51. Phase 2 Study of YS110, a Recombinant Humanized Anti-CD26 Monoclonal Antibody, in Japanese Patients With Advanced Malignant Pleural Mesothelioma
- Author
-
Masato Hirokawa, Mitsuhiro Takenoyama, Takumi Kishimoto, Masayuki Takeda, Takashi Kijima, Keisuke Aoe, Yuichiro Ohe, Morihito Okada, Masahiro Morise, Motoyasu Kato, Nobukazu Fujimoto, Hiroshi Yokouchi, Hironori Matsuki, Kazuhiko Nakagawa, Yutaro Kaneko, Toyoaki Hida, Taketo Yamada, Chikao Morimoto, and Katsuya Hirano
- Subjects
Pulmonary and Respiratory Medicine ,medicine.medical_specialty ,medicine.drug_class ,Salvage therapy ,Phases of clinical research ,Monoclonal antibody ,Gastroenterology ,Phase 2 ,Stable Disease ,Refractory ,Internal medicine ,medicine ,Adverse effect ,Malignant mesothelioma ,RC254-282 ,CD26 ,business.industry ,Interstitial lung disease ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,medicine.disease ,Oncology ,YS110 ,Japanese ,Original Article ,Nivolumab ,business - Abstract
Introduction YS110, a humanized monoclonal antibody with a high affinity to CD26, exhibited promising antitumor activity and was generally well-tolerated in the phase 1 part of a phase 1 and 2 Japanese trial in patients with malignant pleural mesothelioma (MPM). Here we report the results of the phase 2 part of the study. Methods The patients included were aged 20 years and older, had histologically confirmed MPM, were refractory to or intolerant of existing antineoplastic agents, and were not candidates for standard therapy. YS110 6 mg/kg, determined in the phase 1 dose-determination part, was given in 6-weekly cycles (5 × once-weekly infusions, followed by a 1-wk rest). Results The study included 31 patients (median age = 68 y, 90.3% men); 64.5% had stage IV MPM, 90.3% had greater than or equal to 20% CD26 expression in tumor tissue, and 38.7% (12 patients) had previously received nivolumab. The 6-month disease control rate was 3.2%. The best overall response was partial response in one patient and stable disease in 14 patients. The median progression-free survival was 2.8 months (both in patients who had and had not previously received nivolumab—groups A and B, respectively). Respective progression-free survival rates at 6 months were 9.1% and 31.6% in groups A and B. The median overall survival was 9.7 months. A total of 30 patients (96.8%) had at least one adverse event. Common treatment-related adverse events were infusion-related reaction (16.1%), hiccups (9.7%), and interstitial lung disease (9.7%). There were no treatment-related deaths. Conclusions The 6-month disease control rate did not exceed the predefined threshold, but YS110 revealed modest efficacy in response rate as salvage therapy in difficult-to-treat patients with MPM. YS110 was generally well tolerated.
- Published
- 2021