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Zenocutuzumab, an antibody that grips HER2 and HER3 at once so the NRG1 growth signal cannot get through, shrank tumours in about three in ten patients whose cancers carried an NRG1 fusion, with responses lasting close to a year, and did best in pancreatic cancer. It became the first drug approved for a pancreatic cancer driver alteration.
Phase 2 registrational analysis of the eNRGy basket trial of zenocutuzumab 750 mg every two weeks in patients with advanced NRG1 fusion-positive solid tumours, mostly non-small-cell lung cancer and pancreatic cancer, who had progressed on standard therapy. Among efficacy-evaluable patients the objective response rate was about 30 percent with a median duration of response of about 11 months; the response rate in pancreatic cancer was higher, around 40 percent.
The drug was well tolerated, with diarrhoea, fatigue and infusion-related reactions the commonest adverse events and few discontinuations. The US FDA granted accelerated approval in December 2024 for NRG1 fusion-positive non-small-cell lung cancer and pancreatic adenocarcinoma after prior systemic therapy.
Every KRAS wild-type pancreatic cancer should be tested for NRG1 fusions because a specific, approved antibody now exists; zenocutuzumab is the first targeted drug approved for a pancreatic cancer driver.
Shares Zenocutuzumab, NRG1, Wild-type (WT), HER3.
Shares Zenocutuzumab, NRG1, Wild-type (WT), HER3.
Shares Zenocutuzumab, NRG1, HER3, Tumour-agnostic (tissue-agnostic) approval.
Shares NRG1, Tumour-agnostic (tissue-agnostic) approval, Receptor tyrosine kinase activation, HER2.
Shares Eileen M. O'Reilly, KRAS wild-type pancreatic ductal adenocarcinoma, Tumour-agnostic (tissue-agnostic) approval, Pancreatic ductal adenocarcinoma.
Shares NRG1, Wild-type (WT), KRAS wild-type pancreatic ductal adenocarcinoma, Receptor tyrosine kinase activation.
Shares HER3, Receptor tyrosine kinase activation, HER2.
Shares Zenocutuzumab, NRG1.