October 19, 2025 — Leads & Copy — Incyte (Nasdaq:INCY) has announced initial clinical data assessing its TGFβR2×PD-1 bispecific antibody (INCA33890) for patients with microsatellite stable (MSS) colorectal cancer, along with data for its KRAS G12D inhibitor (INCB161734) used in patients with KRAS G12D mutations, specifically pancreatic ductal adenocarcinoma (PDAC). The information was presented at the European Society of Medical Oncology (ESMO) Congress 2025 during two oral sessions.
According to Pablo J. Cagnoni, M.D., President and Head of Research and Development at Incyte, the data underscores the potential of INCA33890 and INCB161734 to fulfill critical medical needs for individuals with advanced solid tumors, including MSS colorectal cancer and PDAC. The favorable safety profiles observed with monotherapies support further clinical development. The company plans to explore these novel targeted therapies in combination with current standard of care as frontline treatments.
Data from the monotherapy arm (Part 1) of the INCA33890 Phase 1 trial, were presented at ESMO on October 17, 2025. The trial included patients with advanced or metastatic solid tumors who had disease progression after receiving available therapies or were intolerant to, ineligible for, or declined standard treatments, including immune checkpoint inhibitors. Patients received doses of INCA33890 ranging from 100 mg to 1,500 mg every two weeks (Q2W) to 900 mg intravenously (IV) every four weeks (Q4W) in continuous 28-day cycles. INCA33890 300 mg, 600 mg and 900 mg Q2W were selected as the recommended doses for expansion (RDE).
Initial data (cut-off July 25, 2025) showed promising clinical efficacy with INCA33890 treatment. Of note:
- INCA33890 demonstrated a manageable safety profile across all enrolled patients (n=260).
- Among patients with metastatic MSS colorectal cancer treated with INCA33890 at RDE (n=105), 93.3% had received more than two prior treatment regimens and 71.4% had active liver metastases at the time of treatment.
- Within this cohort, 16 patients treated with INCA33890 responded (14 confirmed), with 15.2% achieving an objective response rate (ORR) and a median duration of therapy of 7.3 months.
Elena Garralda, M.D., Ph. D., Trial Investigator and Director of Early Drug Development at the Vall d’Hebron Institute of Oncology, stated that the efficacy data presented at ESMO in MSS colorectal cancer, along with a tolerable safety profile, provide proof of concept for on-target inhibition of the TGF-β pathway. Incyte plans to initiate a registrational program for INCA33890 in MSS colorectal cancer in 2026.
In a proffered paper session on October 19, 2025, data were presented from the monotherapy arm (Part 1) of the INCB161734 Phase 1 trial in patients with select advanced or metastatic solid tumors and documented KRAS G12D mutation. Patients received varying doses of INCB161734 ranging from 200 mg to 1,600 mg daily. Two doses, 600 mg daily and 1,200 mg daily, were selected for expansion.
Preliminary data (cut-off August 1, 2025) demonstrated evidence of clinical benefit in advanced or metastatic PDAC patients treated with INCB161734 (n=83). Specifically:
- INCB161734 demonstrated a manageable safety profile across all treated patients (n=136).
- PDAC patients receiving 600 mg (n=25) and 1,200 mg (n=29) INCB161734 daily demonstrated objective response rates (ORR; 20% and 34%) and high DCRs (64% and 86%).
According to Dr. Jayesh Desai, Tiral Investigator, Medical Oncologist and Associate Director of Clinical Research at the Peter MacCallum Cancer Centre, it is encouraging to see promising antitumor activity and strong molecular response with INCB161734 monotherapy in this heavily pretreated patient population.
Evaluation of the data for INCB161734 in patients with PDAC is ongoing with results expected in 2026. Based on the findings, the company will conduct a comprehensive review of the data to inform next steps for the program, including discussions with regulatory authorities.
More information regarding the 2025 ESMO Congress and the data from Incyte’s oncology portfolio being featured at the meeting can be found on the ESMO website: https://www.esmo.org/meeting-calendar/esmo-congress-2025.
The data from the ESMO oral presentations and additional results from INCA33890 in patients with MSS colorectal cancer and INCB161734 in patients with PDAC will also be discussed at an in-person analyst and investor event on Sunday, October 19, 2025, from 1:30 – 3:00 p.m. ET (7:30 – 9:00 p.m. CEST) at ESMO.
The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 30 days.
For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.
Source: Incyte
