May 18, 2011

ASCO Abstracts out

INCYTE Corporation - a small molecule cancer drug research company - has four abstracts in ASCO 2011. (link)
Incyte has collaborative agreements with Pfizer PFE, Eli Lilly LLY and Novartis NVS.
The abstract of highest current interest is the one on which Incyte is working with Novartis. (a Phase III trial).

Supergen has two abstracts.. I was kinda surprised (link) and phase I clinical study of an oral inhibitor
Ok, more information will be added during the evening. Have to do AH trading now..ciao

Vical has posted a very clear abstract on what they have done/found/plan to do.

Background: Allovectin is a plasmid-based immunotherapy expressing HLA-B7 and β2 microglobulin genes designed to stimulate both local and systemic anti-tumor responses. In a phase II single-arm study, VCL-1005-208 (2 mg, intralesional injection in 127 subjects), overall response rate (ORR) was 11.8% and median overall survival (OS) was 18.8 months. Median duration of response was 13.8 months and all responses were durable (> 6 months). A subsequent phase III trial (LX01-315) recently completed enrollment of 390 pts in more than 90 sites in 15 countries. Subjects in phase II with characteristics corresponding to those in this phase III study (chemonaïve with a single lesion injected) had an ORR that was 17% and median OS was 22.5 months. Methods: A time-dependent covariate (TDC) analysis with the Cox proportional hazards model (SAS/STAT PROC PHREG) was used to evaluate the relationship between a time-varying covariate (responder status) to survival in the phase II study. The Cox model analysis combines these results across times (one time point per death) to yield a single p-value for the prognostic significance of responder status. Results: In our analysis of the VCL-1005-208 data, each patient had a single covariate, responder status that permanently switched from 1 to 0 when a non-responder became a responder. The single covariate approach tested the hypothesis that responder status predicted survival. The resulting hazard ratio for the TDC was 4.13 (95% CI: 1.67-10.25, score test p-value=0.002), which is relatively large and highly significant. A simpler analysis, using responder status as if it were a baseline covariate, gave a hazard ratio of 4.82 (95% CI 1.95-11.89, p-value<0.001). The TDC analysis indicates that in a small, open-label phase II trial, responder status strongly predicted survival. Analysis of two other trials (using 10 mcg DNA), VCL-1005-205 (phase II) and VCL-1005-301 (phase III), showed similar results. Conclusions: In three Allovectin melanoma trials, response was a strongly significant predictor of survival and may serve as a marker of clinical benefit for this novel class of cancer immunotherapeutic agents.

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