ezabenlimab (BI 754091) / Boehringer Ingelheim - LARVOL DELTA

A phase I dose escalation trial of obrixtamig + ezabenlimab in patients (pts) with small cell lung cancer (SCLC) or other neuroendocrine carcinomas (NECs) expressing DLL3 (ELCC 2026) - P1 | "Legal entity responsible for the study Boehringer Ingelheim. Funding Boehringer Ingelheim."

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Ezabenlimab (BI 754091) and DCFm (docetaxel, cisplatin and 5-fluorouracil) followed by chemoradiotherapy for the treatment of stage III anal canal cancer. nPhase II study (clinicaltrialsregister.eu) - P1/2 | N=55 | Recruiting | Sponsor: Centre Hospitalier Regional Universitaire | Not yet recruiting ➔ Recruiting

Enrollment open • Anal Carcinoma • Oncology • Solid Tumor

Obrixtamig Plus Ezabenlimab Shows Activity in DLL3-Positive SCLC (OncoDaily) - "At the European Lung Cancer Congress 2026, early-phase data from a dose-escalation trial further evaluated this combination strategy in patients with advanced DLL3-positive....Among patients treated at clinically active doses of at least 90 μg/kg, the objective response rate was 30%, with a disease control rate of 58%. Median progression-free survival was 4.4 months, and median duration of response reached 8.8 months, suggesting meaningful clinical benefit in a heavily pretreated population....In patients with SCLC specifically, response rates were also encouraging. Among 18 patients treated at active dose levels, the objective response rate was 33%, with a disease control rate of 67% and a median progression-free survival of 5.7 months."

P1 data • Large Cell Neuroendocrine Carcinoma • Lung Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Small Cell Lung Cancer

CAR2BRAIN: Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Johann Wolfgang Goethe University Hospital

New P1 trial • Brain Cancer • Glioblastoma • Solid Tumor • HER-2

CAR2BRAIN: Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Johann Wolfgang Goethe University Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Jun 2026 | Trial primary completion date: Oct 2023 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • HER-2

CAR2BRAIN: Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma (clinicaltrials.gov) - P1 | N=42 | Recruiting | Sponsor: Johann Wolfgang Goethe University Hospital | N=30 ➔ 42 | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Sep 2022 ➔ Oct 2023

Enrollment change • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • HER-2

CAR2BRAIN: Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Johann Wolfgang Goethe University Hospital | Trial completion date: Aug 2020 ➔ Dec 2022 | Trial primary completion date: Feb 2020 ➔ Sep 2022

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • HER-2

A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer (clinicaltrials.gov) - P1 | N=57 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | N=171 ➔ 57 | Trial completion date: May 2029 ➔ Jun 2027 | Trial primary completion date: Feb 2029 ➔ Jun 2027

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov) - P1 | N=119 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Biliary Tract Cancer • Cholangiocarcinoma • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer (clinicaltrials.gov) - P1 | N=149 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | Trial completion date: May 2028 ➔ Feb 2028

Enrollment closed • Monotherapy • Trial completion date • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Monotherapy • New P1 trial • Oncology • Solid Tumor

Ezabenlimab with induction chemotherapy and adaptive chemoradiotherapy in stage 3 squamous cell anal carcinoma - Authors' reply. (PubMed, Lancet Oncol) - No abstract available

Journal • Anal Carcinoma • Oncology • Solid Tumor

Ezabenlimab with induction chemotherapy and adaptive chemoradiotherapy in stage 3 squamous cell anal carcinoma. (PubMed, Lancet Oncol) - No abstract available

Journal • Anal Carcinoma • Oncology • Solid Tumor

A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) (clinicaltrials.gov) - P1 | N=119 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: May 2026 ➔ Feb 2026

Trial completion date • Biliary Tract Cancer • Cholangiocarcinoma • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MDM2 • TP53

Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. (ASCO-GI 2023) - P1a/1b, P2a/2b | "Patients in the combination trial received escalating doses of BI 907828 and 240 mg ezabenlimab q3w (doublet); one patient also received the anti-LAG-3 antibody BI 754111 (a drug that has since been discontinued; triplet). The MDM2–p53 antagonist BI 907828 has shown a manageable safety profile and encouraging preliminary efficacy in patients with BTC, with 5 PRs and 2 SD in 8 patients. A phase IIa/IIb trial of BI 907828 (45 mg q3w) in patients with BTC is planned to start recruitment at the end of 2022 (NCT05512377). Clinical trial information: NCT03449381 and NCT03964233."

Clinical • IO biomarker • Metastases • P1 data • Ampulla of Vater Carcinoma • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MDM2 • TP53

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A phase 1b study to evaluate the safety, tolerability and preliminary efficacy of a heterologous prime boost vaccination (ATP150/ATP152/ATP162, VSV-GP154) and ezabenlimab (BI 754091) in patients with pancreatic ductal adenocarcinoma. (ASCO-GI 2026) - P1 | "Clinical trial information: (NCT05846516). Oberstein P*, Rasco D*- *equal contribution as first authors."

Clinical • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CA 19-9

The Second Mitochondria-Derived Activator of Caspases Mimetic BI 891065 in Patients With Advanced Solid Tumors: Results From Two Phase I Studies. (PubMed, Cancer Med) - P1 | "BI 891065 was tolerable in patients with advanced solid tumors, demonstrating target engagement as monotherapy and combined with ezabenlimab. Both studies ended early due to efficacy data that were insufficiently promising to justify continuation."

Journal • P1 data • Oncology • Pneumonia • Solid Tumor

A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer (clinicaltrials.gov) - P1 | N=171 | Recruiting | Sponsor: Boehringer Ingelheim | N=94 ➔ 171 | Trial primary completion date: Jun 2028 ➔ Feb 2029

Enrollment change • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=97 | Recruiting | Sponsor: Boehringer Ingelheim | N=70 ➔ 97

Enrollment change • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Nov 2028 ➔ May 2028 | Trial primary completion date: Jan 2027 ➔ Jul 2026

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Ezabenlimab and induction chemotherapy followed by adaptive chemoradiotherapy in patients with stage 3 squamous cell anal carcinoma (INTERACT-ION): an open-label, single-arm, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "Our study met the primary endpoint, showing antitumour activity (clinical complete response rates) and a manageable safety profile for ezabenlimab and mDCF induction when given with INRT in patients with locally advanced SCAC, enabling personalised INRT, and supporting phase 3 trials of this treatment in patients with stage 3 SCAC."

Journal • P2 data • Anal Carcinoma • Dermatology • Dermatopathology • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Lichen Planus • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

Ezabenlimab (BI 754091) and induction mDCF (modified docetaxel, cisplatin, and 5-fluorouracil) followed by adaptive chemoradiotherapy in patients (pts) with stage III squamous cell anal carcinoma (SCAC): Final results of the phase II INTERACT-ION study (ESMO 2025) - P2 | "Conclusions This Phase II study met its primary endpoint and most pts benefited from ezabenlimab + mDCF induction therapy, enabling personalized INRT. These promising efficacy outcomes support further Phase III investigation of this treatment regimen in pts with stage III SCAC."

Clinical • P2 data • Anal Carcinoma • Oncology • Solid Tumor

Phase Ia results for systemic STING agonist BI 1703880 plus ezabenlimab in patients (pts) with advanced solid tumors: Progress to date (ESMO 2025) - P1 | "Conclusions The study is ongoing to determine the recommended dose for expansion cohorts. Clinical benefit has been observed, including in IO-pretreated pts, with manageable adverse events."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • CD8

A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov) - P1 | N=45 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Phase classification: P1/2 ➔ P1 | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Phase classification • Trial completion date • Trial primary completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3