Incyte Advances Two Solid Tumor Therapies to Phase 3 Trials

At the 2026 European Society for Medical Oncology Congress, biotechnology company Incyte presented updated Phase 1 clinical data for its KRAS G12D inhibitor INCB161734 and bispecific antibody INCA33890, as reported by mychesco.com. The data evaluated these experimental compounds in combinations with standard chemotherapies for metastatic pancreatic ductal adenocarcinoma and microsatellite-stable colorectal cancer, supporting their transition into late-stage trials mychesco.commychesco.commychesco.comOpen source ↗.

Pancreatic Cancer Combinations

In a Phase 1 study cohort of 54 patients, participants received INCB161734 at a daily oral dose of 1,200 milligrams alongside standard chemotherapy regimens. Among 27 patients treated with modified FOLFIRINOX, the reported objective response rate was 89%, the disease control rate reached 100%, and the progression-free survival rate at six months stood at 90%. For patients treated alongside gemcitabine plus nab-paclitaxel, the objective response rate was 69%, the disease control rate reached 96%, and six-month progression-free survival was 80%. Incyte is currently evaluating INCB161734 in the global Phase 3 DAWN-303 trial for first-line metastatic pancreatic cancer, with topline results anticipated in 2028.

Colorectal Cancer Evaluations

For heavily pretreated patients with metastatic KRAS G12D-mutated colorectal cancer, INCB161734 combined with cetuximab demonstrated an objective response rate of 36% and a 100% disease control rate across 22 evaluated patients, with a median progression-free survival of 7.2 months. Incyte plans to launch the Phase 3 DAWN-302 study assessing this combination during the first half of 2027. Separately, the bispecific antibody INCA33890, targeting TGFβR2 and PD-1, was assessed at 900 milligrams intravenously every two weeks in 94 patients with microsatellite-stable colorectal cancer. When combined with FOLFOX and bevacizumab in 42 first-line patients, the reported objective response rate reached 71%, disease control was 100%, and the six-month progression-free survival rate was 81%. This regimen is now being tested in the ongoing Phase 3 NEXERA-303 trial.