Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY)
today announced top-line results from a Phase 3 study evaluating
tanezumab 2.5 mg and 5 mg. The objective of the study was to
compare the long-term joint safety and 16-week efficacy of
tanezumab relative to nonsteroidal anti-inflammatory drugs (NSAIDs)
in patients with moderate-to-severe osteoarthritis (OA) of the hip
or knee. The tanezumab 5 mg treatment arm met two of the three
co-primary efficacy endpoints, demonstrating a statistically
significant improvement in pain and physical function compared to
NSAIDs at the 16-week analysis, while patients’ overall assessment
of their OA was not statistically different than NSAIDs. Patients
who received tanezumab 2.5 mg did not experience a statistically
significant improvement in pain, physical function or patients’
overall assessment of their OA at 16 weeks compared to NSAIDs. In
the safety analysis, there was a higher rate of joint safety events
in the tanezumab arms compared to NSAIDs at 80 weeks; the
difference was statistically significant. Joint safety was a
composite measure consisting of adjudicated outcomes of rapidly
progressive osteoarthritis (RPOA) type 1 or type 2, subchondral
insufficiency fracture, osteonecrosis or pathological fracture.
Tanezumab is a monoclonal antibody that is part of an
investigational class of non-opioid chronic pain medications known
as nerve growth factor (NGF) inhibitors.
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“We are analyzing these findings in the context of the recent
Phase 3 results as we assess potential next steps for tanezumab,”
said Ken Verburg, tanezumab development team leader, Pfizer Global
Product Development. “We plan to review the totality of data from
our clinical development program for tanezumab with regulatory
authorities.”
“Lilly and Pfizer recognize the significant unmet needs for
patients living with osteoarthritis,” said Christi Shaw, president,
Lilly Bio-Medicines. “We are committed to understanding these
results for people who suffer from chronic pain.”
In this study, tanezumab 2.5 mg or 5 mg was administered
subcutaneously (SC) every eight weeks, for a total of 56 weeks.
Preliminary safety data showed that the overall adverse event
profile with tanezumab was generally consistent with previous
studies of tanezumab in OA, though in this study, discontinuations
due to adverse events were higher among those receiving tanezumab
compared to NSAIDs during the 56-week treatment period. The study
also included a 24-week safety follow-up period, for a total of 80
weeks of observation. There were 10 deaths in the study; nine
occurred in the tanezumab treatment arms and one in the NSAID
treatment arm. None were considered treatment-related: five
occurred during the treatment period and five occurred after the
treatment period.
The incidence of the primary composite joint safety endpoint was
7.1 percent in the tanezumab 5 mg arm, 3.8 percent in the tanezumab
2.5 mg arm and 1.5 percent in the NSAIDs arm. RPOA accounted for
the majority of events observed in the composite joint safety
endpoint. The incidence of RPOA overall was 6.3 percent in the
tanezumab 5 mg arm, 3.2 percent in the tanezumab 2.5 mg arm and 1.2
percent in the NSAIDs arm. The majority of RPOA events (81 percent)
observed with tanezumab were RPOA type 1. There was one patient
with osteonecrosis in the tanezumab 5 mg arm, and no patients in
the tanezumab 2.5 mg or NSAIDs arms. Subchondral insufficiency
fracture was observed in seven, six and four patients receiving
tanezumab 5 mg, tanezumab 2.5 mg and NSAIDs, respectively. There
were no pathological fractures observed in patients treated with
tanezumab or NSAIDs. The incidence of total joint replacement was
8.0 percent in the tanezumab 5 mg arm, 5.3 percent in the tanezumab
2.5 mg arm and 2.6 percent in the NSAIDs arm.
The full results from this study will be submitted for future
scientific publication or presentation.
About the Study
Study A4091058 was a randomized, double-blind,
active-controlled, multicenter, parallel-group study evaluating the
safety and efficacy of SC administration of tanezumab for 56 weeks
compared to NSAIDs in patients with moderate-to-severe OA. The
study was conducted worldwide (United States, Europe, Asia and
Latin America).
Patients considered for this study had experienced inadequate
pain relief from or intolerance to acetaminophen and either
tramadol or opioids (or unwilling to take opioids). They were on a
stable dose of NSAID before being screened into the study and had
experienced at least some benefit from stable NSAID treatment
during the period prior to randomization. On average patients had
suffered from OA for approximately eight years and had baseline
Western Ontario and McMaster Universities Osteoarthritis Index
(WOMAC) pain scores of seven out of 10. At the beginning of the
study, they also reported a significant impact of their pain on
their ability to function in everyday life.
A total of 3,021 patients were randomized in a 1:1:1 ratio to
receive either tanezumab 2.5 mg every eight weeks, tanezumab 5 mg
every eight weeks, or oral NSAIDs (either naproxen 500 mg,
celecoxib 100 mg or diclofenac Extended Release 75 mg) twice daily
over the 56-week treatment period. The study also included a
24-week safety follow-up period.
The primary safety endpoint evaluated a composite measure of
adjudicated outcomes of RPOA type 1 or type 2, subchondral
insufficiency fracture, primary osteonecrosis or pathological
fracture through 80 weeks (56 weeks of treatment plus a 24-week
safety follow-up period). RPOA type 1 was defined as a significant
loss of joint space width ≥2 mm (predicated on optimal joint
positioning) within approximately one year, without gross
structural failure. RPOA type 2 was defined as abnormal bone loss
or destruction, including limited or total collapse of at least one
subchondral surface that is not normally present in conventional
end-stage OA. The co-primary efficacy endpoints evaluated changes
from baseline to week 16 in the WOMAC Pain subscale, the WOMAC
Physical Function subscale, and the Patient’s Global Assessment of
OA.
About Tanezumab
Tanezumab is an investigational monoclonal antibody that works
by selectively targeting, binding to and inhibiting NGF. NGF levels
increase in the body as a result of injury, inflammation or in
chronic pain states. By inhibiting NGF, tanezumab may help to keep
pain signals produced by muscles, skin and organs from reaching the
spinal cord and brain. Tanezumab has a novel mechanism that acts in
the periphery in a different manner than opioids and other
analgesics, including NSAIDs, and in studies to date, tanezumab has
not demonstrated a risk of addiction, misuse or dependence.
In June 2017, Pfizer and Lilly announced that the U.S. Food and
Drug Administration (FDA) granted Fast Track designation for
tanezumab for the treatment of OA and chronic low back pain. Fast
Track designation is a process designed to facilitate the
development and expedite the review of new therapies that treat
serious conditions and fill unmet medical needs.
About Pfizer Inc.: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world’s best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world’s premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
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About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with
discovery to make life better for people around the world. We were
founded more than a century ago by a man committed to creating
high-quality medicines that meet real needs, and today we remain
true to that mission in all our work. Across the globe, Lilly
employees work to discover and bring life-changing medicines to
those who need them, improve the understanding and management of
disease, and give back to communities through philanthropy and
volunteerism. To learn more about Lilly, please visit us
at www.lilly.com and https://www.lilly.com/newsroom/social-channels.
PFIZER DISCLOSURE NOTICE:
The information contained in this release is as of April 18,
2019. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about a
product candidate, tanezumab, including its potential benefits,
that involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied
by such statements. Risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement and/or completion dates for our clinical trials,
regulatory submission dates, regulatory approval dates and/or
launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from our clinical studies; whether and when drug
applications for any potential indications for tanezumab may be
filed in any jurisdictions; whether and when regulatory authorities
in any jurisdictions may approve any such applications, which will
depend on myriad factors, including making a determination as to
whether the product’s benefits outweigh its known risks and
determination of the product’s efficacy and, if approved, whether
tanezumab will be commercially successful; decisions by regulatory
authorities impacting labeling, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of tanezumab; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
LILLY DISCLOSURE NOTICE: This press release
contains forward-looking statements (as that term is defined in the
Private Securities Litigation Reform Act of 1995) about tanezumab
as a potential treatment for patients with osteoarthritis, chronic
low back pain, and cancer pain, and reflects Lilly’s current
beliefs. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of drug
development and commercialization. Among other things, there is no
guarantee that future study results will be consistent with study
findings to date, or that tanezumab will be approved by the U.S.
FDA or other regulatory authorities on the anticipated timeline or
at all, or that tanezumab will be commercially successful. For
further discussion of these and other risks and uncertainties, see
Lilly’s most recent Form 10-K and Form 10-Q filings with the United
States Securities and Exchange Commission. Except as required by
law, Lilly undertakes no duty to update forward-looking statements
to reflect events after the date of this release.
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Pfizer Media:Steve
Danehy212-733-1538steven.danehy@pfizer.com
Pfizer Investors:Ryan Crowe212-733-8160ryan.crowe@pfizer.com
Eli Lilly Media:Jen
Dial317-220-1172dial_jennifer_kay@lilly.com
Eli Lilly Investors:Kevin
Hern317-277-1838hern_kevin_r@lilly.com
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