atebimetinib (IMM-1-104) / Immuneering - LARVOL DELTA

Trial In Progress- MAPKeeper-301: A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination with the Modified Gemcitabine and nab-Paclitaxel Regimen Versus Standard Gemcitabine and nab-Paclitaxel for Treatment of Patients with Metastatic Pancreatic Ductal Adenocarcinoma (ESMO 2026) - No abstract available

Clinical • Combination therapy • Metastases • P3 data • Oncology • Pancreatic Ductal Adenocarcinoma

Immuneering to Present at the ESMO Congress 2026 (GlobeNewswire) - "Trial in progress poster will highlight the ongoing Phase 3 MAPKeeper 301 trial of atebimetinib + mGnP in first-line pancreatic cancer patients."

Trial status • Pancreatic Ductal Adenocarcinoma

Results from a phase 2a study of atebimetinib in combination with mGnP in advanced or metastatic pancreatic cancer. (ASCO 2026) - P1/2 | "We report a Phase 2a cohort evaluating atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP) in the first-line treatment of advanced or metastatic PDAC (NCT05585320). Atebimetinib in combination with mGnP demonstrated favorable safety and promising efficacy compared to historic standard-of-care (SoC) GnP.1 A phase 3 registrational trial is planned to start in mid-2026 for evaluation of atebimetinib + mGnP versus SoC GnP. 1. Von Hoff DD, Ervin T, Arena FP, et al."

Combination therapy • Metastases • P2a data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Patient-aligned 3D tumor models identify biomarker-enriched atebimetinib (IMM-1-104) combination strategies in pancreatic ductal adenocarcinoma (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Preclinical • Oncology • Pancreatic Ductal Adenocarcinoma

Atebimetinib, a deep cyclic inhibitor of MEK, combined with chemotherapy: preclinical rationale for treatment of anaplastic thyroid cancer (ATC) (EORTC-NCI-AACR 2026) - "Abstract will be available as of 4 November (with consent of the author)"

Preclinical • Oncology • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma

MAPKeeper-301 Aims to Confirm the Efficacy of Atebimetinib in Metastatic Pancreatic Cancer (OncLive) - "'MEK inhibitors have been a treatment option available for managing solid tumor malignancies for quite a long time now...but atebimetinib is a next-generation MEK inhibitor, and the way it works, based on its half-life and how it inhibits the MAPK pathway, it inhibits it in almost a pulsatile fashion,' Ahn said in an interview with OncLive. 'Not only does it improve treatment tolerability by minimizing adverse effects, but also, based on the half-life, we think it does a better job of inhibiting the MAPK pathway as well.'"

Audio • Interview

Immuneering to Present at the AACR Conference on Pancreatic Cancer, Highlighting Atebimetinib’s Dual Mechanism for Extended Survival (The Manila Times) - "New analyses evaluate the overall survival implications of both preserving body mass and reducing tumor volume."

Clinical data • Pancreatic Cancer

Spotlighting the Efficacy and Safety of Atebimetinib-Based Therapy in Pancreatic Cancer (OncLive) - "Daniel H. Ahn, DO, spotlights the efficacy and safety of atebimetinib-based therapy in pancreatic cancer."

Video

The ongoing first-line treatment race for metastatic pancreatic ductal adenocarcinomas: will a tough disease lose its horror? (PubMed, Future Oncol) - "PDACs are K-RAS addicted (incidence >90%), however, RAS oncogenes have been regarded to be "undruggable." Several highly specific inhibitors have been developed with atebimetinib (MEK inhibitor), daraxonrasib (tri-complex pan-K-RAS inhibitor), zoldonrasib (tri-complex K-RAS G12D inhibitor), INCB161734 (non-covalent ON/OFF inhibitor specific for K-RAS G12D), HRS-4642 (liposomal G12D inhibitor), and setidegrasib (G12D degrader) currently undergoing phase III evaluation in first-line PDACs. Since the benefits provided by chemotherapy regimens are limited, it is conceivable that the novel targeted approaches may have the potential to overcome these limitations. Of note, outcomes for some of these compounds numerically exceeded the historical benchmarks with standard chemotherapy suggesting that a chemotherapy backbone might no longer be needed in the future."

Journal • Oncology • Palliative care • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • KRAS

Anticipated Upcoming Milestones (GlobeNewswire) - "2H 2026: Dose the first patient in Phase 2 trial of atebimetinib + anti-PD-1 (cemiplimab) in non-small cell lung cancer, with a preliminary data readout expected in late-2027. Q4 2026: Additional preclinical data of atebimetinib in combination with anti-PD-1 in non-small cell lung cancer. Mid-2027: Begin IND-enabling studies for our next DCI product candidate program. Mid-2028: Topline data readout from the MAPKeeper 301 trial."

P2 data • P3 data: top line • Preclinical • Non Small Cell Lung Cancer • Pancreatic Ductal Adenocarcinoma

Publication in Cancer Research Details Atebimetinib’s Broad, Durable Preclinical Activity and Favorable Tolerability Across RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition (The Manila Times) - "Atebimetinib demonstrated potent inhibition of both pERK and pMEK across multiple KRAS-, NRAS-, and BRAF-mutant tumor models, including colorectal, lung, and melanoma models...atebimetinib reduced both pERK and pMEK, reflecting its resistance to CRAF-mediated bypass; Atebimetinib’s short half-life enabled deep cyclic inhibition of the MAPK pathway, characterized by deep suppression during peak exposure followed by recovery toward physiologic baseline signaling between doses...In multiple head-to-head in vivo studies, atebimetinib demonstrated greater depth and durability of tumor growth inhibition than the FDA-approved MEK inhibitor binimetinib across KRAS-, NRAS-, and BRAF-mutant tumor models while remaining well tolerated.....In the second half of the year, the company expects to dose the first patient in a Phase 2 trial of atebimetinib plus Libtayo (cemiplimab) in patients with first-line RAS-mutant non-small cell lung cancer."

New P2 trial • Preclinical • Colon Cancer • Colorectal Cancer • Melanoma • Non Small Cell Lung Cancer

Dual-MEK Inhibitor Atebimetinib Displays Broad Activity in RAS- and RAF-Mutant Tumors via Deep Cyclic Inhibition and Resisting RAF-Bypass. (PubMed, Cancer Res) - "Overall, these findings establish atebimetinib as a dual-MEK inhibitor with the potential to provide mutation-agnostic inhibition of the MAPK pathway while leveraging DCI, designed to avoid toxicities associated with existing MEK inhibitors. Atebimetinib offers MEK inhibition that is durable and tolerable, supporting the potential of this therapeutic paradigm."

Journal • Oncology

IMM1104-101: A Phase 1/2a Study of IMM-1-104 in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: Immuneering Corporation | N=210 ➔ 320

Enrollment change • Colorectal Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • APC • HRAS • KRAS

Atebimetinib: “Compelling survival and tolerability in first line pancreatic cancer“; Pancreatic Cancer (Immuneering) - Corporate Presentation: "Only 2 categories of TRAE grade ≥3 in ≥10% of participants, both chemotherapy related"

P2a data

Atebimetinib: Preliminary data from P2 trial in combination with cemiplimab for NSCLC late 2027 (Immuneering) - Corporate Presentation: Topline data from P3 MAPKeeper 301 trial (NCT07562152) for metastatic PDAC in mid-2028

P2 data • P3 data: top line • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma

Dr Ahn on Phase 2a Data With Atebimetinib and Chemotherapy in Pancreatic Cancer (OncLive) - "Daniel H. Ahn, DO...discussed the results from a phase 2a trial (NCT05585320) presented at the 2026 ASCO Annual Meeting that evaluated the combination of atebimetinib and modified gemcitabine and nab-paclitaxel (Abraxane) in patients with advanced or metastatic pancreatic cancer and previewed the forthcoming phase 3 MAPKeeper 301 trial (NCT07562152) in the same population."

Video

A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=210 | Recruiting | Sponsor: Immuneering Corporation | N=156 ➔ 210

Enrollment change • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • APC • HRAS • KRAS

A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=156 | Not yet recruiting | Sponsor: Immuneering Corporation

New P1/2 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • APC • HRAS • KRAS

A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=156 | Recruiting | Sponsor: Immuneering Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • APC • HRAS • KRAS

Immuneering Announces First Patient Dosed in Pivotal Phase 3 MAPKeeper 301 Trial of Atebimetinib + mGnP in First-Line Pancreatic Cancer - "'Pancreatic cancer remains a challenging malignancy to treat,' said Eileen M. O’Reilly, MD...the lead principal investigator of the MAPKeeper 301 study. 'There is an urgent need for new first-line treatment options that can improve treatment outcomes by augmenting survival and improving quality of life. The MAPKeeper 301 trial evaluating atebimetinib with standard of care therapy represents an exciting step toward addressing that need.'"

Media quote

Immuneering Announces First Patient Dosed in Pivotal Phase 3 MAPKeeper 301 Trial of Atebimetinib + mGnP in First-Line Pancreatic Cancer (GlobeNewswire) - "The global MAPKeeper 301 trial (NCT07562152) is evaluating the safety and efficacy of atebimetinib + mGnP in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have received no prior systemic anti-cancer therapy. Patients are being randomized to receive either atebimetinib + mGnP, or standard GnP treatment alone. The primary endpoint is overall survival (OS) of patients in the atebimetinib + mGnP arm versus patients in the GnP arm."

Trial status • Pancreatic Ductal Adenocarcinoma

Atebimetinib Plus mGnP Shows Efficacy in 1L Metastatic Pancreatic Cancer (Cancer Network) - "Among 50 response-evaluable patients in the expanded cohort (n = 55), the combination of 320 mg once daily atebimetinib plus mGnP produced an objective response rate (ORR) of 36% (95% CI, 23%-51%) per RECIST v1.1 guidelines. The disease control rate (DCR) was 82% (95% CI, 69%-91%). The median overall survival (OS) was 17.3 months (95% CI, 11.2-not reached [NR]), consistent across both the initial cohort of 34 patients after a median follow-up of 17.0 months, and the expanded cohort of 55 patients after a median follow-up of 11.6 months. The median progression-free survival (PFS) was 8.3 months (95% CI, 5.9–9.6)...The safety profile of atebimetinib plus mGnP was notable for its tolerability. Grade 3 or higher anemia and neutropenia each occurred in at least 10% of patients and were attributed to the chemotherapy components."

P2a data • Pancreatic Ductal Adenocarcinoma

Immuneering Reports 17.3 Months Median Overall Survival in First-Line Metastatic Pancreatic Cancer Patients Treated with Atebimetinib Plus Chemotherapy - "'In my own patients on this trial, I have seen meaningful benefit without the functional decline I am accustomed to seeing in this disease - patients holding their weight, their energy, and their sense of themselves across many months of treatment,' said Daniel Ahn, DO...an investigator on the Phase 2a trial of atebimetinib. 'When the field has more than one effective first-line option, the deciding factor at the bedside will be tolerability.'"

Media quote

Immuneering Corporation…reported a 17.3-month median overall survival (OS) in first-line metastatic pancreatic cancer patients treated in its Phase 2a clinical trial evaluating atebimetinib (IMM-1-104) plus modified gemcitabine/nab-paclitaxel (mGnP), as of the April 24, 2026 data cutoff date (GlobeNewswire) - "The only treatment-related adverse events observed at Grade 3 or higher in ≥10% of patients were anemia (16%) and neutropenia (18%), both chemotherapy-related. The full data (N=55) including details on OS, progression free survival (PFS), response, safety, weight stability/gain, and other relevant information will be shared in an oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting..."

P2a data • Pancreatic Cancer

The company’s pivotal Phase 3 MAPKeeper 301 (NCT07562152) trial of atebimetinib + mGnP in patients with first-line metastatic pancreatic cancer is currently recruiting, and the company is on track to dose the first patient in mid-2026 (GlobeNewswire)

Trial status • Pancreatic Cancer