Atebimetinib Advances Toward Mid-Stage Registration Trial Launch for Metastatic Pancreatic Cancer

GasFeeCrybaby · 2025-12-26T05:01:42+00:00

Immuneering Corp. has been approved to proceed with a pivotal Phase 3 study of Atebimetinib for first-line metastatic pancreatic cancer. The trial will enroll about 510 patients, comparing Atebimetinib plus gemcitabine and nab-paclitaxel against standard therapy, with results expected in 2026.

GasFeeCrybaby

2025-12-26 05:01:42

Abstract generation in progress

Immuneering Corp. (IMRX) has received regulatory green light to move forward with its pivotal Phase 3 study of Atebimetinib targeting first-line metastatic pancreatic cancer patients. The company completed a successful End-of-Phase 2 meeting with the FDA and obtained formal scientific guidance from the European Medicines Agency, with both authorities endorsing the trial’s core architecture and primary endpoint of overall survival.

Trial Design and Patient Population

The company is positioned to enroll approximately 510 patients in the upcoming Phase 3 registrational study, designated MAPKeeper 301. This global trial will compare Atebimetinib (320 mg once daily) used alongside modified gemcitabine and nab-paclitaxel regimen against the standard gemcitabine and nab-paclitaxel combination alone in treatment-naive metastatic pancreatic cancer patients.

Beyond the primary efficacy measure of overall survival, researchers will monitor progression-free survival, overall response rate, disease control rate, and quality of life metrics as secondary outcomes. The trial architecture reflects consensus between Immuneering and major regulatory bodies regarding the evaluation framework for this combination approach.

Timeline and Data Expectations

First patient dosing in MAPKeeper 301 is anticipated during mid-2026, marking a critical milestone in the company’s clinical pipeline development. Ahead of the Phase 3 launch, Immuneering intends to release an overall survival readout from its Phase 2a study examining Atebimetinib combined with gemcitabine in the first-line pancreatic cancer setting within the coming weeks.

Market Recognition

The company’s progress has attracted broader market attention, with IMRX being added to the Nasdaq Biotechnology Index effective December 22, 2025. Stock trading closed at $5.50, reflecting a 4.18% decline during recent market activity. The clinical advancement in pancreatic cancer treatment options represents a significant development for the company’s late-stage oncology portfolio.

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