RNS Number : 3039T
14 November 2023
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
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, w e will learn from
this trial and we remain committed to improving patient outcomes by
expanding the benefit of immunothe r apy 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).
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 o ne in three patients with
NSCLC are diagnosed at Stage III (locally advanced), where the
majority of tumours are unresectable (cannot be removed with
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)
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 (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
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
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
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 (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 .
For details on how to contact the Investor Relations Team,
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1. World Health Organisation. International Agency for Research
on Cancer. Lung Fact Sheet. Available at:
. 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.
6. ASCO. Cancer.net. Lung Cancer - Non-Small Cell. Available at: https://www.cancer.net/cancer-types/lung-cancer/view-all . Accessed October 2023.
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November 14, 2023 02:05 ET (07:05 GMT)
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