1542P - Updated results of a phase II clinical trial: Paclitaxel and carboplatin plus PD-1 blockades combined with anlotinib as first-line treatment for advanced oesophageal cancer

Background

The combination of PD-1 blockades with chemotherapy is the standard first-line therapy for advanced esophageal cancer. Recent studies exhibited that anti-angiogenic drug combined with PD-1 blockades or chemotherapy demonstrated potential synergistic action and bright prospect in the combined application of anti-tumor therapy. We present updated data from the study of paclitaxel and carboplatin combined with anlotinib and PD-1 blockades in the treatment of advanced oesophageal cancer.

Methods

This study was a parallel, open-label, phase Ⅱ clinical trial. A total of 90 patients (pts) with previously untreated, advanced or metastatic ESCC, with an age ranging from 18-75 years old were planned to be enrolled into three arms with an allocation ratio of 1:1:1. Arm A received TC (paclitaxel + carboplatin) + camrelizumab (200mg, q3w) + anlotinib (8mg, q3w); Arm B received TC with camrelizumab; Arm C received TC only. After 4-6 cycles of induction therapy, arm A and arm B would receive maintenance therapy until disease progression or intolerable adverse events. The primary endpoint was ORR. Secondary endpoints included PFS, OS and safety.

Results

At data cut-off date (Apr. 30, 2023), a total of 90 pts was enrolled. 25 of 30 pts achieved partial response (PR) and 2 pts achieved complete response in arm A, 13 of 30 pts achieved PR in arm B, and 7 of 30 pts achieved PR in arm C. The ORR were 90.0% in arm A, 43.3% in arm B, and 26.7% in arm C. The median PFS (95% CI) were 13.4 months (10.1-16.8) in arm A, 7.2 months (3.6-10.9) in arm B, and 4.8 months (4.0-5.6) in arm C. The median OS was not reached. The rate of treatment related adverse events (TRAEs) of any grade was 100% in all three groups, and grade 3 TRAEs were 30.0%, 23.3% and 13.3%, respectively. The most common grade 3 TRAEs were thrombocytopenia (8.9%), decreased white blood cell count (6.7%), neutropenia (5.6%). No grade 4 or 5 TRAEs were observed.

Conclusions

Addition of anlotinib to immunotherapy plus chemotherapy as first-line therapy showed amazing clinical outcomes in ESCC pts with a manageable safety profile. The study was still ongoing, and the data would be updated to confirm this conclusion subsequently.

Clinical trial identification

NCT04471480.

Editorial acknowledgement

Legal entity responsible for the study

Daping Hospital, Army Medical University.

Funding

This work was funded by the Chongqing Science and Health JointMedical Research Project (No. 2021MSXM009) to MX and the National Natural Science Foundation of China (NSFC, No. 82002443) to MX.

Disclosure

All authors have declared no conflicts of interest.