AstraZeneca (AZN) Issues Encouraging Update on Durvalumab ATLANTIC Trial in NSCLC

December 18, 2015 6:53 AM EST

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AstraZeneca (NYSE: AZN) 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.

DURVALUMAB DEVELOPMENT PROGRAMME

Status as of Year-To-Date and Q3 2015 Financial results on 5 November 2015

Next update with FY 2015 Results on 4 February 2016

LUNG CANCER

Name

Phase

Line of treatment

Population

Design

Timelines

Status

Early disease

Monotherapy
ADJUVANTIIIN/AStage Ib-IIIa NSCLCdurvalumab vs placeboData expected 2020Recruiting
PACIFICIIIN/AStage III unresect-able NSCLCdurvalumab vs placeboData expected 2017Recruiting
Advanced/metastatic disease
Monotherapy
ATLANTICII3rd linePD-L1 pos. NSCLCdurvalumab (single arm)Full data 2016-
Combination therapy
ARCTICIII3rd lineNSCLCdurvalumab vs SoC (PD-L1 pos.) or durvalumab vs tremelimumab vs durva + treme vs SoC (PD-L1 neg.)Data expected 2017Recruiting
MYSTICIII1st lineNSCLC (PFS endpoint)durvalumab vs durva + treme vs SoCData expected 2017First patient dosed
NEPTUNEIII1st lineNSCLC (OS endpoint)durva + treme vs SoCData expected 2018Awaiting first patient dosed
-III1st lineNSCLCdurvalumab + chemotherapy +/- tremelimumab In preparation
CAURALIII2nd lineT790M+ NSCLCosimertinib vs osimertinib + durvalumabData expected 2018Initiated 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
HAWKII2nd linePD-L1 pos. SCCHNdurvalumab (single arm)Data expected
H2 2016
Recruiting

Indication granted FDA Fast Track designation
Combination therapy
CONDORII2nd linePD-L1 neg. SCCHNdurvalumab vs tremelimumab vs durva + tremeData expected 2017Recruiting
EAGLEIII2nd lineSCCHNdurvalumab vs durva + treme vs SoCData expected 2018In preparation
KESTRELIII1st lineSCCHNdurvalumab vs durva + treme vs SoCData expected 2018In preparation

METASTATIC BLADDER CANCER

Name

Phase

Line of treatment

Population

Design

Timelines

Status

DANUBEIII1st lineCisplatin chemo-therapy-eligible/ineligibledurvalumab vs durva + treme vs SoC
Data expected 2018

First patient dosed

OTHER TUMOUR TYPES

Name

Phase

Line of treatment

Indication

Design

Timelines

Status

-II2nd/3rd lineMetastatic gastric cancerdurvalumab vs tremelimumab vs durva + treme


In preparation
-II2nd lineUnresect-able liver cancerdurvalumab vs tremelimumab vs durva + treme In preparation
ALPSII2nd lineUnresect-able liver cancerdurva + treme (single arm) In preparation

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

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.



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