Pembrolizumab: No Survival Gains Second Line In Gastric Cancer
Reporter: Sarah Maxwell
BARCELONA—Pembrolizumab did not significantly improve overall survival (OS) or progression free survival (PFS) compared with paclitaxel as second-line therapy in patients with advanced gastric or gastro-esophageal junction cancer that had progressed after one line of chemotherapy (containing a platinum and fluoropyrimidine) in the KEYNOTE-061 randomized open-label controlled phase three trial reported at the ESMO 20th World Congress on Gastrointestinal Cancer. https://www.ncbi.nlm.nih.gov/pubmed/29880231.
Molecular Biomarker
The lack of statistical benefit was despite the fact that the analysis was with patientswho had been selected because they had programmed cell death ligand 1 (PD-L1) combined positive scores (CPS) of 1 or higher—indicating at least a one per cent positive staining rate in their tumors—marking them as theoretically ideal candidates for therapy with this checkpoint inhibitor antibody that targets programmed cell death 1 (PD-1) molecular features.
The findings call into question the simplistic concept that targeting a molecular feature on a particular tumor will necessarily be sufficient to work as a method of treating that cancer.
Sub-Groups
But lead author Kohei Shitara MD, Chief Doctor in the gastrointestinal department of the National Cancer Center Hospital East in Kashiwa, Japan, said that sub-group analysis yielded positive findings for some patients and that pembrolizumab had a better safety profile than paclitaxel.
He tells the Audio Journal of Oncology: “The trial did not meet the primary endpoints to show survival improvement [or] PFS improvement,” he said. But some of the patients showed “very durable benefit” with pembrolizumab. The sub-group study confirmed that patients with good performance status and having at least 10 per cent staining for PD-L1 expression (defined as a CPS score of 10) had improved prospects—as did those with tumors expressing high microsatellite instability (MSI).
BARCELONA—Pembrolizumab did not significantly improve overall survival (OS) or progression free survival (PFS) compared with paclitaxel as second-line therapy in patients with advanced gastric or gastro-esophageal junction cancer that had progressed after one line of chemotherapy (containing a platinum and fluoropyrimidine) in the KEYNOTE-061 randomized open-label controlled phase three trial reported at the ESMO 20th World Congress on Gastrointestinal Cancer. https://www.ncbi.nlm.nih.gov/pubmed/29880231.
Molecular Biomarker
The lack of statistical benefit was despite the fact that the analysis was with patientswho had been selected because they had programmed cell death ligand 1 (PD-L1) combined positive scores (CPS) of 1 or higher—indicating at least a one per cent positive staining rate in their tumors—marking them as theoretically ideal candidates for therapy with this checkpoint inhibitor antibody that targets programmed cell death 1 (PD-1) molecular features.
The findings call into question the simplistic concept that targeting a molecular feature on a particular tumor will necessarily be sufficient to work as a method of treating that cancer.
Sub-Groups
But lead author Kohei Shitara MD, Chief Doctor in the gastrointestinal department of the National Cancer Center Hospital East in Kashiwa, Japan, said that sub-group analysis yielded positive findings for some patients and that pembrolizumab had a better safety profile than paclitaxel.
He tells the Audio Journal of Oncology: “The trial did not meet the primary endpoints to show survival improvement [or] PFS improvement,” he said. But some of the patients showed “very durable benefit” with pembrolizumab. The sub-group study confirmed that patients with good performance status and having at least 10 per cent staining for PD-L1 expression (defined as a CPS score of 10) had improved prospects—as did those with tumors expressing high microsatellite instability (MSI).
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