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Esophageal and Gastric Cancer ESOPHAGEAL AND GASTRIC CANCER 159 Oral Abstract Session Confirmed three-year RFS and OS of the randomized trial of adjuvant S-1 versus S-1 plus docetaxel after curative resection of pStage III gastric cancer (JACCRO GC-07). Kazuhiro Yoshida, Yasuhiro Kodera, Mitsugu Kochi, Takeshi Sano, Yoshihiro Kakeji, Wataru Ichikawa, Shintaro Kurahashi, Hironori Yamaguchi, Takahiro Toyokawa, Masato Nakamura, Kazumasa Fujitani, Yoshinari Mochizuki, Mitsuhiko Ota, Jun Hihara, Yoichi Makari, Atsushi Takeno, Masahiro Takeuchi, Masashi Fujii; Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan; Nagoya University Graduate School of Medicine, Gastroenterological Surgery, Nagoya, Japan; Department of Digestive Surgery, Nihon University Itabashi Hospital, Tokyo, Japan; The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan; Division of Medical Oncology, Showa University Fujigaoka Hospital, Yokohama, Japan; Department of Gastroenterological Surgery, Aichi Medical University, Nagakute, Japan; Jichi Medical University, Tochigi, Japan; Department of Surgical Oncology, Osaka City University Graduate School of Medicine, Osaka, Japan; Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Japan; Department of Surgery, Osaka General Medical Center, Osaka, Japan; Komaki Municipal Hospital, Komaki, Japan; National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan; Department of Surgery, Hiroshima City Asa Citizens Hospital, Hiroshima, Japan; Sakai City Medical Center, Sakai, Japan; Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan; Department of Clinical Medicine (Biostatistics), School of Pharmacy, Kitasato University, Tokyo, Japan; Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan Background: JACCRO GC-07 is a randomized controlled trial to explore postoperative S-1/ docetaxel compared to S-1 alone after D2 gastrectomy for pStage III gastric cancer (GC) patients. The second interim analysis demonstrated that the significant improvement of RFS was obtained by S-1/docetaxel compared to S-1 alone. The study was terminated by the recommendation of independent data and safety monitoring committee and the results were reported at ASCO 2018 and published in the Journal of Clinical Oncology (Yoshida K et al. 2019; 37:1296-1304). As 3 years have passed after completion of the enrollment, preplanned analysis was performed with the updated information of the patients. Methods: Patients with pStage III GC were randomly assigned to receive either S-1/docetaxel (S-1 80-120mg/body on days 1-14 with a 7-day rest followed by docetaxel 40mg/m2 on day 1 and S-1 80-120mg/body on days 1-14 every 21 days for 6 cycles followed by S-1 80-120mg/body on days 1-28 every 42 days for 4 cycles) or S-1 (80-120mg/body on days 1-28 every 42 days for 8 cycles) after D2 gastrectomy. Block randomization was performed by a central interactive computerized system stratified by the stage (IIIA, IIIB, IIIC) and histological type (differentiated or undifferentiated). The sample size of 1,100 was necessary to detect a 7% increase in the 3-year RFS. The primary endpoint was 3y RFS and the secondary endpoints were OS, TTF and safety. Results: In the present analysis, 400 recurrences and 324 deaths were confirmed among 912 patients during the median follow-up period of 42.5 months (0.3-85.16). The 3y RFS of 67.7% in the S-1/docetaxel group was significantly superior to 57.4% in the S-1 group (HR 0.715, 95% CI: 0.587-0.871, p = 0.0008) and the 3y OS was 77.7% in the S-1/docetaxel group and that of S-1 group was 71.2%, respectively (HR 0.742, 95% CI: 0.596-0.925, p = 0.0076), confirming the significant improving effect on the survival of the patient. Conclusions: Adjuvant S-1 plus docetaxel is recommended for patients with pStage III gastric cancer who underwent D2 gastrec- tomy without neoadjuvant chemotherapy. Clinical trial information: UMIN 000010337. Research Sponsor: Japan Clinical Cancer Research Organization. © 2021 American Society of Clinical Oncology. Visit gicasym.org and search by abstract for disclosure information. ESOPHAGEAL AND GASTRIC CANCER 160 Oral Abstract Session Randomized double-blind placebo-controlled phase 2 study of bemarituzumab combined with modified FOLFOX6 (mFOLFOX6) in first-line (1L) treatment of advanced gastric/ gastroesophageal junction adenocarcinoma (FIGHT). Zev A. Wainberg, Peter C. Enzinger, Yoon-Koo Kang, Kensei Yamaguchi, Shukui Qin, Keun-Wook Lee, Sang Cheul Oh, Jin Li, Haci Mehmet Turk, Alexandra Carolina Teixeira, Giovanni Gerardo Cardellino, Raquel Guardeno,~ Siddhartha Mitra, Yingsi Yang, Helen Collins, Daniel V.T. Catenacci; UCLA Medical Center - Cancer Care - Santa Monica, Los Angeles, CA; Dana-Farber Cancer Institute, Boston, MA; Asan Medical Center, Seoul, South Korea; The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan; Cancer Center of Jinling Hospital, Nanjing, China; Seoul National University Bundang Hospital, Gyeonggi-Do, Seoul, South Korea; Korea University Guro Hospital, Seoul, South Korea; Department of Medical Oncology, Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Bezmialem Vakif University Medical Faculty, Department of Medical Oncology, Istanbul, Turkey; Hospital Senhora Da Oliveira- HSO-EPE/R. dos Cutileiros-Creixomil, Guimaraes, Portugal; Department of Oncology, University Hospital of Udine, Udine, Italy; Medical Oncology, Institut Catala d’Oncologia, Universitary Hospital Dr. Josep Trueta, Girona, Spain; Five Prime Therapeutics, Inc., South San Francisco, CA; Five Prime, South San Francisco, CA; Five Prime Therapeutics, Inc., San Francisco, CA; Gastrointestinal Oncology Program, University of Chicago Medical Center, Chicago, IL Background: Bemarituzumab (bema), a first-in-class humanized IgG1 monoclonal antibody, se- lectively binds to FGFR2b, inhibits ligand binding and mediates antibody-dependent cell-mediated cytotoxicity. A phase 1 study of bema monotherapy in solid tumors had no dose-limiting toxicities and a confirmed objective response rate (ORR) of 18% in patients (pts) with refractory FGFR2b+ gastric cancer (GC). Methods: The FIGHT study (NCT03343301) is a global, randomized, double- blind, placebo-controlled phase 2 trial. Pts with unresectable locally advanced or metastatic GC that was not HER2+ were eligible if their tumor was positive for FGFR2b overexpression by centrally performed immunohistochemistry (IHC) or for FGFR2 amplification by circulating tumor DNA (ctDNA). Pts were treated with mFOLFOX6 and randomized 1:1 to bema 15mg/kg or placebo (pbo) every 2 weeks with 1 additional 7.5mg/kg bema/pbo dose on day 8. Treatment was continued until disease progression, intolerable toxicity, or death. The primary endpoint was investigator- assessed progression-free survival (PFS) and key secondary endpoints include overall survival (OS), overall response rate (ORR), and frequency of adverse events. Statistical significance (2- sided a of 0.2) was tested sequentially for PFS, OS and ORR. Results: Of 910 1L GC pts whose tumors were evaluated 275 (30%) were FGFR2b+. Of 155 pts randomized, 77 to bema+mFOLFOX6 and 78 to pbo+mFOLFOX6, 149 were FGFR2b+ by IHC and 26 by ctDNA. The primary endpoint was met with an improvement in median PFS of 9.5 mo (bema) vs 7.4 mo (pbo) (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.44-1.04; p=0.07). The secondary endpoint of OS was met; median not reached in the bema arm vs 12.9 mo for pbo (HR, 0.58, 95% CI, 0.35-0.95; p=0.03). Among patients with measurable disease, ORR improved from 40% (pbo) to 53% (bema). Improved efficacy was observed across all 3 endpoints (PFS, OS, ORR) with increasing levels of over- expression of FGFR2b on tumor cells. Grade $3 AEs were reported in 83% of pts in the bema arm vs 74% pts in the pbo arm with serious AEs in 32% and 36% respectively. Stomatitis was higher in the bema arm (31.6% vs 13.0%) and corneal AEs were more common in the bema arm (67% vs 10%). There were no reported AEs of retinal detachment or hyperphosphatemia in the bema arm. Conclusion: Approximately 30% of 1L pts with advanced GC not HER2+, were identified to be FGFR2b+, primarily by IHC. In this randomized, placebo controlled, double-blind phase 2 study, the addition of bema to mFOLFOX6 led to clinically meaningful and statistically significant improve- ments in PFS, OS and ORR. An increase in corneal AEs and stomatitis was associated with bema. These results support a prospective randomized phase 3 study in GC and the evaluation of bema in other FGFR2b+ tumor types. Clinical trial information: NCT03694522. Research Sponsor: Five Prime Therapeutics. © 2021 American Society of Clinical Oncology. Visit gicasym.org and search by abstract for disclosure information. ESOPHAGEAL AND GASTRIC CANCER 161 Oral Abstract Session Genomic pathway of gut microbiome to predict efficacy of nivolumab in advanced gastric cancer: DELIVER trial (JACCRO GC-08). Yu Sunakawa, Ryo Matoba, Eisuke Inoue, Yasuhiro Sakamoto, Ryohei Kawabata, Atsushi Ishiguro, Yusuke Akamaru, Yosuke Kito, Masazumi Takahashi, Jin Matsuyama, Hiroshi Yabusaki, Akitaka Makiyama, Takahisa Suzuki, Masahiro Tsuda, Hisateru Yasui, Hisato Kawakami, Kei Muro, Takako Eguchi Nakajima, Wataru Ichikawa, Masashi Fujii; Department of Clinical Oncology, St. Marianna University
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