iTeos Therapeutics and GSK revealed promising results from their phase 2 TIGIT trial at the 2024 European Society for Medical Oncology (ESMO) conference in Barcelona. The mid-stage trial, known as GALAXIES Lung-201, evaluated the combination of belrestotug, an anti-TIGIT antibody, and dostarlimab (Jemperli), GSK’s anti-PD-1 treatment, in patients with previously untreated, unresectable, or metastatic PD-L1-high non-small cell lung cancer (NSCLC).
The results demonstrated a 30% improvement in tumor shrinkage with the combination therapy compared to dostarlimab monotherapy. The overall response rate (ORR) was impressive across all dosing cohorts:
- 63.3% for the 100 mg dose of belrestotug (Group A),
- 65.6% for the 400 mg dose (Group B),
- 76.7% for the 1,000 mg dose (Group C).
These results stand in contrast to the 37.5% ORR for patients who received dostarlimab alone.
Confirmed Response and Follow-Up
In terms of confirmed overall response rate (cORR), the combination therapy showed approximately 60% cORR across all doses, compared to 28.1% with monotherapy. Median follow-up times varied, with 8.5 months for Groups A and B, 6.7 months for Group C, and 7 months for the monotherapy group.
Safety Profile
While the combination therapy was linked to a higher incidence of immune-related adverse events, these were manageable and consistent with the known profile of checkpoint inhibitor treatments. The most common side effects included skin and subcutaneous tissue disorders.
Moving Forward: Phase 3 Trial
Following these strong results, iTeos and GSK have already initiated a phase 3 trial, GALAXIES Lung-301, which will enroll around 1,000 patients and compare the combination therapy against a placebo-Keytruda arm. The study is expected to be completed by 2028.
Dr. Michel Detheux, President and CEO of iTeos, noted the significance of these findings: “The improvement in depth of response in tumor measurement in patients treated with the doublet compared to those treated with PD-1 alone holds promising therapeutic potential for a patient population with limited options.”
This promising data positions iTeos and GSK as key players in the TIGIT-therapy space, especially in light of Roche’s recent setbacks with its TIGIT program.
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External Links:
iTeos Therapeutics: https://www.iteostherapeutics.comGSK: https://www.gsk.com
ESMO 2024 Conference: https://www.esmo.org/meetings/esmo-congress-2024J
emperli (Dostarlimab) Information: https://www.gsk.com/en-gb/media/press-releases/gsk-receives-us-fda-approval-for-jemperli-in-endometrial-cancer/
Clinical Trials: GALAXIES Lung-301: https://clinicaltrials.gov/ct2/show/NCT05246590
Checkpoint Inhibitors Overview: https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/checkpoint-inhibitors