FDA Approves Keytruda plus Chemo for Advanced HER2-Negative Gastric, GEJ Cancers

The Food and Drug Administration (FDA) approved Keytruda (pembrolizumab) plus fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma, according to an announcement from the agency.

The approval was based on findings from the randomized KEYNOTE-859 trial which included 1,579 patients who were randomly assigned to receive Keytruda plus investigator’s choice of chemotherapy or placebo plus investigator’s choice of chemotherapy.

The Keytruda-chemotherapy combination improved overall survival (time from treatment until death of any cause), with median overall survival being 12.9 months in the Keytruda group and 11.5months in theplacebo group. Findings also showed that the Keytruda group had improved mean progression-free survival (time from treatment until disease worsening or death) at 6.9 months and 5.6 months, respectively.

More patients responded to treatment with Keytruda (51%), compared with placebo (42%), with the immunotherapy group also showing improved duration of response compared with the placebo group, at eight and 5.7 months, respectively.

An additional pre-specified analysis showed a statistically significant improvement in overall survival, progression-free survival and response rate in patients receiving Keytruda based on tumors expressing PD-L1, which is the protein on cancer cells that Keytruda targets.

Fifteen percent of patients in the Keytruda group permanently stopped treatment due to side effects. Treatment-discontinuing side effects that occurred in more than 1% of patients taking Keytruda included infections and diarrhea.

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