Memorial Sloan Kettering Cancer Center (MSK) researchers presented pioneering advances in medical oncology for a range of cancer types at the European Society for Medical Oncology Congress 2026 held October 23 to 27 in Madrid, Spain.
Highlights included phase 2 results from the AMPLIFY-7P study of an mKRAS targeted vaccine in Pancreatic ductal adenocarcinoma (PDAC), and final results for a first in-human phase I/II study of a new treatment for advanced Gastrointestinal Stromal Tumor (GIST). Additionally, MSK researchers presented new results from phase I/II studies for new treatments in platinum-sensitive ovarian cancer (PSOC), non-small cell lung cancer (NSCLC) and Undifferentiated Pleomorphic Sarcoma (UPS) and Dedifferentiated Liposarcoma (DDLS).
AMPLIFY-7P: Phase 2 Results of Vaccine Targeting mKRAS in PDAC
Treatment of PDAC is challenging. Immune checkpoint blockade (ICB) is not effective and use of RAS inhibitors, while effective in improving overall survival as second line therapy, often leads to resistance and disease progression.
About 90-95% of patients with PDAC harbor mutated KRAS (mKRAS), making them attractive targets for immunotherapy. T cells targeted at mKRAS have the potential to improve clinical responses. Furthermore, healthy tissue does not express mKRAS, lowering the risk for off-target toxicity. Camupepimut (ELI-002 7P) is an mKRAS vaccine that is being investigated in AMPLIFY-7P, the first randomized, open-label study of this vaccine in the treatment of KRAS-mutated PDAC. Phase 1 results from AMPLIFY-7P have shown that camupepimut drives T cell responses specific to mKRAS, and that these were correlated with disease-free and overall survival.
Gastrointestinal medical oncologist Eileen O’Reilly, MD, presented phase 2 results from AMPLIFY-7P (NCT05726864). In phase 2, patients with resected KRAS-mutated PDAC without recurrence and within 6 months of standard therapy were randomized to camupepimut (n=96) or standard of care/observation (n=48).
While the study did not meet the primary endpoint of overall DFS (HR=0.85, P=0.5329; pre-specified threshold for success (HR<0.70, P<~0.10), the camupepimut group had more patients who were positive for circulating tumor DNA (ctDNA). These are fragments of DNA that are released from cancer cells and found in the blood. Patients with ctDNA positivity have a higher level of residual disease and are at increased risk for relapse. So, this imbalance could have obscured a treatment benefit for camipepimut, particularly as analyses that adjusted for baseline factors affecting prognosis (like ctDNA positivity) showed a strong potential treatment benefit for camupepimut compared to observation (adjusted HR=0.47, 95% CI 0.27-0.82, P=0.0086).
Other results also indicated treatment benefit. Six-month DFS suggested early treatment benefit with camupepimut vs observation (75.7% versus 61.7%), as did analysis of DFS from randomization to 6 months (HR=0.55, P=0.0557). Furthermore, camupepimut was associated with a DFS advantage at 6 months of 14.0% (75.7% versus 61.7%; HR=0.55, P=0.0557). In patients treated with camupepimut, mKRAS-specific T cell responses were associated with improved DFS (HR=0.22, P<0.0001), confirming earlier phase 1 results showing a significant correlation between mKRAS T cell responses and clinical benefit with camipepimut. The safety profile of camupepimut was similar to past studies.
These promising results, with allowance for the imbalance in prognostic factors from the phase II, have paved the way for a confirmatory phase 3 trial. Other early phase trials are underway or planned evaluating ELI-002 7P with immunotherapy and targeted therapy in pancreatic cancer.
Read ESMO Congress 2026 Abstract. The study was sponsored and funded by Elicio Therapeutics. Access disclosures for Dr. O’Reilly. Learn more about MSK clinical trials for patients with solid tumors, including pancreatic and colorectal cancers.
NB003: Final Results for First-in-Human Phase I/II Trial in Advanced GIST
GISTs are the most common sarcomas of the gastrointestinal tract. Among these, 80%-90% have mutations in KIT or platelet derived growth factor α (PDGFRA). Approved tyrosine kinase inhibitors (TKIs) do not target a wide range of drug-resistant mutations in KIT and offer limited clinical benefits. NB003 is a new generation small molecule inhibitor that is designed to selectively target a broad range of drug-resistant KIT mutations in GISTs.
Sarcoma medical oncologist Ping Chi, MD, PhD, presented final results from the first-in-human phase I trial of NB003 in the treatment of advanced GIST (https://clinicaltrials.gov/study/NCT04936178). The global, open-label, phase I/II clinical trial took place at 28 study sites in Asia, Europe, and North America. It included 190 heavily pretreated patients with advanced GIST and a broad range of KIT mutations. The study used a dose-escalation design to evaluate NB003 at doses of 3mg to 40mg twice daily for 28 days (n=42), followed by an expansion phase that included patients with treatment-refractory GIST (n=148).
Results showed that NB003 had promising clinical activity and encouraging antitumor effects against a wide range of mutations in KIT that are resistant to TKIs. The objective response rate (ORR) was 29.1%, with a median duration of response (DoR) of 10.8 months, disease control rate (DCR) of 78.5%, median progression free survival (PFS) of 7.5 months, median OS of 19.8 months, and a manageable safety profile.
Based on the overall safety, efficacy, and pharmacokinetic data, the optimal dosing regimen of NB003 was 15 mg twice daily. This regimen has been selected for an ongoing multi-center, randomized Phase 3 trial of NB003 vs. Regorafenib for the 3rd-line treatment of GIST (NB003-04, NCT07379047).
Read ESMO Congress 2026 Abstract 1389. The study was supported by Ningbo NewBay Technology Development Co., Ltd. Access disclosures for Dr. Chi. Learn more about MSK clinical trials for patients with solid tumors, including cancers of the gastrointestinal tract.
Other Notable MSK News from ESMO Congress 2026:
Sofe-M+bev: Phase 1 Results in Platinum-Sensitive Ovarian Cancer
Gynecologic medical oncologist and early drug development specialist Chrisann Kyi, MD presented efficacy and safety results of a phase 1 study (NCT06400472) of sofetabart mipitecan (Sofe-M), a folate receptor alpha (FRα) targeting antibody drug conjugate (ADC), plus bevacizumab (bev) in recurrent PSOC. The study included 33 patients with heavily pretreated PSOC who received Sofe-M+bev. Results showed SofeM + bev to be a promising platinum alternative in the treatment of PSOC. As of the July 6, 2026, data cutoff, the cORR among the 29 patients with measurable disease was 79.3% (23/29; 6 complete responses [CR, 20.7%] and 17 partial responses [PR, 58.6%]), and DCR was 100%. Responses were consistent across FRα expression levels and prior PARPi exposure. Median duration of response (DOR) and median progression-free survival (PFS) were not reached at median follow-ups of 6.2 and 10.2 months, respectively.
These data have supported the Phase 3 FRAmework-01 study (NCT07213804) of Sofe-M+bev in this patient population, which is actively recruiting.
Read ESMO Congress 2026 Abstract. The study was funded by Eli Lilly and Company. Access disclosures for Dr. Kyi.
Zongertinib: Pooled analysis in HER2-Overexpressed or Amplified NSCLC
In a poster presentation, gynecologic medical oncologist and early drug development specialist Alison Schram, MD presented results from a pooled analysis of 27 patients treated with zongertinib monotherapy for advanced HER2-overexpressed/amplified NSCLC. Zongertinib is an irreversible TKI that selectively inhibits HER2 while sparing wild-type EGFR and minimizing associated toxicities. The pooled analysis included data from Phase Ia of the Beamion LUNG-1 trial (NCT04886804 ) and the ongoing Phase II Beamion PANTUMOR-1 trial (NCT06581432). Results showed excellent tolerability and promising efficacy, with a confirmed ORR of 47% and most patients remaining on treatment at data cutoff.
The Beamion PANTUMOR-1 trial is ongoing in the study of zongertinib as a potential treatment in this patient population.
Read ESMO Congress 2026 Abstract. The study was funded by Boehringer Ingelheim. Access disclosures for Dr. Schram.
Lifileucel: Phase I Results in Undifferentiated Pleomorphic Sarcoma or Dedifferentiated Liposarcoma
Sarcoma medical oncologist and MSK principal investigator Lauren Banks MD, PhD presented results from NCT05607095, a phase 1 pilot trial of lifileucel in patients with refractory metastatic UPS and DDLS. Lifileucel is an autologous tumor infiltrating lymphocyte (TIL) product that is FDA approved in melanoma. Lifileujcel is being investigated in the treatment of UPS/DDLS, in which TILs are also found.
The study included 8 patients with UPS/DDLS who received lifileucel, meeting the feasibility endpoint. Toxicity was consistent with lymphodepletion chemotherapy, IL-2, and adoptive cell therapy. Preliminary results showed evidence of activity and supported the Phase II multicenter IOV-SAR-201/SARATOGA trial (NCT07741877), which is open at US centers including MSK. A pilot angiosarcoma cohort enrolling.
Read ESMO Congress 2026 Abstract.The study was supported Iovance, which is sponsoring the Phase II trial. Access disclosures for Dr. Banks.