WILMINGTON, DE — Incyte Corp. (Nasdaq: INCY) is advancing two experimental cancer treatments into late-stage clinical development after early trials showed tumor responses in patients with pancreatic and colorectal cancers, expanding the Wilmington-based biotechnology company’s efforts to develop therapies for difficult-to-treat solid tumors.
The company presented updated results for its KRAS G12D inhibitor, INCB161734, and its experimental immunotherapy, INCA33890, at the 2026 European Society for Medical Oncology Congress. The findings support ongoing Phase 3 studies and additional trials planned for 2027.
The most advanced programs target metastatic pancreatic ductal adenocarcinoma and microsatellite-stable colorectal cancer, two diseases for which Incyte is evaluating new treatment combinations alongside established chemotherapy regimens.
In a Phase 1 pancreatic cancer study, INCB161734 combined with modified FOLFIRINOX chemotherapy produced a reported objective response rate of 89% among patients with metastatic tumors carrying the KRAS G12D mutation.
The combination also achieved a 100% disease control rate, while 90% of patients remained progression-free at the six-month assessment.
The findings were drawn from an early-stage study involving 54 patients who received INCB161734 at a daily dose of 1,200 milligrams alongside either modified FOLFIRINOX or gemcitabine plus nab-paclitaxel.
The modified FOLFIRINOX group included 27 patients, with a median treatment duration of six months.
Patients receiving INCB161734 with gemcitabine and nab-paclitaxel achieved a reported objective response rate of 69% and a disease control rate of 96%.
The six-month progression-free survival rate in that group was 80%, with a median treatment duration of seven months.
The reported response rates included confirmed and pending responses. The results remain preliminary because they come from relatively small, early-stage treatment groups rather than completed randomized Phase 3 trials.
Incyte is evaluating INCB161734 with either chemotherapy regimen in its ongoing global Phase 3 DAWN-303 study for first-line metastatic pancreatic cancer.
Topline results from that trial are expected in 2028. The company also plans to begin a Phase 3 study in the adjuvant pancreatic cancer setting in 2027, evaluating treatment following initial therapy.
The KRAS G12D inhibitor is designed to target a specific mutation associated with tumor growth, allowing Incyte to pursue treatment strategies based on the molecular characteristics of patients’ cancers.
The company is also expanding its pancreatic cancer research through two planned collaborations.
A Phase 1b study with Bristol Myers Squibb will evaluate INCB161734 alongside navlimetostat, an investigational PRMT5 inhibitor, in patients with advanced or metastatic pancreatic cancer.
A separate planned Phase 1b trial with Synnovation will combine INCB161734 with SNV1521, an experimental PARP1 inhibitor, in the same disease setting.
The studies will examine whether combining treatments that target different biological mechanisms can improve outcomes for patients with advanced disease.
In colorectal cancer, Incyte reported additional Phase 1 results supporting a planned late-stage trial of INCB161734.
Among 22 heavily pretreated patients with advanced or metastatic KRAS G12D-mutated colorectal cancer who received INCB161734 with cetuximab, the objective response rate was 36%.
All patients in the combination group achieved disease control, and median progression-free survival was 7.2 months.
The broader colorectal cancer study included 49 patients evaluated through July 6, 2026, with INCB161734 administered alone or in combination with cetuximab.
The treatment showed a manageable safety profile, according to Incyte. No dose-limiting toxicities were observed during combination dose escalation, and the maximum tolerated dose was not reached.
The company expects to initiate DAWN-302, a Phase 3 study of INCB161734 plus cetuximab in previously treated metastatic colorectal cancer, during the first half of 2027.
Additional research includes an ongoing study combining INCB161734 with cetuximab and standard chemotherapy in first-line metastatic colorectal cancer, as well as a tumor-agnostic cohort examining activity across different cancer types.
Incyte is also pursuing research with Genmab to explore treatment combinations and mechanisms of resistance.
A separate immunotherapy program, INCA33890, produced preliminary responses in patients with microsatellite-stable colorectal cancer, a form of the disease that has historically been difficult to treat with conventional immune checkpoint inhibitors.
INCA33890 is a bispecific antibody targeting TGFβR2 and PD-1, two pathways involved in tumor biology and immune responses.
In Phase 1 results involving 94 patients, Incyte evaluated the antibody at a dose of 900 milligrams intravenously every two weeks alongside several established colorectal cancer treatments.
Among 42 patients receiving INCA33890 with FOLFOX chemotherapy and bevacizumab as first-line treatment, the objective response rate was 71%, and the disease control rate reached 100%.
The six-month progression-free survival rate was 81%.
Responses were also observed among patients with metastatic disease affecting organs commonly associated with poorer treatment outcomes.
The objective response rate reached 83% among 29 patients with liver metastases and 62% among 13 patients with peritoneal metastases.
Among 26 patients whose tumors had a PD-L1 tumor area positivity score of at least 1%, the response rate was 81%.
The company reported no dose-limiting toxicities in the INCA33890 combination study.
The most common treatment-emergent adverse events in the first-line setting were neuropathy, affecting 77% of patients; neutropenia, affecting 58%; and stomatitis, affecting 47%.
Four patients, representing 9% of the relevant treatment group, discontinued treatment.
Incyte is evaluating INCA33890 with FOLFOX and bevacizumab in its ongoing Phase 3 NEXERA-303 trial for first-line microsatellite-stable colorectal cancer.
Topline results are expected in 2029. A separate Phase 2 study is examining the antibody as adjuvant treatment following chemotherapy.
Safety findings from the pancreatic cancer program also showed adverse effects associated with the treatment combinations.
Among patients receiving INCB161734 with modified FOLFIRINOX, the most common treatment-related adverse events were diarrhea in 68%, nausea in 64%, vomiting in 57% and decreased neutrophil counts in 57%.
No treatment-related adverse events led to discontinuation of INCB161734 in that group.
For patients receiving the drug with gemcitabine and nab-paclitaxel, diarrhea, nausea and decreased neutrophil counts each occurred in 65% of patients, while anemia affected 58%.
One patient discontinued INCB161734 because of a treatment-related adverse event.
Most gastrointestinal adverse events were mild or moderate and improved during treatment, according to the company.
Pablo J. Cagnoni, Incyte’s president and global head of research and development, identified the two programs as central to the company’s expansion into solid tumor treatments.
“Across pancreatic and colorectal cancers, we continue to see encouraging evidence of clinical activity and manageable safety profiles, supporting the promise of these programs across tumor types and lines of therapy,” Cagnoni stated.
The data were presented in three rapid oral sessions at the ESMO Congress, covering the pancreatic cancer, KRAS G12D-mutated colorectal cancer and microsatellite-stable colorectal cancer programs.
For Incyte, the next major development milestones will come from its randomized late-stage trials, which are intended to establish whether the response rates and progression-free survival findings observed in early studies translate into clinically meaningful benefits in larger patient populations.
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