The anti-nerve growth factor (NGF) antibody tanezumab can reduce pain in cancer patients, according to research published in The Oncologist.
The benefits of tanezumab were seen only at 8 weeks, however, and the drug is no longer under development.
In this phase 3 trial (ClinicalTrials.gov Identifier: NCT02609828), 155 patients with cancer pain, predominantly due to bone metastasis, were randomly assigned to receive tanezumab at 20 mg (n=72) or placebo (n=73), in addition to background opioid therapy.
Compared to placebo, tanezumab was associated with a greater improvement in the primary endpoint of change in daily average pain in the index bone metastasis cancer pain site.
At week 8, the least-squares mean change from baseline in daily average pain intensity at the index bone metastasis cancer pain site was -1.25 in the placebo arm and -2.03 in the tanezumab arm (P =.0381).
At week 8, the proportion of patients with at least a 50% improvement in average
pain was 12.3% in the placebo arm and 25.4% in the tanezumab arm (P =.0405). The proportion of patients with at least a 50% improvement in worst pain was 9.6% in the placebo arm and 22.5% in the tanezumab arm (P =.0457).
This study was not designed to evaluate the durability of efficacy beyond 8 weeks, the researchers noted.
Treatment-emergent adverse events (TEAEs) were reported over the 24-week safety period in 68.5% of patients in the placebo arm and 73.6% of patients in the tanezumab arm. Serious TEAEs were reported in 30.1% and 40.3%, respectively. Severe TEAEs were reported in 32.9% and 41.7%, respectively.
Prespecified joint safety events were reported in none of the patients in the placebo arm and in 2 (2.8%) patients in the tanezumab arm. Both of these events were considered a pathologic fracture.
The researchers concluded that, at 8 weeks, the primary efficacy endpoint in this study was met. However, the durability of efficacy beyond this time point has not yet been shown, and adjudicated intra-articular pathologic fractures occurred only in the tanezumab-treated population.
The researchers noted that the development program for tanezumab was discontinued in 2021 due to the outcomes of regulatory reviews of the drug for the treatment of osteoarthritis pain.
The development of other anti-NGF antibodies — fasinumab and fulranumab — was stopped as well. This leaves “the future of anti-NGF therapy for cancer-related pain in doubt unless other agents targeting the NGF-signaling pathway (with improved joint safety profiles) emerge in the future,” the researchers concluded.
Disclosures: This research was supported by Pfizer and Eli Lilly and Company. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Fallon M, Sopata M, Dragon E, et al. A randomized placebo-controlled trial of the anti-nerve growth factor antibody tanezumab in subjects with cancer pain due to bone metastasis. Oncologist. Published online June 21, 2023. doi:10.1093/oncolo/oyad188