Further FDA approvals for pembrolizumab, nivolumab
medwireNews: The US FDA has given the go-ahead to pembrolizumab for advanced gastric cancer and to nivolumab for hepatocellular carcinoma (HCC) previously treated with sorafenib under the accelerated approvals program.
The PD-1 inhibitor pembrolizumab is approved for the treatment of recurrent, locally advanced, or metastatic gastric or gastroesophageal junction adenocarcinoma that tests positive for PD-L1 expression, as indicated by a combined positive score of at least 1 on the PD-L1 IHC 22C3 pharmDx test. The assay has also been granted approval.
The decision is based on the findings of the phase II KEYNOTE-059 trial and specifies that pembrolizumab can only be given to patients who have progressed after receiving at least two prior systemic regimens, including fluoropyrimidine- and platinum-based chemotherapy and, if indicated, HER2/neu-targeted therapy.
The FDA recommends that pembrolizumab be given at a dose of 200 mg every 3 weeks for a maximum of 2 years, unless disease progression or unacceptable toxicity occurs.
Nivolumab, also a PD-1 inhibitor, can now be given at a recommended dose of 240 mg every 2 weeks to HCC patients who have progressed after treatment with the tyrosine kinase inhibitor sorafenib.
The FDA has based its approval on the results from a subgroup of patients who progressed on or were intolerant to sorafenib in the phase I/II CheckMate 040 trial. Treatment with nivolumab led to a complete response in three patients, while 19 had a partial response, giving an objective response rate of 14.3%.
Of note, responses were durable, with 91% and 55% of responses lasting for at least 6 and 12 months, respectively.
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