Immuneering is set to progress its lead oncology candidate, atebimetinib, to the next stage of clinical development in both first-line pancreatic and non-small cell lung cancer (NSCLC).
In conversation with Clinical Trials Arena, Immuneering’s CEO, Ben Zeskind highlighted the company’s plans to dose the first patient in its Phase II NSCLC combination trial in H2 2026. This study will evaluate the potential of atebimetinib alongside Regeneron’s programmed death ligand 1 (PD-1) blocker Libtayo (cempilimab) in the first line setting.
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Alongside its progress in lung cancer, Immuneering has taken further steps towards atebimetinib’s use in pancreatic cancer, as the biotech is looking to initiate a Phase III study in the indication.
The trial, which is anticipated to begin dosing in mid-2026, will evaluate the potential of atebimetinib alongside modified gemcitabine plus nab-paclitaxel (mGnP) in frontline pancreatic cancer – with a topline readout expected in 2028.
Initiation of this Phase III study will follow a second topline readout from the Phase II on atebimetinib plus mGnP in pancreatic cancer, which Immuneering intends to share on 7 January, 2026.
This will build on the first OS readout for this trial from September 2025, which saw the combination trigger a nine-month OS rate of 86%, while 47% of patients treated with standard of care (SoC) GnP alone remained alive at nine months.
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By GlobalDataThe Phase III study will use overall survival (OS) as its only primary endpoint, which Zeskind previously called the “ultimate goal” in oncology.
Taking a new approach to cancer treatment
Over the past decade, there have been a plethora of treatment advances that have changed the trajectory of the oncology treatment landscape, with targeted therapies offering significant boosts to patient survival rates and quality of life (QoL).
While this is true for many oncological indications, it is not the case for pancreatic cancer, which Igor Matushansky, CMO at Immuneering noted was one of the “top cancers where the least progress has been made treatment-wise”.
This is evidenced by the indication’s continued reliance on highly toxic chemotherapy regimens, which still make up the backbone of the treatment paradigm for pancreatic cancer.
This has led companies like Immuneering to explore the potential of more tolerable, targeted and effective treatment options – which led to the creation of atebimetinib.
The therapy, which acts through the MAPK pathway, takes a different approach to other treatments in this drug class, as it works through deep cyclic inhibition.
Through this mechanism, atebimetinib facilitates the brief shutdown of the MAPK pathway through short-lived mitogen-activated protein kinase (MEK) inhibition – which is made possible through the drug’s short half-life.
With consistent daily treatment, Zeskind notes that atebimetinib can “throw the tumour off balance,” as you can target a key growth pathway used by pancreatic cancer cells without allowing it to adapt and work around the signal.
According to Zeskind, this also improves the tolerability of the therapy, as it allows healthy cells to recover and utilise the MAPK pathway, which is an essential component of cellular signalling.
Through its favourable tolerability, Immuneering theorises that atebimetinib can allow patients to receive treatment over a prolonged period, which could see the tumour shrink “slowly but steadily over a long period of time.”
In clinical trials, Matushansky noted that, while atebimetinib does not erase the side effects of chemotherapy, its use alongside GnP allows patients to tolerate the therapy for longer than they would have.
Through the combination of targeted and chemotherapies in pancreatic cancer, both Zeskind and Matushansky see a brighter future for patients with the disease.
