Zolbetuximab: Difference between revisions
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Preliminary results from the [[Phases of clinical research|phase II]] 'FAST' trial in June 2016 suggest it is helpful for advanced [[gastric cancer]].<ref name=FAST-2016>{{cite web|url=http://www.medpagetoday.com/MeetingCoverage/ASCO/58317?xid=nl_mpt_DHE_2016-06-06|title=Antibody Shines in Advanced Gastric Cancer|date=5 June 2016|website=medpagetoday.com}}</ref> |
Preliminary results from the [[Phases of clinical research|phase II]] 'FAST' trial in June 2016 suggest it is helpful for advanced [[gastric cancer]].<ref name=FAST-2016>{{cite web|url=http://www.medpagetoday.com/MeetingCoverage/ASCO/58317?xid=nl_mpt_DHE_2016-06-06|title=Antibody Shines in Advanced Gastric Cancer|date=5 June 2016|website=medpagetoday.com}}</ref> |
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Astellas Pharmaceuticals presented the results of their [[Phases of clinical research|phase III]] 'SPOTLIGHT' trial at the 2023 ASCO GI Cancers symposium on January 19, 2023 which indicated that Zolbetuximab plus mFOLFOX6 chemotherapy reduced the risk of progression or death in gastric cancer patients by about 25% over the standard of care (mFOLFOX6) plus placebo.<ref>https://newsroom.astellas.us/2023-01-19-Astellas-to-Present-Positive-Findings-from-Phase-3-SPOTLIGHT-Trial-of-Zolbetuximab-during-2023-ASCO-GI-Cancers-Symposium</ref> |
Astellas Pharmaceuticals presented the results of their [[Phases of clinical research|phase III]] 'SPOTLIGHT' trial<ref name=SPOTLIGHT>{{ClinicalTrialsGov|NCT03504397|A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight)}}</ref> at the 2023 ASCO GI Cancers symposium on January 19, 2023 which indicated that Zolbetuximab plus mFOLFOX6 chemotherapy reduced the risk of progression or death in gastric cancer patients by about 25% over the standard of care (mFOLFOX6) plus placebo.<ref name=Shitara2023-ASCO>{{cite journal|doi=10.1200/JCO.2023.41.3_suppl.LBA292}}</ref><ref>https://newsroom.astellas.us/2023-01-19-Astellas-to-Present-Positive-Findings-from-Phase-3-SPOTLIGHT-Trial-of-Zolbetuximab-during-2023-ASCO-GI-Cancers-Symposium</ref> |
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== References == |
== References == |
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Revision as of 10:39, 7 February 2023
| Monoclonal antibody | |
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| Type | Whole antibody |
| Source | Chimeric |
| Target | CLDN18.2 |
| Clinical data | |
| Other names | IMAB362; Claudiximab |
| ATC code |
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| Legal status | |
| Legal status |
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| Identifiers | |
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Zolbetuximab (development code IMAB362) is an experimental monoclonal antibody against isoform 2 of Claudin-18. It is under investigation for the treatment of gastrointestinal adenocarcinomas and pancreatic tumors. IMAB362 was developed by Ganymed Pharmaceuticals AG.[1] Astellas Pharmaceuticals acquired the rights to Zolbetuximab in December, 2016 when it acquired Ganymed Pharmaceuticals. [2]
The drug was in phase III clinical trials as of November 2021[update].[3]
Preliminary results from the phase II 'FAST' trial in June 2016 suggest it is helpful for advanced gastric cancer.[4]
Astellas Pharmaceuticals presented the results of their phase III 'SPOTLIGHT' trial[5] at the 2023 ASCO GI Cancers symposium on January 19, 2023 which indicated that Zolbetuximab plus mFOLFOX6 chemotherapy reduced the risk of progression or death in gastric cancer patients by about 25% over the standard of care (mFOLFOX6) plus placebo.[6][7]
References
- ^ "Our mission - Ganymed Pharmaceuticals GmbH - Ganymed Pharmaceuticals GmbH". www.ganymed-pharmaceuticals.de.
- ^ https://www.astellas.com/en/news/7846
- ^ "A Study of Zolbetuximab (IMAB362)". clinicaltrials.gov. 19 November 2021.
- ^ "Antibody Shines in Advanced Gastric Cancer". medpagetoday.com. 5 June 2016.
- ^ Clinical trial number NCT03504397 for "A Phase 3 Efficacy, Safety and Tolerability Study of Zolbetuximab (Experimental Drug) Plus mFOLFOX6 Chemotherapy Compared to Placebo Plus mFOLFOX6 as Treatment for Gastric and Gastroesophageal Junction (GEJ) Cancer (Spotlight)" at ClinicalTrials.gov
- ^ . doi:10.1200/JCO.2023.41.3_suppl.LBA292.
{{cite journal}}: Cite journal requires|journal=(help); Missing or empty|title=(help) - ^ https://newsroom.astellas.us/2023-01-19-Astellas-to-Present-Positive-Findings-from-Phase-3-SPOTLIGHT-Trial-of-Zolbetuximab-during-2023-ASCO-GI-Cancers-Symposium
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