In the overall trial population, survival
results numerically favoured AstraZeneca and Daiichi
Sankyo’s datopotamab deruxtecan but did not reach statistical
significance
TROPION-Lung01 previously met the dual
primary endpoint of progression-free survival in the overall
trial population
Results support applications currently under
review by regulatory authorities globally including in the
US and EU
This announcement contains inside information
High-level overall survival (OS) results from the TROPION-Lung01
Phase III trial, which previously met the dual primary endpoint of
progression-free survival (PFS), numerically favoured datopotamab
deruxtecan (Dato-DXd) compared to docetaxel in the overall trial
population of patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) treated with at least one prior
line of therapy. Survival results did not reach statistical
significance in the overall trial population. In the prespecified
subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan
showed a clinically meaningful improvement in OS compared to
docetaxel, the current standard-of-care chemotherapy.
The final analysis of OS builds on the positive progression-free
survival (PFS) results presented at the 2023 European Society for
Medical Oncology Congress which showed datopotamab deruxtecan
demonstrated a statistically significant improvement in PFS in the
overall trial population and a clinically meaningful PFS benefit in
patients with nonsquamous NSCLC. In TROPION-Lung01, patient
enrolment by tumour histology was balanced across treatment arms
and consistent with real-world incidence with approximately 75% of
patients having nonsquamous NSCLC.1,2
The safety profile of datopotamab deruxtecan in TROPION-Lung01
was consistent with the previous analysis including fewer dose
reductions or discontinuations due to adverse events compared to
docetaxel, and no new safety concerns identified. No new
interstitial lung disease events of any grade were adjudicated as
drug-related.
Susan Galbraith, Executive Vice President, Oncology R&D,
AstraZeneca, said: “Datopotamab deruxtecan is the only
investigational therapy to show a clinically meaningful survival
improvement in patients with previously treated nonsquamous
non-small cell lung cancer versus docetaxel, which has long been
unsurpassed in this post-targeted treatment and post-immunotherapy
setting. These results reinforce the potential for datopotamab
deruxtecan to replace conventional chemotherapy in this late-line
setting and underscore our confidence in ongoing trials evaluating
this therapy in first-line lung cancer.”
Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo, said:
“The improvement in overall survival seen with datopotamab
deruxtecan coupled with the previously reported clinically
meaningful progression-free survival, more than doubling of overall
response and prolonged duration of response compared to docetaxel
suggest that this TROP2-directed antibody drug conjugate could
potentially become an important new treatment for patients with
nonsquamous non-small cell lung cancer in this advanced setting.
These data will support our ongoing discussions with regulatory
authorities globally to potentially bring datopotamab deruxtecan to
patients as quickly as possible and mark another step forward in
creating new standards of care for patients with cancer.”
Datopotamab deruxtecan is a specifically engineered
TROP2-directed DXd antibody drug conjugate discovered by Daiichi
Sankyo and being jointly developed by AstraZeneca and Daiichi
Sankyo.
The data will be presented at a forthcoming medical meeting and
will support regulatory applications currently under review
globally, including in the US and EU for the treatment of adult
patients with locally advanced or metastatic nonsquamous NSCLC who
have received prior systemic therapy.
Notes
Advanced non-small cell lung cancer
Nearly 2.5 million lung cancer cases were diagnosed globally in
2022.3 NSCLC is the most common type of lung cancer, accounting for
about 80% of cases.4 Approximately 75% and 25% of NSCLC tumours are
of nonsquamous or squamous histology, respectively.1 While
immunotherapy and targeted therapies have improved outcomes in the
1st-line setting, most patients eventually experience disease
progression and receive chemotherapy.5-7 For decades, chemotherapy
has been the last treatment available for patients with advanced
NSCLC, despite limited effectiveness and known side effects.5-7
TROP2 is a protein broadly expressed in the majority of NSCLC
tumours.8 There is currently no TROP2-directed ADC approved for the
treatment of lung cancer.9,10
TROPION-Lung01
TROPION-Lung01 is a global, randomised, multicentre, open-label
Phase III trial evaluating the efficacy and safety of datopotamab
deruxtecan (6.0mg/kg) versus docetaxel (75mg/m2) in adult patients
with locally advanced or metastatic NSCLC with and without
actionable genomic alterations who require systemic therapy
following prior treatment. Patients with actionable genomic
alterations were previously treated with platinum-based
chemotherapy and an approved targeted therapy. Patients without
known actionable genomic alterations were previously treated,
concurrently or sequentially, with platinum-based chemotherapy and
a PD-1 or PD-L1 inhibitor.
The dual primary endpoints of TROPION-Lung01 are PFS as assessed
by blinded independent central review (BICR) and OS. Key secondary
endpoints include investigator-assessed PFS, objective response
rate, duration of response, time to response, disease control rate
as assessed by both BICR and investigator, and safety.
TROPION-Lung01 enrolled approximately 600 patients in Asia,
Europe, North America and South America. For more information visit
ClinicalTrials.gov.
Datopotamab deruxtecan (Dato-DXd)
Datopotamab deruxtecan (Dato-DXd) is an investigational
TROP2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd
ADC Technology, datopotamab deruxtecan is one of six DXd ADCs in
the oncology pipeline of Daiichi Sankyo, and one of the most
advanced programmes in AstraZeneca’s ADC scientific platform.
Datopotamab deruxtecan is comprised of a humanised anti-TROP2 IgG1
monoclonal antibody, developed in collaboration with Sapporo
Medical University, attached to a number of topoisomerase I
inhibitor payloads (an exatecan derivative, DXd) via
tetrapeptide-based cleavable linkers.
A comprehensive global clinical development programme is
underway with more than 20 trials evaluating the efficacy and
safety of datopotamab deruxtecan across multiple cancers, including
NSCLC, triple-negative breast cancer and HR-positive, HER2-negative
breast cancer.
Daiichi Sankyo collaboration
AstraZeneca and Daiichi Sankyo entered into a global
collaboration to jointly develop and commercialise Enhertu in March
2019 and datopotamab deruxtecan in July 2020, except in Japan where
Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi
Sankyo is responsible for the manufacturing and supply of Enhertu
and datopotamab deruxtecan.
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 (durvalumab)
and Imjudo (tremelimumab); 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 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.
National Cancer Institute. SEER Cancer
Statistics Factsheets: Lung and Bronchus Cancer, 1975-2017.
Accessed May 2024.
2.
Ahn M-J, et al. Datopotamab deruxtecan
(Dato-DXd) vs doxetaxel in previously treated advanced/metastatic
(adv/met) non-small cell lung cancer (NSCLC): results of the
randomized phase 3 study TROPION-Lung01. Presented at: ESMO
Congress 2023, 20-24 October 2023; Madrid, Spain. LBA12.
3.
World Health Organization. Global Cancer
Observatory: Lung. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf.
Accessed May 2024.
4.
Cancer.net. Lung Cancer – Non-Small Cell:
Statistics. Available at:
https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics#:~:text=NSCLC%20is%20the%20most%20common,be%20diagnosed%20with%20lung%20cancer.
Accessed May 2024.
5.
Chen R, et al. Emerging therapeutic agents
for advanced non-small cell lung cancer. J Hematol Oncol.
2020;13(1):58.
6.
Majeed U, et al. Targeted therapy in
advanced non-small cell lung cancer: current advances and future
trends. J Hematol Oncol. 2021;14(1):108.
7.
Pircher, A, et al. Docetaxel in the
Treatment of Non-small Cell Lung Cancer (NSCLC) – An Observational
Study Focusing on Symptom Improvement. Anticancer Research.
2013;33(9):3831-3836.
8.
Mito R, et al. Clinical impact of TROP2 in
non‐small lung cancers and its correlation with abnormal p53
nuclear accumulation. Pathol Int. 2020;70(5):287-294.
9.
Rodríguez-Abreau D, et al. Pemetrexed plus
platinum with or without pembrolizumab in patients with previously
untreated metastatic nonsquamous NSCLC: protocol-specified final
analysis from KEYNOTE-189. Ann Onc. 2021 Jul;32(7): 881-895.
10.
American Cancer Society. Targeted Drug
Therapy for Non-Small Cell Lung Cancer. Available at:
https://www.cancer.org/cancer/types/lung-cancer/treating-non-small-cell/targeted-therapies.html.
Accessed May 2024.
Adrian Kemp Company Secretary AstraZeneca
PLC
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