Abstract 146P
Background
In the ph2 FIGHT trial, BEMA+mFOLFOX6 had promising efficacy in patients with FGFR2b-overexpressed (FGFR2b+) advanced G/GEJC. FORTITUDE-103 explores a Q3W dosing schedule of first-line BEMA in combination with other oral anticancer therapies among patients (pts) in South Korea, Taiwan, Singapore, and Japan (interim analysis, data cutoff 2 May 2023).
Methods
BEMA-dose level 1 (DL1) (15mg/kg Q3W with 1 additional 7.5mg/kg only on C1D8)+CAPOX was assessed in cohort A-DL1. After BEMA-DL1 was found to have an acceptable safety/tolerability profile, BEMA-DL2 (22mg/kg Q3W with 1 additional 11mg/kg only on C1D8) was initiated in newly-enrolled pts as cohort A-DL2, C, and D. Cohorts C and D received BEMA-DL2, NIVO, and CAPOX (C) or SOX (D).
Results
24 pts were enrolled (17 m/7 f, mean age 60.3 y) as follows: BEMA-DL1+CAPOX (A-DL1; N=6), BEMA-DL2 +CAPOX (A-DL2; n=4), BEMA-DL2 +CAPOX+NIVO [C; n=7], BEMA-DL2+SOX+NIVO [D; n=7]. BEMA-DL1+CAPOX was found to have a favorable safety profile. No dose-limiting toxicities were reported across cohorts A-DL1, A-DL2, C, and D; no new safety signals were identified. Median (min-max) BEMA treatment duration was 16.0 wk (3.0-35.9). 6 pts (25.0%) had 8 serious AEs (including 1 pt with AE assessed by PI as BEMA-related); 14 pts (58.3%) had 24 grade ≥3 AEs (including 7 pts with AE assessed by PI as BEMA-related). 5 pts (20.8%) reported one or more grade ≥2 ocular AE. 2 pts in cohort A-DL1 discontinued BEMA for ocular-related non-serious AEs considered related to BEMA (visual acuity reduced [n=2] and corneal opacity [n=1]); both pts recovered. Mean exposures for the first 3 cycles and estimated terminal elimination half-life (7-11 days) were consistent with historical data. No meaningful BEMA exposure changes were observed with the addition of NIVO, indicating no drug interactions. Updated data will be presented at the congress.
Conclusions
This analysis suggest that bemarituzumab Q3W dosing in combination with CAPOX or SOX (with or without NIVO) has an acceptable safety profile.
Clinical trial identification
NCT05322577.
Editorial acknowledgement
Medical writing support was provided by Tim Peoples, MA, ELS, contractor to Amgen Inc.
Legal entity responsible for the study
Amgen Inc.
Funding
Amgen Inc.
Disclosure
K. Lee: Financial Interests, Personal, Advisory Board: BMS (Korea), Bayer (Korea), Daiichi Sankyo (Korea), Merck Sharp & Dohme (Korea), Metafines, Vifor pharma (Korea), Astellas (Korea); Financial Interests, Personal, Invited Speaker: Boryung Co.; Financial Interests, Institutional, Local PI: ABLBIO, ALX Oncology, Amgen, Arcus Biosciences, Astellas Pharma, AstraZeneca, BeiGene, Bolt therapeutics, Daiichi Sankyo, Exelixis, Genexine, Green Cross Corp, InventisBio, LSK BioPharma, Leap therapeutics, Macrogenics, MedPacto, Merck KGaA, Merck Sharp & Dohme, Oncologie, Ono pharmaceutical, Pfizer, Pharmacyclics, Seagen, Taiho Pharmaceutical, Trishula therapeutics, Y-BIOLOGICS, Zymeworks,; Non-Financial Interests, Personal, Leadership Role, SMC chair of ASPEN-06 study: ALX Oncology. Y. Kang: Financial Interests, Personal, Advisory Board: ALX Oncology, Zymeworks, Amgen, Novartis, Macrogenics, Daehwa, Blueprint, Surface Oncology, BMS, Merck, Roche, Liscure. H. Hirano: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Ono Pharmaceutical, Teijin Phama, Novartis; Financial Interests, Personal, Writing Engagement: Nichi-Iko; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, Daiichi Sankyo, Taiho Pharmaceutical, Ono Pharmaceutical, Janssen Pharmaceutical, Merck Biopharma, Bristol Myers Squibb, Pfizer, Eisai, Amgen, Astellas, Seagen, MSD, Insyte, BeiGene, Novartis. Y. Sunakawa: Financial Interests, Personal, Invited Speaker: Eli Lilly Japan, Bristol-Byers Squibbb, Chugai Pharmaceutical, Takeda, Taiho Pharmaceutical, Merck Biopharma, Daiichi Sankyo, Ono Pharmaceutical; Financial Interests, Personal, Advisory Board: Merck Biopharma; Financial Interests, Personal and Institutional, Research Grant: Chugai Pharmaceutical, Taiho Pharmaceutical, Takeda, Otsuka Pharm, Parexel International Inc., IQVIA, Ono Pharmaceutical, CMIC Shift Zero K.K., PRA health sciences, Inc., Amgen; Non-Financial Interests, Personal, Project Lead: Japan Clinical Cancer Research Organization. C. Lin: Financial Interests, Personal, Other, Travel support: BeiGene, Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Blueprint Medicines, Bristol Myers Squibb, Daiichi Sankyo, Novartis, AbbVie, PharmaEngine, Merck KGaA, Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Eli Lilly, Novartis, Roche; Financial Interests, Personal, Other, Travel Support: IMPACT Therapeutics. W.P. Yong: Financial Interests, Personal, Invited Speaker: DKSH Singapore Pte Ltd, AstraZeneca Singapore Pte Ltd, Bristol Myers Squibb (S) Pte Ltd, MSD Pharma (Singapore) Pte Ltd, Novartis (S) Pte Ltd; Financial Interests, Personal, Advisory Board: Ipsen Pharma Singapore Pte Ltd, Amgen; Financial Interests, Institutional, Local PI: Novartis (S) Pte Ltd, Amgen. T. Kawakami: Financial Interests, Personal, Advisory Board: Daiichi Sankyo; Financial Interests, Personal, Other, honoraria: Bristol Myers Squibb, Ono Pharmaceutical, Yakult Honsha, Daiichi Sankyo. T. Oshima: Financial Interests, Personal, Invited Speaker: Taiho, Astellas; Financial Interests, Personal, Writing Engagement: Astellas; Financial Interests, Personal, Other, research grant: Taiho, Kyowa Kirin, Chugai, Nihon kayaku. Z. Li: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. M. Hopkins: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. A. Levin: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. H. Wang: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. L. Goldstein: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. D. Zhou: Financial Interests, Personal, Full or part-time Employment, Employee: Amgen; Financial Interests, Personal, Stocks or ownership, Stockholder: Amgen. S.Y. Rha: Financial Interests, Personal, Advisory Board: Indivumed, Amgen, LG biochemical, Astellas; Financial Interests, Personal, Invited Speaker: MSD, Lilly, Daiichi Sankyo; Financial Interests, Personal, Steering Committee Member: Amgen; Financial Interests, Institutional, Funding: MSD, Lilly; Financial Interests, Institutional, Research Grant: BMS, Daiichi Sankyo; Financial Interests, Institutional, Local PI: Indivumed, AstraZeneca; Financial Interests, Personal, Other, Durg supply for clinical trial: Merck; Financial Interests, Institutional, Coordinating PI, Drug supply for clincal trial: MSD; Financial Interests, Institutional, Local PI, drug supply for clinical trial: Zymeworks; Financial Interests, Institutional, Local PI, drug supply for clincial trial: Beigine; Financial Interests, Personal, Coordinating PI, Drug supply for clnical trial: Incyte. All other authors have declared no conflicts of interest.
Resources from the same session
16P - Patient and healthcare practitioner preferences in early-stage triple-negative breast cancer treatment: A discrete choice experiment
Presenter: Jiun-I Lai
Session: Poster Display
Resources:
Abstract
17P - Initial outcomes of the ACT Now PRIME CARE for breast cancer: Prevention of Breast canceR (screening/ stage shifting) utilizing Integrated MobilE Clinics and pAtient Reported online Evaluations and Education
Presenter: Herdee Gloriane Luna
Session: Poster Display
Resources:
Abstract
18P - Optimizing premenopausal HR+ HER2–ve eBC management in India: Insights from expert consensus
Presenter: Anitha Ramesh
Session: Poster Display
Resources:
Abstract
19P - Referral patterns among breast cancer patients in county-level hospitals in China
Presenter: Ping Lu
Session: Poster Display
Resources:
Abstract
20P - Real-world treatment of HER2+ and HR+/HER2- early breast cancer in county areas of China
Presenter: Ping Lu
Session: Poster Display
Resources:
Abstract
21P - Duration of breast cancer trials: Analysis of predicted versus actual completion date
Presenter: Daniëlle Verschoor
Session: Poster Display
Resources:
Abstract
22P - Impact of an online Asian genetic risk calculator on risk perception: Cancer-related distress and uptake of genetic counselling among Malaysian breast cancer patients (The ARiCa Study)
Presenter: HEAMANTHAA Padmanabhan
Session: Poster Display
Resources:
Abstract
23P - Consensus statements and expert recommendations for BRCAm breast cancer in the Asia-Pacific region (STREAM-AP)
Presenter: Soo Chin Lee
Session: Poster Display
Resources:
Abstract
24P - Germline genetic testing for hereditary cancer: A retrospective analysis in a single site referral centre in Malaysia
Presenter: Vivian Lee
Session: Poster Display
Resources:
Abstract
25P - Clinical presentations and prognostication of HER2-low breast cancer in Taiwan
Presenter: Bo-Fang Chen
Session: Poster Display
Resources:
Abstract