In the middle of November, the Food and Drug Administration (FDA) approved Pembrolizumab (Keytruda) in combination with chemotherapy, for the first-line treatment of patients with advanced unresectable or metastatic gastric or gastroesophageal junction cancer, not suitable for biological treatment.
Keytruda, as mentioned previously, is an immunotherapeutic drug which helps the immune system to fight cancer cells.
The approval is supported by results from a clinical trial that enrolled 1,579 patients meeting the abovementioned criteria, who had not previously received any treatment for metastatic disease. Patients were randomly assigned to receive either Keytruda with chemotherapy (study group), or placebo with chemotherapy (control group).
At the end of the follow-up period, the results pointed towards a significantly higher treatment efficacy among the study group patients receiving Keytruda with chemotherapy, compared to the control group patients receiving placebo with chemotherapy.
A significantly lower risk of disease progression and death was also observed among the study group patients, compared to the control group patients.
Side effects were generally similar to those observed in other trials of Keytruda.
Keytruda in combination with chemotherapy, provides an efficient treatment option as first-line therapy for patients with advanced gastric/gastroesophageal junction cancer, not suitable for biological treatment.