Practice Update | Onology

ASCO 2017 21

the data. Pfizer has filed for approval with a PDUFA date in about 6 months. If that gets approved, I think it will potentially shift everybody toward that as the new stand- ard. Until that time, there might be people embracing it based on the data that we have. I think if this was other solid tumors, like breast cancer and some other diffi- cult-to-treat solid tumors, people would be embracing this data already. I find it good data; I find it interesting data. I think there are patients who are higher risk that I would consider that. And tomor- row they’re also presenting some data on a 16-gene panel in the S-TRAC data that dif- ferentiate high recurrence score from low recurrence score in terms of prognosticat- ing patients who might be at higher risk or lower risk. Maybe that’ll provide additional biologic insight into who ought to be giv- ing adjuvant therapy to and who not to. In order to really push the field, we need an effective biomarker to prognosticate,

in kidney cancer there’s been a lot of false starts; there’s been a lot of negative studies using early immunotherapy with interferon and IL-2 and stuff like that that really has no benefit whatsoever. Then there was early data presented, the ASSURE data, that was also a negative study using sunitinib. So really it didn’t look like things were going anywhere. Then last year the S-TRAC data showed an enhanced disease-free sur- vival… not necessarily overall survival, so there was some cautious acceptance of that data. Nobody went all in on it. Now with ProtecT; very interesting because the study was done initially with the first 400 patients treated at the full dose of [paz- opanib] 800 mg. But when patients had toxicity, they lowered the dose to 600 mg, and did the next 1000 or so patients at 600 mg. When they looked at that data, which was the primary endpoint, there was no benefit in terms of risk reduction using pazopanib in these, generally speaking, high-risk patients for adjuvant therapy. But this dataset now looks at secondary end- point using the 800 mg on that first 400 patients, and then takes the combined dataset and looks at the potential bene- fit. It seems that there probably is a 25% to 30% decrease in disease-free survival using that 800 mg dose. Again, proof of concept for disease-free survival benefit with a VEGF-inhibitor. The same way that the S-TRAC data showed around the same benefit or so that clearly patients required dose reduction of maybe a third or so, and there’s clearly toxicity. Can they tolerate it? Go through the full year that’s required, but I think...there’s clearly going to be some cautious embracing of so much so that I was on social media and I was tweeting there, and I thought the new response criteria for myeloma should be MRD-negative, any response, or pro- gressive disease. And we’re getting to that point, and some of those things really have to be sorted out in phase 3 clinical trials. Fortunately, several of them were presented as well. Dr Haffizulla: So still some information that can be applied to clinical practice. Dr Fonseca: Yes. I think it’s important for peo- ple to realize and this is probably even more important for patients that if one is diagnosed with myeloma, and there is some unique situations where it can be challenging, there is no room to be nihilis- tic. I mean, the opportunities for successful treatment for the disease up front continue to get better.

targeted therapy. There are some data that’s being presented tomorrow on that combination. Some showing impressive results at increased response rate with, for example, avelumab with axitinib in the front line and about 54% response rate, which is high. Jerry and his colleagues are presenting that. There’s the IMpower150 data with ate- zolizumab with bevacizumab that also looks at 45% response in the PD-L1 posi- tive patients; also an impressive response. Those are early-phase studies, so it’s too early to tell whether there’s going to... that will go the distance. So it’s not nec- essarily practice-changing. But in terms of where the field is going, it’s either going to be combination immunotherapy, which I’m optimistic about, or combining current immune agents with targeted therapy.

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and when we...looking at some of these PD-1 inhibitors and adju- vant therapy, I think that that is another place that we need to continue to explore and push the envelope there. Dr Caudle: Any other key trials from this year’s ASCO conference that are likely to change your practice or [you’re] kind of curious about? Dr Somer: I think those are the main things in terms of practice-chang- ing. Where the field is going, it’s either going to be combination immunotherapy, like we just talked about, or combining immu- notherapy with a VEGF-inhibitor

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Dr Haffizulla: So just stay tuned, essentially, until the data refines itself. But remain flex- ible in your treatment options. Dr Fonseca: Exactly. Dr Haffizulla: I know data regarding the performance of two lenalidomide-based tri- plets, RAD versus BRD, prior to autologous stem cell transplant have been released this year at ASCO and comparable efficacy between the two groups, would you say? Dr Fonseca : That is correct, and I’m not sure that’s going to change practice in the US because I think the appetite for the use of some of the standard chemotherapy or older chemotherapy is probably not going to be as high. And people seem to really like what we already have for those com- binations. But those are key questions at the international level, at the global level. Other studies looked at cyclophosphamide,

for instance, combinations as well, which again are pertinent, but I think the more we go and then some of those differences are subtle, but the more we go along it’s probably the PI/IMiD plus dexamethasone as a new standard. Dr Haffizulla: But does the data validate the use of RAD as an alternative to BRD for induction? And which patients do you think might benefit? Dr Fonseca: In my opinion, I would not use the regimen right now…I think I would stick with BRD. Now, if a person lives in a countrywhere there’s a difficulty in obtaining B up front, I think that would be an option. Ironically, it’s harder to get R than B throughout the global community, so I don’t anticipate there’s going to be a lot of traction for RAD.

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VOL. 1 • NO. 2 • 2017