Immuneering announces data from trial of atebimetinib combination

Immuneering (IMRX) announced 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 nine months median follow up. Atebimetinib + mGnP demonstrated remarkable overall survival and progression-free survival at nine months median follow up in first-line pancreatic cancer patients. The MPACT pivotal trial for the standard of care, gemcitabine/nab-paclitaxel, reported significantly lower OS and PFS at nine months. OS observed at nine 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 nine months. As previously reported, OS observed at six months was 94% in patients receiving atebimetinib + mGnP. The standard of care reported a 67% OS at six months. PFS observed at nine months was 53% in patients receiving atebimetinib + mGnP. The standard of care reported a 29% PFS at nine months. PFS observed at six months was 70% in patients receiving atebimetinib + mGnP. The standard of care reported a 44% PFS at six months. Unless otherwise specified, all data are reported using a data cutoff date of August 26 from the same patient cohort as previously reported in June. The estimates of 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 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 updated survival data reflect the potential for a durable, compounding benefit with atebimetinib + mGnP. As of the data cutoff date, Atebimetinib + mGnP continued to demonstrate a favorable tolerability profile in first-line pancreatic cancer patients, with only two categories of adverse events observed at the Grade 3 level in more than 10% of patients. No new safety signals were identified.