Bortezomib, Melphalan, and Prednisone With or Without Daratumumab in Transplant-ineligible Asian Patients With Newly Diagnosed Multiple Myeloma: The Phase 3 OCTANS Study

被引：22

作者：

Fu, Weijun ^{[1
,2
]}

Bang, Soo-Mee ^{[3
]}

Huang, Honghui ^{[4
]}

Kim, Kihyun ^{[5
]}

Li, Wei ^{[6
]}

An, Gang ^{[7
]}

Lee, Je-Jung ^{[8
]}

Cai, Zhen ^{[9
]}

Jin, Jie ^{[9
]}

Wang, Yafei ^{[10
]}

Lin, Tung-Liang ^{[11
]}

Chim, Chor Sang ^{[12
]}

Qi, Ming ^{[13
]}

Wang, Jianping ^{[7
,14
]}

Lu, Xiaolin ^{[15
]}

Song, Yang ^{[15
]}

Jia, Bin ^{[16
]}

Yang, Xue ^{[16
]}

Liu, Wenyu ^{[15
]}

Zhou, Tianyuan ^{[17
]}

Yin, Lu ^{[16
]}

Li, Yunan ^{[18
]}

Zhang, Renyi ^{[19
]}

Hou, Jian ^{[4
,20
]}

Wang, Jianxiang ^{[21
]}

机构：

[1] Tongji Univ, Shanghai Peoples Hosp 4, Sch Med, Dept Hematol, Shanghai, Peoples R China

[2] Changzheng Hosp, Dept Hematol, Shanghai, Peoples R China

[3] Seoul Natl Univ, Bundang Hosp, Seongnam, South Korea

[4] Shanghai Jiao Tong Univ, Renji Hosp, Dept Hematol, Sch Med, Shanghai, Peoples R China

[5] Sungkyunkwan Univ, Samsung Med Ctr, Dept Med, Sch Med, Seoul, South Korea

[6] First Hosp Jilin Univ, Dept Hematol, Oncol Ctr, Changchun, Peoples R China

[7] Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, Tianjin, Peoples R China

[8] Chonnam Natl Univ, Dept Hematol Oncol, Med Sch, Hwasun, Jeollanamdo, South Korea

[9] Zhejiang Univ, Coll Med, Affiliated Hosp 1, Hangzhou, Zhejiang, Peoples R China

[10] Tianjin Canc Hosp, Tianjin, Peoples R China

[11] Chang Gung Mem Hosp, Taoyuan City, Taiwan

[12] Hong Kong Sanat & Hosp, Hong Kong, Peoples R China

[13] Janssen Res & Dev LLC, Spring House, PA USA

[14] Janssen Res & Dev LLC, Raritan, NJ USA

[15] Janssen Res & Dev LLC, Beijing, Peoples R China

[16] Janssen Res & Dev LLC, Shanghai, Peoples R China

[17] AP Ctr Excellence, Janssen China Res & Dev, Translat Sci, Shanghai, Peoples R China

[18] Xian Janssen Pharmaceut Ltd, Med Affairs, Beijing, Peoples R China

[19] Xian Janssen Pharmaceut Ltd, Med Affairs, Shanghai, Peoples R China

[20] Shanghai Jiao Tong Univ, Renji Hosp, Dept Hematol, Sch Med, 160 Pujian Rd, Shanghai, Peoples R China

[21] Chinese Acad Med Sci & Peking Union Med Coll, Inst Hematol & Blood Dis Hosp, 288 Nanjing Rd, Tianjin 300020, Peoples R China

来源：

CLINICAL LYMPHOMA MYELOMA & LEUKEMIA | 2023年 / 23卷 / 06期

关键词：

Clinical trial; Efficacy; Patient-reported outcomes; Pharmacokinetic; Safety; MINIMAL RESIDUAL DISEASE; ANTIBODY DARATUMUMAB; OPEN-LABEL; DEXAMETHASONE; LENALIDOMIDE; CRITERIA; MONOTHERAPY; CD38;

D O I：

10.1016/j.clml.2023.02.009

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The phase 3 OCTANS study evaluated daratumumab+ bortezomib/melphalan/prednisone (D-VMP) compared to VMP alone in Asian patients with newly diagnosed multiple myeloma. At a median follow-up of 1 year, D-VMP reduced the risk of disease progression or death by 57% compared to VMP alone and had a manageable safety profile. Efficacy and safety from OCTANS were consistent with the global ALCYONE study. Introduction: In the global phase 3 ALCYONE trial, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) improved outcomes versus VMP in transplant-ineligible newly diagnosed multiple myeloma (NDMM) patients. Here, we report the primary analysis of the phase 3 OCTANS trial of D-VMP versus VMP in transplant-ineligible Asian NDMM patients. Patients and Methods: In total, 220 patients were randomized (2:1) to receive 9 cycles of VMP (bortezomib 1.3 mg/m2 subcutaneously twice weekly in Cycle 1 and weekly in Cycles 2 to 9; melphalan 9 mg/m2 orally; and prednisone 60 mg/m2 orally on Days 1 to 4 of each cycle) & PLUSMN; daratumumab 16 mg/kg intravenously weekly in Cycle 1, every 3 weeks in Cycles 2 to 9, and every 4 weeks thereafter until disease progression. Results: After a median follow-up of 12.3 months, very good partial response or better rates (primary endpoint) were 74.0% versus 43.2% with D-VMP versus VMP (odds ratio, 3.57; 95% confidence interval [CI], 1.99-6.43; P < .0001). Median progression-free survival (PFS) with DVMP versus VMP was not reached versus 18.2 months (hazard ratio, .43; 95% CI, .24-.77; P = .0033); 12-month PFS rates were 84.2% versus 64.6%. The most frequent grade 3/4 treatment-emergent adverse events with D-VMP/VMP were thrombocytopenia (46.5%/45.1%), neutropenia (39.6%/50.7%), and leukopenia (31.3%/36.6%). Conclusion: D-VMP demonstrated a favorable benefit/risk profile in transplant-ineligible Asian NDMM patients. This trial was registered at www.ClinicalTrials.gov as #NCT03217812.

引用

页码：446 / +

页数：14

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