The ESMO Congress 2026 will feature new pancreatic cancer data across resected, borderline resectable, locally advanced, and metastatic disease. The program includes additional phase III analyses of daraxonrasib, randomized data with an mKRAS-directed amphiphile immunotherapy, the addition of stereotactic body radiotherapy to chemotherapy, and emerging KRAS G12D-directed approaches in both perioperative and advanced disease.
Several of the presentations build on previously reported studies, while others will provide new results from emerging treatment strategies. Together, the five studies span RAS-directed therapies, immunotherapy, SBRT, and perioperative and metastatic treatment settings in pancreatic ductal adenocarcinoma (PDAC). This overview highlights 5 pancreatic cancer trials to watch at ESMO 2026.
RASolute 302: Additional Analyses of Daraxonrasib in Previously Treated Metastatic PDAC
Abstract: LBA82
Presenter: Zev A. Wainberg (Los Angeles, United States of America)
Trial Type: Phase III
Session: Proffered Paper session
RASolute 302 (NCT06625320) is a global, randomized, open-label phase III study comparing daraxonrasib, an oral RAS(ON) multi-selective inhibitor, with investigator’s-choice chemotherapy in patients with previously treated metastatic pancreatic adenocarcinoma. A total of 500 patients were randomized 1:1 to daraxonrasib 300 mg once daily or chemotherapy. The dual primary endpoints were overall survival and blinded independent central review-assessed progression-free survival in patients with RAS G12 mutations.
The primary and final analysis was presented at the 2026 ASCO Annual Meeting and published in The New England Journal of Medicine. In the RAS G12 population, median overall survival was 13.2 months with daraxonrasib versus 6.6 months with chemotherapy (HR 0.40; 95% CI, 0.30–0.54; P<0.0001). Median progression-free survival was 7.3 versus 3.5 months (HR 0.45; 95% CI, 0.34–0.59; P<0.0001), and the objective response rate was 33.2% versus 11.8%.
On August 26, 2026, the FDA approved daraxonrasib for adults with metastatic pancreatic adenocarcinoma who had received at least one prior systemic therapy or were not candidates for multiagent systemic therapy.
At ESMO 2026, RASolute 302 will report additional subgroup analyses from the phase III study.
AMPLIFY-7P: ELI-002 7P Versus Observation After Resection of PDAC
Abstract: LBA83
Presenter: Eileen M. O’Reilly (New York, United States of America)
Trial Type: Randomized Phase II
Session: Proffered Paper session
AMPLIFY-7P (NCT05726864) is a randomized phase II study evaluating ELI-002 7P, a seven-valent mutant KRAS-specific lymph node-targeted amphiphile immunotherapy, versus observation in patients with resected mKRAS-driven PDAC following completion of surgery and standard locoregional therapy. The study enrolled 144 patients across 24 sites in the United States. Sponsor-reported topline results in June 2026 showed that AMPLIFY-7P did not meet its prespecified primary disease-free survival endpoint in the intent-to-treat population.
An imbalance in R1 resection status was observed between the treatment groups, occurring in 19% of patients assigned to ELI-002 7P and 10% assigned to observation. In a post hoc analysis of the R0-resected population, median disease-free survival was 23.8 months with ELI-002 7P versus 12.8 months with observation (HR 0.65; P=0.048; n=121). These findings should be interpreted in the context of the negative primary intent-to-treat analysis and the post hoc nature of the R0 analysis.
At ESMO 2026, investigators will present the randomized phase II AMPLIFY-7P results comparing ELI-002 7P with observation in resected PDAC.
MASTERPLAN: mFOLFIRINOX ± SBRT in High-Risk and Locally Advanced Pancreatic Cancer
Abstract: 3136RO
Presenter: Andrew Oar (Southport, Australia)
Trial Type: Randomized Phase II
Session: Rapid Oral session
The AGITG MASTERPLAN study (ACTRN12619000409178) is a multicenter randomized phase II trial evaluating chemotherapy with or without stereotactic body radiotherapy in patients with high-risk borderline resectable or locally advanced pancreatic cancer. The planned study population was 120 patients, randomized 2:1 to chemotherapy plus SBRT or chemotherapy alone.
The protocol specified six cycles of modified FOLFIRINOX before reassessment, with gemcitabine plus nab-paclitaxel permitted for patients considered unsuitable for mFOLFIRINOX. In the investigational arm, SBRT was delivered to 40 Gy in five fractions. The primary endpoint is 12-month locoregional control. Secondary endpoints include safety, radiological response, progression-free survival, resection and R0 resection rates, pathological response, quality of life, and overall survival.
At ESMO 2026, investigators will present results from the randomized phase II comparison of mFOLFIRINOX with or without SBRT in patients with high-risk, borderline resectable, or locally advanced pancreatic cancer.
HRS-4642 + Chemotherapy ± Adebrelimab as Perioperative Therapy in KRAS G12D-Mutant Pancreatic Cancer
Abstract: LBA85
Presenter: Chenlei Wen (Shanghai, China)
Trial Type: Phase II
Session: Rapid Oral session
HRS-4642 is a selective KRAS G12D inhibitor being investigated across several treatment settings in KRAS G12D-mutant pancreatic cancer. Separate early-phase studies have evaluated HRS-4642 with gemcitabine plus nab-paclitaxel and HRS-4642 with the anti-PD-L1 antibody adebrelimab in advanced disease.
In a phase 1b/2 study published in Nature Medicine in July 2026, HRS-4642 plus gemcitabine and nab-paclitaxel was evaluated in patients with advanced KRAS G12D-mutant PDAC. Among 30 treatment-naive patients included in the phase II efficacy analysis, the confirmed objective response rate was 63.3% (95% CI, 43.9–80.1). Separately, HRS-4642 plus adebrelimab has been evaluated in previously treated metastatic KRAS G12D-mutant PDAC.
At ESMO 2026, investigators will report preliminary results with HRS-4642 plus chemotherapy, with or without adebrelimab, as perioperative therapy in patients with KRAS G12D-mutant pancreatic cancer.
INCB161734 + Chemotherapy in Advanced KRAS G12D-Mutant PDAC
Abstract: 3137RO
Presenter: Antoine Hollebecque (Villejuif, France)
Trial Type: Phase I
Session: Rapid Oral session
INCB161734 is an oral selective KRAS G12D inhibitor being evaluated in the multicenter phase I study NCT06179160 as monotherapy and in combination with other anticancer therapies in patients with KRAS G12D-mutant advanced or metastatic solid tumors. In PDAC, combination cohorts include gemcitabine plus nab-paclitaxel and modified FOLFIRINOX.
Preliminary data presented at the 2026 ASCO Gastrointestinal Cancers Symposium included 83 patients with PDAC treated with INCB161734 monotherapy. Among patients with at least one post-baseline scan, partial responses were reported in 5 of 22 patients (23%) receiving 600 mg daily and 10 of 29 patients (34%) receiving a total daily dose of 1200 mg. Disease control was observed in 73% and 86% of patients, respectively.
At that analysis, combination dose escalation had begun. Among 10 patients with PDAC treated with INCB161734 600 mg daily plus either gemcitabine/nab-paclitaxel (n=6) or mFOLFIRINOX (n=4), no dose-limiting toxicities were observed.
At ESMO 2026, investigators will report safety and efficacy results for INCB161734 in combination with chemotherapy in advanced or metastatic PDAC.
The Bottom Line
The pancreatic cancer program at ESMO 2026 spans several disease settings and treatment strategies. RASolute 302 will extend the phase III daraxonrasib dataset with additional subgroup analyses following the previously reported survival benefit over chemotherapy in metastatic disease.
AMPLIFY-7P will provide randomized phase II results with ELI-002 7P after resection, following sponsor-reported topline data showing that the primary disease-free survival endpoint was not met in the intent-to-treat population. MASTERPLAN will evaluate the addition of SBRT to chemotherapy in high-risk, borderline resectable, and locally advanced disease. The two KRAS G12D-directed presentations will evaluate targeted treatment in different settings: HRS-4642 plus chemotherapy with or without adebrelimab as perioperative therapy and INCB161734 plus chemotherapy in advanced or metastatic PDAC.
Together, these five presentations will provide additional evidence across resected, locally advanced, and metastatic pancreatic cancer, with several studies evaluating RAS-directed treatment strategies.
Presentation details are available in the official ESMO programme.
Read more about 9 Hepatobiliary Cancer Trials to Watch at ESMO 2026 on OncoDaily.
