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Positive Phase 3 Results Released for Tanezumab Treatment

The nerve growth factor (NGF) inhibitor has been developed for osteoarthritis, chronic low back, and cancer pain.

A PPM Brief

Pfizer (New York) and Eli Lilly (Indianapolis, IN) have announced1 positive results from a Phase 3 study evaluating 2.5 mg and 5 mg tanezumab in patients with moderate to severe osteoarthritis (OA) pain. Tanezumab is a humanized monoclonal antibody and part of an investigational class of non-opioid pain medications known as nerve growth factor (NGF) inhibitors.

The most recent study looked at subcutaneous administration of tanezumab 2.5 mg or 5 mg, evaluated every eight weeks for a total of 24 weeks, in patients with moderate to severe OA pain. Patients enrolled experienced inadequate pain relief from or intolerance to at least three different classes of analgesics, and had OA for more than six years on average. Results indicated that:

  • Tanezumab 2.5 mg treatment met two of the three efficacy endpoints compared to placebo, demonstrating statistically significant improvements in pain and physical function, but patients’ overall assessment of their OA was not statistically different from placebo.
  • Tanezumab 5 mg treatment met all three endpoints at 24 weeks, demonstrating statistically significant improvements in pain, physical function, and patients’ overall assessment of their OA compared to placebo.

The trial included a 24-week safety follow-up (a total of 48 weeks of observation), where preliminary data showed that tanezumab was generally well tolerated during the 24-week treatment period, with low rates of treatment discontinuations due to adverse events.

The nerve growth factor (NGF) inhibitor has been developed for osteoarthritis, chronic low back, and cancer pain. (Source: 123RF)

“These findings build on the previously reported positive Phase 3 results in patients with osteoarthritis pain and add to the growing body of evidence supporting tanezumab as a potential innovative treatment option for this difficult-to-treat patient population,” said Ken Verburg, PhD, tanezumab development team leader at Pfizer Global Product Development, in a release.

According to the release, detailed efficacy and safety results from the study will be submitted to a future medical congress. Of note, these positive results are the second readout from the company’s ongoing Phase 3 global clinical development program for tanezumab, which includes six studies of approximately 7,000 patients with OA pain, chronic low back pain (CLBP) and cancer pain from bone metastases.

UPDATE 2/19/19: Pfizer and Eli Lily announced positive top-line results from a Phase 3 study evaluating tanezumab in patients with moderate-to-severe chronic low back pain (CLBP). Treatment with tanezumab 10 mg demonstrated a statistically significant improvement in pain at 16 weeks compared to placebo, and the tanezumab 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at week 16 analysis.

Last updated on: February 19, 2019
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