Boehringer Ingelheim to showcase oncology research at WCLC, highlighting portfolio strength

RIDGEFIELD, Conn., Aug. 27, 2024 – Data from the Phase Ib Beamion LUNG-1 trial has been selected for a late-breaking oral presentation at the Presidential Symposium during the World Conference on Lung Cancer (WCLC) on Monday, September 9. The U.S. FDA and China's CDE have bestowed zongertinib with Breakthrough Therapy Designation for patients with HER2-mutated non-small cell lung cancer (NSCLC) who have undergone prior systemic therapy. Additionally, Phase I trial data of a new DLL3-targeting T-Cell Engager, which has received FDA Fast Track and Orphan Drug Designations, will also be shared.

Boehringer Ingelheim is set to present promising data from its oncology pipeline at the IASLC 2024 World Conference on Lung Cancer. This is part of their goal to make significant strides in cancer treatment. Highlighting this effort, Carinne Brouillon, Head of Human Pharma at Boehringer, stated, "Every year, approximately 40,000 people globally are diagnosed with HER2-mutated NSCLC. While some targeted therapies exist for HER2-driven cancers, options are limited for HER2-mutated NSCLC. We're excited to share new data on our investigational zongertinib in this challenging setting. Our robust oncology pipeline reflects our strategic efforts to advance innovative treatments that can potentially transform patient lives."

The Beamion LUNG-1 trial, focusing on the efficacy and safety of zongertinib (BI 1810631), a HER2-specific tyrosine kinase inhibitor, will showcase new data from a primary analysis of the first Cohort of Phase Ib in pre-treated patients with HER2-mutated NSCLC. This will be presented at the Presidential Symposium on Monday, September 9, between 8:30 AM and 10:00 AM PDT.

Zongertinib, an investigational oral therapy, has recently been granted Breakthrough Therapy Designation by both the U.S. FDA and China's CDE for treating adults with advanced, unresectable, or metastatic NSCLC with activating HER2 mutations who have previously received systemic therapy.

Boehringer is also investigating the potential of DLL3-targeted immunotherapy for neuroendocrine carcinomas. Data from the Phase I trial of BI 764532, a novel DLL3-targeting T-Cell Engager, will be presented in an oral session on Monday, September 9, from 2:22 PM to 2:32 PM PDT. This investigational treatment targets large-cell neuroendocrine carcinoma of the lung (LCNEC-L), small cell lung cancer (SCLC), and extrapulmonary neuroendocrine cancer (epNEC). BI 764532 has already received FDA Fast Track and Orphan Drug Designations from both the FDA and EMA. This therapy aims to redirect T-cells to target DLL3-expressing tumors.

In addition to these presentations, Boehringer will 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 3:45 PM to 4:45 PM PDT. The event will explore patient viewpoints and expectations regarding emerging lung cancer therapies.

Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC being the most prevalent type. The incidence of lung cancer is projected to surpass 3 million cases worldwide by 2040. NSCLC is often diagnosed at an advanced stage, with less than 30% of patients surviving five years post-diagnosis. Advanced NSCLC significantly impacts patients' physical, psychological, and emotional well-being, highlighting the urgent need for novel treatment options. Approximately 4.7% of lung cancers are driven by HER2 mutations.

Zongertinib is an investigational HER2-specific tyrosine kinase inhibitor designed to treat NSCLC. It has been granted FDA Fast Track and Breakthrough Therapy Designations for treating adults with advanced HER2-mutated NSCLC who have had prior systemic therapy. HER2 mutations can lead to overexpression and activation, resulting in unchecked cell growth and tumor spread.

BI 764532 is an investigational DLL3/CD3 T-Cell Engager being explored for treating neuroendocrine carcinomas. The therapy redirects T-cells to selectively kill tumor cells expressing DLL3, and has shown promising pre-clinical results in transforming tumor microenvironments from non-inflamed to inflamed states, triggering significant tumor regression.

Boehringer Ingelheim's commitment to oncology is underscored by its robust pipeline of investigational therapies aimed at delivering meaningful advances in cancer treatment. The company aims to transform cancer care through innovation and collaboration, with a broad approach to addressing challenging areas of cancer research.

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