- Data from the phase Ib Beamion LUNG-1 trial selected for
late-breaking oral presentation in the Presidential Symposium at
WCLC on Monday, September 9.
- The U.S. FDA and China's CDE have granted zongertinib
Breakthrough Therapy Designation for patients with HER2-mutated
NSCLC and who have received prior systemic therapy.
- Phase I trial data of a novel DLL3-targeting T-Cell Engager,
which has already secured FDA Fast Track as well as FDA and EMA
Orphan Drug Designations, will also be presented.
At the IASLC 2024 World Conference on Lung Cancer (WCLC)
Boehringer Ingelheim will present encouraging data from across its
oncology pipeline, illustrating its aspiration to transform the
lives of people with cancer by delivering meaningful advances.
Carinne Brouillon, Head of Human Pharma at Boehringer, said:
“Every year, about 40,000 people worldwide are diagnosed with
non-small cell lung cancer (NSCLC) with a HER2
mutation.1 While targeted therapy is available for some
cancers driven by HER2, people living with HER2-mutated NSCLC have
few options. We are proud to be sharing new data evaluating our
investigational zongertinib in this hard-to-treat setting. Our
strong oncology pipeline underscores our strategic approach in
advancing novel targeted treatments and cancer cell-directed
therapies that have a potential to transform lives for generations
of patients.”
Late-breaking results from the Beamion LUNG-1 trial, which is a
Phase Ia/b trial evaluating the safety and efficacy of zongertinib
(BI 1810631), a HER2-specific tyrosine kinase inhibitor (TKI), will
be presented at WCLC. This includes new data from a primary
analysis of the first Cohort of Phase Ib in pre-treated patients
with HER2m+ NSCLC to be presented in a Presidential Symposium
on Monday, September 9, from 8:30AM - 10:00AM PDT (Location:
Plenary Hall) and featured in the official WCLC Press
Program.
Highlighting the potential of zongertinib, the investigational
oral therapy was recently granted Breakthrough Therapy Designation
by the U.S. FDA and China’s CDE for the treatment of adult patients
with advanced, unresectable or metastatic NSCLC whose tumors have
activating HER2 mutations, and who have received a prior systemic
therapy.
Investigating the potential of DLL3 targeted immunotherapy to
transform the treatment of neuroendocrine carcinomas
Exploring the promise of DLL3-targeted immunotherapy in
transforming the treatment of neuroendocrine carcinomas, Boehringer
will present data from the Phase I trial of its novel
DLL3-targeting T-Cell Engager, BI 764532 in an Oral Presentation on
Monday, September 9, from 2:22PM-2:32PM PDT (Location: 20A). This
investigational treatment, which has been granted FDA Fast Track as
well as FDA and EMA Orphan Drug Designations, is currently being
evaluated in patients with large-cell neuroendocrine carcinoma of
the lung (LCNEC-L), small cell lung cancer (SCLC) and
extrapulmonary neuroendocrine cancer (epNEC). BI 764532 is designed
to redirect T-cells to target tumors that express the DLL3
protein.
In addition to the five abstracts to be presented at WCLC,
Boehringer will also host a symposium titled "Emerging Therapies in
Clinical Practice: What are the Patient Perspectives on the Future
of Lung Cancer Treatment?" on Saturday, September 7, from 3:45PM to
4:45PM PDT (Location: 30DE). At Boehringer, cancer care is
personal, which is why this event will explore patient viewpoints
and expectations regarding the evolving landscape of lung cancer
therapy.
Data from Boehringer’s oncology pipeline to be presented at
WCLC:
About non-small cell lung cancer (NSCLC)
Lung cancer claims more lives than any other cancer type and the
incidence is set to increase to over 3 million cases worldwide by
2040.2 NSCLC is the most common type of lung cancer.3 The
condition is often diagnosed at a late stage,4 and fewer than
3 in 10 patients are alive five years after diagnosis.5 People
living with advanced NSCLC can experience a detrimental physical,
psychological, and emotional impact on their daily lives. There
remains a high unmet need for additional treatment options for
people living with advanced NSCLC. Around 4.7% of lung cancers are
driven by HER2 mutations (or gene alterations).1,6
About zongertinib
Zongertinib (also known as BI 1810631) is an investigational
oral HER2-specific tyrosine kinase inhibitor (TKI) that is highly
selective and being developed as a potential treatment for
non-small cell lung cancer (NSCLC). Zongertinib was granted FDA
Fast Track Designation in 2023, then in 2024 it was granted
Breakthrough Therapy Designation by the U.S. FDA and China CDE for
the treatment of adult patients with advanced NSCLC whose tumors
have activating HER2 mutations, and who have received a prior
systemic therapy. HER2 is a member of the ErbB family of receptor
tyrosine kinases (enzymes that act like chemical messengers).
Mutations in HER2 can lead to overexpression and overactivation,
which can in turn result in uncontrolled cell production,
inhibition of cell death and promotion of tumor growth and spread.
Read more here.
About BI 764532
BI 764532 is an investigational DLL3/CD3 IgG-like T-Cell Engager
under development as a potential new targeted immunotherapy for
patients with large-cell neuroendocrine carcinoma of the lung
(LCNEC-L), small cell lung cancer (SCLC) & extrapulmonary
neuroendocrine cancer (epNEC). The therapy is designed to directly
redirect T-cells, potentially resulting in the selective killing of
tumor cells by the body’s own immune system. Pre-clinical in-vivo
data suggests administration of DLL3/CD3 bispecific T-cell engager
(ITE) monotherapy induces T-cell infiltration into tumor tissues,
transforming a non-inflamed (cold) tumor microenvironment into an
inflamed (hot) state. This process triggers tumor cell apoptosis,
resulting in significant tumor regression. BI 764532 has been
granted FDA Fast Track as well as FDA and EMA Orphan Drug
Designations. Read more here.
About brigimadlin
Brigimadlin (also known as BI 907828) is an investigational oral
MDM2-p53 antagonist being developed as a potential treatment for
certain types of cancer. The small molecule compound may inhibit
the interaction between MDM2 and p53, restoring p53 wild type
function. Inactivation of the tumor suppressor protein p53 is a
central mechanism by which cancer cells drive tumor growth.
Increased levels of the protein MDM2, a key negative regulator of
p53, is a well-characterized inactivation mechanism, seen in about
5-7% of all cancer cases.
About Boehringer Ingelheim in oncology
We have a clear aspiration – to transform the lives of people
with cancer by delivering meaningful advances, with the ultimate
goal of curing a range of cancers. Boehringer Ingelheim’s
generational commitment to driving scientific innovation is
reflected by the company’s robust pipeline of cancer cell-directed
and immuno-oncology investigational therapies, as well as the smart
combination of these approaches. Boehringer’s ambition in oncology
is to take a diligent and broad approach, creating a collaborative
research network to tap into a diversity of minds, which is vital
in addressing some of the most challenging, but potentially most
impactful, areas of cancer research. Simply put, for Boehringer
Ingelheim, cancer care is personal, today and for generations. Read
more here.
About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in
both human and animal health. As one of the industry’s top
investors in Research and Development, the company focuses on
developing innovative therapies in areas of high unmet medical
need. Independent since its foundation in 1885, Boehringer takes a
long-term perspective, embedding sustainability along the entire
value chain. More than 53,500 employees serve over 130 markets to
build a healthier, more sustainable, and equitable tomorrow. Learn
more at www.boehringer-ingelheim.com.
References:
1Chia, P. et al. Prevalence and natural history of ALK positive
non-small-cell lung cancer and the clinical impact of targeted
therapy with ALK inhibitors. Clinical Epidemiology.
http://dx.doi.org/10.2147/CLEP.S69718.
2International Agency for Research on Cancer – World Health
Organization. Rates of trachea, bronchus and lung cancer. Available
at: https://gco.iarc.fr/tomorrow/en (Accessed August 2024).
3Zappa C & Mousa Non-small cell lung cancer: current
treatment and future advances, Transl Lung Cancer Res. 2016 Jun;
5(3): 288–300.
4Polanco D et al. Prognostic value of symptoms at lung cancer
diagnosis: a three-year observational study. J Thorac Dis
2021;13:1485–1494
5National Cancer Institute Surveillance, Epidemiology, and End
Results (SEER). https://seer.cancer.gov/statfacts/html/lungb.html
(Accessed: August 2024).
6Arcila, M. E. et al. Prevalence, clinicopathologic
associations, and molecular spectrum of ERBB2 (HER2) tyrosine
kinase mutations in lung adenocarcinomas. Clin. cancer
Res. an Off. J. Am. Assoc. Cancer Res. 18,
4910–4918 (2012).
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