Immuneering Corporation announced on June 17, 2025, positive data from its ongoing Phase 2a clinical trial evaluating atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients. The data showed an exceptional 94% overall survival (OS) and 72% progression-free survival (PFS) observed at six months in the intent-to-treat population of 34 patients.
Neither median OS nor median PFS had been reached at the time of the data cutoff, indicating strong early efficacy signals. For comparison, the historic benchmark for standard of care gemcitabine/nab-paclitaxel (GnP) showed a 6-month OS of 67%. The trial also demonstrated a 39% overall response rate (ORR) and an 81% disease control rate (DCR) in 36 response-evaluable patients.
Atebimetinib in combination with mGnP exhibited a markedly favorable tolerability profile, with Grade 3 treatment-emergent adverse events limited to Anemia (18%) and Neutropenia (15%), and no Grade 5 TEAEs reported. Based on these results, Immuneering plans to initiate a pivotal trial of atebimetinib in combination with mGnP in first-line pancreatic cancer patients in 2026, with regulatory feedback on registrational trial plans expected in Q4 2025.
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