The final analysis of SPLENDOUR trial did not show improvement in overall survival in advanced Non-Small Lung Cancer

Results of the EORTC- ETOP SPLENDOUR trial will be presented today at the ESMO 2018 congress in Munich. This randomised phase III 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).

Denosumab is a human monoclonal antibody used to treat bone metastases. It is a RANKL inhibitor which works by preventing the development of osteoclasts, the cells that break down.

In this trial, 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 denosumab. 73%of the patients were between 56 and 75 years of age and 93% were former or current smokers. Slightly more than half of the patients did have bone metastasis when entering the study. 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 a previous large retrospective trial, it was suggested that there was a significant overall survival advantage in lung cancer patients receiving denosumab. However even though denosumab was well tolerated, in SPLENDOUR trial, there was no significant difference in overall survival for patients receiving standard chemotherapy compared to the addition of this antibody.

Bakitar Hasan, EORTC senior statistician said “ Even though the results were negative Overall, denosumab is well tolerated without major safety concerns. Our results also show that in patients without bone metastasis at study entry, there was no difference in OS between denosumab and best supportive care.”

Abstract 1385PD: A randomised phase III trial evaluating the addition of denosumab to standard first-line treatment in advanced NSCLC – the ETOP and EORTC SPLENDOUR trial.

Poster Presenter: Solange Peters (Switzerland); Date: 21.10.2018 – Lecture Time 17:15 – Location: ICM – Room 13