NOTABLE (nimotuzumab, KRAS wild-type pancreatic cancer)
In the minority of pancreatic cancers without a KRAS mutation, adding the EGFR antibody nimotuzumab to gemcitabine helped people live longer, and China approved it in 2023.
Overview
NOTABLE randomised patients in China with KRAS wild-type locally advanced or metastatic pancreatic cancer to nimotuzumab or placebo with gemcitabine. Overall survival, the primary endpoint, was longer with nimotuzumab, with the benefit concentrated in patients who had not had biliary obstruction. On this trial China's regulator approved nimotuzumab for KRAS wild-type pancreatic cancer in 2023, the first EGFR-directed approval in the disease since erlotinib.
Setting
Locally advanced or metastatic KRAS wild-type pancreatic cancer: nimotuzumab plus gemcitabine versus placebo plus gemcitabine
Phase
Phase 3
Sponsor
Biotech Pharmaceutical (China)
Registry
Headline result
Overall survival improved with nimotuzumab plus gemcitabine in KRAS wild-type disease.
Reported
2023
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