Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

2081 - Match-adjusted indirect comparison of durvalumab and chemotherapy for locally advanced or metastatic urothelial carcinoma (UC) following failure of platinum-based therapy

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Topics

Tumour Site

Urothelial Cancers

Presenters

Christopher Hoyle

Citation

Annals of Oncology (2018) 29 (suppl_8): viii303-viii331. 10.1093/annonc/mdy283

Authors

C.K. Hoyle1, A.B. Klein2, K.A. Patel2, N. Shire2, H. Wang2, B.C. Chu3, M. Ouwens2, B.L. Nordstrom3, L. Horne4, H. Arkenau5

Author affiliations

  • 1 Health Economics & Payer Analytics, AstraZeneca, CB2 1PG - Cambridge/GB
  • 2 Health Economics & Payer Analytics, AstraZeneca, Cambridge/GB
  • 3 Real-world Evidence, Evidera, Waltham/US
  • 4 Oncology Business Unit, AstraZeneca, Gaithersburg/US
  • 5 Scri, Sarah Cannon Research Institute SCRI UK, London/GB
More

Resources

Abstract 2081

Background

Durvalumab gained FDA approval for locally advanced or metastatic UC following failure of platinum-based chemotherapy (CTx) based on the open-label, single arm study 1108. Real-world evidence can be used to enable comparative analyses by matching patients’ baseline characteristics from independent datasets. Overall survival (OS) of patients on durvalumab vs CTx was evaluated by comparing patients in the phase 1/2 study 1108 (NCT01693562) with a real-world dataset.

Methods

Data from patients on durvalumab were compared with data from patients in the Flatiron oncology electronic medical record database treated with physician’s choice of 2nd line CTx. All patients had progressed following platinum-based CTx. Patients were matched on propensity score to adjust for differences in baseline demographics and disease characteristics. Treatment effect for OS was estimated using Cox proportional hazards models. Prognostic impact of expression of programmed cell death ligand-1 (PD-L1) (≥25% of tumour cells [TC]/immune cells [IC] [high] or < 25% TC/IC [low/negative]) on OS was also evaluated. As PD-L1 expression was only available for patients in study 1108, PD-L1 subgroups were compared to otherwise-matched CTx patients.

Results

After adjustment for baseline differences between the 2 groups, durvalumab demonstrated a statistically significant improvement in OS vs CTx (n = 158/arm; HR = 0.634, 95% CI 0.479-0.839; median OS 11.2 vs 8.19 months). Treatment effect of durvalumab was greater in the PD-L1 high subgroup (n = 91 /arm; HR = 0.434, 95% CI 0.292-0.645; median OS 19.9 vs 7.84 months) vs matched CTx patients. There was no significant difference in OS for the PD-L1 low/negative subgroup for durvalumab vs CTx (n = 74/arm; HR = 0.989, 95% CI 0.679-1.440; median OS 4.86 vs 7.20 months).

Conclusions

This indirect, match-adjusted comparison of durvalumab vs CTx suggests that durvalumab provides a statistically significant improvement in OS vs CTx for patients with locally advanced or metastatic UC who progressed after platinum-based CTx; treatment effect was more pronounced in the PD-L1 high subgroup vs the PD-L1 low/negative subgroup.

Clinical trial identification

CD-ON-MEDI4736-1108 (NCT01693562).

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Editorial Acknowledgement

Editorial support, which was in accordance with Good Publication Practice (GPP3) guidelines, was provided by Anne-Marie Manwaring of Parexel, and was funded by AstraZeneca.

Disclosure

C.K. Hoyle, A.B. Klein, K.A. Patel, N. Shire, H. Wang, M. Ouwens: Employee and shareholder of AstraZeneca. B.C. Chu: Employee of Real-world Evidence, Evidera. B.L. Nordstrom: Employee of Real-world Evidence, Evidera. L. Horne: Contractor and Shareholder: AstraZeneca. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.