ASCO '12 Abstract Dump: Cancer Stocks in Focus

What's new in the ASCO abstract: The response data are little changed from the December update because the ASCO abstract (No. 6053) was submitted in January, reflecting a median 6.6 months of follow up. The overall major cytogenic response for CML patients is 49% (higher than in December.) In the T315I subgroup, the response rate is 62% (lower than in December.)

A significant update of results from the PACE study will be presented at ASCO, with six-month follow-up data on all patients available.

Arqule

What we know already: Top-line data from a phase II study of tivantinib in second-line liver cancer were released in January. Liver cancer patients who progressed after first-line therapy were randomized 2:1 to receive tivantinib or a placebo. The study met its primary endpoint with tivantinib demonstrating a 56% improvement in time to tumor regrowth (time to progression, or TTP) compared to the placebo.

What's new in the ASCO abstract: In the overall patient population, tivantinib-treated patients reported a median time to progression of 1.6 months compared to 1.4 months for placebo patients. The small difference was statistically significant with a p value of 0.04. (Abstract No. 6503)

In a subset of patients who over-expressed c-Met, the molecular target of tivantinib, median TTP was 2.9 months for drug versus 1.5 months for placebo -- a statistically significant benefit. In this same patient subgroup, progression-free survival was 2.4 months for tivantinib compared to 1.5 months for placebo -- statistically significant.

A preliminary overall survival analysis trends in tivantinib's favor but is not yet statistically significant. Placebo patients were allowed to cross over and receive tivantinib when their tumors started to grow again.

Tivantinib dose was reduced mid-study due to reports of low blood cell counts in some patients. This helped reduce the rate of neutropenia from 21% to 6%. The most frequent drug-related serious adverse event was neutropenic sepsis (4.2%).

Other notes: Arqule and partner Daiichi Sankyo are conducting a phase III study of tivantinib in non-small cell lung cancer, with an interim analysis expected in the fourth quarter. A phase II study of tivantinib in colon cancer is also ongoing with results possible by year-end or in early 2013.

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