Atebimetinib nearly doubles 1-year survival in pancreatic cancer study
Over 60% of patients still alive one year into trial testing add-on therapy
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After a year of treatment with the experimental medication atebimetinib as an add-on to chemotherapy, about two-thirds of pancreatic cancer patients in an ongoing study are still alive — nearly twice as many as would be expected to live this long with standard-of-care chemo alone.
That’s according to an update from atebimetinib’s developer Immuneering, which is sponsoring the interventional study.
“We are thrilled to report 64% overall survival at 12 months in first-line pancreatic cancer patients treated with atebimetinib in combination with [chemotherapy],” Ben Zeskind, PhD, CEO of Immuneering, said in a company press release announcing what the developer called “exceptional” overall survival rates.
The new data come from 34 people with pancreatic ductal adenocarcinoma, or PDAC, the most common form of pancreatic cancer. All were treated with atebimetinib as part of the Phase 2a study (NCT05585320), which is testing the therapy candidate in individuals with various types of solid tumors.
These patients had not received any previous treatment. All were given atebimetinib in combination with a modified regimen of gemcitabine/nab-paclitaxel (GnP), a standard first-line chemotherapy combo for PDAC.
In the original trial that supported approval of the GnP chemo combo, about 67% of all patients were alive after six months; 47% were alive at nine months, and 35% were alive after one year. Among the PDAC patients given atebimetinib, survival rates have been markedly better: 94% were alive at six months, 83% at nine months, and 64% at one year.
“The consistently strong separation observed between the overall survival in our clinical trial of atebimetinib in combination with [modified] GnP in first-line pancreatic cancer patients and the benchmark for standard of care GnP … has now held at [six] months, [nine] months, and 12 months,” Zeskind said.
Better outcomes seen with atebimetinib vs. standard treatment
Additionally, patients given atebimetinib are showing better outcomes than standard-of-care benchmarks in other measures, such as time to disease progression and overall response rates. The experimental therapy is also showing an acceptable safety profile, according to Immuneering. The only common serious safety issues reported in patients given atebimetinib have been low blood cell counts, which is a well-established side effect of GnP chemotherapy.
“Based on the exceptional data from the ongoing Phase 2a clinical trial of atebimetinib in combination with mGnP in first-line pancreatic cancer, we believe atebimetinib has the potential to deliver extraordinary overall survival with both durability and tolerability, two patient-centered essentials that oncologists have long struggled to balance,” said Igor Matushansky, Immuneering’s chief medical officer.
In the first half of this year, Immuneering expects to provide further data on a wider group of patients — more than 50 first-line pancreatic cancer patients, Matushansky noted. Added to these data, those results will involve “additional patients we previously announced we planned to enroll, who are approaching sufficient median follow up time for presentation,” the executive noted.
“We are excited to see that overall survival in the expanded cohort is trending consistently with what we have reported in the original 34 patients,” Matushansky said.
Based on the exceptional data from the ongoing Phase 2a clinical trial of atebimetinib in combination with [chemotherapy] in first-line pancreatic cancer, we believe atebimetinib has the potential to deliver extraordinary overall survival with both durability and tolerability, two patient-centered essentials that oncologists have long struggled to balance.
Immuneering has also announced plans for a Phase 3 trial to further test atebimetinib in people with pancreatic cancer. That study, dubbed MAPKeeper 301, is expected to start this year. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both recently okayed the trial’s design.
“Having recently reached alignment on our planned pivotal Phase 3 clinical trial design with the FDA and EMA, with overall survival as our primary endpoint, we plan to dose the first patient in our MAPKeeper 301 pivotal trial in mid-2026, as we move to bring this new treatment option to patients as expeditiously as possible,” Zeskind said.
