356P - Efficacy and safety analysis of anlotinib and durvalumab plus chemotherapy in first-line therapy extensive-stage small cell lung cancer (SCLC)

Background

IMpower133 and CASPIAN showed that the combination of PD-L1 monoclonal antibody and EC regimen chemotherapy as first-line treatment of small cell lung cancer have a median PFS (progession-free survival) of about 5 months, which is comparable to that of simple chemotherapy. We tried to add anlotinib to the first-line treatment with Durvalumab and Chemotherapy in patients with ES-SCLC to observe the efficacy and safety.

Methods

Eligible ES-SCLC pts (18∼75 years old, initial treatment, no obvious heart, liver and kidney dysfunction) were received anlotinib + durvalumab + etoposide + CBP or DDP for 4∼6 cycles, then anlotinib and durvalumab maintenance until the disease progresses or intolerable adverse reactions occur. During the treatment, dose reduction of anlotinib was permitted, which could be reduced to 10mg or 8mg if it was intolerable. The main observation endpoints were ORR, PFS and adverse events.

Results

Between December 2020 and June 2022, a total of 12 patients with extensive-stage SCLC were enrolled in the study, with an average age of 58 (39-71) years old, 8 males (66.7%) and 4 females (33.3%). ORR (objective remission rate) was 100%. 6m PFS% was 66.7%. The median PFS was NE. The most common grade 3 or 4 adverse events related to the trial regimen included: neutropenia was 2/12 (16.7%) and leukopenia was 2/12 (16.7%). No higher-grade adverse reactions.

Conclusions

Durvalumab plus anlotinib and chemotherapy regimen has better ORR, DCR and PFS for the initial treatment of extensive-stage SCLC, and a manageable safety profile.

Clinical trial identification

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.