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Now, for the last part of my presentation,
I want to move into the space of relapsed refractory disease.
I'll move through this relatively promptly for you in the interests of time.
Rational combination strategies are in
the treatment of the relapsed refractory myeloma are critical.
With the advent of novel agents third generation IMiDs,
next generation proteasome inhibitors of monoclonal antibodies,
the playing field has been dramatically changed.
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Now, I want to share with you some of the data from
the combination of pomalidomide, bortezomib,
and dexamethasone compared to a control of
bortezomib and dexamethasone relapsed refractory disease.
This is the so-called OPTIMISMM trial which we presented first at ASCO in last year,
and then this was updated most recently by my colleague,
Dr. Thanos Dimopoulos, at the ASH meeting this last December.
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Progression-free survival by intent to treat was strikingly in
favor of the three drugs over the two with hazard ratio of 0.61.
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But what's really interesting is if you looked at one prior line of therapy,
and importantly in this study,
all the patients were lenalidomide exposed,
and 70 percent of them were in fact lenalidomide refractory.
If you look at the first relapse group,
what we were very pleased to see was despite lenalidomide exposure and/or refractoriness,
the pomalidomide, bortezomib, dexamethasone platform generated
a median progression-free survival to 21 months with a hazard ratio of 0.54.
What was particularly also important,
was that in this context,
the safety signal was excellent.
So this constitutes something that I think is very important for our patients,
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that essentially when lenalidomide treatment has failed a patient,
we have excellent options that are pomalidomide based,
and also potentially affordable because
they incorporate bortezomib which is now generic as
the proteasome inhibitor platform combined with the
two to generate the powerful three-drug platform.
So the OPTIMISIMM data are quite exciting.
