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Anti-IGF-IR antibody CP-751,871 in squamous cell carcinoma


CaroleHammett

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A rare finding showing a targeted therapy that actually has higher success rate for squamous cell carcinoma:

http://www.asco.org/ASCO/Abstracts+%26+ ... ctID=33541

2008 ASCO Annual Meeting, Abstract No. 8015: High activity of the anti-IGF-IR antibody CP-751,871 in combination with paclitaxel and carboplatin in squamous NSCLC. (Sub-category: Metastatic Lung Cancer. Category: Lung Cancer--Metastatic Lung Cancer)

Citation: J Clin Oncol 26: 2008 (May 20 suppl; abstr 8015)

Author(s): D. D. Karp, L. G. Paz-Ares, S. Novello, P. Haluska, L. Garland, F. Cardenal, L. J. Blakely, P. D. Eisenberg, A. Gualberto, C. J. Langer

Background: CP-751,871 is a fully human, IgG2 monoclonal antibody against the Insulin-like Growth Factor type I Receptor (IGF-IR). We reported (ASCO 2007) a preliminary 46% Objective Response Rate (ORR) for the combination of CP-751,871 (I) with Paclitaxel (T) and Carboplatin © in 73 patients (pts) with advanced treatment-naïve NSCLC and performance status 0-1 enrolled in a multi-center phase 2 non-comparative study of TCI and TC with a primary endpoint of ORR by RECIST. The statistical hypotheses were 28% (null) versus 40% (response of interest).

Methods: An additional 108 pts have been enrolled. Pts were randomized (2:1) to T (200 mg/m2), C (AUC of 6) and I (10 or 20 mg/kg), or TC alone every 3 weeks for up to 6 cycles; pts receiving TCI with response (PR) or stable disease were eligible to continue I as single agent until disease progression following discontinuation of chemotherapy. Pts progressing on TC alone were eligible to receive I as single agent or in combination with TC at the judgment of the investigator.

Results: Safety and efficacy information are available for 178 and 143 pts, respectively (70% male, 45% > 65 years old, 82% stage IV, 49% adenocarcinoma, 20% squamous cell carcinoma). Median number of treatment cycles was 4, with 24.6% of pts receiving single agent I beyond cycle 6. TCI was well tolerated. All causality grade 3,4 toxicity included (TCI, TC): hyperglycemia (11%, 4%), fatigue (9%, 7%), and neutropenia (14%, 14%). Forty-three of 85 pts receiving TCI (51%, p<0.001) and 21 of 58 pts (36%) on TC alone had objective responses. Of note, 13 of 18 TCI pts (72%, p<0.001) with squamous cell carcinoma responded to treatment, including 6 striking responses in pts with bulky disease, 2 pts with no further evidence of disease and a reversal of a superior vena cava obstruction. Five of 12 squamous pts (42%) responded to TC alone. Clinical benefit (PR/SD) was also observed in 3 squamous TC pts receiving I upon progression on TC alone. At present, only 38% of pts on study have progressed. Hazard ratio for progression free survival is 1.18 in favor of TCI.

Conclusions: CP-751,871 appears safe and effective in combination with TC. The primary efficacy endpoint (ORR) has been met. Activity observed in squamous cell carcinoma deserves further investigation.

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