Phase II study of avelumab and trastuzumab with FOLFOX chemotherapy in previously untreated HER2-amplified metastatic gastroesophageal adenocarcinoma
Abstract Background Trastuzumab and multiagent chemotherapy have been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress HER2. Preclinical data show that trastuzumab requires a functional adaptive immune system for efficacy, suggesting synergy o...
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| Vydané v: | The oncologist (Dayton, Ohio) Ročník 30; číslo 7 |
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Oxford University Press
01.07.2025
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| Abstract | Abstract
Background
Trastuzumab and multiagent chemotherapy have been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress HER2. Preclinical data show that trastuzumab requires a functional adaptive immune system for efficacy, suggesting synergy of trastuzumab combined with immune checkpoint inhibitors, further supported by current clinical studies.
Methods
HCRN GI17-319 was a multicenter, single-arm, phase II clinical trial with a prespecified 6-subject safety run-in of the anti-PD-L1 antibody avelumab, combined with trastuzumab and mFOLFOX6, in previously untreated, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary endpoint was the best overall response within 24 weeks. Subjects received 9 cycles of induction avelumab, trastuzumab, and mFOLFOX6, followed by maintenance avelumab + trastuzumab. The study was initially designed as a Simon’s 2-stage trial, but enrollment was stopped after the 18-subject first stage for reasons unrelated to safety or efficacy.
Results
A total of 18 subjects, including the 6-subject safety run-in, were enrolled 4/2019-8/2020. The 24-week response rate was 11/18 (61%; 95% CI: 39%-84%), and the confirmed overall response rate is 9/18 (50%). With a median follow-up of 14.6 months, the median PFS was 8.0 months (95% CI: 5.3-NA) and median OS was 13.1 months (95% CI: 11.5-NA). The regimen was well tolerated, without any new safety signals.
Conclusions
The combination of avelumab, trastuzumab, and FOLFOX chemotherapy demonstrated some activity, with a reasonable response rate and median PFS. These outcomes provide some support to other clinical trials of similar agents and support the future evaluation of adding avelumab in this setting. NCT03783936. |
|---|---|
| AbstractList | Trastuzumab and multiagent chemotherapy have been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress HER2. Preclinical data show that trastuzumab requires a functional adaptive immune system for efficacy, suggesting synergy of trastuzumab combined with immune checkpoint inhibitors, further supported by current clinical studies.
HCRN GI17-319 was a multicenter, single-arm, phase II clinical trial with a prespecified 6-subject safety run-in of the anti-PD-L1 antibody avelumab, combined with trastuzumab and mFOLFOX6, in previously untreated, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary endpoint was the best overall response within 24 weeks. Subjects received 9 cycles of induction avelumab, trastuzumab, and mFOLFOX6, followed by maintenance avelumab + trastuzumab. The study was initially designed as a Simon's 2-stage trial, but enrollment was stopped after the 18-subject first stage for reasons unrelated to safety or efficacy.
A total of 18 subjects, including the 6-subject safety run-in, were enrolled 4/2019-8/2020. The 24-week response rate was 11/18 (61%; 95% CI: 39%-84%), and the confirmed overall response rate is 9/18 (50%). With a median follow-up of 14.6 months, the median PFS was 8.0 months (95% CI: 5.3-NA) and median OS was 13.1 months (95% CI: 11.5-NA). The regimen was well tolerated, without any new safety signals.
The combination of avelumab, trastuzumab, and FOLFOX chemotherapy demonstrated some activity, with a reasonable response rate and median PFS. These outcomes provide some support to other clinical trials of similar agents and support the future evaluation of adding avelumab in this setting. NCT03783936. Background: Trastuzumab and multiagent chemotherapy have been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress HER2. Preclinical data show that trastuzumab requires a functional adaptive immune system for efficacy, suggesting synergy of trastuzumab combined with immune checkpoint inhibitors, further supported by current clinical studies. Methods: HCRN Gil7-319 was a multicenter, single-arm, phase II clinical trial with a prespecified 6-subject safety run- in of the anti-PD-L1 antibody avelumab, combined with trastuzumab and mFOLFOX6, in previously untreated, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary endpoint was the best overall response within 24 weeks. Subjects received 9 cycles of induction avelumab, trastuzumab, and mFOLFOX6, followed by maintenance avelumab + trastuzumab. The study was initially designed as a Simon's 2-stage trial, but enrollment was stopped after the 18-subject first stage for reasons unrelated to safety or efficacy. Results: A total of 18 subjects, including the 6-subject safety run-in, were enrolled 4/2019-8/2020. The 24-week response rate was 11/18 (61%; 95% CI: 39%-84%), and the confirmed overall response rate is 9/18 (50%). With a median follow-up of 14.6 months, the median PFS was 8.0 months (95% CI: 5.3-NA) and median OS was 13.1 months (95% CI: 11.5-NA). The regimen was well tolerated, without any new safety signals. Conclusions: The combination of avelumab, trastuzumab, and FOLFOX chemotherapy demonstrated some activity, with a reasonable response rate and median PFS. These outcomes provide some support to other clinical trials of similar agents and support the future evaluation of adding avelumab in this setting. NCT03783936. Key words: HER2; trastuzumab; gastric cancer; esophageal cancer; immunotherapy. Trastuzumab and multiagent chemotherapy has been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress HER2. Preclinical data shows that trastuzumab requires a functional adaptive immune system for efficacy, suggesting synergy of trastuzumab combined with immune checkpoint inhibitors further supported by current clinical studies.BACKGROUNDTrastuzumab and multiagent chemotherapy has been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress HER2. Preclinical data shows that trastuzumab requires a functional adaptive immune system for efficacy, suggesting synergy of trastuzumab combined with immune checkpoint inhibitors further supported by current clinical studies.HCRN GI17-319 was a multicenter, single-arm, phase II clinical trial with a prespecified 6-subject safety run-in of the anti-PD-L1 antibody avelumab, combined with trastuzumab and mFOLFOX6, in previously untreated, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary endpoint was best overall response within 24 weeks. Subjects received 9 cycles of induction avelumab, trastuzumab, and mFOLFOX6, followed by maintenance avelumab + trastuzumab. The study was initially designed as a Simon's two stage trial, but enrollment was stopped after the 18-subject first stage for reasons unrelated to safety or efficacy.METHODSHCRN GI17-319 was a multicenter, single-arm, phase II clinical trial with a prespecified 6-subject safety run-in of the anti-PD-L1 antibody avelumab, combined with trastuzumab and mFOLFOX6, in previously untreated, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary endpoint was best overall response within 24 weeks. Subjects received 9 cycles of induction avelumab, trastuzumab, and mFOLFOX6, followed by maintenance avelumab + trastuzumab. The study was initially designed as a Simon's two stage trial, but enrollment was stopped after the 18-subject first stage for reasons unrelated to safety or efficacy.A total of 18 subjects, including the 6-subject safety run-in, were enrolled 4/2019-8/2020. The 24-week response rate was 11/18 (61%; 95% CI 39-84%), and the confirmed overall response rate is 9/18 (50%). With a median follow-up of 14.6 months, the median PFS was 8.0 mo (95% CI 5.3-NA) and median OS was 13.1 mo (95% CI 11.5-NA). The regimen was well tolerated, without any new safety signal.v The combination of avelumab, trastuzumab, and FOLFOX chemotherapy demonstrated some activity, with reasonable response rate and median PFS. These outcomes provide some support to other clinical trials of similar agents and support the future evaluation of adding avelumab in this setting.RESULTSA total of 18 subjects, including the 6-subject safety run-in, were enrolled 4/2019-8/2020. The 24-week response rate was 11/18 (61%; 95% CI 39-84%), and the confirmed overall response rate is 9/18 (50%). With a median follow-up of 14.6 months, the median PFS was 8.0 mo (95% CI 5.3-NA) and median OS was 13.1 mo (95% CI 11.5-NA). The regimen was well tolerated, without any new safety signal.v The combination of avelumab, trastuzumab, and FOLFOX chemotherapy demonstrated some activity, with reasonable response rate and median PFS. These outcomes provide some support to other clinical trials of similar agents and support the future evaluation of adding avelumab in this setting. Abstract Background Trastuzumab and multiagent chemotherapy have been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress HER2. Preclinical data show that trastuzumab requires a functional adaptive immune system for efficacy, suggesting synergy of trastuzumab combined with immune checkpoint inhibitors, further supported by current clinical studies. Methods HCRN GI17-319 was a multicenter, single-arm, phase II clinical trial with a prespecified 6-subject safety run-in of the anti-PD-L1 antibody avelumab, combined with trastuzumab and mFOLFOX6, in previously untreated, metastatic, HER2-amplified gastric and esophageal adenocarcinomas. The primary endpoint was the best overall response within 24 weeks. Subjects received 9 cycles of induction avelumab, trastuzumab, and mFOLFOX6, followed by maintenance avelumab + trastuzumab. The study was initially designed as a Simon’s 2-stage trial, but enrollment was stopped after the 18-subject first stage for reasons unrelated to safety or efficacy. Results A total of 18 subjects, including the 6-subject safety run-in, were enrolled 4/2019-8/2020. The 24-week response rate was 11/18 (61%; 95% CI: 39%-84%), and the confirmed overall response rate is 9/18 (50%). With a median follow-up of 14.6 months, the median PFS was 8.0 months (95% CI: 5.3-NA) and median OS was 13.1 months (95% CI: 11.5-NA). The regimen was well tolerated, without any new safety signals. Conclusions The combination of avelumab, trastuzumab, and FOLFOX chemotherapy demonstrated some activity, with a reasonable response rate and median PFS. These outcomes provide some support to other clinical trials of similar agents and support the future evaluation of adding avelumab in this setting. NCT03783936. |
| Audience | Professional Academic |
| Author | Mulcahy, Mary F Mukherjee, Sarbajit Akce, Mehmet Alistar, Angela T McRee, Autumn J Somasundaram, Ashwin Chao, Joseph Kasi, Pashtoon M Moore, Dominic T Lee, Michael S |
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| Cites_doi | 10.1016/S1470-2045(23)00515-6 10.1016/S0140-6736(10)61121-X 10.1016/s0140-6736(23)02033-0 10.1001/jamaoncol.2019.5367 10.1016/S1470-2045(20)30169-8 10.1158/1078-0432.CCR-16-1761 10.1200/JCO.20.00892 10.1016/S1470-2045(22)00603-9 10.1093/annonc/mdy264 10.1200/jco.2021.39.15_suppl.4013 10.1093/annonc/mdw423 10.1200/JCO.2016.71.6852 |
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| Keywords | trastuzumab esophageal cancer gastric cancer HER2 immunotherapy |
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| References_xml | – volume: 39 start-page: 218 year: 2021 ident: 2025071710064095000_CIT0001 article-title: A multi-institutional phase Ib/II trial of first-line triplet regimen (Pembrolizumab, Trastuzumab, Chemotherapy) for HER2-positive advanced gastric and gastroesophageal junction cancer (PANTHERA Trial): Molecular profiling and clinical update publication-title: J Clin Oncol doi: 10.1016/S1470-2045(23)00515-6 – volume: 376 start-page: 687 year: 2010 ident: 2025071710064095000_CIT0007 article-title: Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial publication-title: Lancet doi: 10.1016/S0140-6736(10)61121-X – volume: 402 start-page: 2197 year: 2023 ident: 2025071710064095000_CIT0004 article-title: Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial publication-title: Lancet doi: 10.1016/s0140-6736(23)02033-0 – volume: 6 start-page: 375 year: 2020 ident: 2025071710064095000_CIT0009 article-title: Use of immunotherapy with programmed cell death 1 vs programmed cell death ligand 1 inhibitors in patients with cancer: a systematic review and Meta-analysis publication-title: JAMA Oncol doi: 10.1001/jamaoncol.2019.5367 – volume: 21 start-page: 821 year: 2020 ident: 2025071710064095000_CIT0002 article-title: First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial publication-title: Lancet Oncol doi: 10.1016/S1470-2045(20)30169-8 – volume: 23 start-page: 3158 year: 2017 ident: 2025071710064095000_CIT0010 article-title: PD-L2 expression in human tumors: relevance to Anti-PD-1 therapy in cancer publication-title: Clin Cancer Res doi: 10.1158/1078-0432.CCR-16-1761 – volume: 39 start-page: 966 year: 2021 ident: 2025071710064095000_CIT0012 article-title: Phase III trial of avelumab maintenance after First-Line induction chemotherapy versus continuation of chemotherapy in patients with gastric cancers: results from JAVELIN gastric 100 publication-title: J Clin Oncol doi: 10.1200/JCO.20.00892 – volume: 23 start-page: 1430 year: 2022 ident: 2025071710064095000_CIT0006 article-title: Bemarituzumab in patients with FGFR2b-selected gastric or gastro-oesophageal junction adenocarcinoma (FIGHT): a randomised, double-blind, placebo-controlled, phase 2 study publication-title: Lancet Oncol doi: 10.1016/S1470-2045(22)00603-9 – volume: 29 start-page: 2052 year: 2018 ident: 2025071710064095000_CIT0011 article-title: Phase III, randomised trial of avelumab versus physician’s choice of chemotherapy as third-line treatment of patients with advanced gastric or gastro-oesophageal junction cancer: primary analysis of JAVELIN Gastric 300 publication-title: Ann Oncol doi: 10.1093/annonc/mdy264 – volume: 39 start-page: 4013 year: 2021 ident: 2025071710064095000_CIT0003 article-title: Pembrolizumab plus trastuzumab and chemotherapy for HER2+ metastatic gastric or gastroesophageal junction (G/GEJ) cancer: Initial findings of the global phase 3 KEYNOTE-811 study publication-title: J Clin Oncol doi: 10.1200/jco.2021.39.15_suppl.4013 – volume: 27 start-page: 2196 year: 2016 ident: 2025071710064095000_CIT0005 article-title: Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial publication-title: Ann Oncol doi: 10.1093/annonc/mdw423 – volume: 35 start-page: 2558 year: 2017 ident: 2025071710064095000_CIT0008 article-title: HELOISE: Phase IIIb randomized multicenter study comparing Standard-of-Care and Higher-Dose trastuzumab regimens combined with chemotherapy as First-Line therapy in patients with human epidermal growth factor receptor 2-Positive metastatic gastric or gastroesophageal junction adenocarcinoma publication-title: J Clin Oncol doi: 10.1200/JCO.2016.71.6852 |
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| Snippet | Abstract
Background
Trastuzumab and multiagent chemotherapy have been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas... Trastuzumab and multiagent chemotherapy have been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress... Background: Trastuzumab and multiagent chemotherapy have been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that... Trastuzumab and multiagent chemotherapy has been the standard of care for the 20-30% of metastatic gastric and esophageal adenocarcinomas that overexpress... |
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| SubjectTerms | Adenocarcinoma Adenocarcinoma - drug therapy Adenocarcinoma - genetics Adenocarcinoma - pathology Adult Aged Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - pharmacology Antibodies, Monoclonal, Humanized - therapeutic use Antineoplastic Combined Chemotherapy Protocols - pharmacology Antineoplastic Combined Chemotherapy Protocols - therapeutic use Cancer Care and treatment Chemotherapy Clinical Trial Results Drug therapy Esophageal cancer Esophageal Neoplasms - drug therapy Esophageal Neoplasms - genetics Esophageal Neoplasms - pathology Female Fluorouracil - pharmacology Fluorouracil - therapeutic use Humans Leucovorin - pharmacology Leucovorin - therapeutic use Male Middle Aged Organoplatinum Compounds - pharmacology Organoplatinum Compounds - therapeutic use Pharmacology, Experimental Physiological aspects Receptor, ErbB-2 - genetics Stomach cancer Stomach Neoplasms - drug therapy Stomach Neoplasms - genetics Stomach Neoplasms - pathology Trastuzumab - administration & dosage Trastuzumab - pharmacology Trastuzumab - therapeutic use |
| Title | Phase II study of avelumab and trastuzumab with FOLFOX chemotherapy in previously untreated HER2-amplified metastatic gastroesophageal adenocarcinoma |
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