REG - AstraZeneca PLC - Update on Imfinzi ADJUVANT BR.31 trial

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25/06/2024 07:15

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RNS Number : 7457T  AstraZeneca PLC  25 June 2024

25 June 2024

 

Update on ADJUVANT BR.31 Phase III trial

of Imfinzi in non-small cell lung cancer

 

High-level results from the ADJUVANT BR.31 Phase III trial, sponsored by the
Canadian Cancer Trials Group (CCTG), showed Imfinzi (durvalumab) did not
achieve statistical significance for the primary endpoint of disease-free
survival (DFS) versus placebo in early-stage (IB-IIIA) non-small cell lung
cancer (NSCLC) after complete tumour resection in patients whose tumours
express PD-L1 on 25% or more tumour cells.

 

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca,
said: "We are disappointed in the ADJUVANT BR.31 results. Imfinzi has helped
change the treatment landscape and achieved multiple positive Phase III trials
for patients with earlier stages of lung cancer. We are committed to
addressing the remaining unmet need in lung cancer through our broad
development programme."

 

The safety profile for Imfinzi was consistent with its known safety profile,
and no new safety concerns were reported. The data will be shared at a
forthcoming medical meeting.

 

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

 

Imfinzi is also being investigated as monotherapy and in combinations in
several other early-stage lung cancer settings, including in medically
inoperable or unresected Stage I-II NSCLC (PACIFIC-4) and unresectable, Stage
III NSCLC (PACIFIC-5, 8 and 9).

 

Notes

 

Lung cancer

Each year, there are an estimated 2.4 million people diagnosed with lung
cancer globally. Lung cancer is the leading cause of cancer death among both
men and women, accounting for about one-fifth of all cancer deaths.(1-2) Lung
cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with
80-85% of patients diagnosed with NSCLC.(3-4)

 

The majority of NSCLC patients are diagnosed with advanced disease while
approximately 25-30% present with resectable disease at diagnosis.(5-6)
Early-stage lung cancer diagnoses are often only made when the cancer is found
on imaging for an unrelated condition.(7-8)

 

The majority of patients with resectable disease eventually develop recurrence
despite complete tumour resection and adjuvant chemotherapy.(9) Only around
58% of patients with Stage IB disease will survive for five years. This
decreases to 36-46% for patients with Stage II and 24% for patients with Stage
IIIA disease, reflecting a high unmet medical need.(10)

 

ADJUVANT BR.31

ADJUVANT BR.31 is a randomised, multi-centre, double-blind Phase III trial
sponsored by CCTG evaluating Imfinzi in the adjuvant treatment of 1,415
patients with Stage IB (≥4cm), II or IIIA (Seventh Edition AJCC Cancer
Staging Manual) NSCLC following complete tumour resection with or without
adjuvant chemotherapy. AstraZeneca provided Imfinzi and support for the trial.
Patients were randomised 2:1 to receive a 20mg/kg IV infusion of Imfinzi or
placebo every four weeks for up to 48 weeks.

 

The trial is being conducted at 269 centres across 19 countries and regions
including in Canada, the US, Australia, Europe and Asia. The primary endpoint
is DFS in patients whose tumours express PD-L1 on 25% or more tumour cells and
do not have known common EGFR mutations or ALK rearrangements. Key secondary
endpoints include DFS in patients whose tumours express PD-L1 on 1% or more of
cells and in patients regardless of PD-L1 tumour cell expression status,
overall survival and safety. DFS is defined as time from randomisation to date
of first recurrence, new cancer or death from any cause and is recognised as
an important clinical measure by both physicians and patients.

 

Canadian Cancer Trials Group (CCTG)

CCTG is an academic cancer clinical trials research cooperative that runs
Phase I-III trials to test anti-cancer and supportive therapies at over 85
hospitals and cancer centres across Canada. From the operations centre at
Queen's University, CCTG has supported more than 600 trials enrolling 100,000
patients from 40 countries on 6 continents through a global network of 20,000
investigators and clinical trial staff. CCTG is a national program of the
Canadian Cancer Society, and their aim is to improve survival and quality of
life for all people with cancer.

 

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 and the global standard of care in
the curative-intent setting of unresectable, Stage III NSCLC in patients whose
disease has not progressed after chemoradiation therapy. Imfinzi is also
approved for the treatment of extensive-stage SCLC and in combination with a
short course of Imjudo (tremelimumab) and chemotherapy for the treatment of
metastatic NSCLC.

 

Imfinzi also demonstrated statistically significant and clinically meaningful
event-free survival results in patients with resectable early-stage NSCLC
based on the AEGEAN Phase III trial. Imfinzi in combination with neoadjuvant
chemotherapy before surgery and as adjuvant monotherapy after surgery is
approved for patients in Switzerland based on this trial.

 

In limited-stage SCLC, Imfinzi demonstrated statistically significant and
clinically meaningful improvements in the dual primary endpoints of OS and
progression-free survival (PFS) compared to placebo in patients who had not
progressed following standard-of-care concurrent chemoradiotherapy in the
ADRIATIC Phase III trial.

 

In addition to its indications in lung cancers, Imfinzi is approved in
combination with chemotherapy (gemcitabine plus cisplatin) 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 combination with
chemotherapy (carboplatin plus paclitaxel) followed by Imfinzi monotherapy in
primary advanced or recurrent endometrial cancer that is mismatch repair
deficient in the US.

 

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, breast cancer, several
gastrointestinal and gynaecologic cancers, and other solid tumours. 

 

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's innovative medicines are
sold in more than 125 countries and used by millions of patients worldwide.
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References

1.   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 June 2024.

2.   World Health Organization. International Agency for Research on Cancer.
World Fact Sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf)
. Accessed June 2024.

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

4.   Cheema PK, et al. Perspectives on treatment advances for stage III
locally advanced unresectable non-small-cell lung cancer. Curr Oncol.
2019;26(1):37-42.

5.   Cagle PT, et al. Lung Cancer Biomarkers: Present Status and Future
Developments. Arch Pathol Lab Med. 2013;137(9):1191-1198.

6.   Le Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell
Lung Cancer: Where is it Going? Ann Oncol. 2010;21(suppl 7):vii196-198.

7.   Sethi S, et al. Incidental Nodule Management - Should There Be a Formal
Process? J Thorac Dis. 2016:8(Suppl 6);S494-S497.

8.   LUNGevity Foundation. Screening and Early Detection. Available at:
https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection.
(https://www.lungevity.org/lung-cancer-basics/screening-early-detection) .
Accessed June 2024.

9.   Pignon JP, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis
by the LACE Collaborative Group. J Clin Oncol. 2008;26(21):3552-3559.

10.  Goldstraw
(https://pubmed.ncbi.nlm.nih.gov/?term=Goldstraw+P&cauthor_id=17762336) P,
et al. The IASLC Lung Cancer Staging Project: proposals for the revision of
the TNM stage groupings in the forthcoming (seventh) edition of the TNM
Classification of malignant tumours. J Thorac Oncol. 2007;2(8):706-14.

 

Adrian Kemp

Company Secretary

AstraZeneca PLC

 

 

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