Immuneering Receives FDA and EMA Alignment for Phase 3 Atebimetinib Trial in First-Line Pancreatic Cancer
核心洞察
Immuneering Corporation has completed End-of-Phase 2 interactions with the FDA and received scientific advice from the EMA, achieving alignment on key elements of its proposed Phase 3 trial for atebimetinib (搜索) in first-line pancreatic cancer (搜索).
The global Phase 3 registrational trial, MAPKeeper 301, will evaluate atebimetinib (搜索) (320 mg QD) combined with modified gemcitabine and nab-paclitaxel versus standard of care in approximately 510 patients with first-line metastatic pancreatic ductal adenocarcinoma (搜索).
The company expects to dose the first patient in mid-2026 and share topline results in mid-2028, with overall survival as the primary endpoint.
Immuneering Corporation has achieved regulatory alignment with both the FDA and European Medicines Agency for its planned Phase 3 trial of atebimetinib (搜索) in first-line pancreatic cancer (搜索), positioning the company to begin dosing patients in mid-2026. The late-stage clinical oncology company completed its End-of-Phase 2 interactions with the FDA and received scientific advice from the EMA, with both agencies supporting the trial design and primary endpoint of overall survival.
Regulatory Milestone Advances Phase 3 Timeline
The regulatory feedback validates Immuneering's approach to addressing the significant unmet need in first-line metastatic pancreatic cancer (搜索). "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 (搜索)," said Ben Zeskind, Ph.D., Co-Founder and Chief Executive Officer of Immuneering.
The global Phase 3 registrational trial, designated MAPKeeper 301, will evaluate atebimetinib (搜索) at 320 mg once daily in combination with modified gemcitabine and nab-paclitaxel (mGnP), compared to standard of care gemcitabine and nab-paclitaxel (GnP) alone. The trial has been expanded to enroll approximately 510 patients with first-line metastatic pancreatic ductal adenocarcinoma (搜索).
Trial Design and Endpoints
The primary endpoint of MAPKeeper 301 is overall survival, with secondary endpoints including progression-free survival, overall response rate, disease control rate, and quality of life measurements. The company expects to dose the first patient in mid-2026 and share topline results from the trial in mid-2028.
"The constructive guidance from both agencies validates our scientific approach and our understanding of the unmet need in first-line metastatic pancreatic cancer (搜索)," said Igor Matushansky, M.D., Ph.D., Chief Medical Officer of Immuneering. "We look forward to advancing atebimetinib (搜索) into Phase 3 and working with investigators worldwide to bring this potentially transformative therapy to patients as expeditiously as possible."
Deep Cyclic Inhibitor Technology
Atebimetinib (搜索) represents an entirely new category of cancer medicines called Deep Cyclic Inhibitors. The oral, once-daily Deep Cyclic Inhibitor of MEK (搜索) is designed to improve durability and tolerability across many cancer indications, including MAPK pathway (搜索)-driven tumors such as pancreatic cancer (搜索).
The expanded patient enrollment to 510 participants not only increases statistical robustness but also provides more first-line pancreatic cancer (搜索) patients the opportunity to participate in the trial. Immuneering plans to provide an overall survival update for its Phase 2a trial of atebimetinib (搜索) plus mGnP in first-line pancreatic cancer patients in the coming weeks.
Clinical Expert Perspective
"New therapies for pancreatic cancer (搜索) 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 (搜索) and chemotherapy shows a promising signal. I am excited to see this combination move forward to a randomized phase III evaluation."
Financial Position
Immuneering reiterated that its current cash and cash equivalents, based on current operating plans, are sufficient to fund operations into 2029. The company was also recently selected for addition to the Nasdaq Biotechnology Index (NBI), effective prior to market open on December 22, 2025, reflecting its growing presence in the biotechnology sector.