Atebimetinib yields ‘extraordinary’ results in pancreatic cancer trial
86% survival rate vs. 47% with standard chemo alone at 9 months
An experimental cancer therapy known as atebimetinib is delivering “extraordinary” results for patients with pancreatic cancer.
New data from an ongoing Phase 2a clinical trial shows that 86% of patients who received the first-line treatment are still alive nine months later — a higher survival rate than the 47% expected from standard chemotherapy alone, according to the therapy’s developer and trial sponsor, Immuneering, in a company press release.
Immuneering is now hailing the treatment as a potential game-changer for one of the most challenging cancers.
“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,” said Ben Zeskind, PhD, CEO of Immuneering.
Next steps in development
Immuneering plans to meet with regulators later this year to discuss the results. Pending regulatory feedback, the company hopes to launch a Phase 3 trial to further test atebimetinib in first-line cancer patients and to gather enough data to support applications seeking approval of the therapy. The trial could start dosing by mid-2026.
Atebimetinib is designed to block the activity of MEK, a signaling protein that helps to drive abnormal cell growth in most pancreatic tumors. The therapy is a Deep Cyclic Inhibitor (DCI) that, according to the company, takes a different approach to cancer treatment. Unlike other therapies that block cancer continuously, often leading to quick but short-lived responses and several side effects, DCIs work in pulses. By acting faster than tumors can adapt, they seek to shrink cancer more gradually but with longer-lasting results. At the same time, this approach is designed to let healthy cells function more normally, potentially reducing side effects.
The Phase 2a clinical trial (NCT05585320) is testing various regimens using the daily oral therapy in different types of advanced solid tumors.
A few months ago, Immuneering reported survival data from 34 people with pancreatic cancer who were given first-line treatment with atebimetinib in addition to the standard-of-care chemotherapy regimen known as mGnP (modified gemcitabine/nab-paclitaxel). At six months, 94% of patients were still alive, and 70% were free from disease progression.
Now, the company reports that 86% of the patients are still alive at nine months, and 53% are free of disease progression. The expected nine-month survival rate with chemotherapy alone is about 47%, and the expected rate of patients free from disease progression is less than 30%, the company noted.
“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,” Zeskind said.
Favorable safety profile
Atebimetinib has so far shown a favorable safety profile in first-line pancreatic cancer patients. Two types of serious side effects have been commonly observed. Both are related to low blood cell counts and are commonly seen in patients given chemotherapy.
“To combine such meaningful overall survival with such favorable tolerability has the potential to be truly game-changing for first-line pancreatic cancer patients,” Zeskind said.
Vincent Chung, MD, a member of Immuneering’s scientific advisory board and principal investigator of the Phase 2a clinical trial, said the survival and tolerability data are “remarkable.”
“Pancreatic cancer remains one of the most challenging cancers we face in the clinic with far too few treatment options available to patients and survival rates that have remained unacceptably low for decades. I have seen firsthand in my own patients the benefits of atebimetinib’s durability and tolerability,” Chung said.
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