1036P - Anlotinib plus docetaxel vs. docetaxel as 2nd-line treatment of advanced non-small cell lung cancer (NSCLC): Updated results from ALTER-L016

Background

Chemotherapy or Immunotherapy alone as 2^nd-line treatment in driver-negative advanced NSCLC has unsatisfactory efficacy. We previously reported some results of the phase I/II trial (ALTER-L016), which demonstrated anlotinib (10mg) plus docetaxel (60mg/m²) had encouraging efficacy and manageable toxicity as 2^nd-line treatment in advanced NSCLC. Here, we continued to update the efficacy and safety of the combination for advanced NSCLC in the phase II trial of ALTER-L016.

Methods

Pts with advanced NSCLC who had progressed after 1^st-line platinum-based chemotherapy and without sensitizing EGFR/ALK/ROS1 alterations were randomized in a 2:1 ratio 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. Pts were stratified by histology (squamous (sq) NSCLC vs. non-squamous (non-sq) NSCLC). The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.

Results

As of 30 April, 2022, all pts were enrolled in the phase II trial, 57 pts with a median age of 62.1, sq NSCLC (43.9%), ECOG PS 1 (80.7%) in A+D arm and 31 with a median age of 62.9, sq NSCLC (45.2%), ECOG PS 1 (71.0%) in D arm. For pts treated at least one cycle, the median (m) PFS was 5.4 months (m) (95% Cl: 4.06-6.74) in A+D arm and 2.4 m (95% Cl: 1.49-3.31) in D arm (HR: 0.41; 95% Cl: 0.24-0.71, p=0.001). ORR were 30.4% (17/56) in A+D arm and 14.3% (4/28) in D arm, and DCR were 96.4% (54/56) and 64.3% (18/28), respectively. The mOS were not reached in both arms. Subgroup analyses showed the mPFS were significantly longer with A+D than with D in pts with sq NSCLC (5.1m vs. 2.7m, p=0.013) or non-sq NSCLC (5.6m vs. 2.4m, p = 0.033). Grade 3/4 TRAEs mainly included neutropenia (14.3%), leukopenia (7.1%), and hypertension (5.4%) in A+D arm, and neutropenia (7.1%), leukopenia (3.6%) and dysphagia (3.6%) in D arm.

Conclusions

Anlotinib plus docetaxel continued to show better clinical benefit with manageable toxicity for advanced NSCLC previously treated with platinum-based chemotherapy, whether sq NSCLC or non-sq NSCLC.

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.