EDGE-Gastric is a phase II single-arm study that looked at the combination of TIGIT plus anti-PD-1 with FOLFOX in the first-line setting. This is domvanalimab + zimberelimab plus FOLFOX. We presented the overall response rate and progression free survival previously and also today at ESMO we presented overall survival data which was the first time we presented it. It’s also a simultaneous paper in Nature Medicine.
So we were able to show that in PD-L1 positive patients using TAP or TAP-5 criteria the disease control rate with this domvanalimab + zimberelimab + FOLFOX was 100% and progression free survival, even in the intent to treat population which is including PD-L1 negative patients, about 30% of patients were PD-L1 negative, the median PFS is close to a year, 12.9 months. So that’s great to see, particularly because we know anti-PD-1 therapy with chemo, such as FOLFOX + nivolumab, work but the long-term survival still needs to be improved. We also showed overall survival data in this population, showing 56% of patients alive at two years with a long-term overall survival even using for PD-L1 or TAP criteria.
In patients with a TAP positive score, with 5 or greater, the median overall survival was not yet even reached. So it’s data that’s exciting in the phase II setting; of course, we need confirmatory phase III and that’s been already completed, randomised with domvanalimab + zimberelimab + chemo versus chemo + nivolumab and hopefully we’ll be getting results of the phase III study in the near future.
Is there anything else you would like to add?
The safety of domvanalimab + zimberelimab + FOLFOX is similar to what we would see with chemo + anti-PD-1. There were no new safety signals. Most of the side effects come with chemotherapy. The rate of grade 3 or 4 immune-related adverse events was very low, it was actually zero. So phase II data looks very promising, it’s safe, we just have to wait for the efficacy.