Jinlitai (narlumosbart) / CSPC Pharma - LARVOL DELTA

JMT103 versus Non-Denosumab or Denosumab Treatment in Chinese Patients with Unresectable or Surgically Challenging Giant Cell Tumor of Bone: A Propensity Score-Matched Comparison. (PubMed, Cancer Med) - P, P1/2 | "JMT103 has manageable safety profiles with better effectiveness than non-denosumab and a trend toward greater effectiveness than denosumab in patients with unresectable or surgically challenging GCTB."

Clinical • Journal • Retrospective data • Giant Cell Tumor of Bone • Oncology • Osteosarcoma • Solid Tumor

Efficacy and safety of narlumosbart, an anti-RANKL monoclonal antibody, in postmenopausal women with osteoporosis: a multi-center, randomized, double-blind, placebo- and active-controlled, phased II study. (PubMed, EClinicalMedicine) - P2 | "82270938, No. 81970757]; and the Non-profit Central Research Institute Fund of Chinese Academy of Medical Sciences [2023-PT320-10]."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Osteoporosis • Rheumatology

The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=27 | Not yet recruiting | Sponsor: Fudan University | Initiation date: May 2025 ➔ Sep 2025

Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NARLUMOSBART COMPARED WITH DENOSUMAB IN THE TREATMENT OF BONE DISEASE IN PATIENTS WITH MULTIPLE MYELOMA: A MULTICENTER, RANDOMIZED, CONTROLLED, NON-INFERIORITY STUDY (EHA 2025) - "This study demonstrated encouraging efficacy of narlumosbart in reducing biomarkers of bone metabolism and manageable safety profile in MM patients with bone diseases."

Clinical • Head-to-Head • IO biomarker • Back Pain • Endocrine Disorders • Hematological Malignancies • Multiple Myeloma • Musculoskeletal Diseases • Musculoskeletal Pain • Oncology • Orthopedics • Pain

CLO25-072: A Multicenter, Randomized, Controlled, Non-Inferiority Study of Narlumosbart Compared With Denosumab in the Treatment of Bone Disease in Patients With Multiple Myeloma. (PubMed, J Natl Compr Canc Netw) - No abstract available

Head-to-Head • Journal • Hematological Malignancies • Multiple Myeloma • Oncology • Orthopedics

The Efficacy and Safety of Narlumosbart in Combination with Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined with Immunotherapy in Patients with Bone Metastases from Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=27 | Not yet recruiting | Sponsor: Fudan University | Initiation date: Dec 2024 ➔ May 2025

Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Efficacy and safety of JMT103 in patients with bone metastases from solid tumors: A randomized Phase Ib clinical trial. (PubMed, Int J Cancer) - "The most common treatment-related adverse events were hypocalcemia (23.2%), hypophosphatemia (22.9%), and increased aspartate transaminase (11.9%). JMT103 demonstrated a good safety and a strong suppression of the bone turnover markers."

Journal • P1 data • Endocrine Disorders • Oncology • Renal Disease • Solid Tumor

Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study. (PubMed, Nat Commun) - P1/2 | "No serious treatment-related adverse events were observed. Thus, JMT103 demonstrates potential as a therapeutic option for GCTB."

Journal • P1/2 data • Endocrine Disorders • Giant Cell Tumor of Bone • Oncology • Osteosarcoma • Renal Disease • Solid Tumor

Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study (Nature, Nat Commun) - P1b/2 | N=139 | NCT04255576 | Sponsor: Shanghai JMT-Bio Inc. | "A total of 139 patients were enrolled, and 135 were analyzed for efficacy. OTR, determined by the independent review committee (IRC) was 93.3% (95% CI 87.7-96.9). Treatment-related adverse events occurred in 90 (64.7%) patients, with hypophosphatemia and hypocalcemia being the most common. No serious treatment-related adverse events were observed."

P1/2 data • Giant Cell Tumor of Bone

Efficacy and safety of JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone: a multicenter, phase Ib/II study (Nature, Nat Commun) - P1b/2 | N=139 | NCT04255576 | Sponsor: Shanghai JMT-Bio Inc. | "A total of 139 patients were enrolled, and 135 were analyzed for efficacy. OTR, determined by the independent review committee (IRC) was 93.3% (95% CI 87.7-96.9). Treatment-related adverse events occurred in 90 (64.7%) patients, with hypophosphatemia and hypocalcemia being the most common. No serious treatment-related adverse events were observed."

P1/2 data • Giant Cell Tumor of Bone

Efficacy and safety of Narlumosbart (JMT103) in patients with giant cell tumour of bone: a multicenter, single-arm, open-label, phase Ib/II study (CSCO 2024) - "Study group: [CSCO Sarcoma Expert Committee]"

Clinical • P1/2 data • Giant Cell Tumor of Bone • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

Antibodies to watch in 2024. (PubMed, MAbs) - "In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi))...These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa)...Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates..."

Journal • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

A phase Ib study of JMT103, a receptor activator of NF-kB ligand (RANKL) antibody, in patients (pts) with bone metastases from solid tumors. (ASCO 2024) - P1 | "Our study demonstrated a promising efficacy of JMT103 in reducing bone metabolism biomarker and a good safety profile with low immunogenicity. Clinical trial information: NCT04630522."

Clinical • P1 data • Endocrine Disorders • Genito-urinary Cancer • Infectious Disease • Oncology • Pain • Pneumonia • Prostate Cancer • Renal Disease • Respiratory Diseases • Solid Tumor

Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease (clinicaltrials.gov) - P3 | N=478 | Not yet recruiting | Sponsor: RenJi Hospital

Head-to-Head • New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Orthopedics

Narlumosbartmab Combined With Neoadjuvant Chemotherapy in Bone-derived Malignancies With Osteolytic Lesions and Multinucleated Giant Cells (clinicaltrials.gov) - P=N/A | N=60 | Recruiting | Sponsor: Peking University People's Hospital

New trial • Oncology • Osteosarcoma • Solid Tumor

A Study to Assess the Prevention of Bone-related Events in Patients With Bone Metastases From Malignant Solid Tumors Treated With JMT103 Compared to Zoledronic Acid (clinicaltrials.gov) - P3 | N=1360 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P3 trial • Oncology • Solid Tumor

Narlumosbart: First Approval. (PubMed, Drugs) - "Clinical studies of narlumosbart for bone metastases, postmenopausal osteoporosis and glucocorticoid-induced osteoporosis are underway in China. This article summarizes the milestones in the development of narlumosbart leading to this first approval for the treatment of adults with GCTB."

Journal • Review • Giant Cell Tumor of Bone • Oncology • Osteoporosis • Osteosarcoma • Rheumatology • Solid Tumor

Efficacy and Safety of JMT103 in Patients With Bone Metastases From Solid Tumors (clinicaltrials.gov) - P1 | N=295 | Completed | Sponsor: Shanghai JMT-Bio Inc. | Recruiting ➔ Completed | N=150 ➔ 295 | Trial completion date: May 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2021 ➔ Mar 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone (clinicaltrials.gov) - P3 | N=146 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P3 trial • Giant Cell Tumor of Bone • Oncology • Osteosarcoma • Solid Tumor

Efficacy and Safety of JMT103 in Patients With Giant Cell Tumor of Bone (clinicaltrials.gov) - P1/2 | N=139 | Active, not recruiting | Sponsor: Shanghai JMT-Bio Inc. | Unknown status ➔ Active, not recruiting | Trial completion date: May 2022 ➔ Oct 2023 | Trial primary completion date: Dec 2021 ➔ Sep 2023

Enrollment closed • Trial completion date • Trial primary completion date • Giant Cell Tumor of Bone • Immunology • Oncology • Osteosarcoma • Solid Tumor

Safety, tolerability, and pharmacokinetics/pharmacodynamics of JMT103 in patients with bone metastases from solid tumors. (PubMed, Front Oncol) - P1 | "Bone antiresorptive activity shows the potential of JMT103 for treatment of bone metastases from solid tumors. Registration No.: NCT03550508; URL: https://www.clinicaltrials.gov/."

Journal • PK/PD data • Endocrine Disorders • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Renal Disease • Solid Tumor

Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Shanghai JMT-Bio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Osteoporosis • Rheumatology • COL1A2

Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis (clinicaltrials.gov) - P2 | N=231 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2 trial • Osteoporosis • Rheumatology

Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Shanghai JMT-Bio Inc.

New P2 trial • Osteoporosis • Rheumatology • COL1A2

[VIRTUAL] Efficacy and safety of JMT103 in patients with giant cell tumor of bone: A multicenter, single-arm, open-label, phase Ib/II study. (ASCO 2021) - P1/2 | "JMT103 demonstrated encouraging anti-tumor efficacy and manageable safety profile in pts with unresectable GCTB or at high risk of severe morbidity after surgery."

Clinical • P1/2 data • Giant Cell Tumor of Bone • Immunology • Oncology • Osteosarcoma • Pain • Renal Disease • Solid Tumor