Company: IMRX
Filing Date: 2025-11-12
Form Type: 10-Q
Source: 0001790340-25-000135
Chunk: 368

Company: Immuneering Corp
Filing Date: 2025-11-12
Form: 10-Q
Item: Part I, Item 1
Chunk 368
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cribed below) suggest a ~47% OS and ~29% PFS at nine months. 

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Table of Contents

As of the Cutoff Date, the median OS of the 320 mg ITT Population had not been reached and the median PFS was 9.6 months. Also as of the Cutoff Date, 94% OS and 70% PFS were observed in the 320 mg ITT Population at six months. The standard of care reported a 67% OS and 44% PFS at six months. All data reported by us were from the same patient cohort (N=34) as we previously reported in June 2025. 

The estimates of standard of care set forth above with respect to the nine-month follow-up data as of the Cutoff Date were extrapolated and reconstructed by us based on the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel (the "MPACT Trial"). The references to standard of care set forth above with respect to the six-month follow-up data as of the Cutoff Date were reported out directly from the MPACT  trial. Our 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.

We also announced that, as of the Cutoff Date, atebimetinib in combination with mGnP continued to be generally well tolerated. As of the Cutoff Date, Grade ≥ 3 treatment-emergent adverse events ("TEAEs") observed in 10% or greater of patients in the 320 mg ITT Population consisted of Anemia (eight patients or 24%) and Neutropenia (six patients or 18%). Grade ≥ 3 TEAEs observed in less than 10% of patients in the 320 mg ITT Population included Fatigue (6%), Vomiting (3%), Febrile Neutropenia (3%), Hypokalemia (3%) and Nausea (3%). No Grade 5 TEAEs were observed in this patient population and no new safety signals were identified.

We expect regulatory feedback on our pivotal Phase 3 clinical trial plans for atebimetinib in combination with mGnP in first-line pancreatic cancer patients in the fourth quarter of 2025. We also expect to provide further updated survival data in the first half of 2026 from first-line pancreatic cancer patients treated