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) - No abstract available

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

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

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=70 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2027 ➔ Jun 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

KISIMA-02: A Study to Evaluate ATP150/ATP152/ATP162, VSV-GP154 and Ezabenlimab in Patients With Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1 | N=94 | Recruiting | Sponsor: Amal Therapeutics | Trial completion date: Mar 2027 ➔ May 2029 | Trial primary completion date: Dec 2026 ➔ Jun 2028

Trial completion date • Trial primary completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • 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=70 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Feb 2027 ➔ Dec 2027 | Trial primary completion date: Nov 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

EMPIRE: Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Institut Bergonié | N=120 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor • Triple Negative Breast Cancer • PD-L1 • 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=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • 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 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) - P1/2 | N=45 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2025 ➔ Dec 2025

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

A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=100 | Completed | Sponsor: OSE Immunotherapeutics | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2025

Trial completion • Trial completion date • Colorectal Cancer • Endometrial Cancer • Solid Tumor • SIRPA

An open-label, phase Ib trial of the SIRPα inhibitor BI 765063 in combination with the PD-1 inhibitor ezabenlimab and cetuximab in patients (pts) with head and neck squamous cell carcinoma. (ASCO 2025) - P1 | "This Phase Ib study (NCT05249426) is investigating the efficacy and safety of BI 765063 in combination with ezabenlimab + cetuximab (Cohort A) or ezabenlimab + chemotherapy (Cohort B) in pts with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), or in combination with ezabenlimab ± BI 836880 (anti-VEGF/Ang2) in pts with hepatocellular carcinoma. These preliminary data indicate that BI 765063 in combination with ezabenlimab and cetuximab has a manageable safety profile and promising efficacy as second-line treatment in pts with R/M HNSCC. Biomarker data will be presented at the meeting."

Clinical • Combination therapy • IO biomarker • P1 data • Anemia • Cardiovascular • Congestive Heart Failure • Dermatitis • Dermatology • Endocrine Disorders • Head and Neck Cancer • Heart Failure • Hematological Disorders • Hepatocellular Cancer • Hepatology • Immunology • Liver Failure • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors. (ASCO 2025) - P1 | "No DLTs were reported during the MTD evaluation period with BI 770371 monotherapy or with the combination; 1 pt in the monotherapy group had a DLT (grade 2 encephalitis, which resolved within 1 week) during the on-treatment period (likely due to prior nivolumab and ipilimumab treatment). These preliminary data indicate that BI 770371 is well tolerated alone and in combination with ezabenlimab, with promising antitumor activity seen in heavily pretreated pts with advanced solid tumors. The MTD of BI 770371 was not reached in either group."

Clinical • Combination therapy • Metastases • P1 data • CNS Disorders • Dermatology • Fatigue • Oncology • Pruritus • Solid Tumor • SIRPA

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=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2026 ➔ Dec 2025

Trial completion date • 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