Preliminary data on nintedanib after immune checkpoint inhibitors

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

OS from the start of treatment with nintedanib plus docetaxel (n=11)

Kaplan–Meier curve for OS in the Spanish compassionate use study

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

OS from the start of third-line nintedanib plus docetaxel after failure of ICI therapy (n=55)

OS from the start of third-line nintedanib plus docetaxel after failure of ICI therapy (n=55)

CI, confidence interval; ICI, immune checkpoint inhibitor; OS, overall survival.

PFS from the start of third-line nintedanib plus docetaxel after failure of ICI therapy (n=47)

PFS from the start of third-line nintedanib plus docetaxel after failure of ICI therapy

CI, confidence interval; ICI, immune checkpoint inhibitor; PFS, progression-free survival.

References

1

Popat S, et al. Lung Cancer 2020;144:76–84.

2

Corral, J et al. Clin Transl Oncol 2019;21(9):1270–79.

3

Grohé C, et al. Poster presented at ASCO20 Virtual 2020 (Poster 370).

*Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumor histology after first-line chemotherapy. For the full list of country-specific information, please click here. Nintedanib is not approved in other oncology indications.

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Page last updated: August 2020