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

Proffered Paper – Immunotherapy of cancer

2365 - Durvalumab Activity in Previously Treated Patients Who Stopped Durvalumab without Disease Progression

Date

30 Sep 2019

Session

Proffered Paper – Immunotherapy of cancer

Topics

Immunotherapy

Tumour Site

Presenters

Siddharth Sheth

Citation

Annals of Oncology (2019) 30 (suppl_5): v475-v532. 10.1093/annonc/mdz253

Authors

S. Sheth1, C. Gao2, N. Mueller3, P. Martinez3, J. Soria4

Author affiliations

  • 1 Hematology/oncology, University of North Carolina-Lineberger Cancer Center, 27514 - Chapel Hill/US
  • 2 Oncology Clinical Biostatistics, AstraZeneca, 20878 - Gaithersburg/US
  • 3 Clinical Development Oncology, AstraZeneca, 20878 - Gaithersburg/US
  • 4 Early Ica, Medimmune, 20878 - Gaithersburg/US

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2365

Background

A proportion of cancer patients treated with anti-programmed cell death-1 (PD-1) and its ligand (PD-L1) achieve long-lasting responses. Some of these patients stop treatment without disease progression (DP). Limited data exist on re-initiation of the same PD-1/PD-L1 inhibitor upon progression.

Methods

In NCT01693562, a phase I/II study evaluating durvalumab in advanced solid tumors, patients were treated until DP or up to 1 year. Per protocol, patients who benefited from durvalumab and stopped treatment after 1 year of therapy were eligible to be rechallenged at time of DP. Clinical outcomes analyzed were best overall response, duration of response, disease control rate (DCR), and progression-free survival (PFS), defined as time from first day of retreatment with durvalumab to DP or death.

Results

Of 1,022 patients, 160 stopped durvalumab without developing DP after 1 year of treatment. Of those, 70 (43.8%) patients across 14 different primary tumor types were rechallenged with durvalumab after DP (Table). During their first treatment with durvalumab, 5.7% and 50% had achieved complete responses (CR) and partial responses (PR), respectively. While off therapy, median time without DP was 266 days. After rechallenge with durvalumab, 66 of 70 (94.3%) were evaluable. Confirmed best overall response was 0% CR, and 11.4% had PR, 60% had stable disease (SD), and 22.9% had DP. Median duration of response was 16.5 months. DCR at ≥ 24 weeks was 47.1%. PFS at 12 months was 34.2%, with similar rates observed regardless of tumor type.Table:

1175O Best overall response and 12-month PFS with durvalumab rechallenge

Tumour TypeAll Patients (N = 70)NSCLC (n = 21)MSI-High (n = 12)Bladder (n = 8)HNSCC (n = 6)HCC (n = 5)Other (n = 18)
Best overall response, n (%)
CR0000000
PR8 (11.4)3 (14.3)03 (37.5)01 (20.0)1 (5.6)
SD42 (60)8 (38.1)11 (91.7)3 (37.5)4 (66.7)4 (80.0)1212 (66.7)
DP16 (22.9)8 (38.1)1 (8.3)2 (25.0)2 (33.3)03 (16.7)
Nonevaluable4 (5.7)2 (9.5)00002 (11.1)
Duration of response, months16.513.4N/A16.5N/A18.7+12+
CR/PR + SD (DCR ≥24 weeks), %47.133.358.350.033.340.040.0
PFS at 12 months, %34.23159.462.5202572.2

Conclusions

This is the largest cohort supporting the role of rechallenge with a PD-1/PD-L1 inhibitor in patients who have previously progressed after planned interruption. Rechallenge with durvalumab resulted in restored antitumor efficacy, high rates of disease control, and prolonged durability in patients who responded. These findings support the role of durvalumab in patients who progressed after planned treatment interruption.

Clinical trial identification

NCT01693562.

Editorial acknowledgement

Legal entity responsible for the study

AstraZeneca, PLC.

Funding

AstraZeneca.

Disclosure

S. Sheth: Research grant / Funding (institution): AstraZeneca. C. Gao: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. N. Mueller: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. P. Martinez: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca. J. Soria: Shareholder / Stockholder / Stock options, Full / Part-time employment: AstraZeneca.

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.