Trishula Therapeutics, Inc. dina iki ngumumake asil awal saka uji coba Tahap 1 sing terus-terusan ngevaluasi TTX-030 kanthi kombinasi karo budigalimab (anti-PD-1 investigasi) lan FOLFOX kanggo perawatan lini pertama pasien kanthi lambung HER2 negatif utawa metastatik lokal maju / metastatik. kanker junction gastroesophageal. Asil sinau ditampilake ing presentasi lisan ing Rapat Tahunan American Association for Cancer Research (AACR) ing New Orleans. Data sing dituduhake nuduhake yen perawatan kombinasi TTX-030 umume ditoleransi lan nuduhake pratandha aktivitas anti-tumor sing nyengkuyung.
"Tingkat respon kalebu ing pasien tumor PD-L1 kurang sing katon ing analisis awal iki banget nyemangati lan ndhukung potensial TTX-030 kanggo nyebabake standar perawatan kanggo pasien kanker lambung lan gastroesophageal," ujare Zev Wainberg, MD, Profesor Kedokteran ing UCLA lan co-direktur Program Onkologi GI UCLA. "Kita ngarepake temuan lengkap saka uji coba iki lan kemajuan luwih saka pendekatan perawatan sing janjeni iki."
Asil awal khasiat lan safety ditampilake minangka potongan data interim tanggal 1 Maret 2022. Gunggunge 44 pasien sing didaftar. Rong puluh enem (26) pasien isih ing perawatan sinau, lan durasi rata-rata sinau yaiku 214 dina (kisaran 8-464+ dina). Antarane 40 pasien sing bisa dievaluasi efektifitas, 21 pasien (25 pasien kalebu durung dikonfirmasi) entuk respon sakabèhé paling apik saka respon parsial utawa luwih apik kalebu 4 CRs: ORR = 52.5% (62,5% kalebu durung dikonfirmasi), lan tingkat kontrol penyakit = 92.5%. Telung puluh pitu (37) saka pasien sing bisa dievaluasi khasiat wis ngerti Skor Positif Gabungan PD-L1 (CPS); tingkat respon ing pasien karo CPS ≥1 yaiku 65% (77% kalebu durung dikonfirmasi).
Rong puluh pitu saka 44 pasien (61%) ngalami paling ora siji adverse event (AE) saka sembarang kelas sing dianggep ana hubungane karo TTX-030 (penilaian investigator), kalebu 9 pasien (20.5%) karo Grade 3/4 AEs. Kedadeyan salabetipun sakabèhé konsisten karo sing katon karo standar-of-care (kemoterapi plus anti-PD-1).
"Data kita sing disorot ing AACR nggambarake temuan klinis pertama antibodi anti-CD39 ing pasien kanker lambung lan ndhukung peran TTX-030 kanggo mbalikke imunosupresi sing dimediasi adenosin," ujare Anil Singhal, Chief Executive Officer. "Kita ngarepake kemajuan studi klinis TTX-030 iki, sing kita yakin bisa nambah paradigma perawatan kanggo pasien kanker."
APA sing kudu dijupuk saka ARTIKEL INI:
- “The response rates including in patients with PD-L1 low tumors seen in this preliminary analysis are very encouraging and support the potential of TTX-030 to impact the standard of care for patients with gastric and gastroesophageal cancer,”.
- “Our data highlighted at AACR represents the first promising clinical findings of an anti–CD39 antibody in patients with gastric cancers and supports the role of TTX-030 in reversing adenosine-mediated immunosuppression,”.
- today announced preliminary results from an ongoing Phase 1 trial evaluating TTX-030 in combination with budigalimab (investigational anti-PD-1) and FOLFOX for the first-line treatment of patients with locally advanced/metastatic HER2 negative gastric or gastroesophageal junction cancer.
