The majority of patients were treated according to current guideline recommendations with regard to start and interval of Bone Targeted Agents treatment.
Poster 1797P, M. Mark et al.
This randomized phase 3 trial evaluated whether the addition of denosumab to standard first line platinum-based doublet chemotherapy improves overall survival in advanced Non-Small Cell Lung Cancer (NSCLC). 514 patients were randomised to either the control arm receiving standard first-line platinum-based chemotherapy plus best supportive care or the experimental arm receiving standard chemotherapy plus monthly denosumab. The overall survival was 8.2 months for patients receiving standard chemotherapy and denosumab compared to 8.8 months in those that received the standard chemotherapy and best supportive care.
"When denosumab was compared to zoledronic acid in bone metastatic solid tumours in the pivotal trial, an adhoc analysis on overall survival suggested that there was a significant OS benefit in lung cancer patients receiving denosumab. (Henry DH, et al. J Clin Oncol 2011). However, in the SPLENDOUR study, even though denosumab was well tolerated, there was no significant difference in overall survival for patients receiving standard chemotherapy compared to the addition of the anti-RANKL antibody.” (S. Peters, ESMO 2018).
Poster available upon request with
Medinfo.
The slides to the poster can be viewed
here.
Oral presentation by E. Terpos et al. EHA 2017
The primary, non-inferiority endpoint of this randomized, placebo-controlled phase 3 study with denosumab versus zoledronic acid to delay skeletal related complications has been reached in the pivotal trial (HR [95% CI] = 0.98 [0.85, 1.14], P = 0.01). There was no significant difference in overall survival, however the median progression free survival (PFS; exploratory endpoint) was prolonged by 10.7 months in the denosumab arm compared to the zoledronic acid arm (HR (95% CI) = 0.82 (0.68, 0.99), descriptive P = 0.036; PFS was an exploratory endpoint). There was a significantly lower incidence of adverse events potentially related to renal toxicity with denosumab compared to zoledronic acid therapy (10% vs. 17.1%). (
Oral presentation by N. Raje et al. ASCO 2017).
A post-hoc 15-month landmark-analysis demonstrated an improved delay in time to first skeletal-related events for denosumab treated patients. (
Oral presentation by Terpos E, et al. EHA 2017)
Raje NS, Terpos E, Willenbacher W, et al. The Lancet Oncology. 2018. 19: 370–81
The primary, non-inferiority endpoint of denosumab versus zoledronic acid to delay skeletal related complications has been reached in the pivotal trial (HR [95% CI] = 0.98 [0.85, 1.14], P = 0.01). The median progression free survival (PFS) has been prolonged by 10.7 months in the denosumab arm compared to zoledronic acid arm (HR (95% CI) = 0.82 (0.68, 0.99), descriptive P = 0.036; PFS was an exploratory endpoint).
The slides can be viewed
here.