Immuneering Corporation, a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, shared comments following the recent FDA approval of a new second-line pancreatic cancer treatment.

“Approval of this new treatment is good news for the subset of pancreatic cancer patients who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy,” said Ben Zeskind, Ph.D., CEO of Immuneering. “The top priority for the pancreatic cancer field now turns to the development of treatments for first-line metastatic pancreatic cancer patients. Immuneering is focused on treating these patients, and our Phase 3 MAPKeeper 301 study is enrolling them now. Atebimetinib is designed to help cancer patients live longer through a balance of attacking tumors and protecting patients. From the beginning, we have sought to control disease in parallel with maintaining body weight and minimizing harsh side effects such as rash, diarrhea, stomatitis, and fatigue. Our goal is to give first-line pancreatic cancer patients a choice that can help them live long, stay strong, and feel well.”

MAPKeeper 301 (NCT07562152) is a global, randomized pivotal trial evaluating atebimetinib in combination with chemotherapy in patients with first-line metastatic pancreatic cancer. More than 35 trial locations are already listed on ClinicalTrials.gov.

As previously reported, Immuneering's open-label, single-arm Phase 2a trial achieved 17.3 months median overall survival in 55 first-line metastatic pancreatic cancer patients treated with atebimetinib 320 mg once daily plus modified gemcitabine/nab-paclitaxel (mGnP), as of the April 24, 2026 data cutoff, with median follow-up of 11.6 months. Notably, 84% of evaluable patients maintained or gained weight at three months. The only treatment-related adverse events observed at Grade 3 or higher in ≥10% of patients were anemia (16%) and neutropenia (18%), both chemotherapy-related.