Toripalimab plus anlotinib in patients with recurrent or metastatic nasopharyngeal carcinoma: A multicenter, single-arm phase 2 trial (TORAL)
Treatment options for patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) after failure of platinum-based therapy are limited. In this phase 2 trial, 40 patients with RM-NPC who failed platinum-based chemotherapy receive toripalimab plus anlotinib regimen. The objective response rate is 37.5%, and the disease control rate is 85.0%. With a median follow-up of 17.4 months, the median progression-free survival (PFS) is 9.5 months and 1-year overall survival rate is 73.3%. The most common treatment-related grade 3-4 adverse events are hand-foot syndrome (22.5%) and oral mucositis (17.5%). Analyses of plasma circulating tumor DNA (ctDNA) demonstrate that the blood tumor mutation burden at cycle 1/2 is associated with response and PFS, and disease progression indicated by ctDNA precedes radiological progression by a median of 2.3 months. In conclusion, toripalimab plus anlotinib is well tolerated and shows promising efficacy in patients with RM-NPC, and ctDNA could be a potential predictive biomarker. The trial is registered at ClinicalTrials.gov (NCT04996758).
Authors
- Yingxian Liu (ORCID: https://orcid.org/0000-0003-1155-7130)
- Qingqing Cai (ORCID: https://orcid.org/0000-0001-5447-3282)
- Jun Cai (ORCID: https://orcid.org/0000-0002-7503-3427)
- Ning Su (ORCID: https://orcid.org/0000-0002-2799-133X)
- Baitian Zhao
- Zhihua Li (ORCID: https://orcid.org/0000-0003-2003-5457)
- Panpan Liu (ORCID: https://orcid.org/0000-0002-7447-7026)
- Yuchen Zhang (ORCID: https://orcid.org/0000-0001-6262-6015)
- Lirong Li (ORCID: https://orcid.org/0009-0002-7729-9883)
- Xiaojie Fang (ORCID: https://orcid.org/0000-0002-1511-1841)
- Xicheng Wang (ORCID: https://orcid.org/0000-0002-2719-2538)
- Xiaopeng Tian (ORCID: https://orcid.org/0009-0009-4955-7807)
- Yi Xia (ORCID: https://orcid.org/0000-0002-2838-2552)
- Qihua Zou
Institutions
- Sun Yat-sen University (CN)
- Guangdong Pharmaceutical University (CN)
- Sun Yat-sen Memorial Hospital (CN)
- First Affiliated Hospital of Guangdong Pharmaceutical University (CN)
- Sun Yat-sen University Cancer Center (CN)
- Guangzhou Chest Hospital (CN)
Publication Details
- Journal
- Cell Reports Medicine
- Published
- 2024-11-29
- DOI
- https://doi.org/10.1016/j.xcrm.2024.101833
- Citations
- 11
- Primary Topic
- Lung Cancer Research Studies
- Type
- article
- Field-Weighted Citation Impact
- 3.11
Funders
- Shanghai Junshi Biosciences
- National Natural Science Foundation of China
- National Postdoctoral Program for Innovative Talents