Seattle Genetics presents breast cancer data

Seattle Genetics presents updated Phase 1 data for SGN-LIV1A 

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Seattle Genetics presents updated Phase 1 data for SGN-LIV1A

Seattle Genetics (SGEN) announced updated data from an ongoing phase 1 clinical trial evaluating ladiratuzumab vedotin in patients with metastatic triple negative breast cancer at the 2017 San Antonio Breast Cancer Symposium, taking place December 5-9, 2017.

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.

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. Of these patients, 63 were diagnosed with TNBC and 18 had hormone receptor-positive / human epidermal growth factor receptor 2-negative breast cancer.

At the completion of dose escalation at doses ranging from 0.5 to 2.8 milligrams per kilogram, TNBC expansion cohorts were opened at 2.0 and 2.5 mg/kg to further evaluate safety and antitumor activity of ladiratuzumab vedotin in metastatic TNBC patients.

Based on efficacy and safety, the recommended dose is 2.5 mg/kg with a maximum dose of 200 mg per cycle.

Key findings in this heavily pre-treated patient population were presented by Dr. Jennifer Specht, Seattle Cancer Care Alliance and include: Among the 60 efficacy-evaluable patients with metastatic TNBC, the objective response rate (ORR) was 25 percent, representing all partial responses.

The clinical benefit rate was 28 percent. CBR is defined as patients achieving complete response or PR of any duration, plus patients achieving stable disease lasting at least 24 weeks. Of the 17 efficacy-evaluable patients treated at the recommended dose, 29 percent achieved an objective response, and the CBR was 29 percent.

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.

SGEN closed at $56.75.


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