Abstract 1030P
Background
ICIs are widely used in 1st -line or 2nd -line treatment of advanced NSCLC, but effective treatment after resistance to ICIs is still controversial. We previously reported some results of the pooled analysis of ALTER-L016 and ALTER-L018, which demonstrated that anlotinib plus docetaxel had encouraging efficacy and manageable toxicity in advanced NSCLC patients (pts) who had been pre-treated with ICIs. Here, we continued to update the efficacy and safety of the combination in the pooled analysis of ALTER-L016 and ALTER-L018.
Methods
Efficacy and safety data from 2 multi-institutional, randomized, controlled comparative, phase II trials of 73 advanced NSCLC pts who had progressed after 1st-line platinum-based chemotherapy were pooled for this analysis. The studies shared similar dosing intervals and doses, pts were randomly allocated to receive anlotinib (10/12 mg QD from day 1 to 14 of a 21-day cycle) plus docetaxel (60/75 mg/m2 Q3W) (group A+D) or docetaxel (60/75 mg/m2 Q3W) only (group D). Safety assessments included adverse events (AEs), physical examination and clinical laboratory tests.
Results
As of 30 April, 2022, 73 pts were available for efficacy and safety analysis (demographics are shown in Table). The median (m) PFS was 5.20 months (m) (95%Cl: 2.96-7.44) vs 2.20 m (95%Cl: 1.06-3.34) in group A+D and group D, respectively (HR: 0.29; 95%Cl: 0.16-0.52, p<0.0001). The mOS has not been reached. For tumor response, the ORR was 34.90% vs 13.30% and the DCR was 93.02% vs 60.00% in group A+D and group D, respectively. The most common grade 3/4 TRAEs were neutropenia (5, 11.6%) and leukopenia (2, 4.7%) in group A+D, and dysphagia (1, 3.3%) in group D. Table: 1030P
Demographics
| Experimental (anlotinib + docetaxel) (n=43) | Control (docetaxel) (n=30) | |
| Median age, years | 62 (31-74) | 60 (41-73) |
| Age group, years, n (%) | ||
| < 60 | 18 (41.86) | 14 (46.67) |
| ≥ 60 | 25 (58.14) | 16 (53.33) |
| Sex, n (%) | ||
| Men | 40 (93.02) | 24 (80.00) |
| Women | 3 (6.98) | 6 (20.00) |
| Disease stage, n (%) | ||
| III | 5 (11.63) | 2 (6.67) |
| IV | 38 (88.37) | 28 (93.33) |
| ECOG PS, n (%) | ||
| 0 | 13 (30.23) | 9 (30.00) |
| 1 | 30 (69.77) | 21 (70.00) |
| Histologic subtype, n (%) | ||
| ADC | 20 (46.51) | 13 (43.33) |
| Non-ADC | 23 (53.49) | 17 (56.67) |
| Smoking history, n (%) | ||
| Never smoker | 9 (20.93) | 10 (33.33) |
| Current/ Former smoker | 34 (79.07) | 20 (66.67) |
| Brain metastasis, n (%) | ||
| Yes | 6 (13.95) | 4 (13.33) |
| No | 37 (86.05) | 26 (86.67) |
Conclusions
Anlotinib plus docetaxel continued to show better clinical efficacy with manageable safety profile in advanced NSCLC pts who had been pre-treated with ICIs.
Clinical trial identification
ALTER-L016: NCT03726736; ALTER-L018: NCT03624309.
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.