Onyx Pharmaceuticals, Inc.
) recently announced that it has finished enrolling patients for
the phase III FOCUS (Car
mib for Advan
ed Refractory M
ltiple Myeloma European
tudy) trial which is being conducted with Kyprolis (carfilzomib).
The study is being conducted in treatment-experienced patients
(who have received three or more prior therapies) with relapsed
and refractory myeloma.
The study has been designed to compare single-agent Kyprolis
with best supportive care of low-dose steroids plus optional
cyclophosphamide. While the primary endpoint is overall survival,
secondary endpoints include progression-free survival, overall
response rate, clinical benefit response, duration of response
We remind investors that Kyprolis gained US Food and Drug
Administration (FDA) approval in July for use in
treatment-experienced multiple myeloma patients (who have
received at least two prior therapies, including Takeda/
Johnson & Johnson's
) Velcade (bortezomib) and an immunomodulatory agent) and whose
disease has progressed on or within 60 days of completion of the
Approval was based on results from a phase IIb study (003-A1).
The indication for Kyprolis is based on response rate. We note
that currently no data demonstrating an improvement in
progression free survival or overall survival is available on
Immense Commercial Potential
Onyx Pharma has priced Kyprolis at $1,658 per vial, at a
premium to Velcade. The price per 28-day cycle is $9,950 based on
the dosing schedule in the label and assuming a 78 kilogram
individual. The mean duration of treatment was 4.4 months in
study 003-A1, which means treatment cost could reach $44,000.
According to the American Cancer Society, about 20,000 people
in the US could be diagnosed with multiple myeloma every year.
Onyx Pharma estimates that Kyprolis-eligible patients could be
about 10,000 - 15,000 annually in the US. This represents
significant commercial potential for Onyx Pharma.
Onyx Pharma has a dedicated 100 person oncology sales force in
place for the launch. The Kyprolis sales force will call on about
2,000 physician offices and hospitals where a major part of
Kyprolis-eligible patients are treated. As far as reimbursement
and formulary coverage is concerned, Onyx Pharma expects coverage
for about 80% of the indicated population.
While a miscellaneous J-code will be used for the time being,
a Kyprolis specific Medicare J-code is expected in January
We are encouraged by Onyx Pharma's efforts to expand Kyprolis'
label. Besides the FOCUS trial, Kyprolis is being evaluated in
several other studies including a randomized phase III trial
(ASPIRE), which is evaluating the combination of
) Revlimid and low dose dexamethasone with or without Kyprolis in
relapsed multiple myeloma patients.
Kyprolis is also in a head-to-head phase III study (ENDEAVOR)
which is being conducted in patients whose disease relapsed after
one to three treatments. The study is comparing Kyprolis plus low
dose dexamethasone to Velcade plus low dose dexamethasone with
progression free survival being the primary endpoint.
We currently have a Neutral recommendation on Onyx Pharma.
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