Incyte reports new KRAS G12D and bispecific antibody data across pancreatic and colorectal cancer

Incyte has reported new early-stage clinical data across its gastrointestinal cancer pipeline, including results for its KRAS G12D inhibitor INCB161734 and TGFβR2×PD-1 bispecific antibody INCA33890.

The findings were presented at the 2026 European Society for Medical Oncology Congress and included data in pancreatic ductal adenocarcinoma and colorectal cancer.

In metastatic pancreatic ductal adenocarcinoma carrying KRAS G12D mutations, INCB161734 was evaluated at 1,200 mg once daily in combination with standard chemotherapy.

When combined with modified FOLFIRINOX, the investigational KRAS inhibitor produced an objective response rate of 89% when confirmed and pending responses were included.

The confirmed response rate was 81%, while the disease control rate reached 100%.

The six-month progression-free survival rate was 90%.

Median treatment duration for patients receiving INCB161734 plus modified FOLFIRINOX was six months.

A separate group received INCB161734 with gemcitabine and nab-paclitaxel.

This combination produced an objective response rate of 69% when confirmed and pending responses were included, with a confirmed response rate of 58%.

The disease control rate was 96%, while the six-month progression-free survival rate reached 80%.

Median treatment duration was seven months.

Incyte said the safety profile of both pancreatic cancer combinations was broadly consistent with the established profiles of the chemotherapy regimens.

Gastrointestinal treatment-related adverse events were generally Grade 1 or 2 and tended to improve during treatment.

The company is continuing development through the global Phase III DAWN-303 study, which is evaluating INCB161734 with standard chemotherapy in first-line metastatic pancreatic cancer.

Topline data from the study are expected in 2028.

Incyte is also planning a Phase III study of INCB161734 in the adjuvant pancreatic cancer setting in 2027.

Additional combination studies are planned with Bristol Myers Squibb’s PRMT5 inhibitor navlimetostat and Synnovation’s PARP1 inhibitor SNV1521.

INCB161734 also demonstrated activity in patients with advanced or metastatic KRAS G12D-mutated colorectal cancer.

Among heavily pretreated patients receiving INCB161734 with cetuximab, the objective response rate was 36% and the disease control rate reached 100%.

Median progression-free survival was 7.2 months.

No dose-limiting toxicities were observed during combination dose escalation and a maximum tolerated dose was not reached.

A Phase III study, DAWN-302, evaluating INCB161734 plus cetuximab in previously treated metastatic colorectal cancer is expected to begin in the first half of 2027.

Incyte also presented Phase I data for INCA33890, an investigational bispecific antibody targeting TGFβR2 and PD-1, in microsatellite stable colorectal cancer.

In the first-line setting, INCA33890 combined with FOLFOX and bevacizumab achieved a 71% objective response rate and a 100% disease control rate.

The six-month progression-free survival rate was 81%.

Among patients with liver metastases, the response rate reached 83%, while patients with peritoneal metastases achieved a 62% response rate.

An objective response rate of 81% was observed among patients whose tumours had PD-L1 TAP expression of at least 1%.

The most common treatment-emergent adverse events in the first-line group were neuropathy in 77% of patients, neutropenia in 58% and stomatitis in 47%.

Treatment was discontinued in four patients, representing 9% of the group.

The Phase III NEXERA-303 trial is now evaluating INCA33890 with FOLFOX and bevacizumab as a first-line treatment for microsatellite stable colorectal cancer.

Topline results from that study are expected in 2029.



Related Topics and Keywords

, , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Subscribe to our FREE newsletter and WEBINAR UPDATES

We will not sell or give your information to a third party. See our Privacy Policy