT 变化≥50%，而伏立诺他组为 41 名患者（22.0%）；莫格利珠单抗治疗的患者中 mSWAT 改善最常见于 B1 和 B2 患者。在所有 B 类患者中，莫格利珠单抗可迅速、持续降低 CD4 CD26 细胞计数和 CD4:CD8 比值。
本事后分析表明，与伏立诺他相比，B1 和 B2 血液受累的 MF 和 SS 患者接受莫格利珠单抗治疗具有更大的临床获益。
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