Pancreatic cancer treatment atebimetinib set for Phase 3 trial
Immuneering plans 2026 start for trial after FDA, EMA agree on design
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Immuneering is preparing to launch a Phase 3 clinical trial to test its experimental therapy, atebimetinib, in people with pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer.
The company recently received positive feedback from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with both agencies agreeing on key aspects of the Phase 3 study’s design.
“We are very pleased with our interactions with both the FDA and EMA, which we believe speaks to the compelling data we have generated to date in first-line pancreatic cancer, as well as the strength and simplicity of our proposed Phase 3 trial for atebimetinib,” Ben Zeskind, PhD, co-founder and CEO of Immuneering, said in a company press release.
The global trial, dubbed MAPKeeper 301, is expected to enroll 510 people with metastatic PDAC, meaning the cancer has spread outside the pancreas to other parts of the body. To be eligible, patients must not have received any prior cancer therapies. Zeskind said the large number of patients to be included in the trial “gives more first-line pancreatic cancer patients the opportunity to participate, and further increases statistical robustness.”
All participants in the Phase 3 trial will receive a combination of two chemotherapy drugs, gemcitabine and nab-paclitaxel, that are part of the current standard care for PDAC. Some patients will get standard chemo treatment, while others will receive a modified chemo regimen alongside treatment with atebimetinib.
Company eyes mid-year start for trial
The study’s main goal is to demonstrate that the atebimetinib regimen leads to improved overall survival, with secondary goals including impact on disease progression and quality of life measurements. Zeskind said feedback from the FDA and EMA “supports our trial design and key primary endpoint of overall survival.”
Immuneering plans to start enrolling participants in the trial in mid-2026. The company said it expects results to be available in 2028, noting it has sufficient assets on hand to fund operations through 2029.
“We are confident that our team is well-positioned to begin dosing patients in this global registrational trial in mid-2026,” Zeskind said.
Atebimetinib is an oral therapy designed to block the activity of MEK, a signaling protein that contributes to abnormal cell growth in many PDAC tumors. An ongoing Phase 2a clinical trial (NCT05585320) is testing the therapy in people with multiple types of advanced and metastatic solid tumors.
Data from 34 PDAC patients in the Phase 2a study showed that, in patients given atebimetinib combined with chemotherapy, 94% were still alive and 70% were free from disease progression after six months. After nine months, 86% were still alive, with more than half (53%) remaining free of disease progression. Safety data were generally in line with what’s expected for patients undergoing chemotherapy.
“New therapies for pancreatic cancer are urgently needed,” said Eileen M. O’Reilly, MD, an oncologist at Memorial Sloan Kettering Cancer Center. “The phase IIa data of atebimetinib and chemotherapy shows a promising signal. I am excited to see this combination move forward to a randomized phase III evaluation.”
Zeskind said Immuneering will “provide an update on overall survival in the Phase 2a trial in the coming weeks.”
