Latest news! Anlotinib combined with etoposide/carboplatin can improve the survival rate of extensive-stage small cell lung cancer

According todata from the ETER701 trial (NCT04234607) announced at the 2024 European Lung Cancer Conference, anlotinib combined with etoposide, carboplatin and placebo showed an effect of extending progression-free survival (PFS) in patients with extensive-stage small cell lung cancer (ES-SCLC).

The results of the study showed that in the intention-to-treat (ITT) population, the median PFS for patients (n = 245) who received anlotinib plus etoposide, carboplatin, and placebo was 5.62 months, compared with 4.21 months for patients who received etoposide plus carboplatin and 2 placebos. The 12-month PFS rate was 12.61% in the anlotinib group and 2.29% in the double placebo group.

Despite the improvement in PFS, no statistically significant overall survival (OS) benefit was observed between the two groups. The median OS in the anlotinib group was 13.27 months, while the median OS in the double placebo group was 11.89 months. The 12-month OS rates were 54.63% and 49.00% respectively.

ETER701 data previously submitted at the 2023 World Lung Cancer Congress showed that compared with placebo plus etoposide and carboplatin, anlotinib, etoposide and carboplatin can significantly improve PFS and OS in the first-line treatment of ES-SCLC patients.

The multicenter, placebo-controlled, randomizedETER701 trial enrolled patients aged 18 to 75 years with pathologically confirmed ES-SCLC who had not received prior systemic therapy. Additionally, patients were required to have measurable disease according to RECIST v1.1 criteria; an ECOG performance status of 0 or; and adequate organ function. Of note, patients with asymptomatic or treated and stable brain metastases are allowed.

Eligible patients were randomly assigned in a 1:1:1 ratio to 1 of 3 treatment regimens, consisting of four 21-day induction cycles followed by a maintenance phase. In all three groups, etoposide was given at a dose of 100 mg/m on days 1 to 3 of each induction cycle and carboplatin was given at a dose of area under the curve 5 on day 1 of each induction cycle. Patients were stratified according to ECOG performance status (0 vs 1), brain metastases (yes vs no), and liver metastases (yes vs no). The study's primary endpoints were OS and PFS as assessed by an independent review committee according to RECIST v1.1 criteria. Secondary endpoints again included investigator-assessed PFS; overall response rate (ORR); disease control rate (DCR); duration of response (DOR); 6- and 12-month PFS rates; 12- and 18-month OS rates; quality of life; and safety and tolerability.

Total1005 patients were assessed as eligible; 267 patients were excluded, 217 did not meet the eligibility criteria, and 50 withdrew consent, leaving 738 patients randomly assigned to 1 of 3 treatment groups. The data cutoff date is May 14, 2022, and the median follow-up time is 14.0 months (12.8-15.5 months).

Other data showed that the ORR of patients in the anlotinib/placebo group was 81.22%, while the ORR of patients in the double placebo group was 66.80%. The complete response rate of patients in the experimental group was 0.41%; the partial response (PR) rate was 80.82%; the stable phase (SD) rate was 11.43%; and the incidence of progressive disease (PD) was 1.22%. It is worth noting that 6.12% of patients could not be evaluated for efficacy. In contrast, in the double placebo group, the PR rate was 66.8%; the SD rate was 20.24%; the PD rate was 6.48%; and 6.48% of patients could not evaluate the efficacy.

It is worth noting that the DCR of the study group was 92.5% and that of the placebo group was 87.04%. The median DOR was 5.49 months for the anlotinib/placebo regimen and 3.09 months for the double-placebo regimen.

In short, research has shown to a certain extent that anlotinib combined with etoposide/carboplatin can improve the survival rate of extensive-stage small cell lung cancer. Let us look forward to this drug combination opening up new treatment possibilities for patients in the future.