Complete Results from First Study in Ongoing Phase 3 Program for Tanezumab Demonstrated Significant Improvement in Pain and Function in Osteoarthritis Patients
Over Half of Patients Treated with Tanezumab Reported a 50 Percent or Greater Reduction in Osteoarthritis Pain of the Knee or Hip
Pfizer and Lilly Present Late-Breaking Data at 2018 ACR/ARHP Annual Meeting
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“The results demonstrated by tanezumab in this study are particularly meaningful, given that patients had moderate-to-severe pain and were unable to achieve adequate pain relief with other treatment options, including opioids and NSAIDs,” said
More than 27 million Americans are living with OA, a progressive disease that can cause ongoing debilitating pain. Treatments for OA pain are limited, and many individuals are unable to find relief from or tolerate currently available options. Tanezumab is part of an investigational class of pain medications known as nerve growth factor (NGF) inhibitors, and in addition to OA pain, is also being studied as a potential treatment for chronic low back pain (CLBP) and cancer pain (due to bone metastases). If approved, tanezumab would be a first-in-class, non-opioid treatment for OA pain and CLBP.
“Pfizer and Lilly each have a long-standing heritage of scientific innovation in developing novel pain treatments and a shared commitment to the development of tanezumab,” said
The Phase 3 OA study evaluated changes from baseline to 16 weeks for three co-primary efficacy endpoints of pain intensity and physical function, assessed using the
|N = 232||N = 231||N = 233|
|WOMAC Pain: Change from Baseline (p-value) versus placebo||-2.6||-3.2*||-3.4**|
|Reduction from Baseline at Week 16|
|WOMAC Physical Function: Change from Baseline (p-value) versus placebo||-2.6||-3.2**||-3.5***|
|PGA-OA: Change from Baseline (p-value) versus placebo||-0.65||-0.87*||-0.90**|
*p ≤ 0.05; **p ≤ 0.01; ***p ≤ 0.001 vs. placebo
In the study, nasopharyngitis (common cold), pain in extremity and paresthesia (tingling or numbing) were the most common adverse events (AEs ≥3%) and had a higher frequency in both tanezumab treatment groups compared to placebo-treated patients. Tanezumab was generally well tolerated, with 0.4 percent and 1.3 percent of patients in the tanezumab 2.5 mg and 2.5/5 mg arms, respectively, discontinuing treatment due to AEs; 1.3 percent of patients in the placebo arm discontinued treatment due to AEs.
There were no cases of osteonecrosis observed in the study. Rapidly progressive osteoarthritis (RPOA) was observed with tanezumab-treated patients at a frequency of 1.3 percent and was not observed in the placebo arm. The incidence of RPOA type 1 (accelerated joint space narrowing) in the tanezumab 2.5 mg and 2.5/5 mg arms was 1.3 and 0.4 percent, respectively, and the incidence of RPOA type 2 (damage or deterioration of the joint) was 0.9 and 0 percent, respectively. In the study, 3.5 percent and 6.9 percent of patients receiving tanezumab 2.5 mg and 2.5/5 mg, respectively, had total joint replacement surgery, compared to 1.7 percent receiving placebo. The majority of surgeries (68 percent) took place after treatment was completed, during or shortly after the 24-week safety follow-up period of the study. All surgeries in this study took place among patients with more severe OA at screening (Kellgren-Lawrence grade 3-4).
The Phase 3 global clinical development program evaluating the efficacy and safety of tanezumab includes six studies in approximately 7,000 patients with OA pain, CLBP and cancer pain (due to bone metastases). Additional readouts from the Phase 3 program are anticipated beginning in the first half of 2019.
About the Study
The Phase 3 OA study (A4091056) was a 16-week randomized, double-blind, placebo-controlled, multicenter, parallel-group trial evaluating the efficacy and safety of subcutaneous administration of tanezumab compared to placebo in patients with OA of the knee or hip. The trial included a 24-week safety follow-up period. In the study, patients were enrolled with moderate-to-severe OA pain who had experienced inadequate pain relief with other treatment options for OA pain or were unable to take other pain medications. A total of 698 patients were randomized to three treatment groups in a 1:1:1 ratio to receive two injections over the 16-week treatment period, once every eight weeks; 696 patients received treatment. One group received two doses of placebo, the second group received two doses of tanezumab 2.5 mg, and the third group received one dose of tanezumab 2.5 mg followed by one dose of tanezumab 5 mg eight weeks later.
Efficacy in the study was measured based on change from baseline to 16 weeks using the WOMAC Pain and Physical Function subscales (11-point numerical rating scale, where higher scores indicate higher pain levels or worse function) and
Tanezumab is an investigational humanized 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 a different manner than opioids and other analgesics, including nonsteroidal anti-inflammatory drugs (NSAIDs), and in studies to date, tanezumab has not demonstrated a risk of addiction, misuse or dependence.
In 2013, Pfizer and Lilly entered into a worldwide co-development and co-commercialization agreement for the advancement of tanezumab. In
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PFIZER DISCLOSURE NOTICE: The information contained in this release is as of
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 trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when new drug applications may be filed in any jurisdictions for tanezumab; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted and, if approved, whether tanezumab will be commercially successful; decisions by regulatory authorities regarding labeling and 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
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.
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