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Immuneering Announces Updated Survival And Safety Data From Its Ongoing Phase 2a Trial Of Atebimetinib In Combination With Modified Gemcitabine/Nab-Paclitaxel In First-line Pancreatic Cancer Patients, With 9 Months Median Follow Up; 86% Overall Survival Observed At 9 Months; Co. Expects Regulatory Feedback On Pivotal Trial Plans In Q4 2025 And, Subject To That Feedback, Expects To Initiate Pivotal Trial By The End Of 2025 And Begin Dosing Patients By Mid-2026

Author: Benzinga Newsdesk | September 24, 2025 03:04pm

NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (NASDAQ:IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34), with 9 months median follow up. The data, to be presented at the Pancreatic Cancer Action Network (PanCAN) Scientific Summit 2025, marks a milestone for the Company in the treatment of one of the deadliest and most treatment-resistant solid tumors. The Company also announced it will not be hosting its previously scheduled conference call.

"Overall survival is the gold standard in oncology and has been Immuneering's goal from the very beginning. In cancer nothing matters more than keeping patients alive and helping them thrive. We are beyond thrilled to report that not only was our extraordinary 94% overall survival at 6 months sustained with additional follow up time, but that our observed 9-month overall survival of 86% shows an even larger gap with standard of care benchmarks," said Ben Zeskind, Ph.D., CEO of Immuneering. "To combine such meaningful overall survival with such favorable tolerability has the potential to be truly game-changing for first-line pancreatic cancer patients."

Extraordinary and Growing Survival Advantage Observed

Atebimetinib (320mg dosed once-daily) + mGnP demonstrated remarkable overall survival (OS) and progression-free survival (PFS) at 9 months median follow up in first-line pancreatic cancer patients (N=34). The MPACT pivotal trial for the standard of care, gemcitabine/nab-paclitaxel, reported significantly lower OS and PFS at 9 months.

  • OS observed at 9 months was 86% in patients receiving atebimetinib + mGnP. The median OS was not yet reached as of the data cutoff date. The standard of care reported a ~47% OS at 9 months.
    • As previously reported, OS observed at 6 months was 94% in patients receiving atebimetinib + mGnP. The standard of care reported a 67% OS at 6 months.
  • PFS observed at 9 months was 53% in patients receiving atebimetinib + mGnP. The standard of care reported a ~29% PFS at 9 months.
    • PFS observed at 6 months was 70% in patients receiving atebimetinib + mGnP. The standard of care reported a ~44% PFS at 6 months.
  • Unless otherwise specified, all data are reported using a data cutoff date of August 26, 2025, from the same patient cohort (N=34) as previously reported in June 2025. The estimates of (and other references to) standard of care with respect to the nine-month follow-up data were extrapolated and reconstructed by the Company based on the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The estimates of (and other references to) standard of care set forth above with respect to the six-month follow-up data were reported out directly from the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The Company's Phase 1/2a clinical trial of atebimetinib does not include a head-to-head comparison against any other agents, and caution should be exercised when comparing data across trials.



     

The Company believes these compelling updated survival data reflect the potential for a durable, compounding benefit with atebimetinib + mGnP.

Posted In: IMRX

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