Tagitanlimab

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

4 months ago

• Arvinas plans to initiate two Phase 3 trials in 2025 for vepdegestrant in ER+/HER2- metastatic breast cancer, one in the first-line setting with atirmociclib and another in the second-line setting with a CDK4/6 inhibitor. • Topline data from the Phase 3 VERITAC-2 monotherapy trial of vepdegestrant in second-line-plus ER+/HER2- metastatic breast cancer is anticipated in the first quarter of 2025. • Arvinas is set to present initial data from the Phase 1 trial of ARV-393 in B-cell lymphomas and file an IND application for a novel PROTAC KRAS G12D degrader in 2025. • Phase 1 trial with PROTAC LRRK2 degrader ARV-102 in patients with Parkinson’s disease has been initiated, with data expected to be presented in the first half of 2025.

Sacituzumab Tirumotecan (Sac-TMT) Approved in China for Advanced TNBC

7 months ago

• Kelun-Biotech's Sacituzumab tirumotecan (Sac-TMT) has received marketing approval in China for treating advanced or metastatic triple-negative breast cancer (TNBC). • The approval is based on the Phase III OptiTROP-Breast01 trial, which showed Sac-TMT significantly improved progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. • Sac-TMT is the first domestically developed TROP2-directed antibody-drug conjugate (ADC) to be fully approved for marketing in China. • Kelun-Biotech is also pursuing approval for Sac-TMT as a monotherapy for EGFR-mutant non-small cell lung cancer (NSCLC) after EGFR-TKI therapy.

Kelun-Biotech's SKB264 (Sac-TMT) Demonstrates Promising Results Across Multiple Solid Tumors

8 months ago

• Sacituzumab tirumotecan (sac-TMT) significantly improved progression-free survival (PFS) and overall survival (OS) in patients with triple-negative breast cancer (TNBC) compared to chemotherapy. • In advanced non-small cell lung cancer (NSCLC), sac-TMT combined with KL-A167 showed high objective response rates (ORR) and promising PFS in treatment-naive patients. • Sac-TMT plus pembrolizumab demonstrated a high ORR and encouraging PFS in patients with recurrent or metastatic cervical cancer, including those pre-treated with anti-PD-1 therapy. • Sac-TMT showed clinically meaningful activity in heavily pre-treated patients with advanced endometrial and ovarian cancers, with notable ORRs and PFS, particularly in TROP2 high-expressing tumors.

Arvinas Advances Vepdegestrant into Phase 3 Trials for Breast Cancer and Updates Pipeline Milestones

Sacituzumab Tirumotecan (Sac-TMT) Approved in China for Advanced TNBC

Kelun-Biotech's SKB264 (Sac-TMT) Demonstrates Promising Results Across Multiple Solid Tumors

Drug Development Updates