Immuneering Corporation (IMRX), a late-stage clinical oncology company, on Monday reported efficacy results of the Phase 2a trial evaluating Atebimetinib in combination with modified gemcitabine nab paclitaxel (mGnP) in treating first-line metastatic pancreatic ductal carcinoma (PCAD). Data was presented at the 2026 annual meeting of the American Society for Clinical Oncology (ASCO).
Following the announcement, shares fell over 22% on Monday.
Atebimetinib is a Deep Cyclic inhibitor of MEK, a pathway that controls cellular proliferation and mutations in tumor cells. Currently available inhibitors of such pathways offer temporary benefits, as tumors acquire new mutations in the MAPK pathway. The drug acts by mitigating selective pressure that drives these resistance mechanisms, thus providing more durable anti-tumor activity.
The open-label, single-arm Phase 2a trial yielded encouraging results in the expanded cohort of 55 patients. Patients were administered a 320 mg daily dose of atebimetinib in combination with mGnP, and demonstrated a median overall survival (OS) of 17.3 months, more than twice the median OS of 8.5 months observed in patients on mGnP alone. The participants also showed a median progression-free survival (PFS) of 8.3 months, a disease control rate (DCR) of 82%, and an objective response rate (ORR) of 36%.
The safety profile of the drug was manageable, as primarily two Grade 3 adverse events were recorded in about 10% of participants. Moreover, 84% of patients maintained or even gained weight during the therapy, indicating that it was well-tolerated.
The company is actively recruiting for the global, randomized, pivotal Phase 3 MAPKeeper 301 trial, which will assess the atebimetinib and mGnP combination versus the standard-of-care mGnP treatment using OS as the primary endpoint. The first patient is expected to be dosed in mid-2026, with topline data anticipated in mid-2028.
Additionally, a Phase 2 trial for atebimetinib in combination with anti-PD-1 cemiplimab for the treatment of non-small cell lung cancer (NSCLC) is planned for initiation in the second half of this year. Preclinical data validating the same is expected in the fourth quarter of 2026, and Phase 2 preliminary data planned for late 2027.
IMRX closed Monday at $4.49, down 22.10%. In the premarket, shares are trading at $4.59, up 2.11%.
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