1467P - Combination therapy of envafolimab and suvemcitug with chemotherapy in patients with non-small cell lung cancer (NSCLC): Results from a phase II clinical trial

Background

The combination of anti–PD-1/PD-L1 antibody and chemotherapy with or without anti-angiogenic agent has shown antitumor activity in NSCLC. This study aims to assess the efficacy and safety of envafolimab (anti- PD-L1 antibody) in combination with suvemcitug (anti-VEGF antibody) and chemotherapy as second-line or later therapy in patients(pts) with advanced NSCLC.

Methods

This was an open-label, multi-cohort, multicenter, phase II trial conducted in China. In Cohort C, NSCLC pts with at least one prior line of treatment were enrolled, stratified by the history of prior immunotherapy (IO). Envafolimab plus suvemcitug and docetaxel were administrated until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) assessed by investigator review using RECIST v1.1. Secondary endpoints included progression-free survival (PFS), duration of overall response (DoR), disease control rate (DCR) and safety.

Results

As of March 31, 2023, there were 40 pts were enrolled in NSCLC cohort, including 20 IO treated NSCLC and 20 IO naïve NSCLC. 72.5% (29/40) pts were treated with one prior therapy and 27.5% (11/40) pts with EGFR/ALK / ROS1 alterations. For IO treated NSCLC, with a median follow-up time of 6.5 (4.6, 7.9) months, 18 pts have at least one assessment, the ORR and DCR were 27.8% (5/18) and 83.3% (15/18) respectively. The PFS was not reached (NR) (3.02-NR). Grade 3/4 TRAEs occurred in 13 pts (65.0%), most commonly occurred were neutrophil count decreased (n = 8; 40.0%) and leucopenia (n = 6; 30.0%). For IO naïve NSCLC, the median follow-up time was 6.3 (4.8, 7.1) months,17 pts have at least one assessment, 3 patients achieved partial response and the DCR was 82.4% (14/17). The PFS was NR (2.99-NR). Grade 3/4 TRAEs occurred in 15 pts (75%), most commonly occurred were neutrophil count decreased (n = 12; 60%) and leucopenia (n = 11; 55%). There was no grade 5 TRAE in either cohort.

Conclusions

This phase II clinical trial demonstrated antitumor activity and manageable safety profile of immunotherapy plus anti-angiogenic agent and chemotherapy in pts with NSCLC, who had failed at least one line of therapy.

Clinical trial identification

NCT05148195.

Editorial acknowledgement

Legal entity responsible for the study

Shanghai Xianxiang Medical Technology Co., Ltd. and 3D Medicines Inc.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.