REG - AstraZeneca PLC - Update on CALLA Phase III trial for Imfinzi

AstraZenecaAnnouncement

24/03/2022 07:00

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RNS Number : 8857F  AstraZeneca PLC  24 March 2022

24 March 2022 07:00 GMT

 

Update on CALLA Phase III trial of concurrent use of Imfinzi

and chemoradiotherapy in locally advanced cervical cancer

 

The CALLA Phase III trial for AstraZeneca's Imfinzi (durvalumab) given
concurrently with chemoradiotherapy (CRT) did not achieve statistical
significance for the primary endpoint of improving progression-free survival
(PFS) versus CRT alone in the treatment of patients with locally advanced
cervical cancer.

 

Bradley Monk, MD, FACOG, FACS, Professor at the University of Arizona College
of Medicine and principal investigator in the CALLA Phase III trial, said:
"While today's results were not statistically significant, they underscore the
need for further evaluation of novel therapeutic options and will inform
future strategies to improve treatment for patients with locally advanced
cervical cancer."

 

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: "CALLA tested a novel immunotherapy approach in locally advanced
cervical cancer, a devastating and complex disease where many patients
progress following available treatments. While the results were not what we
hoped for, insights from the trial will advance our understanding and
application of immunotherapy across our broad clinical development programme,
exploring the benefits of Imfinzi in many tumour types."

 

The safety and tolerability in this trial were consistent between the two arms
and no new unexpected safety findings were observed. The data will be
presented at a forthcoming medical meeting.

 

Notes

 

Locally advanced cervical cancer

Cervical cancer is the eighth most common, and ninth most deadly, cancer
worldwide, with approximately 600,000 people diagnosed each year.(1)
Approximately 40-50% of cervical cancer cases are diagnosed in the locally
advanced stage.(2) Following current standard-of-care treatment,
platinum-based chemotherapy with radiation therapy, patients with locally
advanced cervical cancer face an approximately 40% chance of disease
recurrence and a five-year survival rate of about 65-70%.(2,3) The
standard-of-care treatment for these patients has not changed in over two
decades.(4)

 

CALLA

CALLA is a randomised, multi-centre, double-blind, global Phase III trial in
which 770 patients with locally advanced cervical cancer were treated with
standard-of-care CRT in combination with either a 1,500mg fixed dose of
Imfinzi or placebo every four weeks for up to 24 cycles or until disease
progression.

 

The trial was conducted at 120 centres across 15 countries including in the
US, Europe, Latin America, Africa and Asia. The primary endpoint was PFS and
key secondary endpoints included overall survival and safety and tolerability.
For more information about the trial, please visit Clinicaltrials.gov
(https://clinicaltrials.gov/ct2/show/NCT03830866) .

 

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.

 

Imfinzi is the only approved immunotherapy in the curative-intent setting of
unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose
disease has not progressed after chemoradiotherapy, and is the global standard
of care in this setting based on the PACIFIC Phase III trial.

 

Imfinzi is also approved in the US, EU, Japan, China and many other countries
around the world for the treatment of extensive-stage small cell lung cancer
based on the CASPIAN Phase III trial.

 

In the past year, Imfinzi has demonstrated clinical benefit in multiple
additional cancer settings with positive Phase III trials in advanced biliary
tract cancer (TOPAZ-1), unresectable advanced liver cancer (HIMALAYA) and
metastatic NSCLC (POSEIDON).

 

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 small cell lung cancer, NSCLC, bladder cancer, several gastrointestinal
cancers, ovarian cancer, endometrial cancer and other solid tumours.

 

AstraZeneca in immuno-oncology

Immunotherapy is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. The Company's Immuno-Oncology (IO) portfolio
is anchored in immunotherapies that have been designed to overcome evasion of
the anti-tumour immune response. AstraZeneca is invested in using IO
approaches that deliver long-term survival for new groups of patients across
tumour types.

 

The Company is pursuing a comprehensive clinical trial programme that includes
Imfinzi as a single treatment and in combination with tremelimumab and other
novel antibodies in multiple tumour types, stages of disease and lines of
treatment, and where relevant using the PD-L1 biomarker as a decision-making
tool to define the best potential treatment path for a patient.

 

In addition, the ability to combine the IO portfolio with radiation,
chemotherapy and targeted small molecules from across AstraZeneca's oncology
pipeline, and from research partners, may provide new treatment options across
a broad range of tumours.

 

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 Twitter @AstraZeneca (https://twitter.com/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.   World Health Organization. Globocan 2020. World fact sheet. Available
at:
https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf
(https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.)
. Accessed March 2022.

2.   Gennigens C, et al. Optimal treatment in locally advanced cervical
cancer. Expert Rev Anticancer Ther. 2021;21(6):657-671.

3.   Espenel S, et al. From IB2 to IIIB locally advanced cervical cancers:
report of a ten-year experience. Radiat Oncol. 2018;13(16):1-11.

4.   Marth C, et al. Cervical cancer: ESMO Clinical Practice Guidelines for
diagnosis, treatment and follow-up. Annals of Oncology 2017; 28 (4):IV72-IV83.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

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