For patients diagnosed with advanced gastric or gastroesophageal junction cancer, the prognosis has historically been bleak. However, new research may change that narrative.
A recent international phase 3 clinical trial, involving Weill Cornell Medicine and NewYork-Presbyterian, has unveiled a targeted therapy that promises longer survival rates for patients.
The drug in question, zolbetuximab, could mark a major advancement in the fight against this deadly form of cancer.
The Study: GLOW and SPOTLIGHT
Published in Nature Medicine, the GLOW study provided compelling results for the use of zolbetuximab in combination with standard chemotherapy (CAPOX).
A total of 507 patients participated in the trial. Those receiving zolbetuximab saw significant increases in progression-free survival, and their risk of disease progression or death was lowered by 31%.
Similarly, a parallel SPOTLIGHT study corroborated these findings, strengthening the evidence for the drug’s efficacy.
FDA’s Attention
Due to these compelling results, the U.S. Food and Drug Administration has granted priority review for zolbetuximab. The target decision date is set for January 12, 2024.
If approved, it will be a game-changer, being the first targeted therapy for advanced gastric or gastroesophageal cancers in the United States.
Why Is This a Big Deal?
Gastric cancer ranks as the fifth most diagnosed cancer globally, and most patients are diagnosed at an advanced stage due to a lack of early symptoms.
Current treatment options are limited, making this discovery particularly groundbreaking.
Zolbetuximab targets a specific protein, CLDN 18.2, which is overexpressed in certain gastric cancers. This makes it a precise and potent weapon against this deadly disease.
Safety and Side Effects
One of the most reassuring findings of the study was that the drug did not significantly increase treatment-related adverse events.
Common side effects like nausea, vomiting, and decreased appetite were similar between the group treated with zolbetuximab and the placebo group.
Looking Forward
According to Dr. Manish Shah, who led the study, “If zolbetuximab is approved, patients will be able to decide with their physicians whether zolbetuximab plus CAPOX or mFOLFOX is the right regimen for them.”
This opens up treatment avenues that were previously nonexistent, addressing a significant unmet need for these patients.
Key Takeaways
The preliminary success of zolbetuximab offers new hope for patients suffering from advanced gastric and gastroesophageal cancers.
With FDA review pending, the medical community waits in anticipation, hoping this drug will provide a new, life-extending option for those who need it the most.
While we must await further confirmatory studies and official approval, the initial findings are a leap forward in the fight against gastric cancer.
If you care about cancer, please read studies about a new method to treat cancer effectively, and this low-dose, four-drug combo may block cancer spread.
For more information about cancer prevention, please see recent studies about nutrients in fish that can be a poison for cancer, and results showing this daily vitamin is critical to cancer prevention.
The study was published in Nature Medicine.
Follow us on Twitter for more articles about this topic.
Copyright © 2023 Knowridge Science Report. All rights reserved.
