( ity in multiple tumor types underscori...)Kosan Presents Promising Phase 1 Data on Second-Generation Hsp90,Inhibitor, Alvespimycin, Showing Antitumor Activity in Refractory,Breast and Ovarian Cancers at ASCO,Health

Phase 1 Alvespimycin Results

Alvespimycin is a second-generation Hsp90 inhibitor that has demonstrated the potential to disrupt the activity of multiple oncogenes and cell signaling pathways implicated in tumor growth, including HER2, a key signaling pathway in breast cancer.

The Phase 1 trial of alvespimycin in combination with trastuzumab was designed to identify the recommended Phase 2 dose through the evaluation of toxicity and activity in patients with solid tumors. Patients were enrolled in three dose cohorts. The dosing schedule for alvespimycin was a one-hour weekly intravenous infusion of 60, 80 or 100 mg/m2 administered along with the standard dose of trastuzumab.

Of the 25 heavily-pretreated patients enrolled in the trial, 22 patients had HER2-positive breast cancer and 3 patients had ovarian cancer (HER2 status unknown). The median number of prior regimens excluding hormonal therapy was 6.5, and the median prior trastuzumab-containing regimens for the HER2-positive breast cancer patients was 4. Clinical benefit was observed in 35% of patients (7 of 20 evaluable) with HER2-positive metastatic breast cancer:

    -- 1 patient (13 prior regimens, including progression on single-agent

       lapatinib and 3 prior trastuzumab-containing regimens) showed near

       complete resolution of lung metastases by CT/PET with significant

       improvement in shortness of breath (8 cycles at 60 mg/m2);


    -- 1 patient (11 prior regimens, 5 with trastuzumab, 2 with lapatinib)

       showed 10% reduction in tumor mass (change consistent with tumor

       necrosis) and a decrease in 2 tumor markers (64% CEA, 63% CA27); this

       patient continues on study;


    -- 5 patients had extended stable disease (4, 5, 6+, 11+ and 12 months).


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