Open AccessA Phase I/II Open‐Label Study of Nivolumab in Previously Treated Advanced or Recurrent Nasopharyngeal Carcinoma and Other Solid Tumors
Author(s) -
Ma Yuxiang,
Fang Wenfeng,
Zhang Yang,
Yang Yunpeng,
Hong Shaodong,
Zhao Yuanyuan,
Tendolkar Amol,
Chen Lu,
Xu Dong,
Sheng Jennifer,
Zhao Hongyun,
Zhang Li
Publication year - 2019
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2019-0284
Subject(s) - nivolumab , medicine , nasopharyngeal carcinoma , pharmacokinetics , adverse effect , population , toxicity , oncology , gastroenterology , pharmacology , surgery , cancer , radiation therapy , immunotherapy , environmental health
Lessons Learned Nivolumab treatment at doses of 3 mg/kg once every 2 weeks (Q2W), 240 mg Q2W, and 360 mg once every 3 weeks was well tolerated in the Chinese population, with no new safety signals identified. Comparison of intensive pharmacokinetic profiles of nivolumab at 3 mg/kg Q2W in Chinese versus global populations revealed no ethnic differences of nivolumab treatment. Nivolumab shows promising preliminary antitumor activity in nasopharyngeal carcinoma.Background This phase I/II study investigated the safety and pharmacokinetics (PK) of nivolumab (anti‐programmed cell death‐1 monoclonal antibody) in Chinese patients with nasopharyngeal carcinoma (NPC) and other solid tumors. Methods A dose evaluation phase (3 mg/kg once every 2 weeks [Q2W]) was followed by a cohort expansion phase (3 mg/kg Q2W or flat doses of 240 mg Q2W or 360 mg once every 3 weeks). Results In the dose evaluation phase, 8/8 patients completed one cycle with no dose‐limiting toxicities. At data cutoff, 46/51 patients were evaluable for safety (all cohorts). Treatment‐related adverse events (TRAEs) occurred in 35 (76%) patients and were primarily grade 1–2; one patient (3 mg/kg Q2W) discontinued because of study drug toxicity. Intensive PK profiles at 3 mg/kg, 240 mg, and 360 mg were well characterized at single and multiple doses of nivolumab. An objective response was determined in six (6/46) patients, four (4/32) of whom had NPC tumors. Conclusion Nivolumab monotherapy at 3 mg/kg and flat doses of 240 mg and 360 mg were well tolerated in this Chinese patient population, with PK profiles at 3 mg/kg being similar to those of global patients. Preliminary efficacy results showed promising antitumor activity of nivolumab in advanced NPC.