A Randomized Placebo-Controlled Trial of the Anti-Nerve Growth Factor Antibody Tanezumab in Subjects With Cancer Pain Due to Bone Metastasis

• Published in: The oncologist (Dayton, Ohio) Vol. 28; no. 12; pp. e1268 - e1278
• Main Authors: Fallon, Marie, Sopata, Maciej, Dragon, Erika, Brown, Mark T, Viktrup, Lars, West, Christine R, Bao, Weihang, Agyemang, Alex
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 01.12.2023
• Subjects: Analysis; Antibodies; Cancer; Cancer pain; Care and treatment; Clinical trials; Dosage and administration; Metastasis; Monoclonal antibodies; Nerve growth factor; Pain; Pharmaceutical industry; Prevention; Risk factors; Symptom Management and Supportive Care; Viral antibodies; United States; cancer pain; nerve growth factor; tanezumab; randomized controlled trial
• ISSN: 1083-7159; 1549-490X; 1549-490X
• DOI: 10.1093/oncolo/oyad188

Background This phase III, randomized, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of tanezumab in subjects with cancer pain predominantly due to bone metastasis receiving background opioid therapy. Methods Subjects were randomized (stratified by (1) tumor aggressiveness and (2) presence/absence of concomitant anticancer treatment) to placebo or tanezumab 20 mg. Treatment was administered by subcutaneous injection every 8 weeks for 24 weeks (3 doses) followed by a 24-week safety follow-up period. The primary outcome was change in daily average pain in the index bone metastasis cancer pain site (from 0 = no pain to 10 = worst possible pain) from baseline to week 8. Results LS mean (SE) change in pain at week 8 was −1.25 (0.35) for placebo (n = 73) and –2.03 (0.35) for tanezumab 20 mg (n = 72). LS mean (SE) [95% CI] difference from placebo was –0.78 (0.37) [–1.52, –0.04]; P = .0381 with α = 0.0478. The number of subjects with a treatment-emergent adverse event during the treatment period was 50 (68.5%) for placebo and 53 (73.6%) for tanezumab 20 mg. The number of subjects with a prespecified joint safety event was 0 for placebo and 2 (2.8%) for tanezumab 20 mg (pathologic fracture; n = 2). Conclusion Tanezumab 20 mg met the primary efficacy endpoint at week 8. Conclusions on longer-term efficacy are limited since the study was not designed to evaluate the durability of the effect beyond 8 weeks. Safety findings were consistent with adverse events expected in subjects with cancer pain due to bone metastasis and the known safety profile of tanezumab. Clinicaltrials.gov identifier: NCT02609828. Bone metastasis is a common cause of cancer-related pain. This article reports on the potential of anti-nerve growth factor therapies, such as tanezumab, to reduce pain caused by bone metastases.