1335P - Updated results from a phase I/II study of anlotinib plus docetaxel vs docetaxel as second-line treatment of advanced non-small cell lung cancer (NSCLC)

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, which demonstrated that 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.

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. The primary endpoint was progression-free survival (PFS). Secondary endpoints included the objective response rate (ORR), the disease control rate (DCR), overall survival (OS) and safety.

Results

As of 1 May, 2021, 51 pts were enrolled, 34 pts with a median age of 62.7, squamous cell carcinoma (47.1%), ECOG PS 1 (85.3%) in A+D arm and 17 pts with a median age of 60.6, squamous cell carcinoma (47.1%), ECOG PS 1 (70.6%) in D arm. Median PFS was 6.5 months (95% Cl: 3.20-9.80) in A+D arm and 2.7 months (95% Cl: 0.05-5.35) in D arm (HR: 0.30; 95% Cl: 0.12-0.74, p=0.004). Of 46 evaluable pts, the ORR was 21.9% (7/32) in A+D arm and 14.3% (2/14) in D arm (p=0.70), and significant DCR benefit was observed for the combination treatment (A+D arm vs. D arm = 100.0% vs. 57.1%, p< 0.001). The median OS was not reached. Most common grade 1-2 treatment-related adverse events (TRAEs) in A+D arm were hypertension (17.6%), neutropenia (14.7%), leukopenia (14.7%), and proteinuria (14.7%). Grade 3/4 TRAEs mainly included neutropenia (5.9%), leukopenia (5.9%), oral mucositis (5.9%) and hypertension (5.9%) in A+D arm and were not observed in D arm.

Conclusions

Anlotinib plus docetaxel continued to show better clinical benefit with manageable toxicity for advanced NSCLC pts with progression after 1^st-line platinum-based chemotherapy. The combination regimen may become a new option for the 2^nd-line treatment.

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.