Practice Update | Onology

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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
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,
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
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.
Watch the full interview on
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.
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.
Watch the full interview on
© ASCO 2017/Matt Herp
ASCO 2017 21
VOL. 1 • NO. 2 • 2017