392P - Clinical data from the real world: Efficacy analysis of ceritinib (450mg) in ALK-positive non-small cell lung cancer patients with brain metastases in China

Background

The real-world intracranial efficacy data of ceritinib at a dose of 450mg QD are still unavailable, thus this study aims to analyze the intracranial efficacy of ceritinib (450mg QD) in ALK-rearrangement NSCLC patients in China.

Methods

The intracranial and whole body efficacies [objective response rate (ORR) and disease control rate (DCR)] were respectively evaluated according to the Response Assessment in Neuro-Oncology (RANO) and Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) standards, along with progression-free survival (PFS)/survival time and adverse events (AEs) obtained through follow-ups.

Results

A total of 57 ALK-rearrangement NSCLC patients with brain metastases (BM) were enrolled in this study. Among them, 53 patients experienced progression at baseline during or after prior crizotinib, and 24 patients received prior brain radiotherapy. The intracranial ORR and DCR were 73.7% and 93.0%, respectively. The whole body ORR and DCR were 87.7% and 98.2%, respectively. The median intracranial PFS and median whole body PFS in patients reached the endpoint were 8.75 months and 7.6 months, respectively; while those in all patients were not reached and predicted to be not evaluable (NE) (intracranial: 95% CI: 12.9-NE and whole body: 95% CI: 15.2-NE). The estimated 12-month event-free probabilities (EFP) of intracranial lesions was 68.1% ; and these of whole body lesions was 74.7%. Subgroup analysis showed the estimated 12-month EFP of intracranial lesions was relatively higher in patients with prior brain radiotherapy (93.8% vs 47.1%, P=0.0006). Additionally, we reported a 74-year-old female ALK-rearrangement NSCLC patient with BM achieved continuous response (intracranial PFS: 12.9 months) to ceritinib reduced to 150mg QD due to intolerable AE and administered for 7.5 months.

Conclusions

Ceritinib administered at a dose of 450mg QD to ALK-rearrangement NSCLC patients with BM in China demonstrates superior ORR and DCR, as well as PFS and EFP that are expected to be improved. Especially the estimated 12-month EFP of intracranial lesions was improved in patients with prior brain radiotherapy.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

West China Hospital, SIchuan Universtiy.

Funding

National Science Foundation of China (81700095, 81870034).

Disclosure

All authors have declared no conflicts of interest.