This is a bifunctional protein which is a fusion protein where it binds by one hand to the PD-L1 ligand and on the other hand is trapping TGF-β.
When it comes to employing this in clinical practice what are we reporting at this year’s conference?
This clinical trial here is a randomised study of two doses – 500mg versus 1200mg – of this very compound. The main result is that clinical efficacy is quite encouraging, particularly at a high dose with the response rate being in the range of 37% for patients which are PD-L1 positive, being particularly surprising for those patients with expression of PD-L1 in more than 80% of the cells, the response rate being 81%. PFS data are also consistent – 9.5 for the PD-L1 positive population, being more than 15 months for those which are PD-L1 high high. Safety data are purely favourable, just some pruritus, a skin rash and some keratoacanthomas or skin neoplasms.
When it comes to expanding the platform to include possibly other disease types and disease areas?
Yes, I would say this trial is somehow done. The next step will be in stage 4 patients, those previously untreated, because this trial was in pre-treated patients but we’ll go to untreated patients with high PD-L1 expression and do a randomised study comparing this new agent, M7824, as compared to pembrolizumab. The other area of main interest in lung cancer would be stage 3; because of the TGF-β inhibition factor apart from the PD-L1 inhibition, it makes a lot of sense to do trials in conjunction with radiation, so a trial of chemoradiation plus this agent is being planned at the present time.
And in combination with any other targeted agents?
As far as I know in lung cancer it’s not being planned.