REG - AstraZeneca PLC - Imfinzi improved OS & PFS in limited-stage SCLC

AstraZenecaAnnouncement

05/04/2024 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240405:nRSE4110Ja&default-theme=true

RNS Number : 4110J  AstraZeneca PLC  05 April 2024

05 April 2024

 

Imfinzi significantly improved overall survival and progression-free survival
for patients with limited-stage small cell lung cancer in ADRIATIC Phase III
trial

 

First and only immunotherapy to demonstrate survival benefit in this setting
in a global Phase III trial

 

Positive high-level results of the ADRIATIC Phase III trial showed
AstraZeneca's Imfinzi (durvalumab) demonstrated a statistically significant
and clinically meaningful improvement in the dual primary endpoints of overall
survival (OS) and progression-free survival (PFS) in patients with
limited-stage small cell lung cancer (LS-SCLC) who had not progressed
following concurrent chemoradiotherapy (cCRT) compared to placebo after cCRT.

 

Small cell lung cancer (SCLC) is a highly aggressive form of lung cancer that
typically recurs and progresses rapidly despite initial response to
chemotherapy and radiotherapy in LS-SCLC patients.(1,2) The prognosis is
particularly poor for LS-SCLC, as only 15-30% of these patients will be alive
five years after diagnosis.(3)

 

Suresh Senan, PhD, Professor of Clinical Experimental Radiotherapy at the
Amsterdam University Medical Center, The Netherlands, and principal
investigator in the trial said: "Many patients treated for limited-stage small
cell lung cancer face disease recurrence and the standard of care has remained
unchanged for decades. ADRIATIC is the first global Phase III immunotherapy
trial to deliver significant, clinically meaningful improvement in survival in
this setting, marking a breakthrough for patients with this devastating
disease."

 

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: "These exciting results build on the transformative efficacy of Imfinzi
in extensive-stage small cell lung cancer and demonstrate the potential to
bring a curative-intent immunotherapy treatment to this earlier-stage setting
of small cell lung cancer for the first time. These data, together with the
PACIFIC data in unresectable, Stage III non-small cell lung cancer, underscore
the pioneering role of Imfinzi in the treatment of early lung cancer following
chemoradiotherapy."

 

The safety profile for Imfinzi was consistent with its known profile, and no
new safety signals were identified.

 

These data will be presented at a forthcoming medical meeting and shared with
global regulatory authorities.

 

The second experimental arm testing the efficacy of Imjudo (tremelimumab)
added to Imfinzi as a secondary endpoint remains blinded and will continue
to the next planned analysis.

 

Imfinzi is approved in the US, EU, Japan, China and many other countries
around the world for the treatment of extensive-stage SCLC (ES-SCLC) based on
the CASPIAN Phase III trial. Imfinzi is also the only approved immunotherapy
and the global standard of care in the curative-intent setting of
unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose
disease has not progressed after CRT based on the PACIFIC Phase III trial.

 

 

Notes:

 

Small cell lung cancer

Lung cancer is the leading cause of cancer death among men and women and
accounts for about one-fifth of all cancer deaths.(4) Lung cancer is broadly
split into NSCLC and SCLC, with about 15% of cases classified as SCLC.(5)

 

LS-SCLC (Stage I-III) is classified as SCLC that is generally only in one lung
or one side of the chest.(6) LS-SCLC accounts for approximately 30% of SCLC
diagnoses and the prognosis remains poor despite curative-intent treatment
with standard-of-care cCRT.(7)

 

ADRIATIC

The ADRIATIC trial is a randomised, double-blind, placebo-controlled,
multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi
plus Imjudo versus placebo in the treatment of 730 patients with LS-SCLC who
had not progressed following cCRT. In the experimental arms, patients were
randomised to receive a 1500mg fixed dose of Imfinzi with or without Imjudo
75mg every four weeks for up to four doses/cycles each, followed by Imfinzi
every four weeks for up to 24 months.

 

The dual primary endpoints are PFS and OS for Imfinzi monotherapy versus
placebo. Key secondary endpoints included OS and PFS for Imfinzi plus Imjudo
versus placebo, safety and quality of life measures. The trial includes 164
centres in 19 countries across North and South America, Europe and Asia.

 

Imfinzi 

Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1
protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins,
countering the tumour's immune-evading tactics and releasing the inhibition of
immune responses.

 

In addition to its indications in unresectable, Stage III NSCLC and ES-SCLC,
Imfinzi is currently approved in a number of countries in combination with a
short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC.

 

Imfinzi is also approved in a number of countries in combination with
chemotherapy in locally advanced or metastatic biliary tract cancer and in
combination with Imjudo in unresectable hepatocellular carcinoma (HCC).
Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the
EU and in previously treated patients with advanced bladder cancer in a small
number of countries.

 

Since the first approval in May 2017, more than 220,000 patients have been
treated with Imfinzi. As part of a broad development programme, Imfinzi is
being tested as a single treatment and in combinations with other anti-cancer
treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer,
several gastrointestinal cancers and other solid tumours.

 

Imjudo

Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity
of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the
activity of CTLA-4, contributing to T-cell activation, priming the immune
response to cancer and fostering cancer cell death.

 

In addition to its approved indications in combination with Imfinzi in liver
and lung cancers, the combination of Imjudo and Imfinzi is being evaluated
across multiple tumour types including locoregional HCC (EMERALD-3) and
bladder cancer (VOLGA and NILE).

 

AstraZeneca in lung cancer

AstraZeneca is working to bring patients with lung cancer closer to cure
through the detection and treatment of early-stage disease, while also pushing
the boundaries of science to improve outcomes in the resistant and advanced
settings. By defining new therapeutic targets and investigating innovative
approaches, the Company aims to match medicines to the patients who can
benefit most.

 

The Company's comprehensive portfolio includes leading lung cancer medicines
and the next wave of innovations, including Tagrisso (osimertinib) and Iressa
(gefitinib); Imfinzi and Imjudo; Enhertu (trastuzumab deruxtecan) and
datopotamab deruxtecan in collaboration with Daiichi Sankyo; Orpathys
(savolitinib) in collaboration with HUTCHMED; as well as a pipeline of
potential new medicines and combinations across diverse mechanisms of action.

 

AstraZeneca is a founding member of the Lung Ambition Alliance, a global
coalition working to accelerate innovation and deliver meaningful improvements
for people with lung cancer, including and beyond treatment.

 

AstraZeneca in immuno-oncology (IO)

AstraZeneca is a pioneer in introducing the concept of immunotherapy into
dedicated clinical areas of high unmet medical need. The Company has a
comprehensive and diverse IO portfolio and pipeline anchored in
immunotherapies designed to overcome evasion of the anti-tumour immune
response and stimulate the body's immune system to attack tumours.

 

AstraZeneca strives to redefine cancer care and help transform outcomes for
patients with Imfinzi as a monotherapy and in combination with Imjudo as well
as other novel immunotherapies and modalities. The Company is also
investigating next-generation immunotherapies like bispecific antibodies and
therapeutics that harness different aspects of immunity to target cancer,
including cell therapy and T cell engagers.

 

AstraZeneca is pursuing an innovative clinical strategy to bring IO-based
therapies that deliver long-term survival to new settings across a wide range
of cancer types. The Company is focused on exploring novel combination
approaches to help prevent treatment resistance and drive longer immune
responses. With an extensive clinical programme, the Company also champions
the use of IO treatment in earlier disease stages, where there is the greatest
potential for cure.

 

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide
cures for cancer in every form, following the science to understand cancer and
all its complexities to discover, develop and deliver life-changing medicines
to patients.

 

The Company's focus is on some of the most challenging cancers. It is through
persistent innovation that AstraZeneca has built one of the most diverse
portfolios and pipelines in the industry, with the potential to catalyse
changes in the practice of medicine and transform the patient experience.

 

AstraZeneca has the vision to redefine cancer care and, one day, eliminate
cancer as a cause of death.

 

AstraZeneca 

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical
company that focuses on the discovery, development, and commercialisation of
prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals,
including Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries
and its innovative medicines are used by millions of patients worldwide.
Please visit astrazeneca.com (http://www.astrazeneca.com/) and follow the
Company on social media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca/) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   National Cancer Institute. NCI Dictionary - Small Cell Lung Cancer.
Available at:
https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer
(https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer)
. Accessed April 2024.

2.   Qin A and Kalemkerian GP. Treatment Options for Relapsed Small-Cell
Lung Cancer: What Progress Have We Made? J Oncol Pract. 2018;14(6):369-370.

3.   Bebb DG, et al. Symptoms and Experiences with Small Cell Lung Cancer: A
Mixed Methods Study of Patients and Caregivers. Pulm Ther. 2023:9;435-450.

4.   World Health Organization. International Agency for Research on Cancer.
Lung Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf)
. Accessed April 2024.

5.   LUNGevity Foundation. Types of Lung Cancer. Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer
(https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer)
. Accessed April 2024.

6.   American Cancer Society. Treatment Choices by Stage for Small Cell Lung
Cancer. Available at:
https://www.cancer.org/cancer/lung-cancer/treating-small-cell/by-stage.html.
(https://www.cancer.org/cancer/lung-cancer/treating-small-cell/by-stage.html.%C2%A0Accessed%20April%202024)
Accessed April 2024.

7.   Senan S, et al. ADRIATIC: A phase III trial of durvalumab ±
tremelimumab after concurrent chemoradiation for patients with limited stage
small cell lung cancer. Ann Oncol. 2019;30(suppl. 2):ii25.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCQKQBDCBKDOQK