Atebimetinib shows potential for advanced pancreatic cancer: Trial
Most patients given first-line treatment alive, progression-free after 6 months
Most people with advanced pancreatic cancer who received first-line treatment with atebimetinib were alive and free from disease progression six months after starting treatment, according to new data from a Phase 2 clinical trial.
Among 34 evaluable patients who were given atebimetinib in addition to chemotherapy, 94% were alive and 72% were free from disease progression at six months. Historical data indicate 67% of pancreatic patients live for six months and more than half experience disease progression in that time with standard of care first-line treatment, according to Immuneering, the company developing atebimetinib and sponsoring the trial.
“These exceptional data demonstrate the potential of atebimetinib plus [chemotherapy] to dramatically extend the lives of patients with advanced pancreatic cancer,” Ben Zeskind, PhD, co-founder and CEO of Immuneering, said in a company press release. “94% overall survival at 6 months is remarkable in first-line pancreatic cancer patients.”
Zeskind added that “Atebimetinib was designed to deliver exceptional durability and tolerability to a broad range of patients with different cancers, and it is deeply gratifying to see evidence of that playing out first in one of the most aggressive and deadly types of cancer. Our ultimate goal is to help cancer patients outlive their disease, and today’s announcement represents an important milestone on that journey.”
Most patients had stable disease, reduced tumor burden
Atebimetinib, also known as IMM-1-104, is a daily oral medication designed to block the activity of MEK, a protein that’s involved in molecular signaling pathways that drive tumor cell growth in most pancreatic cancers. A Phase 1/2a clinical trial (NCT05585320) is testing the therapy, on its own and in combination with other treatments, in a variety of advanced solid tumor types.
The new data come from patients with pancreatic cancer who received first-line treatment with atebimetinib in addition to mGnP, a chemotherapy regimen that uses the drugs gemcitabine and nab-paclitaxel, which is sold as Abraxane and generics. In addition to high survival rates, data from 36 evaluable patients showed a disease control rate of 81% and an overall response rate of 39%. In other words, most patients had stable disease or experienced a reduction in tumor burden.
“Current standard of care therapies in pancreatic cancer can be associated with limited durability and severe side effects, leading to poor patient outcomes,” said Vincent Chung, MD, a principal investigator of the trial and professor at City of Hope, a research and treatment organization. “We have not seen significant improvement in standard of care for decades, and there is an urgent need for more durable and better tolerated new treatments that help patients live longer.”
Chung added “the encouraging clinical data reported thus far for atebimetinib (IMM-1-104) represent a potential new and significantly more durable treatment option for pancreatic cancer patients, for whom limited therapeutic options are currently available.”
Number of patients treated with atebimetinib to expand
Safety data from the study suggest atebimetinib’s safety profile is overall favorable, according to Immuneering. The company noted few serious safety issues that are associated with chemotherapy have been reported.
Based on the favorable data thus far, Immuneering is expanding the number of first-line pancreatic cancer patients who will be treated with atebimetinib plus mGnP in the trial to 50. Recruitment in the study is ongoing at several sites across the U.S.
These data clearly establish atebimetinib’s potential as a more durable and better tolerated MEK inhibitor positioned to help patients both live longer and live better, with exciting potential opportunities in pancreatic cancer and a variety of other cancers.
The company also plans to get feedback from regulators for a larger, pivotal study expected to begin next year. It will test atebemetinib with mGnP as a first-line treatment for pancreatic cancer, along with starting additional clinical trial arms testing the drug in other combinations. A pivotal study is normally used to provide the evidence needed for a regulatory approval.
“These data clearly establish atebimetinib’s potential as a more durable and better tolerated MEK inhibitor positioned to help patients both live longer and live better, with exciting potential opportunities in pancreatic cancer and a variety of other cancers,” said Igor Matushansky, MD, PhD, chief medical officer of Immuneering. “We look forward to advancing atebimetinib to a pivotal trial as rapidly as possible.”
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