Abstract 129P
Background
IMpower150 subgroup analysis showed patients with EGFR mutated advanced NSCLC could achieve efficacy from ICI-combination therapy after resistance to EGFR TKIs, but the safety should be improved. A retrospective study from our center showed that ICI plus single-agent chemotherapy (chemo-reform1) might be a better choice. This study was designed to further explore the efficacy and safety of tislelizumab (Tis) plus bevacizumab (Beva) and nab-paclitaxel for advanced NSCLC failed to EGFR TKIs. Herein, the preliminary analysis for early safety and efficacy is reported.
Methods
This is a single-arm, phase II study (NCT04310943). Pts with EGFR mutations who had failed to prior EGFR-TKIs accepted Tis (200mg, d1) plus Beva (15mg/kg, d1) and nab-paclitaxel (100mg/m2, d1,8,15) Q3W for up to 4 cycles, followed by Tis plus Beva (7.5mg/kg) maintenance therapy. Primary endpoints are safety and 1-year PFS rate, and secondary endpoints include ORR and 1-year OS rate. We planned to enroll 24 pts.
Results
As of 26 August 2022, 14 pts were enrolled and treated. The median age was 57 (range: 30-70). Seven pts (50.0%) harbored EGFR exon 19del and 7 pts (50.0%) had exon 21 L858R at the initial diagnosis. Ten pts (71.4%) had progression on both 1st/2nd and 3rd EGFR-TKIs. Two pts (14.3%) had prior chemotherapy. The median follow-up time was 11.2 months. Among 14 pts, the safety was manageable: the incidence of ≥grade 3 TEAE and ≥grade 3 irAE were 35.7% and 14.3% respectively. Among 9 efficacy evaluable pts, the ORR was 66.7% (95%CI: 29.9-92.5), mDOR was 5.3 months (95% CI: 4.9-5.7), and DCR was 100.0%. Table: 129P
| AEs, n (%) | N=14 |
| Any TEAEs | 14 (100) |
| TEAEs ≥10% | |
| Alopecia Decreased WBC Anemia Hyperglycemia Mucositis oral Pruritus Hypoalbuminemia Pneumonitis Fatigue Neutrophil count decreased GGT increased | 14(100.0) 6 (42.9) 6 (42.9) 6 (42.9) 3 (21.4) 3 (21.4) 2 (14.3) 2 (14.3) 2 (14.3) 2 (14.3) 2 (14.3) |
| Any irAEs | 8 (57.1) |
| irAEs ≥10% | |
| Hyperglycemia Pruritus Pneumonitis | 6 (42.9) 3 (21.4) 2 (14.3) |
Conclusions
Tislelizumab combined with bevacizumab plus nab-paclitaxel has shown a promising anti-tumor efficacy with a manageable safety profile for patients who failed to EGFR TKIs. The results will be monitored continuously.
Clinical trial identification
NCT04310943.
Editorial acknowledgement
BeiGene.
Legal entity responsible for the study
The authors.
Funding
BeiGene.
Disclosure
All authors have declared no conflicts of interest.