FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of November 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.Update
on PACIFIC-2 Phase III trial for Imfinzi
14 November 2023
Update on PACIFIC-2 Phase III trial
of Imfinzi concurrently administered with
platinum-based chemoradiotherapy in unresectable, Stage III
non-small cell lung cancer
The PACIFIC-2 Phase III trial for Imfinzi (durvalumab) concurrently administered with
chemoradiotherapy (CRT) did not achieve statistical significance
for the primary endpoint of progression-free survival (PFS) versus
CRT alone for the treatment of patients with unresectable, Stage
III non-small cell lung cancer (NSCLC).
Imfinzi sequentially
administered after platinum-based CRT is the established, global
standard of care for the treatment of unresectable, Stage III NSCLC
based on the results of the PACIFIC Phase III trial. The PACIFIC-2
trial was initiated to evaluate concurrent Imfinzi administration with CRT, with the aim of
addressing patients who progress or discontinue treatment during
CRT and are therefore ineligible for the PACIFIC
regimen.
Initial analysis of the safety and tolerability
for Imfinzi and CRT in this patient population showed
that the profiles were broadly consistent with the known profiles
of these treatments, although there was an increased rate of
infection observed during the concurrent treatment period in the
experimental arm.
Jeffrey D. Bradley, MD,
Vice Chair of Proton Therapy & Technology Development, Penn
Medicine, Philadelphia and principal investigator for the
trial said: "While the
PACIFIC-2 trial results did not show what we hoped, the PACIFIC
regimen remains the standard of care for patients
with unresectable,
Stage III non-small cell lung cancer. As a community, we will take
insights from these results to advance future
research."
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: "Our goal with the PACIFIC-2 trial
was to address a remaining unmet need for patients in this setting
by introducing immunotherapy even earlier and concurrently
administering Imfinzi with chemoradiotherapy.
While today's results did not reach statistical
significance, we
will learn from this trial and we remain committed to improving
patient outcomes by expanding
the benefit
of immunotherapy to lung
cancer patients across
treatment settings."
AstraZeneca has several ongoing registrational trials focused on
testing Imfinzi in early stages of lung cancer, including in
resectable NSCLC (ADJUVANT BR.31), medically inoperable or
unresected Stage I-II NSCLC (PACIFIC-4) and unresectable, Stage III
NSCLC (PACIFIC-5, 8 and 9), and in limited-stage small-cell lung
cancer (SCLC) (ADRIATIC).
Notes:
Stage III NSCLC
Each year, an estimated 2.2 million people are diagnosed with lung
cancer globally.1 Lung
cancer is the leading cause of cancer death among both men and
women, accounting for about one-fifth of all cancer
deaths.1 Lung
cancer is broadly split into NSCLC and SCLC, with 80-85% classified
as NSCLC, making it the most common form of lung
cancer.2-3 Approximately
one in three patients with
NSCLC are diagnosed at Stage III (locally advanced), where the
majority of tumours are unresectable (cannot be removed with
surgery).4-5
Stage III NSCLC is divided into three subcategories (IIIA, IIIB and
IIIC), defined by how much the cancer has spread
locally.6 In
contrast to Stage IV, when cancer has spread to other parts of the
body (metastasised), the majority of Stage III patients are
currently treated with curative intent.3,6
PACIFIC-2
The PACIFIC-2 trial was a Phase III, randomised, double-blind,
placebo-controlled, multi-centre international study
of Imfinzi concurrently
administered with platinum-based CRT in patients with unresectable,
Stage III NSCLC. In the trial, patients were
randomised 2:1 to receive a 1,500mg
fixed dose of Imfinzi or
placebo every four weeks starting at the beginning of definitive
CRT. Patients continued to
receive Imfinzi or
placebo as consolidation treatment after CRT until disease
progression.
The trial was conducted at 88 centres across more than 20 countries
involving 328 patients. The primary endpoint was PFS, and key
secondary endpoints included overall survival, objective response
rate and duration of response.
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 based on the PACIFIC Phase III trial results which have
been confirmed in the real-world setting in the PACIFIC-R
study.
Imfinzi is
also approved in the US, EU, Japan, China and many other countries
around the world for the treatment of extensive-stage SCLC based on
the CASPIAN Phase III trial. Additionally, Imfinzi is
approved in combination with a short course
of Imjudo (tremelimumab)
and chemotherapy for the treatment of metastatic NSCLC in the US,
EU and Japan based on the POSEIDON 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 in
the US, EU, Japan and several other countries based on the TOPAZ-1
and HIMALAYA Phase III trials,
respectively. Imfinzi is also approved in previously treated
patients with advanced bladder cancer in a small number of
countries.
Since the first approval in May 2017, more than 200,000 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, several gastrointestinal cancers and
other solid tumours.
In 2023, AstraZeneca announced positive results for several Phase
III trials evaluating Imfinzi in various combinations, including in
ovarian (DUO-O) and endometrial (DUO-E) cancers
with Lynparza (olaparib), gastric and gastroesophageal
cancer (MATTERHORN) and resectable NSCLC
(AEGEAN).
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 aims to reimagine cancer care and help transform
outcomes for patients with Imfinzi as a single treatment and in combination
with Imjudo as well as other novel immunotherapies and
modalities. The Company is also exploring next-generation
immunotherapies like bispecific antibodies and therapeutics that
harness different aspects of immunity to target
cancer.
AstraZeneca is boldly 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. 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 and
follow the Company on social media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. World
Health Organisation. International Agency for Research on Cancer.
Lung Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf.
Accessed October 2023.
2. LUNGevity
Foundation. Types of Lung Cancer. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed October 2023.
3. 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.
4. Hansen
RN, et
al. Long-term
survival trends in patients with unresectable stage III non-small
cell lung cancer receiving chemotherapy and radiation therapy: a
SEER cancer registry analysis. BMC
Cancer.
2020;20(1):276.
5. Provencio
M, et
al. Inoperable
stage III non-small cell lung cancer: Current treatment and role of
vinorelbine. J Thorac
Dis.
2011;3(3):197-204.
6. ASCO. Cancer.net.
Lung Cancer - Non-Small Cell. Available at: https://www.cancer.net/cancer-types/lung-cancer/view-all.
Accessed October 2023.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
14 November 2023
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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