DAREON ® -Lung-1: A Phase III Multi-center, Open-label, Randomised Trial of Intravenous Obrixtamig in Combination With Atezolizumab, Carboplatin, and Etoposide vs. Atezolizumab, Carboplatin, and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer

This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3.
Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein.
Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Start Date10 Apr 2026

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT05963867

/ RecruitingPhase 1

An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma

This study is open to adults with small cell lung cancer and other neuroendocrine cancers. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out how a medicine called BI 764532 gets distributed in the body and in tumours.
Participants get BI 764532 when starting treatment. In the first weeks, doctors check how BI 764532 is taken up in tumours by means of an imaging method. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.

Start Date06 Aug 2024

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT05990738

/ Active, not recruitingPhase 1

DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With a Single Agent Chemotherapy for the Treatment of Patients With Relapsed/Refractory Small Cell Lung Cancer After Platinum-based Chemotherapy

This study is open to adults with extensive stage small cell lung cancer. The study is in people with advanced cancer that had previously received platinum-based chemotherapy and are eligible to receive a single agent chemotherapy treatment.
The purpose of this study is to find the highest dose of BI 764532 that people can tolerate when taken together with a single agent chemotherapy. BI 764532 is an antibody-like molecule that may help the immune system fight cancer.
Participants may continue to take BI 764532 as long as they benefit from treatment and can tolerate it. During this time, participants visit the study site regularly. The visits also depend on the response to the treatment. At the study visits, the doctors check the health of the participants, take necessary laboratory tests, and note any health problems that could have been caused by the study treatment.

Start Date14 Feb 2024

Sponsor / Collaborator

Boehringer Ingelheim GmbH

100 Clinical Results associated with Obrixtamig

100 Translational Medicine associated with Obrixtamig

100 Patents (Medical) associated with Obrixtamig

Literatures (Medical) associated with Obrixtamig

20 Sep 2025·JOURNAL OF CLINICAL ONCOLOGY

Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas

Article

Author: Arriola, Edurne ; Fang, Xiaoyan ; Villaruz, Liza C. ; Kuboki, Yasutoshi ; Alese, Olatunji B. ; Morgensztern, Daniel ; Bertulis, Julia ; Sanmamed, Miguel F. ; Wermke, Martin ; Studeny, Matus ; Gambardella, Valentina ; Felip, Enriqueta ; Wolf, Jürgen ; Sayehli, Cyrus M. ; Bouzaggou, Mohamed

PURPOSE:

We report phase I results for obrixtamig (BI 764532), a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager, in patients with previously treated DLL3-positive small cell lung cancer (SCLC), extrapulmonary neuroendocrine carcinomas (epNECs), or large cell neuroendocrine carcinoma of the lung (LCNEC-L).

METHODS:

Patients received escalating intravenous obrixtamig doses using four regimens: a fixed dose once every 3 weeks (A); a fixed dose once weekly (B1); a step-up dose once weekly for two weeks and target dose once weekly (B2); and a step-up dose once weekly for 3 weeks, target dose once weekly for 3 weeks, and once every 3 weeks thereafter (B3). The primary objective was maximum tolerated dose (MTD). Secondary objectives included safety, pharmacokinetics, and tumor response (RECIST v1.1).

RESULTS:

As of February 21, 2024, 168 patients received obrixtamig, 72% received ≥2 lines of previous anticancer therapy, and 51% received previous anti–PD-1/PD-L1 therapy. Seven dose-limiting toxicities occurred during MTD evaluation (Regimen A, n = 1; Regimen B2, n = 6). MTD was not reached. The most common treatment-related adverse event was cytokine release syndrome (any grade: 57%; grade ≥3: 3%); most cases occurred early and were reversible. Across all doses, regimens, and tumor types, the overall response rate (ORR) was 23% (95% CI, 17.4% to 30.2%), the median duration of response (DoR) was 8.5 months (95% CI, 6.2 to not reached), and the 6-month DoR rate was 70% (95% CI, 53% to 88%). All patients in Regimens B2/B3 received the minimum effective dose (≥90 μg/kg once weekly or once every 3 weeks), achieving an ORR of 28% (95% CI, 20.7% to 35.9%). With Regimens B2/B3, ORRs were 21% (95% CI, 12.9% to 33.1%), 27% (95% CI, 17.4% to 39.6%), and 70% (95% CI, 39.7% to 89.2%) for SCLC, epNECs, and LCNEC-L, respectively.

CONCLUSION:

The demonstrated tolerability and efficacy of obrixtamig regimens, administered as step-up followed by target doses of 90-1,080 μg/kg (once weekly or once every 3 weeks), in patients with heavily pretreated DLL3-positive tumors support further exploration in SCLC, epNEC, and LCNEC-L.

01 Aug 2022·Future oncology (London, England)

Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas

Article

Author: Owonikoko, Taofeek K ; Hamed, Zohra Oum’ ; Studeny, Matus ; Wermke, Martin ; Felip, Enriqueta ; Gambardella, Valentina ; Liu, Meiruo ; Kuboki, Yasutoshi ; Morgensztern, Daniel

Poorly differentiated neuroendocrine carcinomas such as small-cell lung cancer (SCLC) have poor survival and high relapse rates. DLL3 is found on these carcinomas and has become a target of increasing interest in recent years. The bispecific DLL3/CD3 T-cell engager BI 764532 has been shown to induce complete tumor regression in a human T cell-engrafted mouse model. Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.

MEDICAL ONCOLOGY

Structural and functional insights into CD3 bispecific antibodies targeting DLL3 in cancer immunotherapy

Article

Author: Chen, Shanshan ; He, Xiangyi ; Zhang, Guangshun ; Li, Yuze ; Li, Dong

CD3 bispecific antibodies (BsAbs) targeting delta-like ligand 3 (DLL3) have emerged as promising candidates in cancer immunotherapy by enabling T-cell-mediated tumor lysis. A critical unmet need is to establish structural correlates of their preclinical activity and clinical efficacy to guide rational drug optimization. This study systematically characterized three clinical-stage CD3×DLL3 BsAbs, Tarlatamab (AMG757), BI764532 and HPN328, via structural modeling, T-cell activation assays, cytokine profiling, and tumor cytotoxicity tests. Preclinical data were further correlated with clinical trial outcomes to verify the predictive value of in vitro models. Preclinical data demonstrate a strong correlation with clinical outcomes, confirming that in vitro assays can reliably predict therapeutic response. Notably, structural features including immune synapse (IS) distance and epitope binding are tightly correlated with efficacy and safety. HPN328 exhibited the most potent T-cell activation and tumor killing activity, which aligned with its clinical confirmed complete response rate (cORR) of 50% in small cell lung cancer. BI764532 demonstrated a balanceed efficacy (ORR 18% in SCLC), while Tarlatamab achieved an ORR range of 13-40% across clinical trials. IS distance and epitope binding are strongly correlated with efficacy and safety of DLL3-targeted BsAbs, providing a critical framework for optimizing T-cell engager design in cancer immunotherapy.

News (Medical) associated with Obrixtamig

24 Jul 2025

·www.fiercebiotech.com

\'Crossing fingers\': Boehringer awaits key FDA decisions to spearhead \'maturing\' pipeline

Boehringer Ingelheim\'s chief medical officer told Fierce that the FDA’s decision on zongertinib could come at “any moment.”\n It\'s shaping up to be a big year for Boehringer Ingelheim—at least if the FDA plays ball. The German drugmaker is awaiting the agency\'s decision on approving key therapies for lung cancer and idiopathic pulmonary fibrosis (IPF) with the aim of launching both meds before the end of 2025.The privately owned company’s top oncology prospect is zongertinib, a HER2-selective tyrosine kinase inhibitor that earlier this year was tied to an objective response rate of 71% among patients with advanced non-small cell lung cancer.If the FDA gives zongertinib the green light in the coming months, the drug would be the first orally administered targeted therapy available for patients with previously treated HER2-mutated lung cancer.“Zongertinib selectively inhibits HER2 while sparing EGFR, which is critical,” Boehringer Chief Medical Officer Lykke Hinsch Gylvin, M.D., told Fierce Biotech in an interview ahead of the company’s first-half earnings results. “So it has the potential to be the first oral and also, as far as we can see, potential to be a best-in-class treatment with a very benign safety and tolerability profile.”For now, the company is “really excited” and “crossing fingers” while it waits for the FDA’s verdict, which could come at “any moment,” Hinsch Gylvin said. Another FDA decision Boehringer is “eagerly waiting” this year is for its PDE4B inhibitor nerandomilast in IPF. Phase 3 data posted in May were considered by analysts to be a step up from Boehringer’s approved IPF drug Ofev, but not a game changer.Still, Hinsch Gylvin argued that nerandomilast has “got the potential to really revolutionize care” for the chronic lung disease.Just days after the nerandomilast readout, PureTech reaffirmed a phase 2b trial success for its own IPF candidate deupirfenidone. Hinsch Gylvin wouldn’t be drawn on whether this meant nerandomilast could soon have a tough battle on its hands, instead pointing out that the aim of Boehringer’s option is to create “a solution for patients that hopefully will change this condition, which is actually fatal.”The CMO also didn’t commit herself to a ballpark figure for sales of Boehringer’s two prospective approvals, but did point out that more than one million patients worldwide have the condition.Another late-stage asset that Hinsch Gylvin is keen to raise awareness of is a DPP1/CatC inhibitor called verducatib, which Boehringer is now evaluating in a late-stage study of non-cystic fibrosis bronchiectasis.“This is part of our maturing pipeline,” she said. “We have over 10 more late-stage trials coming within the next 12 to 18 months.”It seems like any Big Pharma worth the name has a contestant in the obesity race, and Boehringer is no exception. The company’s glucagon/GLP-1 receptor dual agonist survodutide is in late-stage development for both weight loss and metabolic dysfunction-associated steatohepatitis (MASH). Phase 2 readouts for the Zealand Pharma-partnered drug have already demonstrated a placebo-adjusted 64.8% improvement in the fatty liver disease as well as almost 19% weight loss at 46 weeks.But with everyone from Novo Nordisk’s weight loss mainstay Wegovy to up-and-comer candidates from the likes of Rivus Pharmaceuticals showing promise in both obesity and MASH, does Boehringer still think it can stand out in such a crowded space?“We expect a lot from survodutide,” said Hinsch Gylvin, who pointed to the fact that weight loss hadn’t plateaued in the phase 2 trial by the 46-week readout. “In MASH, we had very strong data in phase 2 that helped us to really accelerate.”The company’s MASH ambitions aren’t limited to survodutide, however. There’s also a SIRPα antagonist in a midstage trial that Boehringer “expects a lot from.” Another red-hot space Boehringer has been dabbling in is T-cell engagers. The DLL3/CD3 T-cell engager obrixtamig is being evaluated in midstage trials in both extrapulmonary neuroendocrine carcinoma and small-cell lung cancer.“That\'s definitely also one to look out for,” Hinsch Gylvin said.Further back in development, Boehringer has a B7-H6/CD3 T-cell engager that is tasked with “turn[ing] cold tumors hot.” Another phase 1-stage cancer drug name-checked by Hinsch Gylvin is a CD137/FAP bispecific agonist being aimed at head and neck cancer.In April, Boehringer committed more than $30 million to a new R&D facility specifically focused on antibody-drug conjugates. The site is run by the company’s Swiss subsidiary NBE Therapeutics, which Boehringer bought for $1.5 billion in 2020 in a deal centered around a ROR1-directed ADC. More recently, Boehringer has continued to seek out partners in the ADC arena, kicking off 2025 with a $1.3 billion biobucks licensing deal with Synaffix.Announcing the site in Basel in April, Boehringer said the location will “contribute to building a broad pipeline of ADCs, addressing novel tumor target space to develop next-generation cancer treatments.”Hinsch Gylvin placed this ADC work in the broader context of the company’s “very robust oncology pipeline.”“Apart from small molecule inhibitors, we\'re also exploring T cell engagers, protein degraders, ADCs, cancer vaccines [and] oncolytic viruses,” she continued. “So we really do have a robust pipeline, and we continue to look to strengthen it even further.”One disease area for which Boehringer is less well known is eye health, but the company has been working to change that in recent years—including by licensing a bispecific antibody from Surrozen and a geographic-atrophy-focused pact with RetinAI.Hinsch Glyvin said this ophthalmology work is “fairly new for Boehringer” but has already been “recognized by clinicians as something to look out for.” Boehringer’s Human Pharma business grew 5.7% in the first half of 2025, reaching 11.3 billion euros ($13.2 million) in net sales. This growth was credited to the likes of Jardiance for diabetes, heart failure and kidney disease as well as IPF drug Ofev.According to Hinsch Glyvin, Boehringer invests around 28% of this Human Pharma revenue back into its innovation pipeline—a ratio at the top end of its Big Pharma peers.So, is the company eyeing some of this cash to seek out new drugs to plug any remaining gaps in its portfolio?“About 50% of our pipeline is already anchored in partnerships, and so we continue to always look outside, whether it is for actual partnerships on our current pipeline, or anywhere else to invest,” Hinsch Glyvin said.“I would say we are very fortunate also with this maturing pipeline and the outlook we have to potentially launch up to 20 indications in the coming years,” she added.

Phase 2AcquisitionLicense out/in

22 May 2025

·www.prnewswire.com

Boehringer Ingelheim Showcases Bold Vision for the Future of Cancer Care at ASCO 2025

Data to be presented at ASCO reflect Boehringer's broad pipeline and growing body of evidence supporting innovative therapies for various cancers Patient-reported outcomes from the Beamion LUNG-1 study in previously treated patients with HER2 (ERRB2)-mutant advanced non-small cell lung cancer (NSCLC) reported physical function and disease-related symptom improvement while being treated with zongertinib1 New data from a study of T-cell engager, obrixtamig, show encouraging findings in the treatment of extrapulmonary neuroendocrine carcinomas in patients with high DLL3 expression2 RIDGEFIELD, Conn., May 22, 2025 /PRNewswire/ --Boehringer Ingelheim will present the latest data in its robust oncology pipeline at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, including patient-reported outcomes (PRO) from the Beamion LUNG-1 study evaluating zongertinib as an orally administered targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC). In addition, new data evaluating the efficacy and safety of obrixtamig for the treatment of extrapulmonary neuroendocrine carcinomas with high or low DLL3 expression will be featured in an oral session. "Tackling difficult-to-treat cancers requires a multi-pronged approach, which is why we're exploring multiple pathways to address key cancer drivers, including HER2 and DLL3, to deliver meaningful advancements for the patients who need them most," said Vicky Brown, U.S. Senior Vice President and Head of Oncology, Immunology & Eye Health, Boehringer Ingelheim. "Our data at ASCO underscore our generational commitment to pioneering critical innovations that address patients' greatest needs." Developing zongertinib for the treatment of HER2-mutant advanced NSCLC Patient reported outcomes (N=30) from the Beamion LUNG-1 study (NCT04886804) evaluating zongertinib, showed improvements in physical functioning and disease-related symptoms in previously treated patients with HER2 (ERBB2)-mutant advanced NSCLC, identified through the following surveys: EORTC IL46/Q168 Survey (side effect burden): 80% to 90% (24 to 27) of patients reported "not at all" or "a little" side-effect trouble across all visits.1 PRO-CTCAE: Patient-reported symptomatic adverse events assessed were in line with the previously reported safety profile of zongertinib in the Beamion LUNG-1 study; the majority of patients who reported they experienced diarrhea stated "rarely" or "occasionally".1 NSCLC Symptom Assessment Questionnaire: At weeks 15 and 27, over 50% of patients reported "no coughing at all" – a key disease-related symptom – double the proportion at baseline with remaining patients responding with "mild to moderate" coughing.1 EORTC QLQ-C30 Physical Functioning: After 15 weeks of treatment with zongertinib, participants showed a 60% improvement in physical functioning from baseline (95% CI: 6.3-12.9).1 This improvement was sustained throughout the PRO data collection period.1 Physical functioning was measured by the ability to complete strenuous activities, go on long or short walks, ability to sit in a chair (versus need to stay in bed), and need for assistance completing daily tasks.1 "In treating HER2-mutant advanced non-small cell lung cancer – a disease with limited options and a poor prognosis – patient reported outcomes are critical in understanding not only how well a treatment works, but also how it is received by patients," said Dr. Joshua K. Sabari, study investigator and Associate Professor, Department of Medicine, New York University (NYU) Grossman School of Medicine; Medical Director, Thoracic Medical Oncology, NYU Langone Health's Perlmutter Cancer Center. "The study's reported outcomes provide further confidence in the potential of zongertinib to have a meaningful impact on the lives of patients living with this aggressive disease." Exploring precision medicine through DLL3 targeted therapy, obrixtamig New data will be presented from the ongoing, Phase I dose escalation study (NCT04429087) evaluating T-cell engager, obrixtamig, in previously treated patients with extrapulmonary neuroendocrine carcinomas with high or low DLL3 expression (N=60). In the study, obrixtamig demonstrated efficacy in patients with high DLL3 expression.2 The objective response rate was 40% (95% CI: 24.6-57.7) in patients with high DLL3 expression compared to 3.3% (95% CI: 0.6-16.7) in patients with low DLL3 expression.2 The median duration of response was 7.9 months (95% CI: 6.2-not calculable [NC]) in patients with high DLL3 expression compared to 2.8 months (95% CI: NC-NC) in patients with low DLL3 expression.2 The disease control rate was 66.7% (95% CI: 48.8-80.8) in patients with high DLL3 expression compared to 26.7% (95% CI: 14.2-44.4) in patients with low DLL3 expression.2 Most treatment-related adverse events (AEs) were mild to moderate in both groups. Grade ≥3 treatment-related AEs occurred in 23.3% of patients with high DLL3 expression and 20% of those with low DLL3 expression.2 "Neuroendocrine carcinomas are a relatively rare form of cancer that are unfortunately often diagnosed at advanced stages, leading to poor outcomes for patients due to both the nature of the disease and the lack of standard of care, with limited treatment options," said Dr. Jonathan Strosberg, Professor and Medical Oncologist, Neuroendocrine Tumor Division & Department of Gastrointestinal Oncology Research Program, Moffitt Cancer Center. "DLL3 is highly expressed in neuroendocrine carcinomas, making DLL3 an important biomarker in precision medicine. Findings from this study, including a 40% objective response rate, underscore the potential of obrixtamig to produce an effective and durable response in patients with high DLL3 expression, and offer a targeted approach to treating this cancer." An ongoing Phase II DAREON®-5 trial (NCT04429087) is assessing obrixtamig in patients with relapsed/refractory DLL3-high extrapulmonary neuroendocrine carcinomas.2 Additionally, new clinical data from two early-stage trials evaluating BI 765063 and BI 770371 will be presented, strengthening Boehringer's partnership with OSE Immunotherapeutics. Presentations at ASCO 2025 from Boehringer Ingelheim's innovative pipeline highlight vision of transforming cancer care: About non-small cell lung cancer (NSCLC) Lung cancer claims more lives than any other cancer type3 and the incidence is set to increase to over 3 million cases worldwide by 2040.4 NSCLC is the most common type of lung cancer.5 The condition is often diagnosed at a late stage,6 and fewer than 3 in 10 patients are alive five years after diagnosis.7 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. Up to 4% of lung cancers are driven by HER2 mutations (or gene alterations).8 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.9 About zongertinib Zongertinib is an investigational irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby limiting associated toxicities. This orally administered, targeted therapy was granted FDA Fast Track Designation in 2023, followed by Breakthrough Therapy Designation in the U.S. and China for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations and who have received prior systemic therapy. An application for accelerated approval was granted Priority Review status by the FDA in February 2025. In addition, Japan's Pharmaceuticals and Medical Devices Agency granted Orphan Drug Designation to zongertinib. A recent study has shown pre-clinically that the investigational compound zongertinib has potential for further clinical study in HER2 dependent solid cancers as monotherapy and as concurrent treatment with ADC therapy. In addition, zongertinib is being evaluated in Beamion LUNG-2 (NCT06151574)4, a global Phase III trial, compared to standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic NSCLC who have activating HER2 TKD mutations. About the Beamion clinical trial program Beamion LUNG-1 (NCT04886804) is an open-label, Phase I dose escalation trial, with dose confirmation and expansion of zongertinib as monotherapy in people with advanced or metastatic solid tumors and NSCLC with activating HER2 alterations. The study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumors with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with advanced non-small cell lung cancer with a specific mutation in the HER2 gene. Beamion LUNG-2 is a Phase III, open label, randomized, active-controlled study in patients with unresectable, locally advanced or metastatic non-squamous NSCLC harboring HER2 TKD mutations to evaluate zongertinib compared with standard of care. About obrixtamig Obrixtamig is an investigational novel Immunoglobin G (IgG)-like bispecific T-cell engager designed to bind concomitantly to DLL3 on tumor cells and CD3 on T-cells.10 By creating a physical link between T-cells and tumor cells, the T-cell engager could potentially activate T-cells against DLL3-expressing tumor cells, potentially resulting in their destruction by the body's own immune system. Activated T-cells could indirectly stimulate other immune cells to broaden the immune response against the tumor tissue. NCT04429087 is a Phase I trial evaluating obrixtamig in patients whose tumors are positive for DLL3. The aim of the study is to determine the highest dose of obrixtamig that can be tolerated by patients before reaching the maximum tolerated dose. The study also aims to assess the side effects of obrixtamig to evaluate early evidence of antitumor activity. In addition, obrixtamig is being evaluated in additional tumor types, including an ongoing Phase II trial (DAREON®-5) in patients with relapsed/refractory DLL3-high epNECs. About extrapulmonary neuroendocrine carcinomas Extrapulmonary neuroendocrine carcinomas (epNECs) are rare, aggressive cancers arising outside the lungs, from neuroendocrine cells present in various organs such as the gastrointestinal tract, pancreas, and others.11 Delta-like ligand 3 (DLL3) is a protein that is expressed specifically on the surface of up 77% of NECs. In normal tissue, DLL3 is minimally expressed, which makes it an ideal therapeutic target. These cancers are often diagnosed at an advanced stage, leading to poor survival rates. Like other aggressive cancers, epNECs can significantly impact patients' physical, psychological, and emotional well-being.12 There remains a high unmet need for effective treatment options for individuals with advanced epNECs. Research is ongoing to identify molecular targets and develop new therapies.13 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. 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 . 1Sabari JK, Ruiter G, Nadal E, et al. Patient-reported outcomes evaluating physical functioning and symptoms in patients with pretreated HER2-mutant advanced non-small cell lung cancer (NSCLC) – results from the Beamion LUNG-1 trial. Presented at: 2025 American Society of Clinical Oncology (ASCO) Annual Meeting; Chicago, IL. 2Capdevila J. Efficacy and safety of the DLL3/CD3 T-cell engager obrixtamig in patients with extrapulmonary neuroendocrine carcinomas with high or low DLL3 expression: results from an ongoing phase I trial . The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Published online 2025. 3World Health Organization Cancer Factsheet. (Accessed April 2025). 4International Agency for Research on Cancer – World Health Organization. Rates of trachea, bronchus and lung cancer. Available at: (Accessed August 2024). 5Zappa C & Mousa Non-small cell lung cancer: current treatment and future advances, Transl Lung Cancer Res. 2016 Jun; 5(3): 288–300. 6Polanco D et al. Prognostic value of symptoms at lung cancer diagnosis: a three-year observational study. J Thorac Dis 2021;13:1485–1494 7National Cancer Institute Surveillance, Epidemiology, and End Results (SEER). (Accessed: August 2024). 8Arcila, 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). 9Galogre M, et al. A review of HER2 overexpression and somatic mutations in cancers, Critical Reviews in Oncology/Hematology, Volume 186, 2023, 103997. 10Hallet, J. et. al. 2015 Feb 15;121(4):589-97. doi: 10.1002/cncr.29099. Epub 2014 Oct 11Liu Y, Li X, Zhang Y, et al. A novel approach to cancer therapy: targeting the tumor microenvironment. Cancer Res. 2024;84(2):123-134. doi:10.1158/0008-5472.CAN-23-4567. 12Pellegrini CA, Bodei L, Papi M, et al. Impact of neuroendocrine tumors on patients' personal and work lives. J Global Oncol. 2015;1(1):37-42. doi:10.1200/JGO.2015.002980. 13Muğlu H, Sünger E, Mıldanoğlu MM, Engin Delipoyraz E, Yücel MH, Özçelik H, Hamdard J, Açıkgöz Ö, Ölmez ÖF, Yıldız Ö, et al. Clinicopathological Characteristics of Extrapulmonary Neuroendocrine Carcinomas: Treatment Responses and Survival Outcomes: Single-Center Experience. Journal of Clinical Medicine. 2025;14(7):2264. doi:10.3390/jcm14072264. SOURCE Boehringer Ingelheim WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOClinical ResultPhase 2Fast TrackPhase 1

14 May 2025

·firstwordpharma.com

Boehringer Ingelheim expands oncology pipeline with real-world data from Tempus AI

Boehringer Ingelheim has entered a multi-year partnership with Tempus AI to leverage its real-world data and AI platform in support of Boehringer's expanding oncology pipeline. Through the partnership, Boehringer will gain access to Tempus' de-identified data and its advanced data analytics platform, Lens."Leveraging real-world patient data is crucial for strengthening our data foundation and harnessing advanced AI methodologies, ultimately accelerating drug development," said Jan Nygaard Jensen, head of computational innovation at Boehringer Ingelheim. "Integrating these comprehensive datasets with our internal data and techniques not only drives innovation but also enhances the precision and efficiency of pharmaceutical research, paving the way for groundbreaking medical advancements."Tempus' database comprises over eight million research records. Its AI-enabled Lens platform allows researchers to define patient cohorts using molecular and clinical filters, or to automatically build cohorts using Tempus One, an AI-enabled assistant that applies inclusion and exclusion criteria. Researchers can visualise or download datasets for in-depth analysis. These insights can support biomarker discovery, patient stratification, novel target identification, hypotheses for combination therapies and patient education. Boehringer currently markets three oncology drugs — Gilotrif (afatinib) and Ofev (nintedanib) for non-small-cell-lung cancer (NSCLC) and Tevimbra (tislelizumab) for oesophageal and gastric cancers. Its oncology pipeline includes a broad portfolio of investigational agents, such as anti-DLL3 T-cell engager BI 764532 in phase II trials for small cell lung cancer and neuroendocrine cancers; HER2 exon 20 inhibitor zongertinib in phase III trials for NSCLC and MDM2-p53 antagonist brigimadlin in phase III trials for de-differentiated liposarcoma and soft tissue sarcoma, and phase II trials for NSCLC and bile duct cancer. Additional early-stage assets target a variety of solid tumours."By combining internal, pre-clinical experimental data, with real-world data from Tempus on its AI-powered platform, we can profoundly deepen our understanding of cancer biology and accelerate our drug discovery and development efforts," said Mark Paul Petronczki, head of oncology research at Boehringer Ingelheim.

Phase 2Phase 3ASCO

100 Deals associated with Obrixtamig

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Small Cell Carcinoma	Phase 3	China	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Argentina	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Australia	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Austria	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Belgium	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Brazil	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Bulgaria	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Canada	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Chile	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026
Advanced Lung Small Cell Carcinoma	Phase 3	Czechia	Boehringer Ingelheim (China) Investment Co., Ltd.	02 Apr 2026

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05882058 (DAREON-5, ASCO_GI2026 \| ASCO_GU2026)	Phase 2	Neuroendocrine Carcinoma DLL3-high expressing	51	Obrixtamig	cftijuoypv(xfipitxgsa) = sfrhxopykh dmgkekgoro (jbpbonakir )	Positive	08 Jan 2026
NCT05990738 (DAREON-9, ESMO2025)	Phase 1	Advanced Lung Small Cell Carcinoma	25	Obrixtamig + Topotecan	knumgukhpg(etbpfjrzmx) = dypkxbommj zyqojtxstc (opzsdgifsa, 70 - 96) View more	Positive	17 Oct 2025
NCT05990738 (DAREONTM-9, ASCO2025) Manual	Phase 1	Small Cell Lung Cancer	25	Obrixtamig+Topotecan Hydrochloride	aeweuzqvhe(cmcmrfaibs) = ieruorkffo zianqmkkum (dozachzhhf ) View more	Positive	30 May 2025
NCT04429087 (ESMO2024) Manual	Phase 1	Neoplasms DLL3 Positive	168	BI 764532 RA	cxxyctdjtq(wzzklrkfda) = None iqmfohwclm (yarmtojvjn ) View more	Positive	14 Sep 2024
				BI 764532 RB1
NCT04429087 (WCLC2024) Manual	Phase 1	Large cell neuroendocrine carcinoma of lung DLL3-positive	168	BI 764532 (Regimen A)	qdlubynqzi(dpwmocwgiu) = not reached gafpofcljs (drvsmvvumm ) View more	Positive	09 Sep 2024
				BI 764532 (Regimen B1)
NCT04429087 (ESMO_ASIA2023)	Phase 1	DLL3 positive Small Cell Lung Cancer DLL3+	107	BI 764532	cjwlmzudgg(lyuygbvevt) = gbqfkbpppa rfqrhteawc (qieqkjdlhh )	-	01 Dec 2023
NCT04429087 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Neuroendocrine Carcinoma DLL3-positive	129	BI 764532	kcboyocpdp(ssvyvfusum) = pigissalgw ppkricvaqw (ltlgbxiyvu )	Positive	22 Oct 2023
				BI 764532 (epNEC)	reatphkpmp(bultiauuma) = iritvxuuos djtuigehqz (jhyqhzqxxf ) View more
NCT04429087 (WCLC2023) Manual	Phase 1	Small Cell Lung Cancer \| DLL3 positive Small Cell Lung Cancer DLL3 Positive	90	BI 764532	ohehuuenhy(ammjysnggz) = DLTs were seen in one patient on Regimen A (Grade 3 confusion) and four patients on Regimen B2 (Grade 4 cytokine release syndrome [CRS]; Grade 3 CRS; Grade 3 nervous system disorder; and Grade 2 infusion-related reaction). cqmrfvxxbl (ynhmaevsip ) View more	Positive	10 Sep 2023
NCT04429087 (ASCO 12023 \| ASCO 22023) Manual	Phase 1	Small Cell Lung Cancer \| Neuroendocrine Carcinoma DLL3 Expression	90	BI 764532 (RA)	cxraaudcnt(mqtbmmpjjd) = ehfmyfhbvx wupvugbreg (taiynqhpaj ) View more	Positive	31 May 2023
				BI 764532 (RB1)	cxraaudcnt(mqtbmmpjjd) = buklzuhzwq wupvugbreg (taiynqhpaj ) View more

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