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Biotech / Medical : Biotech Lock-Up Expiration Hell Portfolio -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (873)	12/8/2003 2:18:07 PM
From: tuck	Read Replies (1) \| Respond to of 1005

SGN-15 . . . >>Phase II study of SGN-15 (cBR96-doxorubicin immunoconjugate) combined with docetaxel in patients with advanced stage or metastatic non-small cell lung cancer (NSCLC) Abstract No: 690 Citation: Proc Am Soc Clin Oncol 22: page 172, 2003 (abstr 690) Author(s): H. Ross, C. M. Rudin, L. Hart, R. A. Figlin, A. Jacobs, M. Rarick, A. S. Sandler, A. P. Sing, C. Siegall; Earle A. Chiles Research Institute, Providence Portland Medical Center, Portland, OR; University of Chicago, Chicago, IL; Florida Cancer Specialists, Ft. Myers, FL; UCLA, Los Angeles, CA; Virginia Mason Research Center, Seattle, WA; Kaiser Permanente, Portland, OR; Seattle Genetics, Seattle, WA Abstract: Current therapies for late stage NSCLC continue to fall short of extending survival. Only one agent, docetaxel (Doc), has been approved, as monotherapy, in second line treatment. SGN-15 is a novel antibody-drug conjugate that delivers doxorubicin to tumor tissues expressing the Lewis-y antigen. Preclinical studies demonstrated significant enhancement of antitumor activity of SGN-15 when combined with a taxane. This ongoing randomized phase II study prospectively compares response, toxicity, and quality of life of SGN-15 plus Doc to Doc alone, as second line therapy for NSCLC. Randomization is weighted 2:1 in favor of the combination arm. Treatment consists of SGN-15 (200 mg/m2) administered intravenously prior to Doc (35 mg/m2) (Arm A); or Doc (35 mg/m2) alone (Arm B). The original treatment schedule consisted of 6 weekly doses of the assigned treatment followed by 2 weeks rest (8 week cycle). Due to minimal SGN-15-related toxicity, the protocol was amended after the first 27 patients had been accrued. This amendment allows for an intra-patient dose escalation of SGN-15 in 50 mg/m2 increments to a maximum dose of 350 mg/m2 and a change in administration schedule to 3 weeks on and 1 week rest with 2 courses per 8 week cycle. Forty-one patients have been enrolled (Arm A: 26 patients/Arm B: 15 patients). In the 31 evaluable patients (Arm A: 18 patients/Arm B: 13 patients), there is evidence of antitumor activity with minimal non-hematologic toxicity (> Gr 2) at all SGN-15 doses. One patient on Arm A had complete resolution of a 2.5x2.1 cm RLL nodule (CR) and symptomatic improvement in back pain and appetite after a single 8 week cycle of therapy. Conclusion: The combination of SGN-15/Doc is well tolerated and early results suggest activity in the second line setting. Due to the low toxicity observed in Arm A, an intra-patient dose escalation of SGN-15 is currently being conducted. Accrual is targeted for completion in early 2003. Updated response rates and toxicity data will be presented at the meeting. << Cheers, Tuck