8 December 2017 - - Bothell, Washington-based cancer treatment developer Seattle Genetics, Inc. (NASDAQ: SGEN) has released updated data from an ongoing phase 1 clinical trial evaluating ladiratuzumab vedotin in patients with metastatic triple negative breast cancer (TNBC), the company said.
Ladiratuzumab vedotin is an investigational antibody-drug conjugate designed to deliver a potent and clinically validated cell-killing agent, monomethyl auristatin E, to cancer cells which express the protein LIV-1. LIV-1 is expressed on multiple solid tumors including breast, prostate, melanoma, ovarian, uterine, and cervical cancers.
The updated results describe the safety, tolerability, and antitumor activity of ladiratuzumab vedotin in 28 additional patients with TNBC.
A total of 81 patients with LIV-1-expressing metastatic breast cancer were treated with ladiratuzumab vedotin monotherapy given every three weeks. Patients enrolled in the study had received a median of four prior systemic metastatic therapies.
Among the 60 efficacy-evaluable patients with metastatic TNBC, the objective response rate was 25%, representing all partial responses (PRs). The clinical benefit rate, defined as patients achieving complete response or PR of any duration, plus patients achieving stable disease lasting at least 24 weeks, was 28%.
Of the 17 efficacy-evaluable patients treated at the recommended dose, 29% achieved an objective response (confirmed and unconfirmed), and the CBR was 29%.
The median progression-free survival and median duration of response for patients treated across all dose levels were 11 weeks and 13.3 weeks, respectively. In 19 patients treated at the recommended dose, the median PFS was 12.1 weeks, and the median DOR was 17.4 weeks.
At the recommended dose, ladiratuzumab vedotin was generally well-tolerated and most adverse events were Grade 1/2.
Seattle Genetics develops and commercializes novel antibody-based therapies for the treatment of cancer. The company's antibody-drug conjugate technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells.