426P - The overall survival data of FUTURE-C-PLUS: Combination of famitinib with camrelizumab plus nab-paclitaxel as first-line treatment for advanced, immunomodulatory triple-negative breast cancer, an open-label, single-arm, phase II trial

Background

Camrelizumab and nab-paclitaxel demonstrated promising anti-tumour activity in metastatic immunomodulatory triple-negative breast cancer (IM-TNBC) in FUTURE trial. Anti-angiogenic agents have been reported to facilitate immune infiltration. Famitinib is a tyrosine kinase inhibitor targeting VEGFR-2, PDGFR and c-kit. The FUTURE-C-PLUS trial (NCT04129996) which added famitinib to camrelizumab and nab-paclitaxel is a single-arm, phase 2 trial evaluating this triplet combinatorial strategy in advanced IM-TNBC. Study design and the primary endpoint ORR has been reported (Zhi-ming Shao, et al. ASCO 2021, Abstract 1007). The final PFS data had been published in Clinical Cancer Research (Clin Cancer Res 2022;28:2807–17). Here, we reported the updated overall survival.

Methods

This study enrolled women aged 18-70 years, with previously untreated, unresectable, locally advanced, recurrent or metastatic IM-TNBC. IM-TNBC was defined as CD8 expression on at least 10% of cells using IHC analysis. Eligible patients received the triple therapy.

Results

Forty-eight patients were enrolled between Oct 2019 and Oct 2020. The median follow-up was 33.1 months (range, 31.8–34.4). 39 (81.3%, 95% CI 70.2-92.3) patients had a confirmed objective response which has been reported in ASCO 2021. At this updating data cutoff (May 1, 2023), the median progression-free survival was 13.6 months (95% CI, 8.4-18.8). While overall survival was 29.4 months (95% CI, 23.3-35.5). The most common treatment-related grade 3 or 4 adverse events were neutropenia (16 [33.3%]), anemia (5 [10.4%]), febrile neutropenia (5 [10.4%]), and thrombocytopenia (4 [8.3%]). No new safety concerns were detected. No treatment-related deaths were reported.

Conclusions

These data, combined with our previous reports, provide further evidence for the triplet combination as an active therapy in advanced IM-TNBC. To our knowledge, this is the best over survival reached in first-line treatment of advanced TNBC. A randomized controlled FUTURE-Super trial (NCT04395989) is ongoing to further validate these findings.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.