A number of oncology firms introduced key trial milestones this week throughout the panorama of each blood cancers and strong tumors.
A number of oncology firms introduced key trial milestones this week throughout the panorama of each blood cancers and strong tumors.
Notably, SynOx Therapeutics accomplished enrollment in its international part 3 TANGENT examine of emactuzumab for tenosynovial large cell tumors, with outcomes anticipated in 2026, whereas ALX Oncology additionally launched a part 1 trial of ALX2004, an antibody-drug conjugate focusing on EGFR-expressing strong tumors.
These developments spotlight ongoing efforts to broaden therapy choices throughout uncommon tumors, blood cancers, lung most cancers, strong tumors, and myeloid problems, all of that are areas the place important unmet wants stay.
Section 3 Tenosynovial Large Cell Tumor Trial Completes Enrollment
Affected person enrollment in TANGENT, a worldwide part 3 scientific trial of emactuzumab, has been accomplished for sufferers with tenosynovial large cell tumors (TGCT), in keeping with a information launch from SynOx Therapeutics.
The TANGENT examine is evaluating emactuzumab, an investigational monoclonal antibody that blocks CSF-1R, in sufferers with TGCT who can not endure or wouldn’t profit from surgical procedure. The trial enrolled sufferers throughout the USA, Canada, Europe and Asia, and top-line outcomes are anticipated in early 2026. The first aim of the examine is to measure tumor response at six months, with extra outcomes centered on ache, stiffness, vary of movement and high quality of life. Sufferers will likely be adopted for 2 years, and people whose tumors progress might obtain open-label emactuzumab.
TGCT is a uncommon however aggressive joint illness that always impacts the knee, hip or ankle. It may possibly trigger ache, swelling and restricted mobility. Surgical procedure is usually used to take away tumors, however greater than half of sufferers with diffuse TGCT see their illness return inside three years. In extreme instances, untreated TGCT can result in joint injury or the necessity for joint fusion or amputation.
GTB-3650 Expands Use in Section 1 Trial for Blood Cancers
GT Biopharma has begun dosing in Cohort 3 of its part 1 scientific trial of GTB-3650 for relapsed or refractory CD33-expressing blood cancers, following a security evaluation of earlier cohorts, the corporate introduced in a information launch.
GTB-3650 is a next-generation remedy constructed on the corporate’s TriKE pure killer (NK) cell engager platform. The trial is testing the therapy in sufferers whose illness has returned or has not responded to different therapies. Early knowledge from the primary two cohorts confirmed that GTB-3650 activated NK cells and spurred their growth, with no security or tolerability points reported.
The continued trial will enroll as much as roughly 14 sufferers throughout seven dose ranges. Sufferers obtain therapy in two-week cycles, with as much as 4 months of remedy relying on scientific profit. Researchers are assessing security, immune activation, drug habits within the physique and indicators of scientific exercise.
Preliminary outcomes from the examine are anticipated later in 2025, in keeping with the corporate.
First Affected person Dosed with Ivonescimab in Section 3 Trial for Restricted-Stage SCLC
The primary affected person in a part 3 scientific trial testing ivonescimab as a possible new therapy for folks with limited-stage small cell lung most cancers (LS-SCLC) has been dosed, in keeping with a information launch from Akeso.
The trial, referred to as HARMONi-9, is evaluating ivonescimab, a first-in-class bispecific antibody that targets PD-1 and VEGF, as consolidation remedy for sufferers whose most cancers has not progressed after commonplace chemoradiotherapy. Researchers intention to measure whether or not ivonescimab may also help delay illness recurrence and enhance survival on this aggressive type of lung most cancers.
Small cell lung most cancers accounts for about 15% of all lung cancers and is understood to unfold rapidly. At present, just one immunotherapy is accredited for consolidation in LS-SCLC, leaving a major unmet want. Ivonescimab goals to fill that want and has beforehand proven profit in extensive-stage small cell lung most cancers by prolonging progression-free survival.
With HARMONi-9 now underway, Akeso is increasing its effort to check the drug throughout earlier phases of lung most cancers.
First Affected person Dosed in Section 1 Trial of ALX2004 for EGFR-Expressing Strong Tumors
ALX Oncology has begun a part 1 scientific trial of ALX2004, a brand new antibody-drug conjugate designed to focus on EGFR-expressing strong tumors, in keeping with an organization information launch. The primary affected person has now been handled. ALX2004 is constructed to beat security challenges seen with earlier EGFR-targeted therapies. In preclinical research, the drug confirmed robust anti-tumor exercise and a good security profile, main researchers to maneuver it into human testing.
The trial will enroll sufferers with superior or metastatic cancers, together with non-small cell lung most cancers, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal most cancers. The examine will first check totally different dose ranges, then broaden to discover security and early indicators of effectiveness in bigger teams of sufferers.
Preliminary security outcomes from the examine are anticipated within the first half of 2026.
World Section 3 Research of Lisaftoclax for First-line Remedy MDS Cleared by U.S. FDA
The U.S. Meals and Drug Administration and the European Medicines Company have granted clearance to start GLORA-4, a worldwide part 3 scientific trial testing lisaftoclax together with azacitidine for sufferers with newly recognized higher-risk myelodysplastic syndrome (MDS), in keeping with a information launch from Ascentage Pharma.
Lisaftoclax is a novel oral drug that targets Bcl-2, a protein that helps most cancers cells survive. In earlier research, lisaftoclax mixed with azacitidine confirmed useful response charges and a manageable security profile, suggesting it might enhance outcomes for sufferers dealing with higher-risk MDS, a illness with few efficient first-line choices. As a result of present commonplace therapies for MDS solely profit about one-third of sufferers, there’s a important unmet want.
The GLORA-4 examine is enrolling sufferers throughout the U.S., Europe and China. If profitable, lisaftoclax might turn into the primary Bcl-2 inhibitor accredited for higher-risk MDS and the primary new focused remedy for this situation in additional than 20 years.
References
- “SynOx Therapeutics Completes Enrollment in Registrational Section 3 TANGENT Medical Trial Considerably Forward of Timeline,” by SynOx Therapeutics Restricted. Information launch; Aug. 5, 2025.
- “GT Biopharma Advances into Cohort 3 of GTB-3650 Section 1 Trial Following Security Evaluate of Cohort 2, by GT Biopharma, Inc. Information launch; Aug. 11, 2025.
- “Akeso Publicizes First Affected person Dosed in Section III Trial of Ivonescimab as Consolidation Remedy for Restricted-Stage SCLC After Definitive Radiotherapy,” by Akeso, Inc. Information launch; Aug. 10, 2025.
- “ALX Oncology Doses First Affected person in Section 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Remedy of EGFR-Expressing Strong Tumors,” by ALX Oncology. Information launch; Aug. 19, 2025.
- “Ascentage Pharma Publicizes World Registrational Section III Research of Lisaftoclax for First-line Remedy of Sufferers with Greater-Danger Myelodysplastic Syndrome Cleared by US FDA and EMA,” by Ascentage Pharma Group Worldwide. Information launch; Aug. 17, 2025.
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