
Phase II study of ceritinib in alectinib‐pretreated patients with anaplastic lymphoma kinase‐rearranged metastatic non‐small‐cell lung cancer in Japan: ASCEND ‐9
Author(s) -
Hida Toyoaki,
Seto Takashi,
Horinouchi Hidehito,
Maemondo Makoto,
Takeda Masayuki,
Hotta Katsuyuki,
Hirai Fumihiko,
Kim Young Hak,
Matsumoto Shingo,
Ito Masayuki,
Ayukawa Koichi,
Tokushige Kota,
Yonemura Masataka,
Mitsudomi Testuya,
Nishio Makoto
Publication year - 2018
Publication title -
cancer science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.035
H-Index - 141
eISSN - 1349-7006
pISSN - 1347-9032
DOI - 10.1111/cas.13721
Subject(s) - ceritinib , alectinib , medicine , crizotinib , anaplastic lymphoma kinase , response evaluation criteria in solid tumors , lung cancer , clinical endpoint , gastroenterology , adverse effect , alk inhibitor , nausea , regimen , progressive disease , anaplastic large cell lymphoma , phases of clinical research , surgery , oncology , chemotherapy , lymphoma , clinical trial , malignant pleural effusion
Clinical experience of ceritinib in patients who progressed on alectinib is limited. In this prospective phase II study, we evaluated the activity of ceritinib in alectinib‐pretreated patients with anaplastic lymphoma kinase ( ALK )‐rearranged metastatic (stage IIIB / IV ) non‐small‐cell lung cancer ( NSCLC ) in Japan. All patients were required to have ≥1 measurable lesion per RECIST , 1.1, and a World Health Organization Performance Status ( WHO PS ) of 0‐1. Prior crizotinib and/or up to 1 chemotherapy regimen was allowed. Primary endpoint was investigator‐assessed overall response rate ( ORR ) per RECIST 1.1. Ceritinib was given at a dose of 750 mg/day fasted. A total of 20 patients were enrolled from August 2015 to March 2017. All patients received prior alectinib (100%), 13 (65.0%) patients received prior platinum‐based chemotherapy, and 4 (20%) patients received prior crizotinib. Median duration of exposure and the follow‐up time with ceritinib were 3.7 months (range: 0.4‐15.1) and 11.6 months (range: 4.8‐23.0), respectively. Investigator‐assessed ORR was 25% (95% CI : 8.7‐49.1). Key secondary endpoints, all investigator assessed, included disease control rate (70.0%; 95% CI : 45.7‐88.1), time to response (median, 1.8 months; range: 1.8‐2.0), and duration of response (median, 6.3 months; 95% CI : 3.5‐9.2). Median progression‐free survival was 3.7 months (95% CI : 1.9‐5.3). The most common adverse events reported were diarrhea (85.0%), nausea (80.0%), and vomiting (65.0%). Based on our findings, ceritinib could be considered as one of the treatment options for patients with ALK ‐positive NSCLC who progressed on alectinib. (Trial registration no. NCT 02450903)