reozalimab (IBI318) / Innovent Biologics, Eli Lilly - LARVOL DELTA

Magnesium Is Associated with Favorable Outcomes of Cancer Patients Treated with Immune Checkpoint Inhibitors (ASH 2024) - "Included in the study were patients who received various ICIs treatments, such as IBI318, pembrolizumab, nivolumab, atezolizumab, durvalumab, cemiplimab, tislelizumab, toripalimab, and sintilimab, with monitoring of their serum magnesium ion levels. These findings underscore the predictive value of serum magnesium levels in evaluating clinical outcomes among patients receiving ICIs therapy.Conclusion : This multicenter study demonstrates that patients receiving ICIs exhibit significantly improved outcomes among those with elevated serum magnesium levels compared to those with low levels. Further prospective validation studies are essential to evaluate magnesium levels in ICI-treated patients and to supplement magnesium preparations in patients with magnesium deficiency to confirm these findings."

Checkpoint inhibition • Clinical • Esophageal Cancer • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Oncology • Solid Tumor • CD8

The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined with Lenvatinib in NSCLC. (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Phase classification: P1 ➔ P2

Phase classification • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer (clinicaltrials.gov) - P1 | N=10 | Terminated | Sponsor: Eli Lilly and Company | Completed ➔ Terminated; Study did not achieve its primary objective due to early termination of the study

Monotherapy • Trial termination • Biliary Tract Cancer • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma

Octreotide plus IBI-318 plus anlotinib in the treatment of multiple neuroendocrine metastases of unknown primary lesions: a case report. (PubMed, Front Oncol) - "This report presented a patient who received octreotide plus IBI-318 plus anlotinib as a second-line treatment for multiple metastatic NETs of unknown primary lesions after the failure of octreotide plus everolimus. Octreotide plus IBI318 plus anlotinib achieved benefits in a patient with advanced NETs of unknown primary lesions after first-line treatment failure, even though with low PD-L1 expression. This case suggests that combining SSAs, TKIs and PD-1/PD-L1 inhibitors could be an alternative second-line treatment for patients with advanced, well-differentiated NETs."

IO biomarker • Journal • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • CD4 • CD8

The first-in-class bispecific antibody IBI318 (LY3434172) targeting PD-1 and PD-L1 in patients with advanced tumors: a phase Ia/Ib study (J Hematol Oncol) - P1a/1b | N=103 | NCT03875157 | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | "From February 11, 2019, to January 25, 2022, a total of 103 eligible patients were enrolled (Phase Ia, n = 55; Phase Ib, n = 48). The median follow-up was 10.1 months (range 0.7–28.6). The RP2D was determined to be 300 mg Q2W. Treatment-related adverse events (TRAEs) of any grades occurred in 88 patients (85.4%), while 10 patients (9.7%) experienced grade ≥ 3 TRAEs. The objective response rate (ORR) was 15.5% and the disease control rate (DCR) was 49.5% in all patients. In Phase Ib, the confirmed ORR was 45.5% in treatment-naïve NSCLC patients and 30.0% in IO-naïve NPC patients who had failed or were intolerant to platinum-based treatments."

P1 data • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer

The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined With Lenvatinib in NSCLC. (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Trial completion date: Nov 2023 ➔ Dec 2025 | Trial primary completion date: Aug 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined With Lenvatinib in NSCLC. (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Trial completion date: May 2023 ➔ Nov 2023 | Trial primary completion date: Mar 2023 ➔ Aug 2023

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=15 | Terminated | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | N=56 ➔ 15 | Trial completion date: Aug 2023 ➔ Mar 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2022 ➔ Mar 2023; Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

A Study on the Safety and Effectiveness of IBI318 Combined With Conventional TACE (cTACE) as a Perioperative Treatment for Potentially Resected Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=10 | Terminated | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | N=20 ➔ 10 | Trial completion date: Nov 2023 ➔ Mar 2023 | Not yet recruiting ➔ Terminated; Due to the company's development strategy adjustment ，Innovent Bioligics decided not to continue the study after consultation with investigators.

Enrollment change • Trial completion date • Trial termination • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial (clinicaltrials.gov) - P1/2 | N=9 | Terminated | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | N=129 ➔ 9 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2021 ➔ Feb 2023; Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.

Enrollment change • Monotherapy • Trial primary completion date • Trial termination • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed | Trial completion date: Nov 2023 ➔ Jan 2023 | Trial primary completion date: May 2023 ➔ Jan 2023

Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

Study of IBI318 in Participants With Advanced Malignancies (clinicaltrials.gov) - P1 | N=101 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | N=327 ➔ 101 | Trial completion date: Dec 2023 ➔ Feb 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Bispecific Targeting of PD-1 and PD-L1 Enhances T-cell Activation and Antitumor Immunity. (PubMed, Cancer Immunol Res) - "In mouse tumor models reconstituted with human immune cells, LY3434172 therapy induced dramatic and potent antitumor activity compared with each parent antibody or their combination. Collectively, these results demonstrated the enhanced immunomodulatory (immune blockade) properties of LY3434172, which improved antitumor immune response in preclinical studies, thus supporting its evaluation as a novel bispecific cancer immunotherapy."

Journal • Immune Modulation • Inflammation • Oncology • PD-1

Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2 | N=56 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2022 ➔ Aug 2023 | Trial primary completion date: Aug 2021 ➔ Dec 2022

Enrollment closed • Trial completion date • Trial primary completion date • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial (clinicaltrials.gov) - P1/2 | N=129 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Study of IBI318 in Participants With Advanced Malignancies (clinicaltrials.gov) - P1 | N=327 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined With Lenvatinib in NSCLC. (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Trial primary completion date: Apr 2022 ➔ Mar 2023

Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined With Lenvatinib in NSCLC. (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Hunan Province Tumor Hospital | N=30 ➔ 100

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined With Lenvatinib in NSCLC. (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Hunan Province Tumor Hospital; Phase classification: P2 ➔ P1; Initiation date: Mar 2021 ➔ Aug 2021

Clinical • Phase classification • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

[VIRTUAL] Phase Ia dose escalation of IBI318, a first-in-class bispecific anti-PD-1/PD-L1, in patients with advanced tumors. (ASCO 2020) - P1 | "IBI318 has shown an acceptable safety profile. Preliminary efficacy results are promising in advanced cancer patients. The study is currently ongoing at dose level of 600 mg Q2W."

Clinical • P1 data • Hematological Disorders • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Oncology • Rheumatology

The Efficacy and Safety of the Bispecific Anti-PD-1/PD-L1 Antibody IBI318 Combined With Lenvatinib in NSCLC. (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Hunan Province Tumor Hospital

Clinical • New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • ROS1

A Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • Combination therapy • New P1 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Evaluation of Safety and Efficacy of IBI318 Monotherapy for Relapsed/Refractory Extranodal NK/T Cell Lymphoma (Nasal Type) Trial (clinicaltrials.gov) - P1/2; N=129; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Monotherapy • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P1/2; N=56; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Non-melanoma Skin Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Skin Cancer