TIDMAZN
RNS Number : 5817L
AstraZeneca PLC
09 September 2019
9 Sept 2019 08:38 BST
Imfinzi is first immunotherapy to show both significant survival
benefit
and improved, durable responses in extensive-stage small cell
lung cancer
In the Phase III CASPIAN trial Imfinzi at a fixed, convenient
dose improved
survival with either a cisplatin or carboplatin chemotherapy
backbone
AstraZeneca today presented detailed results from the Phase III
CASPIAN trial, showing Imfinzi (durvalumab) significantly improved
overall survival (OS) in patients with previously-untreated
extensive-stage small cell lung cancer (SCLC).
Imfinzi in combination with four cycles of standard-of-care
(SoC) chemotherapy (etoposide with either cisplatin or carboplatin)
demonstrated a statistically-significant and clinically-meaningful
improvement in OS vs. SoC consisting of up to six cycles of
chemotherapy and optional prophylactic cranial irradiation
(PCI).
The risk of death was reduced by 27% (equal to a hazard ratio of
0.73), with median OS of 13.0 months for Imfinzi plus chemotherapy
vs. 10.3 months for SoC. Results showed a prolonged OS benefit with
an estimated 33.9% of patients alive at 18 months following
treatment with Imfinzi plus chemotherapy vs. 24.7% of patients
following SoC.
Across all efficacy endpoints, benefits were observed in
patients treated with Imfinzi plus chemotherapy vs. SoC. Results
showed a significantly higher progression-free survival (PFS) rate
at 12 months (17.5% vs. 4.7%), a 10.3% increase in confirmed
objective response rate (ORR) (67.9% vs. 57.6%), and improved
duration of response (DOR) at 12 months (22.7% vs. 6.3%).
The results were presented at the Presidential Symposium of the
IASLC 2019 World Conference on Lung Cancer hosted by the
International Association for the Study of Lung Cancer in
Barcelona, Spain.
Jose Baselga, Executive Vice President, Oncology R&D said:
"We are encouraged to see more than a third of small cell lung
cancer patients treated with Imfinzi plus chemotherapy alive at the
18-month landmark, which is remarkable given the aggressive nature
of the disease. It is also noteworthy that these results may enable
physicians to choose Imfinzi in combination with either cisplatin
or carboplatin chemotherapy backbones. We look forward to working
with regulatory authorities to bring Imfinzi to patients with small
cell lung cancer around the world as soon as possible."
Luis Paz-Ares, MD, Ph.D., Chair, Medical Oncology Department,
Hospital Universitario Doce de Octubre, Madrid, Spain and principal
investigator in the Phase III CASPIAN trial said: "Patients have
had limited treatment options for small cell lung cancer, a
devastating disease where the five-year survival rate has been as
low as 6%. The significant survival benefit demonstrated with
Imfinzi combined with only four cycles of a choice of chemotherapy
compared to a robust control arm, provides evidence and hope of a
new treatment option for these patients."
SCLC is an aggressive, fast-growing cancer that recurs and
progresses rapidly despite initial response to platinum-based
chemotherapy.(1)
Summary of results
EP + Imfinzi(i) EP(i)
(n=268) (n=269)
OS (primary endpoint)(ii)
=============================
Number of deaths (%) 155 (57.8%) 181 (67.3%)
=============== ============
Hazard ratio 0.73 (0.591, 0.909)
(95% CI)
=============================
p-value 0.0047
=============================
Median in months 13.0 10.3
(95% CI) (11.5, 14.8) (9.3, 11.2)
=============== ============
OS rate (18 months) 33.9% 24.7%
=============== ============
PFS (secondary endpoint)(ii,iii)
=============================
Number (%) of patients with event 226 (84.3%) 233 (86.6%)
=============== ============
Hazard ratio 0.78 (0.645, 0.936)
(95% CI)
=============================
Median in months 5.1 5.4
(95% CI) (4.7, 6.2) (4.8, 6.2)
=============== ============
PFS rate (12 months) 17.5% 4.7%
=============== ============
ORR (secondary endpoint)(ii,iv)
=============================
Number (%) of patients with response 182 (67.9%) 155 (57.6%)
=============== ============
Odds ratio 1.56 (1.095, 2.218)
(95% CI)
=============================
DOR at 12 months (secondary endpoint) 22.7% 6.3%
-------------------------------------- --------------- ------------
(i) Etoposide plus investigator choice of cisplatin or
carboplatin chemotherapy.
(ii) The data cut-off date for analysis of OS, PFS and ORR was
11 March 2019.
(iii) PFS was not formally tested for statistical
significance.
(iv) Confirmed responses according to investigator assessment
per RECIST v1.1.
The safety and tolerability of Imfinzi in combination with SoC
etoposide and platinum-based chemotherapy was consistent with
previous trials. Results showed that 61.5% of patients experienced
a Grade 3 or 4 AE with Imfinzi plus SoC (all causes) vs. 62.4% with
SoC, and patients discontinuing treatment due to AEs were similar
between arms (9.4% vs. 9.4%).
Imfinzi is also being tested following concurrent chemoradiation
therapy in limited-stage SCLC in the Phase III ADRIATIC trial.
Imfinzi is approved in the curative-intent setting of
unresectable, Stage III non-small cell lung cancer after
chemoradiotherapy in 49 countries, including the US, Japan and
across the EU, based on the Phase III PACIFIC trial.
About CASPIAN
The CASPIAN trial is a randomised, open-label, multi-centre,
global, Phase III trial in the 1st-line treatment of patients with
extensive-stage SCLC. The trial compared Imfinzi in combination
with etoposide and either cisplatin or carboplatin chemotherapy, or
Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone. In
the experimental arms, patients were treated with up to four cycles
of chemotherapy. In comparison, the control arm allowed up to six
cycles of chemotherapy and optional PCI. The trial will continue to
the final analysis of OS for the combination of Imfinzi,
tremelimumab and chemotherapy.
The trial is being conducted in more than 200 centres across 22
countries, including in the US, Europe, South America, Asia and the
Middle East. The primary endpoint is OS.
About small cell lung cancer
Lung cancer is the leading cause of cancer death among both men
and women and accounts for about one-fifth of all cancer deaths.(2)
Lung cancer is broadly split into NSCLC and SCLC, with about 15%
classified as SCLC.(3) About three quarters of SCLC patients are
diagnosed with extensive-stage disease, in which the cancer has
spread widely through the lung or to other parts of the body.
Prognosis is particularly poor, as only 6% of all SCLC patients
will be alive five years after diagnosis.(4)
About Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds
to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80,
countering the tumour's immune-evading tactics and releasing the
inhibition of immune responses.
Imfinzi is also approved for previously-treated patients with
advanced bladder cancer in 10 countries, including the US.
As part of a broad development programme, Imfinzi is also being
tested as a monotherapy and in combination with tremelimumab, an
anti-CTLA4 monoclonal antibody and potential new medicine, as a
treatment for patients with NSCLC, small cell lung cancer, bladder
cancer, head and neck cancer, liver cancer, cervical cancer,
biliary tract cancer and other solid tumours.
About AstraZeneca in lung cancer
AstraZeneca has a comprehensive portfolio of approved and
potential new medicines in late-stage clinical development for the
treatment of different forms of lung cancer spanning several stages
of disease, lines of therapy and modes of action. We aim to address
the unmet needs of patients with EGFR-mutated tumours as a genetic
driver of disease, which occur in 10-15% of NSCLC patients in the
US and EU and 30-40% of NSCLC patients in Asia, with our approved
medicines Iressa (gefitinib) and Tagrisso (osimertinib), and
ongoing Phase III trials ADAURA, LAURA, FLAURA and FLAURA2 as well
as the Phase II combination trials SAVANNAH and ORCHARD.(5-7)
Our extensive late-stage Immuno-Oncology programme focuses on
lung cancer patients without a targetable genetic mutation which
represents approximately three-quarters of all patients with lung
cancer.(8) Imfinzi (durvalumab), an anti-PDL1 antibody, is in
development for patients with advanced disease (Phase III trials
POSEIDON, PEARL, and CASPIAN) and for patients in earlier stages of
disease including potentially-curative settings (Phase III trials
AEGEAN, PACIFIC-2, ADRIATIC, ADJUVANT BR.31, PACIFIC-4, and
PACIFIC-5) both as monotherapy and in combination with tremelimumab
and/or chemotherapy.
About AstraZeneca's approach to Immuno-Oncology (IO)
IO is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. Our IO portfolio is anchored by
immunotherapies that have been designed to overcome anti-tumour
immune suppression. We believe that IO-based therapies offer the
potential for life-changing cancer treatments for the clear
majority of patients.
We are pursuing a comprehensive clinical-trial programme that
includes Imfinzi (anti-PDL1) as monotherapy and in combination with
tremelimumab (anti-CTLA4) in multiple tumour types, stages of
disease, and lines of therapy, 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 our IO portfolio
with radiation, chemotherapy, small targeted molecules from across
our Oncology pipeline, and from our research partners, may provide
new treatment options across a broad range of tumours.
About AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a
quickly-growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, the
Company is committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investments that
accelerate the delivery of our strategy, as illustrated by the
investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and, one day, eliminate cancer as a cause
of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit astrazeneca.com and follow us on Twitter
@AstraZeneca.
Media Relations
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References
1. Kalemkerian GP, et al. Treatment Options for Relapsed
Small-Cell Lung Cancer: What Progress Have We Made? Journal of
Oncology Practice, volume 14, issue no. 6 (June 1, 2018)
369-370.
2. World Health Organization. International Agency for Research
on Cancer. Available at
http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed
May 2019.
3. LUNGevity Foundation. Types of Lung Cancer. Available at
https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer.
Accessed May 2019.
4. Cancer.Net. Lung Cancer - Small Cell. Available at
https://www.cancer.net/cancer-types/33776/view-all. Accessed May
2019.
5. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on
Cytological and Histological Samples in Non-Small Cell Lung Cancer:
a Polish, Single Institution Study and Systematic Review of
European Incidence. Int J Clin Exp Pathol. 2013:6;2800-12. Accessed
July 2019.
6. Keedy VL, et al. American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy. J Clin Oncol. 2011:29;2121-27. Accessed July 2019.
7. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a
Review of Available Methods and Their Use for Analysis of Tumour
Tissue and Cytology Samples. J Clin Pathol. 2013:66;79-89. Accessed
July 2019.
8. Pakkala, S, et al. Personalized therapy for lung cancer:
striking a moving target. JCI Insight. 2018;3(15):e120858.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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