THTX - Theratechnologies' Sudocetaxel Zendusortide ASCO 2024 Presentation Demonstrates Signs of Long-Term Efficacy and Manageable Safety Profile in Patients with Solid Tumors | Benzinga
- Poster highlights durable disease stabilization lasting beyond treatment completion
- Results suggest a unique, multimodal mechanism of action that differs from other cancer therapeutics
- Favorable tolerability sets stage for Part 3 (dose optimization) of Phase 1 trial, already underway
MONTREAL, May 23, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced Phase 1 data demonstrating signs of long-term efficacy and a manageable safety profile of its lead investigational peptide drug conjugate (PDC) candidate, sudocetaxel zendusortide (TH1902), in patients with solid tumors. The data will be presented in a poster session on June 1, 9:00 AM-12:00 PM CDT (abstract #3081, poster board #226) at the 2024 American Society of Clinical Oncology (ASCO) annual meeting, which is taking place May 31-June 4, 2024, in Chicago, IL.
In an updated analysis from Parts 1 and 2 of an ongoing Phase 1 clinical trial, sudocetaxel zendusortide induced durable disease stabilization (up to 45 weeks) lasting beyond treatment completion. The results suggest a unique, multimodal mechanism of action distinct from other cancer therapeutics, including induction of immune cell infiltration even in "cold" tumor models, inhibition of vasculogenic mimicry, targeting of chemotherapy-resistant cancer stem cells, and activation of the cGAS/STING immune pathway, among other actions. Additionally, investigators observed an early efficacy signal primarily in female cancers (ovarian cancer, endometrial cancer, triple-negative breast cancer [TNBC]), with seven of 16 participants (44%) achieving a clinical benefit rate (complete response + partial response + stable disease), as confirmed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The poster presentation, which constitutes the first report of long-term efficacy, safety, and pharmacokinetic (PK) data from the Phase 1 study, also suggests that sudocetaxel zendusortide has a manageable safety profile when dosed at 300mg/m2, with few Grade 3 adverse events (AEs).
"The initial long-term Phase 1 data further validate and expand upon the preliminary evidence of antitumor activity with sudocetaxel zendusortide in individuals with solid tumors," said Ira Winer, M.D., Ph.D., FACOG, a member of the Gynecologic Oncology and Phase 1 Clinical Trials Multidisciplinary Teams at Karmanos Cancer Center and Associate Professor of Oncology at Wayne State University. "It is highly unusual to see such long-lasting disease stabilization even after treatment cessation in patients with advanced disease. These updated data provide an informative baseline as we seek to optimize the dose of this novel peptide-drug conjugate in patients with platinum-resistant ovarian cancer in the next stage of the Phase 1 trial."
Study details
Dr. Winer and colleagues conducted an analysis of the long-term efficacy, safety, and PK of sudocetaxel zendusortide from Parts 1 and 2 of the Phase 1 trial, which seeks primarily to characterize the agent's safety and tolerability. Part 1 (modified intrapatient dose escalation, n=18) included patients with recurrent/refractory advanced tumors (all comers) with no limit on the number of previous therapies, including taxanes. Part 2 (dose expansion, n=18) included patients with cancers with known high ...