abituzumab (EMD 525797) / EMD Serono, SFJ Pharma - LARVOL DELTA

Inside a Metastatic Fracture: Molecular Bases and New Potential Therapeutic Targets. (PubMed, Cancer Med) - "This paper underscores the importance of advanced molecular biology and transcriptomics in identifying novel therapeutic targets. The integration of these biomarkers with clinical and radiological assessments using artificial intelligence tools could revolutionize the diagnostics and treatment strategies for patients with bone metastases."

Biomarker • Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Oncology • Orthopedics • Solid Tumor • ISLR • TNFRSF11B

Integration of NMR Spectroscopy in an Analytical Workflow to Evaluate the Effects of Oxidative Stress on Abituzumab: Beyond the Fingerprint of mAbs. (PubMed, Anal Chem) - "Here, the effects of forced oxidative stress by HO on the monoclonal antibody Abituzumab have been characterized by a multianalytical approach combining NMR spectroscopy, mass spectrometry, differential scanning calorimetry, surface plasmon resonance, computational tools, and bioassays. This integrated strategy has provided qualitative and semiquantitative characterization of the samples and information at residue level of the effects that oxidation has on the HOS of Abituzumab, correlating them to the loss of the biological activity."

Journal

Patient selection for targeting integrin with abituzumab in patients with metastatic colorectal cancer (mCRC). A retrospective analysis of the randomized phase I/II Poseidon study. (ESMO 2018) - P1/2; "Although the sample size is small, patients with left sided KRAS wt mCRC and high expression of ανβ6 integrin in their tumor seem to benefit most from the addition of abituzumab to irinotecan+cetuximab compared to irinotecan+cetuximab alone. A prospective study in 1L left sided RAS wild-type mCRC with high expression of ανβ6 is planned with the addition of abituzumab 1000mg to SOC."

P1/2 data • Retrospective data • Colorectal Cancer

Combining bintrafusp alfa with abituzumab enhances suppression of the TGF-β signaling pathway (SITC 2021) - "In vivo, the combination led to increased tumor growth inhibition of Detroit 562 xenograft tumors relative to either monotherapy, further supporting the potential of this combination. Conclusions Collectively, these preclinical findings support clinical development of bintrafusp alfa and abituzumab combination therapy to maximally suppress TGF-β signaling in the TME."

IO biomarker • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TGFB1

EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Merck KGaA; N=24 ➔ 40; Recruiting ➔ Completed; Trial primary completion date: Jul 2013 ➔ Nov 2013

Clinical • Enrollment change • Trial completion • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor • MRI

EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases (clinicaltrials.gov) - P1; N=61; Completed; Sponsor: Merck KGaA; Recruiting ➔ Completed

Clinical • Trial completion • Oncology • Ovarian Cancer • Solid Tumor • MRI

EMD 525797 in Colorectal and Ovarian Cancer Patients With Liver Metastases (clinicaltrials.gov) - P1; N=61; Completed; Sponsor: Merck KGaA; Trial primary completion date: Jul 2013 ➔ Nov 2013

Clinical • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor • MRI

STRATUS, a Phase II Study of Abituzumab in Patients with Systemic Sclerosis-associated Interstitial Lung Disease. (PubMed, J Rheumatol) - P2 | "Further investigation of abituzumab for treatment of SSc-ILD is required."

Clinical • Journal • P2 data • Fibrosis • Immunology • Interstitial Lung Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone for patients with KRAS wild-type metastatic colorectal cancer: the randomised phase I/II POSEIDON trial (Ann Oncol) - P1/2, N=216; POSEIDON (NCT01008475); Sponsor: Merck KGaA; "PFS was similar in the three arms: Arm A vs SoC, HR 1.13 (95% CI 0.78-1.64); Arm B vs SoC, HR 1.11 (0.77-1.61). RRs were also similar. A trend toward improved OS was observed: Arm A vs SoC, HR 0.83 (0.54-1.28); Arm B vs SoC, HR 0.80 (0.52-1.25). Grade ≥3 treatment-emergent adverse events (TEAEs) were observed in 72%, 78% and 67% of patients."

P1/2 data • Biosimilar • Colorectal Cancer • Oncology

Abituzumab Targeting of AlphaV-class Integrins Inhibits Prostate Cancer Progression. (PubMed) - Mol Cancer Res - "This work identifies that therapeutic targeting of integrins containing an alpha V integrin unit inhibits cancer progression and thus may be of clinical benefit."

Journal • Biosimilar • Genito-urinary Cancer • Oncology • Prostate Cancer

Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer. (clinicaltrials.gov) - P2; N=230; Not yet recruiting; Sponsor: SFJ Pharmaceuticals X, LTD.

New P2 trial • Biosimilar • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Study of Abituzumab in Combination With Cetuximab and FOLFIRI in Patients With Metastatic Colorectal Cancer. (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: SFJ Pharmaceuticals X, LTD.; N=230 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Combination therapy • Enrollment change • Trial withdrawal

Integrins as A New Target for Cancer Treatment. (PubMed, Anticancer Agents Med Chem) - "Despite the great progress in the development of targeted therapies for different types of cancer utilizing monoclonal antibodies (e.g., cetuximab for colorectal cancer and head and neck cancer therapy), kinase inhibitors (e.g., sorafenib for kidney cancer and gastrointestinal stromal tumours therapy), and immunomodulatory treatments (e.g., nivolumab and pembrolizumab for melanoma therapy and lung cancer therapy), there is still a need to search for new, more effective treatments...There are different groups of anti-integrin drugs: monoclonal antibodies (e.g., abituzumab) and other such as cilengitide, E7820 and MK-0429...Studies have shown that patient selection using biomarkers might improve the efficacy of anti-integrin cancer treatment. Many preclinical models have demonstrated promising results using integrin visualization for cancer detection and treatment efficacy monitoring; however, these strategies require further evaluation in humans."

Biomarker • Journal

Ongoing clinical trials and treatment options for patients with systemic sclerosis-associated interstitial lung disease. (PubMed, Rheumatology (Oxford)) - "Newer agents targeting the pathogenic mechanisms underlying SSc-ILD, including fibrotic and inflammatory pathways, lymphocytes, cell-cell and cell-extracellular membrane interactions, hold promise for better treatment outcomes, including improved lung function, patient-related outcomes and quality of life. Here we review ongoing trials of established and novel agents that are currently recruiting patients with SSc-ILD."

Clinical • Journal