Immuneering Touts 64% 12-Month Survival for Atebimetinib in Pancreatic Cancer, Eyes Phase 3

Immuneering (NASDAQ:IMRX) Chief Executive Officer and co-founder Ben Zeskind told attendees at Oppenheimer’s 36th Annual Healthcare Life Sciences Conference that the company is focused on improving survival in first-line pancreatic cancer and “beyond,” led by its oral MEK inhibitor candidate atebimetinib. Zeskind highlighted interim results from an ongoing Phase 2a study combining atebimetinib with modified gemcitabine/nab-paclitaxel (mGnP) and outlined plans for a global Phase 3 trial in first-line pancreatic cancer.

Phase 2a survival update and cross-trial context

Zeskind said Immuneering reported 64% overall survival (OS) at 12 months in January from its ongoing Phase 2a study of atebimetinib plus mGnP in first-line pancreatic cancer patients. He contrasted this with a 35% benchmark for standard-of-care gemcitabine/nab-paclitaxel, noting that cross-trial comparisons should be interpreted cautiously.

He added that the median OS in Immuneering’s cohort had not yet been reached with a median follow-up of 13.4 months, and he compared this to an 8.5-month median OS cited for the pivotal standard-of-care benchmark study. In additional cross-trial comparisons, he said the company’s survival curve appeared “head and shoulders above” benchmarks for three approved first-line regimens: gemcitabine/nab-paclitaxel, FOLFIRINOX, and NALIRIFOX.

Three mechanisms the company ties to overall survival

Zeskind described atebimetinib as the first of a new category the company calls “Deep Cyclic Inhibitors,” designed to improve OS through three mechanisms:

  • Shrinking tumors durably with less resistance
  • Preserving body mass by counteracting cachexia
  • Minimizing side effects to maintain performance status and enable combination therapy

To support the linkage between these factors and survival, Zeskind cited published literature discussed in the presentation, including a correlation between disease control rate and OS (correlation coefficient 0.74), a hazard ratio of 1.55 associated with weight loss in pancreatic cancer, and hazard ratios around 1.48 to 1.51 related to performance status decline or inability to receive second-line therapy due to side effects.

In the Phase 2a combination dataset he summarized, Zeskind reported an 81% disease control rate and said 84% of patients were stable or gained weight. He also pointed to tolerability, stating that only two categories of Grade 3 or higher adverse events occurred in more than 10% of patients—neutropenia and anemia—and attributed these to the chemotherapy backbone rather than atebimetinib, noting they were not seen in atebimetinib monotherapy.

Additional efficacy and tolerability details

Beyond OS, Zeskind highlighted separation versus cited standard-of-care benchmarks on other endpoints. He reported median progression-free survival of 8.5 months (versus a 5.5-month benchmark), an overall response rate of 39% (versus 23%), and reiterated the 81% disease control rate (versus 48%).

He also emphasized that the company is using a 320 mg dose of atebimetinib in combination with chemotherapy, describing it as the “full dose,” and argued that maintaining tolerability is important for keeping patients on therapy and preserving eligibility for later lines of treatment.

To “gut check” cross-trial comparisons, Zeskind compared baseline demographics, saying the company’s study population was broadly similar to pivotal standard-of-care studies except for age. Immuneering’s cohort had a median age of 69, compared with low-to-mid 60s in the pivotal studies, with more than two-thirds of Immuneering patients over 65.

Next catalyst: expanded cohort readout in 1H 2026

Zeskind said Immuneering plans to report OS data in the first half of 2026 from an expanded cohort of over 50 first-line pancreatic cancer patients treated with atebimetinib plus mGnP. He explained the original enrollment goal for the arm was 30 patients, but the company enrolled 34 and then reopened enrollment due to site demand, adding roughly 20 more patients. He said Immuneering previously stated the expanded cohort’s OS was “trending consistently” with the initial 34-patient results, while also noting the expanded cohort has a shorter median follow-up because those patients started later.

During the discussion, Zeskind referenced a case shared previously by an investigator, describing a patient who had two liver lesions become undetectable after about five months of treatment as of the data cutoff, along with improved quality of life and a reported 33-pound weight gain.

Phase 3 MAPKeepeR-301 plans and broader pipeline comments

Zeskind said Immuneering is aligned with the FDA and EMA and is fully funded to move into a Phase 3 study in first-line pancreatic cancer: MAPKeepeR-301. He described it as a global randomized pivotal trial of atebimetinib plus mGnP versus standard-of-care gemcitabine/nab-paclitaxel, with overall survival as the primary endpoint and a planned enrollment of 510 patients. He said the company expects to dose the first patient mid-year and anticipates a top-line readout roughly two years later.

On trial conduct, he said treatment beyond progression occurred in less than 10% of patients in the company’s study to date, and in Phase 3 it will be allowed at investigator discretion. He also said investigator enthusiasm for MAPKeepeR-301 has been “extremely high.”

Looking beyond pancreatic cancer, Zeskind said atebimetinib targets MEK and could apply across RAS-, RAF-, and other MAPK-driven cancers, which he estimated represent about half of all tumors. He also noted a planned Phase 2 trial combining atebimetinib with Libtayo in lung cancer, with the first patient expected to be dosed in the second half of this year, and referenced additional combinations and a preclinical pipeline in the Deep Cyclic Inhibitor category.

Zeskind also stated that a U.S. composition-of-matter patent for atebimetinib was granted “this summer,” and he cited exclusivity “into at least 2042,” potentially extending to 2044 with extensions.

About Immuneering (NASDAQ:IMRX)

Immuneering (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company leveraging artificial intelligence and its proprietary RABIT (Repurposing and Accelerating Biotechnology Tools) platform to design and optimize small-molecule and peptide therapies. By analyzing large-scale biomedical datasets, Immuneering’s machine learning algorithms identify novel drug–target interactions, repurpose existing drug scaffolds and accelerate lead candidate selection. The company’s AI-driven approach aims to reduce development timelines and improve therapeutic profiles in areas of high unmet medical need.

The company’s lead program, IRX-2, is a small-molecule candidate currently in Phase 2 clinical trials for the treatment of painful diabetic peripheral neuropathy.

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