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ESMO 2024: GSK/iTeos's TIGIT Shows Promise in NSCLC, Intensifying the Competitive Landscape

NextEdge Admin

16 Sep 2024

2 min 31 sec

TIGIT inhibitors have faced a challenging path in the race to treat non-small cell lung cancer (NSCLC). At ESMO 2024, GSK and iTeos presented the first data on their TIGIT inhibitor, belrestotug, in combination with Jemperli (dostarlimab) for PD-L1-high NSCLC patients. The interim results from the Phase II GALAXIES Lung-201 trial, with a median follow-up of 7.3 months, showed promising efficacy. Across three dose levels of belrestotug (100, 400, and 1000mg), the combination nearly doubled the overall response rate (ORR) compared to dostarlimab monotherapy. Higher dose levels also demonstrated a 90% reduction in circulating tumor DNA (ctDNA).

Despite these encouraging findings, the analysis lacked insights into key secondary survival and durability endpoints, limiting the ability to assess how the combination compares to MSD’s Keytruda (pembrolizumab), a standard treatment in NSCLC. The trial’s small sample size (124 patients) further challenges the conclusions drawn.

The recommended Phase III dose (RP3D) of 400mg will be tested in the ongoing GALAXIES Lung-301 trial, comparing the belrestotug-Jemperli combination against Keytruda in 1,000 patients. In the smaller Phase II trial, the 400mg dose achieved a 59.4% ORR compared to 28.1% for Jemperli monotherapy, though no complete responses were reported in either arm. The combination also showed a median 94% decrease in ctDNA, indicating a deeper response.

However, the combination increased treatment-related adverse events (TRAEs) and immune-related adverse events (TR-irAEs). Belrestotug must demonstrate a clear overall survival benefit to challenge established PD-1 therapies and fend off competition from emerging antibody-drug conjugates and bispecific antibodies in the NSCLC treatment landscape.