Gilead and Arcus Announce New Data Showing Encouraging Clinical Activity of Anti-TIGIT Domvanalimab-Containing Regimen as First-line Treatment for Upper GI Cancers - Seite 2

The efficacy results including ORR and six-month PFS rates are summarized in the table below:

PD-L1-high*

(TAP ≥5%)

N=15

n (%)

PD-L1-low*
(TAP <5%)

N=24

n (%)

Overall

N=41

n (%)

ORR (95% CI)

80%

(52,96)

46%

(26,67)

59%

(42,74)

Confirmed ORR (95% CI)

73%

(45,92)

46%

(26,67)

56%

(40,72)

6-month PFS Rate (95% CI)

93%

(81,100)

68%

(48,88)

77%

(64,90)

*Tumor samples from 2 patients were not available for central PD-L1 testing

CI: confidence interval

The domvanalimab-containing regimen was well tolerated, with a similar safety profile to what has been reported for anti-PD-1 plus chemotherapy in this setting. The most common adverse events (AEs) were neutropenia (59%), nausea (54%), anemia (27%) and fatigue (27%). Infusion-related reactions were observed in 20% and the majority (17%) were related to chemotherapy. No patients experienced serious immune-mediated AEs, and there were no treatment-emergent adverse events (TEAEs) resulting in death.

These data add to the growing body of evidence that domvanalimab, an Fc-silent anti-TIGIT antibody, has a differentiated safety and tolerability profile relative to published data from studies with Fc-enabled anti-TIGIT antibodies.

The preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study support the ongoing Phase 3 study, STAR-221, in unresectable or metastatic upper GI cancers. The companies have three additional ongoing Phase 3 registrational studies of domvanalimab-containing regimens in lung cancer, including STAR-121, ARC-10 and PACIFIC-8.