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Denosumab Oncology congress data

ESMO 2019: SAKK study of patterns of care for patients with metastatic bone disease in solid tumors

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.

ppt (416 KB)

ESMO 2018: Final analysis of the EORTC- ETOP SPLENDOUR trial

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.

ASBMR 2018: Analysis of denosumab discontinuation in the ABSCG-18 study

At the ASBMR (American Society of Bone Mineral Research) 2018, G. Pfeiler et al. presented the «rebound-associated fracture» analysis after discontinuation of denosumab (Prolia) in early-stage breast cancer patients of the ABSCG-18 study. They analysed clinical fractures in the off-treatment period, starting at 6 months after the last dose of denosumab/placebo (n=1613/n=1576) with a median follow-up of 36 months. Abstract (LB-1167).

Conclusions of the authors (oral presentation):

There was no difference in overall fracture risk observed in patients who stopped denosumab compared to patients who stopped placebo.
After stopping denosumab there was a significant increase in clinical vertebral (1.4% vs. 0.6% ≈2.5-fold) and clinical multiple vertebral fractures (0.7% vs 0.2%; 3.5-fold), even though the (absolute) numbers were small.
There was no signal for an increase in clinical vertebral fractures in patients who ended AI treatment within 6 months of stopping denosumab.

Further information on Denosumab therapy management in AIBL can be found here.

ASCO 2018: Analysis of DFS in the ABCSG-18 study

Oral presentation by M. Gnant et al. at ASCO 2018

ppt (9.25 MB)

M. Gnant presented a descriptive, time-driven Disease-Free Survival analysis of the ABCSG-18 study investigating denosumab versus placebo in postmenopausal women with early-stage breast cancer receiving aromatase inhibitors. Denosumab improved the DFS compared to placebo (HR=0.82; 95% CI 0.69-0.98; p=0.026 descriptive) and was well tolerated with overall AE rates similar to placebo.

M. Gnant et al. Lancet Oncol 2019. Published Online February 19, 2019
http://dx.doi.org/10.1016/S1470-2045(18)30862-3

ASCO 2018: Primary analysis of the D-CARE study

Oral presentation by R. Coleman et al. ASCO 2018

ppt (1.59 MB)

The primary analysis of the randomized phase 3 study with adjuvant denosumab (120 mg Q4W) in high risk early breast cancer patients has been presented. There was no difference in the primary endpoint Bone Metastasis Free Survival between denosumab and placebo (HR (95% CI) 0.97 CI 0.82-1.14, p=0.7). Denosumab was generally well tolerated and events were consistent with the known safety profile.

ASCO & EHA 2017: Analysis by renal status and Landmark analysis of the phase 3 trial 482 of denosumab vs. zoledronic acid for the treatment of bone disease in multiple myeloma

Oral presentation by E. Terpos et al. EHA 2017

ppt (1.88 MB)

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

IMW 2017: Primary analysis of the phase 3 trial 482 of denosumab vs. zoledronic acid for the treatment of bone disease in multiple myeloma

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.

All analyses are available upon request at Medinfo

Abbreviations: Overall Survival (OS); Progression Free Survival (PFS); Months (Mo); Hazard Ratio (HR); versus (vs); weeks (we)

This congress-section could contain information to non-licensed treatment lines, combinations and dosage regimens.

SC-CH-AMG162-00162

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