On August 27, 2024 Boehringer Ingelheim reported that it will present encouraging data from across its oncology pipeline, illustrating its aspiration to transform the lives of people with cancer by delivering meaningful advances at the IASLC 2024 World Conference on Lung Cancer (WCLC) (Press release, Boehringer Ingelheim, AUG 27, 2024, View Source [SID1234646133]).
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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.i 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 2:22 PM-2:32 PM 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:
Presenter
Abstract title
Presentation details
Gerrina Ruiter
Primary Phase Ib Analysis of Beamion LUNG-1: Zongertinib (BI 1810631) in Patients with HER2 Mutation-Positive NSCLC
Oral Presentation (PL04.04.)
Presidential Symposium 2, Plenary Hall
• September 9, 2024
• 8:39 AM-8:46 AM PDT
Frans Opdam
Zongertinib (BI 1810631) for HER2-positive Solid Tumors with Brain Metastases: Subanalysis for the Beamion LUNG-1 Trial
Mini Oral (MA12.10.)
Session: Paving the Path to Precision Oncology: Targeting EGFR and HER2, 20D
• September 10, 2024
• 2:13 PM-2:18 PM PDT
Martin Wermke
Phase I Trial of DLL3/CD3 IgG-like T-Cell Engager BI 764532 in Patients with DLL3-Positive Tumors: Patients with LCNEC
Oral Presentation (OA10.05.)
Session: DLL3 Targeting BiTE Therapies in SCLC, 20A
• September 9, 2024
• 2:22 PM-2:32 PM PDT
Yi-Long Wu
Beamion LUNG-1 and LUNG-2: The Zongertinib Clinical Program in Patients with Non-Small Cell Lung Cancer and HER2 Mutations
Poster (P3.12D.06.)
Poster Session: Metastatic Non-small Cell Lung Cancer – Targeted Therapy, Exhibit Hall
• September 9, 2024
• 12:00 PM PDT
Noboru Yamamato
Efficacy and safety of brigimadlin, a MDM2-p53 agonist in patients with advanced lung adenocarcinoma
Poster (P3.12C.)
Session: Metastatic Non-small Cell Lung Cancer – Targeted Therapy – BRAF/HER2/ MET/Novel Targets, Exhibit Hall
• September 9, 2024
• 12:00 PM PDT
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.ii NSCLC is the most common type of lung cancer.iii The condition is often diagnosed at a late stage,iv and fewer than 3 in 10 patients are alive five years after diagnosis.v 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).i,vi
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.