Pfizer and Eli Lilly and Company announced complete results from a Phase 3 study evaluating the efficacy and safety of subcutaneous administration of tanezumab, an investigational humanized monoclonal antibody, in patients with osteoarthritis (OA) pain treated for 16 weeks. The study met all three co-primary efficacy endpoints, demonstrating that among patients with moderate-to-severe OA pain of the knee or hip, both dosing regimens of tanezumab were associated with a statistically significant improvement in pain, physical function and patient’s global assessment of their OA, compared to placebo. These data were presented during a late-breaking oral session at the 2018 American College of Rheumatology/Association of Rheumatology for Health Professionals (ACR/ARHP) Annual Meeting in Chicago.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
“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 Ken Verburg, tanezumab development team leader, Pfizer Global Product Development. “Our goal is to be able to offer tanezumab as a potential non-opioid treatment option for these patients suffering from osteoarthritis pain.”
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 Christi Shaw, senior vice president, Eli Lilly and Company and president, Lilly Bio-Medicines. “These initial results from our Phase 3 program for tanezumab are promising, and we’re eager to gain further insights as additional data report out next year.”
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 Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscale and patient’s overall assessment of their OA (PGA-OA). At 16 weeks of treatment, tanezumab was associated with a significant reduction in pain compared to placebo; additional efficacy findings are detailed in the table below.
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.