Immuneering Announces Extraordinary 86% Overall Survival at 9 Months in First-Line Pancreatic Cancer Patients Treated with Atebimetinib + mGnP
Immuneering (Nasdaq: IMRX) reported exceptional clinical trial results for atebimetinib combined with mGnP in first-line pancreatic cancer treatment. The Phase 2a trial (N=34) demonstrated remarkable 86% overall survival (OS) at 9 months, significantly outperforming the standard of care benchmark of ~47%. The study also showed 53% progression-free survival (PFS) at 9 months, compared to the standard ~29%.
The drug maintained a favorable tolerability profile, with only two Grade 3 adverse events occurring in more than 10% of patients. Atebimetinib, a Deep Cyclic Inhibitor targeting MEK, represents a novel approach in targeted therapy by pulsing faster than tumors can adapt. The company expects regulatory feedback on pivotal trial plans in Q4 2025 and aims to initiate a Phase 3 trial by year-end.
Immuneering (Nasdaq: IMRX) ha riportato risultati clinici eccezionali per atebimetinib combinato con mGnP nel trattamento della pancreatite in prima linea. Il trial di fase 2a (N=34) ha mostrato un OS globale all’9° mese dell’86%, superando di gran lunga il benchmark standard di circa 47%. Inoltre lo studio ha evidenziato un PFS all’9° mese del 53%, rispetto al ~29% tipico. Il farmaco ha mantenuto un profilo di tollerabilità favorevole, con solo due eventi avversi di grado 3 verificatisi in oltre il 10% dei pazienti. Atebimetinib, un Inibitore Ciclico Profondo (Deep Cyclic Inhibitor) mirato al MEK, rappresenta un approccio innovativo nella terapia mirata pulsando più rapidamente di quanto i tumori possano adattarsi. L’azienda prevede feedback regolatori sui piani dei trial pivotal nel Q4 2025 e intende avviare uno studio di fase 3 entro la fine dell’anno.
Immuneering (Nasdaq: IMRX) informó resultados clínicos excepcionales para atebimetinib combinado con mGnP en el tratamiento de primera línea del cáncer de páncreas. El ensayo de fase 2a (N=34) mostró un OS global del 86% a los 9 meses, superando significativamente el umbral estándar de ~47%. El estudio también mostró un PFS del 53% a los 9 meses, frente al ~29% habitual.
El fármaco mantuvo un perfil de tolerabilidad favorable, con solo dos eventos adversos de grado 3 observados en más del 10% de los pacientes. Atebimetinib, un Inhibidor Cicloopico Profundo (Deep Cyclic Inhibitor) dirigido al MEK, representa un enfoque novedoso en la terapia dirigida al pulsar más rápido de lo que los tumores pueden adaptarse. La empresa espera comentarios regulatorios sobre los planes de ensayos pivotal en el Q4 de 2025 y pretende iniciar un ensayo de fase 3 para finales de año.
Immuneering (Nasdaq: IMRX)은 1차 치료에서의 췌장암 치료에 atebimetinib과 mGnP의 조합으로 exceptional한 임상 결과를 발표했습니다. 2a상(N=34)에서 9개월 OS가 86%로 나타나 표준 관리 벤치마크인 약 47%를 크게 상회했습니다. 연구는 또한 9개월 PFS가 53%로 나타났으며 표준 약 29%에 비해 높았습니다.
약물은 내약성 프로필이 우수했고, 10%를 초과하는 환자에서 3등급 이상 부작용은 두 건뿐이었습니다. MEK를 표적으로 하는 Deep Cyclic Inhibitor인 Atebimetinib은 종양이 적응하기보다 더 빠르게 맥박을 울리는 표적 치료의 새로운 접근을 나타냅니다. 회사는 2025년 4분기 규제 피드백을 기대하고 연말까지 3상 시험을 시작하는 것을 목표로 한다고 밝혔습니다.
Immuneering (Nasdaq: IMRX) a publié des résultats cliniques exceptionnels pour l’association atebimetinib + mGnP dans le traitement du cancer du pancréas en première ligne. L’essai de phase 2a (N=34) a démontré un OS global à 9 mois de 86%, dépassant largement le seuil standard d’environ 47%. L’étude a également montré un PFS à 9 mois de 53%, contre environ 29% habituel.
Le médicament a conservé un profil de tolérance favorable, avec seulement deux événements indésirables de grade 3 survenus chez plus de 10% des patients. Atebimetinib, un Inhibiteur Cyclique Profond (Deep Cyclic Inhibitor) ciblant MEK, représente une approche novatrice dans la thérapie ciblée en pulsant plus rapidement que les tumeurs ne peuvent s’adapter. L’entreprise attend des retours réglementaires sur les plans d’essais pivot au T4 2025 et vise à lancer un essai de phase 3 d’ici la fin de l’année.
Immuneering (Nasdaq: IMRX) meldete außergewöhnliche klinische Ergebnisse für Atebimetinib in Kombination mit mGnP in der Erstlinienbehandlung von Bauchspeicheldrüsenkrebs. Die Phase-2a-Studie (N=34) zeigte eine bemerkenswerte OS von 86% nach 9 Monaten, deutlich über dem Standard-Benchmark von ca. 47%. Die Studie zeigte auch PFS von 53% nach 9 Monaten, gegenüber dem Standard von ~29%.
Das Medikament zeigte ein günstiges Verträglichkeitsprofil, mit nur zwei grad-3-Unerwünschten Ereignissen bei mehr als 10% der Patienten. Atebimetinib, ein Deep Cyclic Inhibitor, der MEK zielgerichtet, repräsentiert einen neuartigen Ansatz in der zielgerichteten Therapie, indem er schneller „poniert“ als Tumore sich anpassen können. Das Unternehmen erwartet regulatorisches Feedback zu den Plänen für zentrale Studien im Q4 2025 und plant, bis Ende des Jahres eine Phase-3-Studie zu beginnen.
Immuneering (Nasdaq: IMRX) أبلغت عن نتائج سريرية استثنائية لعلاج Atebimetinib مقترنًا بـ mGnP في علاج سرطان البنكرياس في خط العلاج الأول. أظهر تجربة المرحلة 2a (N=34) زيادة ملحوظة في البقاء على قيد الحياة الإجمالي عند 9 أشهر بنسبة 86%، متفوقة بشكل كبير على العتبة القياسية البالغة ~47%. كما أظهرت الدراسة البقاء دون تقدم عند 9 أشهر بنسبة 53%، مقارنةً بـ ~29% القياسي.
المخدر حافظ على ملف تحمل مفضل، مع حدثين جانبيين من الدرجة 3 فقط حدثا لدى أكثر من 10% من المرضى. Atebimetinib، وهو مثبِّط دوري عميق يستهدف MEK، يمثل نهجًا جديدًا في العلاج الموجه من خلال النبض بسرعة أكبر من قدرة الأورام على التكيّف. تتوقع الشركة تعليقات تنظيمية على خطط التجارب المحورية في الربع الرابع من 2025 وتهدف لبدء تجربة المرحلة 3 بنهاية العام.
Immuneering (纳斯达克代码：IMRX) 报告了 Atebimetinib 结合 mGnP 在一线胰腺癌治疗中的卓越临床结果。Phase 2a 试验（N=34）显示 9 个月总体存活率为 86%，显著高于标准治疗基线约 47%。研究还显示 9 个月无进展生存率为 53%，高于标准约 29%。
该药物保持了良好的耐受性谱，超过 10% 的患者未出现两项 3 级不良事件。Atebimetinib 是一种面向 MEK 的 Deep Cyclic Inhibitor，代表一种新颖的靶向治疗方法，其节律性“脉动”速度快于肿瘤的适应速度。公司预计在 2025 年第四季度获得关于关键性试验计划的监管反馈，并计划在年底前启动 Phase 3 试验。
- Exceptional 86% overall survival at 9 months vs ~47% standard of care
- Strong 53% progression-free survival at 9 months vs ~29% standard of care
- Favorable tolerability profile with only two Grade 3 adverse events above 10%
- Median overall survival not yet reached as of data cutoff date
- Plans to initiate pivotal Phase 3 trial by end of 2025
- Regulatory feedback on pivotal trial plans still pending
- No direct head-to-head comparison with standard of care in the trial
- Phase 3 trial patient dosing won't begin until mid-2026
Insights
Immuneering's atebimetinib shows remarkably high survival rates in pancreatic cancer trial, potentially transformative if confirmed in Phase 3.
The reported 86% overall survival at 9 months for atebimetinib combined with modified gemcitabine/nab-paclitaxel (mGnP) is truly exceptional for pancreatic cancer treatment. To put this in perspective, standard treatment (gemcitabine/nab-paclitaxel) historically achieves only about 47% survival at this timepoint.
Similarly impressive is the 53% progression-free survival at 9 months, nearly double the ~29% benchmark for current standard care. These consistent survival advantages at both 6 and 9 month timepoints suggest a durable treatment effect rather than a statistical anomaly.
What's particularly noteworthy is the favorable tolerability profile. Only two Grade 3 adverse events occurred in >10% of patients (neutropenia and anemia) - both commonly associated with the chemotherapy component rather than atebimetinib itself. This suggests atebimetinib adds minimal toxicity burden while substantially improving efficacy.
The mechanism behind these results appears tied to atebimetinib's innovative Deep Cyclic Inhibitor approach - pulsatile rather than sustained MEK inhibition. This prevents cancer adaptation while minimizing toxicity by allowing healthy cells to maintain normal signaling between inhibition cycles.
While these results are undeniably promising, several important caveats exist: the patient sample is small (N=34), there's no direct head-to-head comparison with standard therapy, and the median follow-up is still relatively short at 9 months. The planned pivotal Phase 3 trial will be crucial for confirming these remarkable early signals in a larger population.
If these results hold in the pivotal trial slated to begin enrollment by mid-2026, atebimetinib could represent one of the most significant advances in pancreatic cancer treatment in decades - a disease that has seen frustratingly little progress despite intensive research efforts.
Extraordinary pancreatic cancer survival data positions Immuneering's atebimetinib as potential blockbuster with near-term regulatory catalysts.
Immuneering's data release represents a potential breakthrough in pancreatic cancer treatment with significant market implications. The 86% overall survival at 9 months substantially outperforms current standard-of-care therapies in a notoriously treatment-resistant cancer with limited therapeutic options.
Most compelling is the growing survival advantage between the 6-month and 9-month timepoints. While standard care shows a steep decline from 67% to 47% survival, atebimetinib combination therapy maintains a much higher plateau (94% to 86%), suggesting the treatment effect may be compounding over time rather than diminishing.
The favorable safety profile further strengthens atebimetinib's value proposition. The observed Grade 3 adverse events (neutropenia, anemia) are typical chemotherapy effects, suggesting atebimetinib itself contributes minimal additional toxicity - critical for maintaining quality of life and treatment compliance in cancer patients.
From a regulatory pathway perspective, the company has positioned itself well for accelerated development, with pivotal trial feedback expected in Q4 2025 and patient dosing targeted by mid-2026. Given the substantial survival advantage in a high-mortality indication, there's meaningful potential for breakthrough designation or accelerated approval pathways.
The expansion into non-small cell lung cancer trials planned for 2026 indicates the company recognizes atebimetinib's potential beyond pancreatic cancer, suggesting a strategy to build a broader MEK inhibitor franchise targeting MAPK pathway alterations across multiple tumor types.
While these results are promising, key questions remain about the durability of response beyond 9 months, performance in larger patient populations, and confirmatory trial design that regulators will ultimately accept. The relatively small patient cohort (N=34) and lack of randomized control arm are limitations that will need addressing in the pivotal program.
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- Company expects regulatory feedback on pivotal trial plans in Q4 2025 and, subject to that feedback, expects to initiate pivotal trial by the end of 2025 and begin dosing patients by mid-2026 -
NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34), with 9 months median follow up. The data, to be presented at the Pancreatic Cancer Action Network (PanCAN) Scientific Summit 2025, marks a milestone for the Company in the treatment of one of the deadliest and most treatment-resistant solid tumors. The Company also announced it will not be hosting its previously scheduled conference call.
“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. We are beyond thrilled to report that not only was our extraordinary
Extraordinary and Growing Survival Advantage Observed
Atebimetinib (320mg dosed once-daily) + mGnP demonstrated remarkable overall survival (OS) and progression-free survival (PFS) at 9 months median follow up in first-line pancreatic cancer patients (N=34). The MPACT pivotal trial for the standard of care, gemcitabine/nab-paclitaxel, reported significantly lower OS and PFS at 9 months.
- OS observed at 9 months was
86% in patients receiving atebimetinib + mGnP. The median OS was not yet reached as of the data cutoff date. The standard of care reported a ~47% OS at 9 months.- As previously reported, OS observed at 6 months was
94% in patients receiving atebimetinib + mGnP. The standard of care reported a67% OS at 6 months.
- As previously reported, OS observed at 6 months was
- PFS observed at 9 months was
53% in patients receiving atebimetinib + mGnP. The standard of care reported a ~29% PFS at 9 months.- PFS observed at 6 months was
70% in patients receiving atebimetinib + mGnP. The standard of care reported a ~44% PFS at 6 months.
- PFS observed at 6 months was
- Unless otherwise specified, all data are reported using a data cutoff date of August 26, 2025, from the same patient cohort (N=34) as previously reported in June 2025. The estimates of (and other references to) standard of care with respect to the nine-month follow-up data were extrapolated and reconstructed by the Company based on the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The estimates of (and other references to) standard of care set forth above with respect to the six-month follow-up data were reported out directly from the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The Company’s Phase 1/2a clinical trial of atebimetinib does not include a head-to-head comparison against any other agents, and caution should be exercised when comparing data across trials.
The Company believes these compelling updated survival data reflect the potential for a durable, compounding benefit with atebimetinib + mGnP.
Favorable Tolerability Profile Observed:
- As of the data cutoff date, Atebimetinib (320mg dosed once-daily) + mGnP continued to demonstrate a favorable tolerability profile in first-line pancreatic cancer patients (N=34), with only two categories of adverse events observed at the Grade 3 level in more than
10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy). No new safety signals were identified.
How Did Atebimetinib Achieve Such Extraordinary Survival?
Atebimetinib is a Deep Cyclic Inhibitor: A New Paradigm in Targeted Therapy
- Immuneering’s proprietary Deep Cyclic Inhibitors (DCIs) challenge the conventional model of sustained or continuous inhibition in oncology.
- Most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily.
- Deep Cyclic Inhibitors are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably.
- Sustained inhibition also causes suppressed transient signaling in healthy cells, leading to many adverse events.
- Deep Cyclic Inhibitors aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events.
Atebimetinib Targets MEK: A Broader, Potentially More Durable Approach
- MEK is a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately
97% of pancreatic cancers. - Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit.
“Deep Cyclic Inhibitors like atebimetinib represent a fundamental shift in targeted therapy, away from continuous inhibition and toward pulsatile modulation of key oncogenic pathways,” said Brett Hall, Ph.D., Chief Scientific Officer at Immuneering. “This approach has the potential to deliver both durability and tolerability, two patient-centered essentials oncology has long struggled to balance.”
“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,” said Vincent Chung, M.D., F.A.C.P., Professor, Department of Medical Oncology and Therapeutics Research at City of Hope, principal investigator of the Phase 2a clinical trial and a paid member of the company’s scientific advisory board. “I have seen firsthand in my own patients the benefits of atebimetinib’s durability and tolerability. The remarkable overall survival, progression-free survival, and tolerability data we are seeing with atebimetinib + mGnP in first-line pancreatic cancer patients, now out to 9 months of median follow up, represent an important step towards creating urgently needed new options for these patients. We are also planning a confirmatory study.”
Near-Term Milestone Expectations
Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including:
- Regulatory feedback on pivotal trial plans in Q4 2025
- Announcing further updated OS and PFS data from first-line pancreatic cancer patients (N=34) treated with atebimetinib + mGnP, including at a scientific conference in 2026
- Pending regulatory feedback, initiating a pivotal Phase 3 trial of atebimetinib in combination with mGnP in first-line pancreatic cancer by the end of 2025, and dosing the first patient by mid-2026
- Initiating additional atebimetinib clinical trial combination arms in 2026, including in non-small cell lung cancer
About Immuneering
Immuneering is a clinical-stage oncology company focused on keeping cancer patients alive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com.
Forward-Looking Statements
This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of Deep Cyclic Inhibitors, including atebimetinib, alone or in combination with other agents, including modified Gemcitabine/nab-paclitaxel (mGnP), as well as the extraordinary and growing survival advantage observed and potential for a durable, compounding benefit from pulsatile modulation of signaling pathways; the timing of regulatory feedback, initiation of a pivotal trial and related patient dosing; the ability of targeting MEK to deliver a more durable benefit; the timing and content of future data releases and presentations; and the timing for the initiation of additional atebimetinib clinical trial combination arms, including in non-small cell lung cancer.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports.
These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Media Contact:
Carson Creehan
817-412-1096
carson.creehan@padillaco.com
Investor Contact:
Laurence Watts
619-916-7620
laurence@newstreetir.com
Figures accompanying this announcement are available at:
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https://www.globenewswire.com/NewsRoom/AttachmentNg/168aba3d-8079-49a8-9959-cfe8c9ec6dae
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