1334P - Efficacy and safety of anlotinib plus docetaxel in non-small cell lung cancer (NSCLC) after failure of previous immune checkpoint inhibitors (ICIs) therapy: Results from a phase I/II trial

Background

ICIs are widely used in 1^st -line or 2^nd -line treatment of advanced NSCLC, but effective treatment after resistance to ICIs is still controversial. We previously reported that anlotinib plus docetaxel as 2^nd-line treatment in advanced NSCLC showed better clinical efficacy than docetaxel alone in a phase I/II trial. Here, we provided the efficacy and safety of the combination in advanced NSCLC patients (pts) who had been pre-treated with ICIs in the phase II study.

Methods

Pts with driver-negative advanced NSCLC who had progressed after 1^st-line platinum-based chemotherapy were randomized 2:1 to receive anlotinib (10mg, QD, d1 to 14 of a 21-day cycle) plus docetaxel (60mg/m², q3w, 4-6 cycles) (A+D arm) or docetaxel (60mg/m², q3w, 4-6 cycles) (D arm) until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints were the objective response rate (ORR), the disease control rate (DCR), overall survival (OS) and safety. This data analysis was based on pts with progression after prior treatment with ICIs in A+D arm.

Results

At data cut-off (May 1, 2021), 14 pts were treated with anlotinib/docetaxel after pre-treatment with ICIs, 12 pts treated with 1^st -line chemotherapy/ICIs and 3 pts treated with 1^st line chemotherapy and 2^nd line ICIs. The median age was 63.7 years (range:50-73), 7 pts (50%) were squamous cell carcinoma and 11 pts (78.6%) were ECOG PS 1. Among the 14 pts, 6 pts achieved partial response (PR) and 8 pts had stable disease (SD). Median PFS was 7.60 months (95%CI, 1.56-13.65). The median OS was not reached. The ORR was 42.9% and the DCR was 100%, respectively. Most common grade 1-2 treatment-related adverse events (TRAEs) were hypertriglyceridemia (28.6%), hypertension (21.4%), neutropenia (21.4%), leukopenia (21.4%), proteinuria (21.4%) and decreased platelet count (21.4%). Grade 3/4 TRAEs included neutropenia (7.1%), leukopenia (7.1%) and oral mucositis (7.1%).

Conclusions

Anlotinib plus docetaxel exhibited clinically meaningful efficacy and a manageable safety profile in advanced NSCLC pts who had been pre-treated with ICIs, which might be an especially effective option in this setting.

Clinical trial identification

NCT03726736.

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.