Found 1 Presentation For Request "990p"
990P - Osimertinib for RT-naïve CNS metastasis of EGFR mutation-positive NSCLC: Phase II OCEAN study (LOGIK 1603/WJOG 9116L), part of the first-line cohort
- Hiroyuki Yamaguchi (Nagasaki, Japan)
Abstract
Background
Non-small cell lung cancer
Methods
The primary endpoint was response rate of brain metastasis (BMRR) by the PAREXEL criteria in T790M cohort, BMRR, PFS and OS in 1st-line cohort were secondary endpoints. We set a threshold RR 55% and an expected RR 80% in 1st-line cohort. Based on alpha 0.05 (one-sided) and 80% power, the sample size of first-line cohort was set to 25.
Results
Between September 2019 to July 2020, 26 patients were enrolled in the 1st-line cohort. The median age was 72.0 years old with 80.8% female. Only 4 patients had symptomatic CNS metastasis and 20 patients had multiple CNS metastasis (76.9%). BMRR by PAREXEL criteria (n=26) was 76.9% (90%CI 63.3–90.5%) and CNS metastasis median PFS was 22.0 months (95%CI 9.7 m–NE). Systemic ORR (n=26) by RECIST, median PFS and OS were 64.0% (95%CI 45.2–82.8%), 11.5 months (6.9–NE), and 23.7 months (16.0-NE), respectively. Stomatitis, paronychia, diarrhea, anemia, leukopenia, thrombocytopenia, increased AST / Cr levels, and hypoalbuminemia were observed in more than 40% of patients, however, G3 and higher-grade adverse events were less than 10% and there was no treatment related death. Pneumonitis was observed in 5 patients (19.2%, G1 2 pts and G2 3 pts).
Conclusions
The OCEAN study met the endpoint in the 1st-line cohort in addition to T790M cohort, and the results suggested that osimertinib can be a treatment option for patients with RT-naïve CNS metastasis of EGFR mutations. Clinical trial information: jRCTs071180017.
Legal entity responsible for the study
The authors.
Funding
AstraZeneca.
Disclosure
H. Yamaguchi: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharmaceutical, Novartis, 5 Boehringer Ingelheim, Eli Lilly Japan K.K.; Financial Interests, Personal, Other: Chugai Pharmaceutical; Financial Interests, Institutional, Funding: Taiho Pharmaceutical Co., Ltd., Meiji Seika Pharma Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Asahi Kasei Pharma Corporation, Torii Pharmaceutical Co., Ltd, Chugai Pharmaceutical, Boehringer Ingelheim, Eli Lilly Japan K.K., 5 Co., Ltd., Janssen Pharmaceutical K.K., Otsuka Pharmaceutical, Taisho Pharmaceutical Co., Ltd., 5, Eisai Co., Ltd., Ono Pharmaceutical Co., Ltd., Fujifilm Toyama Chemical Co., Ltd. K. Wakuda: Financial Interests, Personal and Institutional, Research Grant: Lilly; Financial Interests, Personal, Invited Speaker: Nippon Kayaku, Takeda, Chugai, Taiho, Novartis, Pfizer, MSD. M. Fukuda: Financial Interests, Personal and Institutional, Research Grant: Lilly; Financial Interests, Personal, Invited Speaker: Nippon Kayaku, Takeda, Chugai, Taiho, Novartis, Pfizer, MSD. H. Kenmotsu: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co, Ltd., Ono Pharmaceutical Co, Ltd., Boehringer Ingelheim, Eli Lilly K.K, Kyowa Hakko Kirin Co., Ltd., Bristol-Myers Squibb, MSD, Novartis Pharma K.K., Daiichi Sankyo Co., Ltd., AstraZeneca K.K., Pfizer, Taiho Pharma, Merk, Amgen inc., Bayer, Takeda Pharmaceutical Co., Ltd; Financial Interests, Institutional, Research Grant: AstraZeneca, Chugai Pharmaceutical Co, Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co, Ltd., LOXO Oncology, Eli Lilly K.K; Non-Financial Interests, Principal Investigator: AstraZeneca K.K., Eli Lilly K.K, Boehringer Ingelheim, Takeda Pharmaceutical Co., Ltd. K. Ito: Financial Interests, Personal and Institutional, Invited Speaker: Eli Lilly, Boehringer Ingelheim, Takeda Pharmaceutical, Chugai Pharmaceutical, MSD; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Pfizer, Taiho Pharmaceutical, AstraZeneca; Financial Interests, Institutional, Research Grant: GSK, AbbVie, Novartis, Janssen Pharmaceutical, Sanofi, Nihon Sinyaku, Bayer. Y. Tsuchiya-Kawano: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Chugai Pharma, Ono Pharmaceutical, Kyowa Kirin, Bristol-Myers Squibb. K. Tanaka: Financial Interests, Personal, Invited Speaker: AstraZeneca. S. Miura: Non-Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, Taiho Pharmaceutical, Ono Pharmaceutical, AstraZeneca, Bristol-Myers Squibb, Pfizer, Eli Lilly, Boehringer Ingelheim Japan, Novartis, MSD, Kyowa Hakko Kirin, Daiichi Sankyo, Amgen, Merck, Takeda Pharmaceutical. T. Yokoyama: Financial Interests, Personal, Invited Speaker: AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Pfizer Japan Inc, Bristol-Myers Squibb Co. Ltd., Ono Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Nippon Kayaku Co., Ltd.; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim Japan Inc., MSD K.K. A. Nakamura: Financial Interests, Personal, Invited Speaker: MSD, Thermo, AstraZeneca, Eli Lilly, Chugai Pharmaceutical, Taiho Pharmaceutical, Nippon Kayaku, Novartis. S. Ikeda: Financial Interests, Institutional, Research Grant: AstraZeneca, Chugai; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Bristol Myers Squibb, Ono, Eli Lilly, Pfizer, Boehringer Ingelheim. K. Takayama: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co., AstraZeneca Co., Chugai-Roche Co., MSD-Merck Co., Boehringer Ingelheim Co., Eli-Lilly Co., Novartis pharma Co.; Financial Interests, Personal, Advisory Board: Ono Pharmaceutical Co.; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical Co., Taiho Pharmaceutical Co., Eli-Lilly Co., Fukuda Denshi Co.; Financial Interests, Institutional, Principal Investigator: Ono Pharmaceutical Co. K. Yoshimura: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Eli Lilly, MSD, Daiichi Sankyo, Kyowa Kirin, Ohara, Pfizer, Eisai. K. Nakagawa: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Amgen Inc., Nippon Kayaku Co., Ltd., AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., MSD K.K., Pfizer Japan Inc., Nippon Boehringer Ingelheim Co., Ltd., Taiho Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd., CMIC ShiftZero K.K., Life Technologies Japan Ltd., Neo Communication, Merck Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Takeda Pharmaceutical Co., Ltd., 3H Clinical Trial Inc., Care Net, Inc., Medical Review Co., Ltd., Medical Mobile Communications co., Ltd, Yodosha Co., Ltd., Nikkei Business Publications, Inc., Japan Clinical Research Operations, CMIC Co., Ltd., Novartis Pharma K.K., Taiyo Pharma Co., Ltd.; Financial Interests, Personal, Advisory Board: Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K.K.; Financial Interests, Institutional, Other, patents sales fee: Daiichi Sankyo Co., Ltd.; Financial Interests, Institutional, Research Grant: Parexel International Corp., PRA Health Sciences, EPS Corporation., Kissei Pharmaceutical Co., Ltd., EPS International Co., Ltd,., Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., MSD K.K., Ono Pharmaceutical Co., Ltd., PPD-SNBL K.K, SymBio Pharmaceuticals Limited., IQVIA Services Japan K.K., Syneos Health Clinical K.K., Nippon Kayaku Co., Ltd., EP-CRSU Co., Ltd., Mebix, Inc., Bristol-Myers Squibb K.K., Janssen Pharmaceutical K.K., Eisai Co., Ltd., AstraZeneca K.K., Mochida Pharmaceutical Co., Ltd., Covance Japan Inc., Japan Clinical Research Operations, Takeda Pharmaceutical Co., Ltd., GlaxoSmithKline K.K., Sanofi K.K., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Sysmex Corporation, Medical Research Support, Eli Lilly Japan K.K., Amgen Inc., Novartis Pharma K.K., Novartis Pharma K.K., SRL, Inc. N. Yamamoto: Financial Interests, Personal, Invited Speaker: MSD K.K, AstraZeneca, Ono Pharmaceutical Co., Ltd., Thermo Fisher Scientific, Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Boehringer Ingelheim, Novartis, Pfizer Inc., Bristol-Myers Squibb, Nippon Kayaku, GlaxoSmithKline K.K., Sanofi K.K., Hisamitsu Pharmaceutical Co., Inc., Merk Biopharma; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Boehringer Ingelheim, Novartis, Bristol-Myers Squibb, Nippon Kayaku, Life Technologies Japan Ltd., Amgen Inc., Guardant Health Japan, Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Research Grant: MSD K.K; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical CO., Ltd., Pfizer Inc., Amgen Inc., Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Funding: Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical CO., Ltd., Toppan Printing, Terumo. K. Sugio: Financial Interests, Institutional, Research Grant: Eli Lilly Japan, Taiho, Boehringer Ingelheim, Chugai Pharmaceutical, Daiichi Sankyo, Covidien Japan. All other authors have declared no conflicts of interest.