Funding

This work was funded by Janssen Research & Development, LLC, and Legend Biotech USA Inc. The journal’s Rapid Service fees were funded by Janssen Research & Development, LLC. Authors employed by the funder were involved in the design and conduct of the analysis, interpretation of the data, preparation, review, and approval of the manuscript, and the decision to submit.

Medical Writing and Other Assistance

The authors thank the investigators from the LEGEND-2 study, including Ai-Li He, Wan-Hong Zhao, Bai-Yan Wang, Wei-Jun Fu, Li-Juan Chen, and Jian-Qing Mi for their critical review of the manuscript. Medical writing support was provided by Valerie P. Zediak, PhD, of Eloquent Scientific Solutions. Medical writing support was funded by Janssen Global Services, LLC.

Author Contributions

Concept and design: Rafal Slowik, Hilary Phelps, Stephen Palmer, Nasuh Buyukkaramikli, and Feng Pan; Acquisition of data: Hilary Phelps, Nasuh Buyukkaramikli, and Feng Pan; Analysis and interpretation of data: Rafal Slowik, Hilary Phelps, Stephen Palmer, Nasuh Buyukkaramikli, Feng Pan, and Satish Valluri; Drafting manuscript: Rafal Slowik, Hilary Phelps, Stephen Palmer, Nasuh Buyukkaramikli, and Feng Pan; Critical revision of manuscript for important intellectual content: Rafal Slowik, Hilary Phelps, Stephen Palmer, Nasuh Buyukkaramikli, Feng Pan, Satish Valluri, Yi Lin, Thomas G. Martin, Sundar Jagannath, Andrzej Jakubowiak, Saad Z. Usmani, Lida Pacaud, and Graham Jackson. All authors read and approved the final manuscript version.

Disclosures

Stephen Palmer held a consulting or advisory role at Amgen, Autolos, Bristol-Myers Squibb, Janssen, Merck, Pfizer, and Takeda Pharmaceuticals. Yi Lin received research funding from Bluebird Bio, Celgene, Janssen, Kite, a Gilead Company, Merck, and Takeda Pharmaceuticals, and held a consulting or advisory role at Bluebird Bio, Celgene, Gamida Cells, Janssen, Juno/BMS, Kite, a Gilead Company, Novartis, Sorrento, and Vineti. Thomas G. Martin received research funding from Janssen. Sundar Jagannath held a consulting or advisory role at Bristol-Myers Squibb, Janssen, Karyopharm Therapeutics, Merck, Sanofi, and Takeda Pharmaceuticals. Andrzej Jakubowiak held a consulting or advisory role at AbbVie, Adaptive, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Juno, Karyopharm, and Sanofi, and received honoraria from AbbVie, Adaptive, Amgen, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Juno, Karyopharm, and Sanofi. Saad Z. Usmani received research funding from Amgen, Array Biopharma, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Incyte, Janssen, Merck, Pharmacyclics, Sanofi, Seattle Genetics, SkylineDX, and Takeda Pharmaceuticals, held a consulting or advisory role at AbbVie, Amgen, Array Biopharma, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Merck, Sanofi, Seattle Genetics, SkylineDX, and Takeda Pharmaceuticals, received honoraria from Amgen, Bristol-Myers Squibb, Celgene, Janssen, Pharmacyclics, Sanofi, and Takeda Pharmaceuticals, and received speaking fees from Amgen, Janssen, and Takeda Pharmaceuticals. Nasuh Buyukkaramikli, Hilary Phelps, Rafal Slowik, Feng Pan, and Satish Valluri are employed by Janssen. Lida Pacaud is employed by Legend Biotech USA Inc. Graham Jackson received research support from Celgene/BMS, Takeda, and Onyx Pharmaceuticals, served on advisory boards for Celgene/BMS, Amgen, Sanofi, Takeda, Janssen, Pfizer, and Oncopeptides, and received speaker fees from Celgene/BMS, Amgen, Sanofi, Takeda, Janssen, Pfizer, and Oncopeptides.

Compliance with Ethics Guidelines

The LEGEND-2 and CARTITUDE-1 studies were conducted in accordance with the Declaration of Helsinki and an institutional review board or independent ethics committee at each study site approved the respective study protocol. The current analysis is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors. All patients in the LEGEND-2 and CARTITUDE-1 studies provided informed consent.

Data Availability

For LEGEND-2 data, access may be requested from the investigators of that study (Jian-Qing Mi [jianqingmi@shsmu.edu.cn]; Sai-Juan Chen [sjchen@stn.sh.cn]; and Ai-Li He [heaili@xjtu.edu.cn]). For CARTITUDE-1 data, and the analyses herein, the data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access [YODA] Project site at http://yoda.yale.edu.