HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma patients haven’t seen a drug approval for their disease state in a decade. That is until the FDA approved Keytruda in combination with trastuzumab, fluoropyrimidine-and platinum-containing chemotherapy. This is very exciting news for patients and doctors alike.
Approval for New Regimen
Approval for this Keytruda-based regimen was based on the KEYNOTE-811 trial. The ongoing study has enrolled and analyzed the data of 264 patients. These patients were separated into two groups, one of which received a placebo while the other received the Keytruda-based treatment regimen.
The overall response rate (ORR) was 74% for the group receiving Keytruda, which can be compared to a 52% ORR in the placebo group. In regard to the median duration of response, the Keytruda group saw a response of 10.6 months, while the placebo group sat at 9.5 months.
While survival data is not yet available, these results are already very exciting. “To show a dramatic improvement in overall response rate in (this) space is relatively unusual,” said Dr. Yelena Janjigian, the chief of gastrointestinal oncology service and medical oncologist at Memorial Sloan Kettering Cancer Center.
Because gastric cancer can be difficult to diagnose in its earlier stages, many patients do not receive their diagnosis until their disease has progressed to stage 4. Surgery is not an option at this point, but treatment can still slow progression. It’s important to get these patients on a first-line therapy as quickly as possible. Now that this Keytruda-based regimen has been approved, patients have another first-line option.
About Gastric Cancer
Gastric cancer, also commonly referred to as stomach cancer, comes in many different forms. This cancer begins in the inner layer of the stomach before spreading outwards, which means that many cases are asymptomatic in the earlier stages. When symptoms do appear, they include fatigue, nausea, vomiting, unintentional weight loss, stomach pain, indigestion, feeling bloated and full after eating small portions, blood in the still, heartburn, jaundice, and trouble swallowing.
Medical professionals are unsure as to what exactly causes stomach cancer, but they have identified a number of risk factors. These include old age, a family history of gastric cancer, GERD, an infection with the H. pylori bacteria, smoking, obesity, and a diet that is low in fruit and vegetables but high in salted and smoked foods. This cancer also impacts males more than females. In terms of treatment, it varies depending on the cancer’s location and stage, alongside the patient’s overall health and preferences. Options include chemotherapy, targeted drugs, radiation therapy, surgery, and palliative care.
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