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AstraZeneca Presents Imfinzi (durvalumab) Plus tremelimumab Combination Data at AACR Annual Meeting

Nachrichtenquelle: GlobeNewswire
16.04.2018, 23:39  |  586   |   |   

Phase Ib Study 006 long-term follow-up shows clinical activity in PD-L1 greater than or equal to 25% and less than 25% groups in 2nd-line non-small cell lung cancer

Phase I Study 10 data shows clinical activity with combination treatment in 2nd-line metastatic urothelial carcinoma

CAMBRIDGE, United Kingdom, April 16, 2018 (GLOBE NEWSWIRE) -- AstraZeneca and MedImmune, its global biologics research and development arm, today presented efficacy and safety data from two Phase I trials evaluating Imfinzi (durvalumab) in combination with tremelimumab in 2nd-line immunotherapy-naïve patients with either non-squamous advanced non-small cell lung cancer (NSCLC) (Study 006) or metastatic urothelial carcinoma (mUC) (Study 10).1,2 The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2018.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The mature data sets from these Phase I trials help further characterise the overall survival of durvalumab plus tremelimumab combination in 2nd-line non-squamous non-small cell lung cancer and 2nd-line metastatic urothelial carcinoma. We look forward to exploring whether OS is distinguished from durvalumab monotherapy in our Phase III MYSTIC and DANUBE trials, expected to read out later this year and next year, respectively."

Study 006: Safety and activity of 2nd-line durvalumab + tremelimumab in non-squamous advanced NSCLC
The Study 006 long-term follow-up results showed clinical activity in both PD-L1 greater than or equal to 25% and less than 25% groups.1 Tumour PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay, PD-L1 cut-off: greater than or equal to 25% of tumour cells with membrane staining.1 The table below shows anti-tumour activity and survival by PD-L1 status.1

Response and survival PD-L1 greater than or equal to 25%
N = 57
PD-L1 less than 25%
N = 136
Totala
N = 213
Complete Response (CR) 1 (1.8) 0 1 (0.5)
Partial Response (PR) 19 (33.3) 16 (11.8) 39 (18.3)
Stable Disease (SD) 17 (29.8) 55 (40.4) 77 (36.2)
Progressive Disease (PD) 16 (28.1) 52 (38.2) 77 (36.2)
Confirmed Objective Response Rate (ORR) 
(CR + PR)

n (%)
95% CI
 20 (35.1)
22.9-48.9
16 (11.8)
6.9-18.4
40 (18.8)
13.8-24.7
Duration of Response (DOR) 
Median, weeks
95% CI
 51.7
25.1-NE
NR
24.3-NE
51.7
40.3-NE
PFS
Median, months
95% CI
 7.1
3.4-9.2
 3.3
1.7-3.5
 3.5
1.8-4.0
OS
12-month OS, % 
95% CI
71.6
57.3-81.9
 47.3
38.2-55.9
 53.8
46.4-60.6
Note: Investigator-assessed anti-tumour activity according to RECIST v1.1. NE, not estimable.
a20 patients had unknown PD-L1 expression

The combination of durvalumab and tremelimumab demonstrated a manageable safety profile in patients with advanced NSCLC.1 The most common treatment-related adverse events (AEs) were fatigue (19%), pruritus (17%), diarrhoea (15%), reduced appetite (14%) and rash (14%).1 14 patients (7%) experienced a treatment-related AE that led to treatment discontinuation, and 23% experienced a Grade 3/4 treatment-related AE.1 There was one treatment-related death (multifactorial hypoxia).1

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