BI 836826 / Boehringer Ingelheim - LARVOL DELTA

Development of PSB202, a bifunctional antibody pair that target CD20 and CD37, for the treatment of B-cell malignancies (AACR 2022) - P1a/1b | "Systemic depletion of normal and malignant B-cells by anti-CD20 antibodies (e.g. rituximab and obinutuzumab) and anti-CD37 antibodies (e.g. otlertuzumab and BI 836826) has been well tolerated in clinical studies...Synergy was demonstrated for PSB202 in combination with lenalidomide...PSB202 offers the potential to improve clinical efficacy, decrease drug resistance, provide administration convenience especially when combining with additional therapeutics, lower the cost for treatment, and reduce the unwanted side effects from chemotherapy. PSB202 is currently being evaluated in patients with previously treated, relapsed, indolent B-cell malignancies (NCT05003141)."

Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A phase Ib, open label, dose escalation trial of the anti-CD37 monoclonal antibody, BI 836826, in combination with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia. (PubMed, Invest New Drugs) - "BI 836826 + ibrutinib did not exceed the MTD at doses up to 200 mg in patients with CLL. However, RP2D and MTD were not formally established, as the sponsor discontinued the trial."

Clinical • Combination therapy • Journal • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

A phase Ib, open-label, dose-escalation trial of the anti-CD37 monoclonal antibody, BI 836826, in combination with gemcitabine and oxaliplatin in patients with relapsed/refractory diffuse large B-cell lymphoma. (PubMed, Invest New Drugs) - P2 | "Overall objective response rate was 38%, including two patients (10%) with complete remission and six patients (29%) with partial remission. Conclusions BI 836826 in combination with GemOx was generally well tolerated but did not exceed the MTD at doses up to 100 mg given every 14 days."

Clinical • Combination therapy • Journal • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia

This Study in Patients With Chronic Lymphocytic Leukaemia is Done to Determine a Safe and Effective Dose of BI 836826 in Combination With Venetoclax (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Boehringer Ingelheim

New P1 trial • Biosimilar • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology

BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) (clinicaltrials.gov) - P1; N=53; Suspended; Sponsor: Boehringer Ingelheim; Recruiting ➔ Suspended

Trial suspension • Biosimilar • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase I, first-in-human trial of BI 836826 (an anti-CD37 antibody) in patients (PTS) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) (EHA 2015) - Presentation time: From 13.06.2015 17:15 to 13.06.2015 18:45; Abstract #P589; P1, N=33; NCT01296932; "Of 26 evaluable pts (i.e., received full intended dose) at ≥9 mg doses, the overall response rate based on investigator assessment was 42.3% (all partial remission); 14 pts (53.8%) had stable disease."

P1 data • Non-Hodgkin’s Lymphoma • Oncology

Phase I dose escalation study of BI 836826 (CD37 antibody) in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. (PubMed, Invest New Drugs) - P1; "BI 836826 demonstrated preliminary activity; the most frequent adverse events were hematotoxicity and infusion-related reactions which were manageable after amending the infusion schedule. Although BI 856826 will not undergo further clinical development, these results confirm CD37 as a valid therapeutic target in B cell NHL."

Clinical • Journal • P1 data

Phase 1 first-in-human trial of the anti-CD37 antibody BI 836826 in relapsed/refractory chronic lymphocytic leukemia. (PubMed, Leukemia) - No abstract available

Journal • P1 data

Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib (clinicaltrials.gov) - P1; N=7; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting ➔ Completed

Clinical • Combination therapy • Trial completion

NEW DRUGS FOR NON‐HODGKIN LYMPHOMA: BEYOND CHEMOTHERAPY: NEW DRUGS FOR OLD TARGETS (ICML 2019) - P1, P1/2, P1a/1b, P1b, P1b/2, P2, P2/3, P3; "...Ofatumumab was approved for patients with chronic lymphocytic leukemia (CLL) at different lines of treatment of this disease, alone or in combination, but failed to demonstrate a benefit and to gain approval in phase 3 studies performed in combination with chemotherapy in relapsed diffuse large B-cell lymphoma (DLBCL) (NCT01014208) or as single agent in patients with relapsed/refractory (R/R) follicular (FL) or other indolent lymphoma (NCT01200589)...In a randomized study comparing bendamustine single agent versus bendamustine combined with obinutuzumab and followed by obinutuzumab maintenance in patients who were assessed as refractory to rituximab, the experimental arm resulted in significant progression free survival (PFS) and overall survival (OS) benefits.6 The GALLLIUM phase 3 study7 demonstrated a significant improvement of PFS in combination with chemotherapy in untreated patients with FL, while no benefit was observed in the

Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib (clinicaltrials.gov) - P1; N=7; Active, not recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Nov 2019 ➔ Jul 2019; Trial primary completion date: Oct 2019 ➔ Jun 2019

Clinical • Combination therapy • Trial completion date • Trial primary completion date