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- | bemarituzumab (FPA-144) / Five Prime
Journal: FGFR Inhibitor Stymies Gastric Cancer. (Pubmed Central) - Feb 13, 2021
In the phase II FIGHT trial, adding bemarituzumab to chemotherapy led to longer progression-free survival and overall survival in patients with advanced FGFR2b-positive gastric or gastroesophageal junction cancers. However, the agent was also associated with more side effects, including eye problems.
- || bemarituzumab (AMG 552) / Amgen
Trial completion date, Trial primary completion date, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (clinicaltrials.gov) - Feb 5, 2021
P2, N=155, Active, not recruiting, Sponsor: Five Prime Therapeutics, Inc.
However, the agent was also associated with more side effects, including eye problems. Trial completion date: Jul 2024 --> Dec 2021 | Trial primary completion date: Jul 2022 --> Mar 2021
- ||||| bemarituzumab (FPA-144) / Five Prime
NEWS from @ASCO #GI21 - Adding bemarituzumab to chemo improves outcomes in certain gastric cancers https://t.co/P3ir4aeUyn @FivePrime_FPRX / study presented by Zev A. Wainberg, MD @UCLAJCCC / Perspective by Joseph Chao, MD (@JoeChaoMD) @cityofhope (Twitter) - Jan 20, 2021
- || Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca, bemarituzumab (FPA-144) / Five Prime
Asco-GI 2021 round-up – Cardiff disappoints while Arcus intrigues (Via @JacobPlieth) @Asco #GI21 #Enhertu $AZN $FPRX $BBIO $AGIO $RCUS $CRDF #bemarituzumab https://t.co/mR9g55haEi (Twitter) - Jan 18, 2021
- ||| bemarituzumab (FPA-144) / Five Prime
FDAで承認となるか？FGFR2b陽性進行胃癌の1次治療として抗FGFR2b抗体bemarituzumabとmFOLFOX6併用療法が有効 (FIGHT試験)。#ASCOGI2021 #日経メディカルOncology (Twitter) - Jan 18, 2021
- |||| bemarituzumab (FPA-144) / Five Prime
FGFR2b陽性進行胃癌の1次治療として抗FGFR2b抗体bemarituzumabとmFOLFOX6併用療法が有効な可能性【ASCO GI 2021】：がんナビ 進行胃がんの新しい分子標的薬になる可能性があります #胃がん #bemarituzumab #FGFR2b #GI21 https://t.co/RRZ3QhdeJW (Twitter) - Jan 17, 2021
- ||| bemarituzumab (FPA-144) / Five Prime
Bemarituzumab Anti-FGFR2 antibody for ‘Fgfr2+’ #GEA. #crescendo plots!!! Who knows what this means?! 🧐🧐🧐🤔 Who got the 🔑s to my #bema?! (Twitter) - Jan 15, 2021
- |||||| bemarituzumab (FPA-144) / Five Prime
Clinical: Dr. Zev Wainberg presents the results of the FIGHT trial re: the role of FGFR2 with Bemarituzumab + FOLFOX vs. FOLFOX for advanced gastric and gastroesophageal #Cancer. #GI21 #clinicaltrials #cancerresearch @VUMC_Cancer (Twitter) - Jan 15, 2021
- |||||| bemarituzumab (FPA-144) / Five Prime
Clinical: #GI21 Dr. Zev Wainberg presenting randomized ph2 FIGHT trial bemarituzumab in #stomachcancer. Interesting FGFR2 target expression-response relationship (Twitter) - Jan 15, 2021
- bemarituzumab (FPA-144) / Five Prime
[VIRTUAL] 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). () - Dec 9, 2020 - Abstract #ASCOGI2021ASCO_GI_463;
P1a
In this randomized, placebo controlled, double-blind phase 2 study, the addition of bema to mFOLFOX6 led to clinically meaningful and statistically significant improvements in PFS, OS and ORR. An increase in corneal AEs and stomatitis was associated with bema.
- |||| bemarituzumab (FPA-144) / Five Prime
Congrats Dan! The inverse relationship w/ PD-L1 seems more specific to FGFR3 (and some FGFR1). Crude analysis suggests no correlation (unlike bladder, though not accounting for splicing variations). Bemarituzumab being a effective as a 2b splice-specific antibody is fascinating! (Twitter) - Nov 11, 2020
- ||| Journal, Adverse events: Markedly increased ocular side effect causing severe vision deterioration after chemotherapy using new or investigational epidermal or fibroblast growth factor receptor inhibitors. (Pubmed Central) - Sep 27, 2020
Contrary to the low probability of ocular complication with old EGFR drugs, recently introduced EGFR and FGFR agents showed a high incidence of ocular complication with severe vision distortion. Doctors should forewarn patients planning chemotherapy with these agents that decreased visual acuity could develop due to corneal epithelial changes and also reassure them that the condition could be improved after the end of treatment without the use of steroid eye drops.
- ||| bemarituzumab (AMG 552) / Amgen
Phase classification, Enrollment change, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (clinicaltrials.gov) - Aug 8, 2020
P2, N=155, Active, not recruiting, Sponsor: Five Prime Therapeutics, Inc.
Doctors should forewarn patients planning chemotherapy with these agents that decreased visual acuity could develop due to corneal epithelial changes and also reassure them that the condition could be improved after the end of treatment without the use of steroid eye drops. Phase classification: P3 --> P2 | N=548 --> 155
- |||| bemarituzumab (FPA-144) / Five Prime
Video: VIDEO: Bemarituzumab in solid tumours w/ @DocCatenacci of @UChicago: https://t.co/NCMms1oGH6 @VJOncology @WCGIC #WorldGI2020 @myESMO @OncoAlert #GCsm #OncoAlert (Twitter) - Jul 30, 2020
- ||||| bemarituzumab (AMG 552) / Amgen
Enrollment closed, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (clinicaltrials.gov) - Jul 2, 2020
P3, N=548, Active, not recruiting, Sponsor: Five Prime Therapeutics, Inc.
Phase classification: P3 --> P2 | N=548 --> 155 Recruiting --> Active, not recruiting
- ||||| bemarituzumab (FPA-144) / Five Prime
Bemarituzumab, a potent anti-FGFR antibody, active against Gastroesophageal adenocarcinomas with IHC + FGFR by @DocCatenacci et al in @ASCO_pubs https://doi. org/10.1200/JCO.19. 01834 (Twitter) - Apr 5, 2020
- |||||| bemarituzumab (FPA-144) / Five Prime
Clinical: Bemarituzumab (anti-FGFR2 monoclonal antibody) demonstrated single-agent activity as late-line therapy in patients with advanced-stage gastroesophageal adenocarcinoma https://t.co/W40G4cPf7c #esocsm #stcsm #JCO @DocCatenacci (Twitter) - Apr 5, 2020
- ||||| bemarituzumab (FPA-144) / Five Prime
Clinical: Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma Congratulations to all the authors! @DocCatenacci https://t.co/09zIPaosHW (Twitter) - Mar 31, 2020
- | bemarituzumab (FPA-144) / Amgen
Journal: Bemarituzumab Is Active in FGFR2b-High Gastroesophageal Adenocarcinoma. (Pubmed Central) - Mar 30, 2020
Recruiting --> Active, not recruiting The FGFR2b inhibitor bemarituzumab was effective in high-FGFR2b gastroesophageal adenocarcinoma.
- |||| bemarituzumab (FPA-144) / Five Prime
Meetings may be on hold but learning is not. Phase I of Bemarituzumab (FPA144) in Advanced Solid Tumors and FGFR2b-Selected #Gastroesophageal Adenocarcinoma. Congrats @DocCatenacci and others. #GEAwesome. https://t.co/1l4X1plW33 (Twitter) - Mar 17, 2020
- |||| bemarituzumab (FPA-144) / Five Prime
Yes with FOLFOX IN 1L: Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design | Future Oncology 2019 https://t.co/AQ5kE9Bc4H (Twitter) - Mar 14, 2020
- ||||| bemarituzumab (FPA-144) / Five Prime
Clinical: Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma https://t.co/3YvqZ7V0Pv (Twitter) - Mar 14, 2020
- ||| bemarituzumab (AMG 552) / Amgen
Trial completion, Metastases: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Mar 11, 2020
P1, N=79, Completed, Sponsor: Five Prime Therapeutics, Inc.
The FGFR2b inhibitor bemarituzumab was effective in high-FGFR2b gastroesophageal adenocarcinoma. Active, not recruiting --> Completed
- || Enrollment closed, Tumor mutational burden: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression (clinicaltrials.gov) - Feb 20, 2020
P2, N=80, Active, not recruiting, Sponsor: University of Chicago
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| bemarituzumab (FPA-144) / Five Prime
P3 data, Journal: Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase 3 study design. (Pubmed Central) - Dec 23, 2019
P1, P1a
Eligible patients are selected based on the presence of either FGFR2b protein overexpression determined by immunohistochemistry or FGFR2 gene amplification determined by circulating tumor DNA. The primary end point is overall survival, and secondary end points include progression-free survival, objective response rate and safety.
- Keytruda (pembrolizumab) / Merck (MSD), bemarituzumab (FPA-144) / Five Prime Therap
Evaluation of FGFR2b in context of relevant biomarkers supports potential combination of anti-FGFR2b with anti-PD-(L)1 therapy in gastric cancer (Board 33: Level 2 - Hall D) - Sep 18, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_68;
Further mechanistic insight and support comes from preclinical studies (Pierce et al. AACR 2016), which showed an increase in efficacy with the combination treatment of bemarituzumab and anti-PD1 in an orthotopic mouse model.
- | bemarituzumab (AMG 552) / Amgen
Trial completion date, Trial primary completion date, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (clinicaltrials.gov) - Aug 14, 2019
P1a, N=10, Active, not recruiting, Sponsor: Five Prime Therapeutics, Inc.
AACR 2016), which showed an increase in efficacy with the combination treatment of bemarituzumab and anti-PD1 in an orthotopic mouse model. Trial completion date: Feb 2019 --> Jul 2024 | Trial primary completion date: Jul 2018 --> Jul 2022
- || Trial completion date, Trial primary completion date, Tumor mutational burden: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression (clinicaltrials.gov) - May 1, 2019
P2, N=104, Recruiting, Sponsor: University of Chicago
Trial completion date: Feb 2019 --> Jul 2024 | Trial primary completion date: Jul 2018 --> Jul 2022 Trial completion date: Oct 2018 --> Feb 2022 | Trial primary completion date: Oct 2018 --> Feb 2020
- |||||| bemarituzumab (AMG 552) / Amgen
New trial: An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer (clinicaltrials.gov) - Jan 11, 2019
P, N=0, Available, Sponsor: Five Prime Therapeutics, Inc.
- | bemarituzumab (AMG 552) / Amgen
New P3 trial, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (clinicaltrials.gov) - Oct 2, 2018
P3, N=548, Recruiting, Sponsor: Five Prime Therapeutics, Inc.
- | bemarituzumab (AMG 552) / Amgen
Enrollment closed, Enrollment change, Trial completion date, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (clinicaltrials.gov) - Aug 2, 2018
P1a, N=10, Active, not recruiting, Sponsor: Five Prime Therapeutics, Inc.
Trial completion date: Oct 2018 --> Feb 2022 | Trial primary completion date: Oct 2018 --> Feb 2020 Recruiting --> Active, not recruiting | N=21 --> 10 | Trial completion date: Jun 2018 --> Feb 2019
- || bemarituzumab (AMG 552) / Amgen
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Apr 10, 2018
P1, N=100, Active, not recruiting, Sponsor: Five Prime Therapeutics, Inc.
Recruiting --> Active, not recruiting | N=21 --> 10 | Trial completion date: Jun 2018 --> Feb 2019 Recruiting --> Active, not recruiting | Trial completion date: Nov 2019 --> Mar 2019 | Trial primary completion date: Sep 2019 --> Nov 2018
- bemarituzumab (AMG 552) / Amgen
Phase classification, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (clinicaltrials.gov) - Feb 27, 2018
P1a, N=21, Recruiting, Sponsor: Five Prime Therapeutics, Inc.
Recruiting --> Active, not recruiting | Trial completion date: Nov 2019 --> Mar 2019 | Trial primary completion date: Sep 2019 --> Nov 2018 Phase classification: P1 --> P1a
- bemarituzumab (AMG 552) / Amgen
Enrollment open, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (clinicaltrials.gov) - Jan 9, 2018
P1, N=21, Recruiting, Sponsor: Five Prime Therapeutics, Inc.
Phase classification: P1 --> P1a Not yet recruiting --> Recruiting
- || Trial primary completion date, Tumor mutational burden: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression (clinicaltrials.gov) - Dec 7, 2017
P2, N=104, Recruiting, Sponsor: University of Chicago
Not yet recruiting --> Recruiting Trial primary completion date: Oct 2017 --> Oct 2018
- || bemarituzumab (AMG 552) / Amgen
Enrollment change, Trial primary completion date, Metastases: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Nov 24, 2017
P1, N=100, Recruiting, Sponsor: Five Prime Therapeutics, Inc.
Trial primary completion date: Oct 2017 --> Oct 2018 N=210 --> 100 | Trial primary completion date: Mar 2019 --> Sep 2019 | N=210 --> 100 | Trial primary completion date: Mar 2019 --> Sep 2019 | N=210 --> 100 | Trial primary completion date: Mar 2019 --> Sep 2019
- | bemarituzumab (AMG 552) / Amgen
New P1 trial, Metastases: FIGHT: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer (clinicaltrials.gov) - Nov 17, 2017
P1, N=21, Not yet recruiting, Sponsor: Five Prime Therapeutics, Inc.
- | Phase classification, Tumor mutational burden: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression (clinicaltrials.gov) - Dec 29, 2016
P2, N=104, Recruiting, Sponsor: University of Chicago
N=210 --> 100 | Trial primary completion date: Mar 2019 --> Sep 2019 | N=210 --> 100 | Trial primary completion date: Mar 2019 --> Sep 2019 | N=210 --> 100 | Trial primary completion date: Mar 2019 --> Sep 2019 Phase classification: P1/2 --> P2
- || bemarituzumab (AMG 552) / Amgen
Metastases: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 26, 2016
P1, N=210, Recruiting, Sponsor: Five Prime Therapeutics, Inc.
Phase classification: P1/2 --> P2 N=120 --> 210 | Trial primary completion date: Nov 2016 --> Mar 2019
- || Trial primary completion date, Tumor mutational burden: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression (clinicaltrials.gov) - Apr 13, 2016
P1/2, N=104, Recruiting, Sponsor: University of Chicago
N=120 --> 210 | Trial primary completion date: Nov 2016 --> Mar 2019 Trial primary completion date: Oct 2016 --> Oct 2017
- || bemarituzumab (AMG 552) / Amgen
Metastases: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Jun 11, 2015
P1, N=120, Recruiting, Sponsor: Five Prime Therapeutics, Inc.
Trial primary completion date: Oct 2016 --> Oct 2017 N=100 --> 120
- |||| Enrollment open, Trial initiation date, Tumor mutational burden: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression (clinicaltrials.gov) - Mar 9, 2015
P1/2, N=104, Recruiting, Sponsor: University of Chicago
N=100 --> 120 Not yet recruiting --> Recruiting | Initiation date: Oct 2014 --> Jan 2015
- ||| bemarituzumab (AMG 552) / Amgen
Metastases: Open-Label, Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - Dec 19, 2014
P1, N=100, Recruiting, Sponsor: Five Prime Therapeutics, Inc.
- | Phase classification, Tumor mutational burden: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression (clinicaltrials.gov) - Aug 25, 2014
P1/2, N=104, Not yet recruiting, Sponsor: University of Chicago
Not yet recruiting --> Recruiting | Initiation date: Oct 2014 --> Jan 2015 Phase classification: P2 --> P1/2
- ||||| New P1/2 trial, New P2 trial, Tumor mutational burden: PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression (clinicaltrials.gov) - Aug 11, 2014
P2, N=104, Not yet recruiting, Sponsor: University of Chicago