Durvalumab ATLANTIC trial supports clinical activity and AstraZeneca’s overall immuno-oncology strategy

fredag, 18 december 2015

Durvalumab demonstrated clinical activity and durable responses in 3rd-line or later stage NSCLC patients; full data to be presented at a scientific congress in 2016
Durvalumab monotherapy and combination trials on track in multiple cancers, including 1st-line therapy for NSCLC, head & neck and bladder cancers

AstraZeneca today provided an update on preliminary findings from the ATLANTIC trial of durvalumab as 3rd-line or later stage therapy in patients with locally advanced or metastatic programmed death ligand-1 (PD-L1) positive non-small cell lung cancer (NSCLC) that lacks epidermal growth factor receptor (EGFR) or ALK alterations. An initial analysis supports durvalumab’s clinical activity, with durable responses and an established safety profile in these difficult-to-treat patients.

ATLANTIC investigated the efficacy and tolerability of durvalumab in patients who received at least two prior systemic treatment regimens including platinum-based chemotherapy, and who have limited options for further therapy. A full evaluation of the data is ongoing and the results will be presented at a scientific congress in 2016.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “As we have seen in other studies, durvalumab has demonstrated expected clinical activity and durable response in these heavily pre-treated patients. As previously communicated, the treatment and regulatory landscape in lung cancer is evolving. We now believe it is unlikely that ATLANTIC can be used for regulatory submission as a monotherapy, but we will make that determination following a full analysis of the data. Durvalumab is a cornerstone of our immuno-oncology portfolio with a fast advancing development programme focused primarily on novel combinations.”

A comprehensive durvalumab registration programme is underway across multiple tumour types, stages of disease, and lines of therapy both as monotherapy and in combination. This forms part of AstraZeneca’s late-stage immuno-oncology programme and includes more than 9,000 patients in 16 clinical trials in lung, bladder, head & neck, and other cancers, summarised below.

Name

Phase

Line of treatment

Population

Design

Timelines

Status

Early disease

Monotherapy

ADJUVANT

III

N/A

Stage Ib-IIIa NSCLC

durvalumab vs placebo

Data expected 2020

Recruiting

PACIFIC

III

N/A

Stage III unresect-able NSCLC

durvalumab vs placebo

Data expected 2017

Recruiting

Advanced/metastatic disease

Monotherapy

ATLANTIC

II

3rd line

PD-L1 pos. NSCLC

durvalumab (single arm)

Full data 2016

-

Combination therapy

ARCTIC

III

3rd line

NSCLC

durvalumab vs SoC (PD-L1 pos.) or durvalumab vs tremelimumab vs durva + treme vs SoC (PD-L1 neg.)

Data expected 2017

Recruiting

MYSTIC

III

1st line

NSCLC (PFS endpoint)

durvalumab vs durva + treme vs SoC

Data expected 2017

First patient dosed

NEPTUNE

III

1st line

NSCLC

(OS endpoint)

durva + treme vs SoC

Data expected 2018

Awaiting first patient dosed

-

III

1st line

NSCLC

durvalumab + chemotherapy +/- tremelimumab

 

In preparation

CAURAL

III

2nd line

T790M+ NSCLC

osimertinib vs osimertinib + durvalumab

Data expected 2018

Initiated enrolment; currently on partial clinical hold to characterise incidence of interstitial lung disease

METASTATIC HEAD AND NECK CANCER

Name

Phase

Line of treatment

Population

Design

Timelines

Status

Monotherapy

HAWK

II

2nd line

PD-L1 pos. SCCHN

durvalumab (single arm)

Data expected

H2 2016

Recruiting

 

Indication granted FDA Fast Track designation

Combination therapy

CONDOR

II

2nd line

PD-L1 neg. SCCHN

durvalumab vs tremelimumab vs durva + treme

Data expected 2017

Recruiting

EAGLE

III

2nd line

SCCHN

durvalumab vs durva + treme vs SoC

Data expected 2018

In preparation

KESTREL

 

III

1st line

SCCHN

durvalumab vs durva + treme vs SoC

Data expected 2018

In preparation

METASTATIC Bladder CANCER

Name

Phase

Line of treatment

Population

Design

Timelines

Status

DANUBE

III

1st line

Cisplatin chemo-

therapy-eligible/

ineligible

durvalumab vs durva + treme vs SoC

Data expected 2018

First patient dosed

OTHER TUMOUR TYPES

Name

Phase

Line of treatment

Indication

Design

Timelines

Status

-

II

2nd/

3rd line

Metastatic gastric cancer

durvalumab vs tremelimumab vs durva + treme

 

In preparation

-

II

2nd line

Unresect-able liver cancer

durvalumab vs tremelimumab vs durva + treme

 

In preparation

ALPS

II

2nd line

Metastatic pancreatic cancer

durva + treme (single arm)

 

In preparation

SoC = Standard of Care, PFS = Progression Free Survival, OS = Overall Survival

NOTES TO EDITORS

About durvalumab (MEDI4736)

Durvalumab is an investigational human monoclonal antibody directed against PD-L1. Signals from PD-L1 help tumours avoid detection by the immune system. Durvalumab blocks these signals, countering the tumour's immune-evading tactics. Durvalumab is being developed, alongside other immunotherapies, to empower the patient's immune system and attack the cancer. Durvalumab is being investigated in an extensive clinical trial programme, as monotherapy or in combination with tremelimumab, in NSCLC, head and neck, gastric, pancreatic, bladder and blood cancers.

About the ATLANTIC trial

ATLANTIC is a Phase II, non-comparative, open-label, multi-centre, international trial of durvalumab in patients with locally advanced or metastatic NSCLC (Stage IIIB-IV) who have received at least two prior systemic treatment regimens including one platinum-based chemotherapy regimen.

About AstraZeneca in Oncology

Oncology is a therapy area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as a cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease areas – lung, ovarian, breast and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com.

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