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Biotechnology: Pharmaceutical Preparations
Clinical TrialJun 11, 2026, 07:31 AM

Immuneering Doses First Patient in Pivotal Phase 3 Pancreatic Cancer Trial

AI Summary

Immuneering Corporation announced the dosing of the first patient in MAPKeeper 301, a global, randomized, open-label pivotal Phase 3 clinical trial. This trial evaluates atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP) in first-line metastatic pancreatic cancer patients, a challenging malignancy with an urgent need for new treatment options. Atebimetinib is a novel MEK inhibitor designed to improve survival and tolerability. Topline data, including the primary endpoint of overall survival, is expected in mid-2028.

Key Highlights

  • First patient dosed in MAPKeeper 301, a global pivotal Phase 3 trial for atebimetinib.
  • Trial evaluates atebimetinib + modified gemcitabine/nab-paclitaxel (mGnP) in first-line metastatic pancreatic cancer.
  • Primary endpoint is overall survival (OS); key secondary endpoints include PFS, ORR, DCR.
  • Topline data readout, including primary endpoint of OS, anticipated in mid-2028.
  • Atebimetinib is a novel MEK inhibitor designed to target RAS, RAF, and MAPK pathway-driven cancers.
  • Pancreatic ductal adenocarcinoma (PDAC) has a poor prognosis with approximately 13% five-year survival rate.
  • The global MAPKeeper 301 trial identifier is NCT07562152.