Preliminary data on nintedanib after immune checkpoint inhibitors

Following the introduction of immune checkpoint inhibitors (ICIs), more treatment options are becoming available in non-small cell lung cancer (NSCLC), and many patients are now treated with first- or second-line ICIs. Consequently, it is becoming increasingly important in clinical practice to establish the optimal treatment after failure on ICI therapy (with or without chemotherapy).¹

In the post-(chemo-) immunotherapy setting, there is a lack of high-quality evidence from prospective clinical trials to optimize later-line treatment selection.¹ Anti-angiogenic modulation may facilitate normalization of tumor vasculature and promote a more immune-supportive environment.¹ Thus, treatment with an anti-angiogenic plus docetaxel may be an option in patients who progress after chemotherapy and ICI therapy.¹  

Preliminary data from two published datasets suggest that patients who progress on previous chemotherapy and ICI therapy may benefit from treatment with nintedanib* plus docetaxel.^2,3

Nintedanib plus docetaxel after chemotherapy and ICI therapy in the Spanish compassionate use study²

In this retrospective analysis of patients in Spain who participated in the nintedanib compassionate use study, 11 patients received nintedanib plus docetaxel after chemotherapy and ICI therapy (nivolumab, n=3; pembrolizumab, n=4; atezolizumab, n=4).²

Treatment with nintedanib plus docetaxel was associated with:

• Objective response rate (ORR) of 36%²
• Disease control rate (DCR) of 82%²
• Median progression-free survival (PFS) of 6.3 months for immunotherapy followed by nintedanib plus docetaxel, and 3.2 months for nintedanib plus docetaxel²
• Median overall survival (OS) of 12.4 months from the start of ICI therapy, and 7.7 months from the start of nintedanib plus docetaxel²

CI, confidence interval; OS, overall survival.

VARGADO Cohort B: nintedanib plus docetaxel after first-line chemotherapy and second-line ICI therapy

VARGADO is a prospective, non-interventional study of nintedanib plus docetaxel after first-line chemotherapy in the routine clinical treatment of patients with locally advanced, metastatic or locally recurrent adenocarcinoma NSCLC.³ 

In a recent interim analysis of Cohort B, 57 patients had received nintedanib plus docetaxel after first-line chemotherapy and second-line treatment with ICIs.³ At the time of the interim analysis (data cut-off: 2 December 2019), median duration of follow-up was 6.6 months.³ Median PFS was 6.5 months (95% confidence interval [CI]: 4.8–8.7; n=47) and median OS was 12.4 months (CI: 11.4–14.1; n=55). ORR was 50% (n=20/40) and DCR was 85% (n=34/40).³

The most common Grade ≥3 nintedanib-related adverse events were decreased white blood cell count (9%), stomatitis (5%), and diarrhea or nausea (both 2%).³