DR FUCHS: It’s an antibody, but specific to the VEGF receptor-2. At least the Phase II single-arm data suggested that the antibody had efficacy in this disease. And, in fact, the idea is that it may have benefited any of the disease that we anticipate that targeting angiogenesis may be worthwhile.
So there is an ongoing randomized Phase III in patients who had failed sorafenib randomized to ramucirumab or best supportive care. And I think it’s certainly a worthwhile study.
Two in gastric cancer, one completed, which was in patients who had failed first-line therapy, randomized to the antibody, which targets the VEGF receptor-2 or best supportive care. That study completed enrollment in January. So I anticipate we’ll get results early next year.
The second study, which was reported as a trial in progress, is, again, the same population, second line, but in this case they actually get paclitaxel with or without the antibody. So everyone gets chemotherapy on that trial.
So all, I think, are well-designed studies to see whether the antibody works either as a single agent in gastric or hepatocellular carcinoma or in addition to a taxane in the second line.
DR LOVE: What about your study in colorectal, Axel?
DR GROTHEY: So ramucirumab is tested in colorectal cancer, similar to the VELOUR study. Kind of what aflibercept did in VELOUR is what ramucirumab does in RAISE, with the exception that in this ramucirumab study all patients have to have prior bevacizumab. So it’s really testing this idea of VEGF inhibition beyond progression. And it’s a multinational study, which has accrued about half of the patient population that’s needed.
It’s interesting. After ASCO, we actually saw an increase in the number of registrations of patients because in a lot of countries VEGF inhibition beyond progression is not available. So now there is a parent trial open where half the patients get VEGF inhibitors beyond progression. So that makes it more intriguing for physicians to enroll patients, apparently.
And there has been some discussion about should we redesign it? Should we have a bev control arm? Should we whatever.
But in a lot of countries the access to VEGF inhibitors is very limited. And that’s why this will eventually stand alone and you would move over to a cross-trial comparison to make a judgment call on whether you use this drug versus aflibercept, versus bev beyond progression in your clinical practice if it’s positive, if it gets approved. And I think the main issue is also to get a better understanding about toxicity profile, because we talked about toxicity profile of aflibercept. And eventually it will come down to having options. We might have 3 different options for second-line therapy in colorectal cancer, aflibercept, bevacizumab and, perhaps, ramucirumab.