On December 2, 2013 Celldex Therapeutics announced that it has launched a randomized study (METRIC) of Glembatumumab vedotin (CDX-011) in patients with metastatic triple negative breast cancers that over-express glycoprotein NMB (gpNMB) (Press release Celldex Therapeutics, DEC 2, 2013, View Source [SID:1234500219]). Initial sites are now open to screen patients in the United States. Additional sites in the United States and in Canada and Australia will open in early 2014. The study is expected to include up to 100 sites and will enroll approximately 300 patients.
The company also plan to further expand the clinical development program for Glembatumumab vedotin in 2014 by initiating additional studies in other cancers known to express gpNMB including melanoma and squamous cell lung cancer.
The METRIC study is a pivotal, open-label, prospectively controlled, randomized study of Glembatumumab vedotin in patients with metastatic gpNMB-expressing triple-negative breast cancer. Eligible patients must have received no more than 1 prior line of chemotherapy for advanced disease and therapy must have included a taxane and anthracycline. Patients will be randomized (2:1) to receive Glembatumumab vedotin or capecitabine. Study treatment will continue until disease progression or intolerance with tumor assessments performed at six week intervals for six months and nine week intervals thereafter. The primary objective is to evaluate the anti-cancer activity of Glembatumumab vedotin as measured by the objective response rate (ORR) and duration of progression-free survival (PFS). The study is designed to enable Celldex to apply for registration with positive results for either endpoint. Secondary endpoints include duration of response, overall survival, safety and tolerability. The Company will also assess improvements in quality of life and/or cancer-related pain as exploratory endpoints.
Patients will be stratified as follows:
* No prior chemotherapy for advanced disease vs. 1 prior line of chemotherapy for advanced disease
* "Resistant" to anthracycline therapy (i.e., progression-free interval of ≤ 6 months after completing treatment) vs. "Exposed" to anthracycline therapy (i.e., progression-free interval of > 6 months after completing treatment)
Clinical Data Supporting Glembatumumab vedotin in Triple Negative Breast Cancer
In the Phase 2 EMERGE study, final data supported an overall survival benefit in specific sub-groups of breast cancer patients with tumors that over-express gpNMB. Treatment of patients with both triple negative breast cancer and over-expression of gpNMB showed a high overall response rate (ORR) of 33% (n=12) when treated with Glembatumumab vedotin. In comparison, no responses (n=4) were seen in patients with both triple negative breast cancer and over-expression of gpNMB with standard chemotherapies. In this same patient population, the median overall survival (OS) for patients treated with Glembatumumab vedotin was 10 months vs. 5.5 months (p= 0.003) and progression free survival (PFS) was 3 months for the Glembatumumab vedotin arm vs. 1.5 months for the control arm (p=0.008), respectively. The most common adverse event was rash.

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