On December 17, 2025 Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, reported that it is on track to dose the first patient in its planned global Phase 3 registrational trial in first line pancreatic cancer patients in mid-2026, evaluating atebimetinib (320 mg QD) in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared with gemcitabine and nab-paclitaxel (GnP) alone.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Notably, the company completed its End-of-Phase 2 (EOP2) interactions with the U.S. Food and Drug Administration (FDA) and received scientific advice from the European Medicines Agency (EMA). Immuneering achieved alignment with both agencies on the key elements of the company’s proposed Phase 3 trial.

"We are very pleased with our interactions with both the FDA and EMA, which we believe speaks to the compelling data we have generated to date in first-line pancreatic cancer, as well as the strength and simplicity of our proposed Phase 3 trial for atebimetinib," said Ben Zeskind, Ph.D., Co-Founder and Chief Executive Officer of Immuneering. "Importantly, the regulators’ feedback supports our trial design and key primary endpoint of overall survival, and we are confident that our team is well-positioned to begin dosing patients in this global registrational trial in mid-2026. We are also thrilled to expand the planned trial to 510 patients, which gives more first-line pancreatic cancer patients the opportunity to participate, and further increases statistical robustness. In addition, we are excited to provide an update on overall survival in the Phase 2a trial in the coming weeks."

MAPKeeper 301 is designed as a global Phase 3 trial that will evaluate atebimetinib (320 mg QD) in combination with mGnP, compared to standard of care GnP alone, in first-line metastatic pancreatic ductal adenocarcinoma. The primary endpoint of the trial is overall survival, and secondary endpoints include progression-free survival, overall response rate, disease control rate, and quality of life measurements. Immuneering plans to enroll a total of approximately 510 patients in the Phase 3 trial.

The company expects to dose the first patient in mid-2026 and share topline results from the trial in mid-2028. Immuneering also reiterated management’s belief that the company’s current cash and cash equivalents, based on current operating plans, are sufficient to fund operations into 2029.

"The constructive guidance from both agencies validates our scientific approach and our understanding of the unmet need in first-line metastatic pancreatic cancer," said Igor Matushansky, M.D., Ph.D., Chief Medical Officer of Immuneering. "We look forward to advancing atebimetinib into Phase 3 and working with investigators worldwide to bring this potentially transformative therapy to patients as expeditiously as possible."

"New therapies for pancreatic cancer are urgently needed," said Eileen M. O’Reilly, MD, FASCO, Winthrop Rockefeller Endowed Chair in Medical Oncology at Memorial Sloan Kettering Cancer Center. "The phase IIa data of atebimetinib and chemotherapy shows a promising signal. I am excited to see this combination move forward to a randomized phase III evaluation."

(Press release, Immuneering, DEC 17, 2025, View Source [SID1234661502])