Comment: Trial updates from GALAXIES Lung-201 and RELATIVITY-104 in NSCLC

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Published: 26 Sep 2024
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Dr Marina Garassino - University of Chicago, Chicago, USA

Dr Marina Garassino comments on the interim analysis of GALAXIES Lung-201 and the results from the randomized phase II RELATIVITY-104 study.

The interim analysis of GALAXIES Lung-201 was a phase II, randomized, open-label platform study of belrestotug plus dostarlimab in patients with previously untreated locally advanced or metastatic PD-L1 high (TPS ≥50%) non-small cell lung cancer.

Dr Garassino comments that in this interim analysis, belrestotug and dostarlimab demonstrat clinically meaningful anti-tumour activity at each dose and a manageable safety profile, supporting further evaluation in patients with previously untreated, unresectable LA/M PD-L1 high NSCLC.

The RELATIVITY-104 trial is a phase 2 study that investigates the combination of nivolumab, relatlimab (1:1), and chemotherapy as the initial treatment for stage IV or recurrent NSCLC.

In this study, the combination of nivolumab and relatlimab with platinum-doublet chemotherapy shows improved clinical benefits compared to nivolumab and platinum-doublet chemotherapy, especially in the PD-L1 ≥ 1% and NSQ pre-specified subgroups.

Here in ESMO I was the discussant of two trials, one was for TIGIT and the other one was for the LAG-3. For the LAG-3 there was a phase III trial called RELATIVITY that compared the patients with carboplatin/nivolumab and the LAG-3 compound that is called [??] over chemotherapy immunotherapy. The trial didn’t show a benefit in the overall population but there was a benefit in the population of patients with PD-L1 more than 1%. Dr Girard, who presented the data, showed also some results of non-preplanned other subgroup analyses and there was a very favourable benefit in the population between 1-49% where the company will go and will do a clinical trial.

The other compound was the TIGIT and the TIGIT was the TIGIT of GSK. There was a multi-cohort trial with different doses of the TIGIT compound, belrestotug, it’s difficult to say. The trial showed a very good safety profile for multiple doses and clearly an increased activity when also the drug was increased with doses. That will go in a phase III trial with the combination of 400mg, which is an average between the toxicity and the activity, over pembrolizumab and over dostarlimab which is the backbone of the combination in PD-L1 more than 50%.

So there is a desperate research on finding new immune checkpoint inhibitors that is good research. We will see in the future if some of these trials will become positive.