Today we have some presentation about the called VOLTAGE study. This is a single arm study with targeting MSS, microsatellite stable, locally advanced resectable rectal cancer. To my best knowledge, this is the first report using the immuno-checkpoint inhibitor for this indication.

Could you say more on the study design?

The study design is a single arm phase II study using the nivolumab treatment, five cycles with nivolumab every two weeks, after chemoradiotherapy for resectable advanced rectal cancer.

What were the results?

This trial was conducted as an investigator initiated trial at several hospitals in Japan. The primary endpoint was pathological complete response rate by centrally assessed assessment. Surprising, the pathological CR rate was 30%. This is a very high response rate, usually it’s 10-20% of the pathological CR according to several literature. In addition, 8% of the patients were not CR but major response so the total is 38% of the patients had a major response rate. It’s a great result.

Looking at the downstaging parameter, the NAR score showing less than 10, this is suggesting that our pCR rate, the 30%, is promising.

How do you expect this to affect the clinical landscape?

We are now also conducting comprehensive translational research. Today I would like to present about some translational research results. The PD-L1 expression as well as CD8 T-regulation will also be an important indicator predictive of nivolumab treatment benefit. So I will now be conducting comprehensive ongoing translational research already based on this data moving forward with a large scale phase II/phase III trial in the near future.

Have you noticed differences between how trials like this are run in Europe and Japan?

Yes, of course global confirmation is important across different countries. So I guess a next step is a global trail, in my hope, depending on a discussion about the corresponding companies.