Onco-Summaries: Daily Oncology Updates at a Glance

15/05/2025

Another TIGIT agent fails as iTeos and GSK terminate the belrestotug development program based on disappointing NSCLC and SCCHN trials (Ref 1, Ref 2)

iTeos Therapeutics and GSK announced topline results from an updated interim analysis of the Ph2 GALAXIES Lung-201 trial of iTeos & GSK's belrestotug (anti-TIGIT) + GSK & Anaptys' dostarlimab (anti-PD-1) as a first-line Tx of unresectable, locally advanced or metastatic NSCLC with PD-L1 ≥50%, in which clinically meaningful improvements in ORR (primary endpoint) were observed. 

• However, clinically meaningful improvements in PFS (secondary endpoint) were not achieved with belrestotug + dostarlimab cohorts vs dostarlimab mono

Also, in the Ph2 GALAXIES H&N-202 trial, belrestotug combination cohorts showed a trend below the meaningful threshold for ORR vs dostarlimab mono as a first-line Tx of R/M SCCHN with PD-L1 CPS ≥1.

Based on these results, iTeos and GSK announced the decision to terminate the belrestotug development program and end the collaboration:

• All belrestotug-containing cohorts will end, and any new enrollment in the ongoing Ph3 GALAXIES Lung-301 trial in NSCLC is also ending

• The companies are discussing with investigators, institutional review boards, ethics committees, and health authorities about next steps for appropriate management of currently enrolled pts

Eftilagimod alpha + pembrolizumab + chemo continued to show promising ORR in non-sq NSCLC pts regardless of PD-L1 status (Ref 3, Ref 4)

Immutep announced updated response outcomes from the Ph1 INSIGHT-003 trial of Immutep & EOC Pharma's eftilagimod alpha (soluble LAG-3 protein) + pembrolizumab + chemotherapy as a first-line Tx of metastatic, non-squamous NSCLC .

At a data cutoff of May 06, 2025 (N=51), an ORR of 60.8% and DCR of 90.2% were demonstrated

• ORR (PD-L1 <1%, n=22): 54.5%

• ORR (PD-L1 1-49%, n=25): 64.0%

• ORR (PD-L1 ≥50%, n=4): 75.0%

• A favorable safety profile for the triple combination was observed with no new safety signals

• Additional data updates from this trial are expected to be presented at a medical conference in 2025 and beyond

• Per previously reported results (Ref 4), the combo elicited the following survival outcomes (data cutoff of Oct 15, 2024; minimum follow-up of 22.0 mos; PD-L1 unselected pts with mature survival data, n=21):

  • mPFS: 12.7 mos

  • mOS: 32.9 mos