Point Therapeutics: Research shows talabostat shrinks tumors in lung cancer patients

By E. Janene Geiss

Philadelphia, Nov. 16 - Point Therapeutics, Inc. said results from the company's phase 2 study of talabostat in combination with docetaxel in patients with advanced non-small cell lung cancer showed a positive clinical response to treatment.

The trial enrolled 55 patients, 42 of whom met evaluability criteria for response. Five patients demonstrated clinical response to treatment, as defined by a 50% or greater reduction in tumor size, for a response rate of 11.9%. Two of these patients had a complete response, defined as complete disappearance of the tumor. The first complete responder was observed in March 2005 and the second was in April 2005. Both continue to be in complete response, according to a company news release.

The current Kaplan-Meier estimate of median progression-free survival is 4.2 months and median survival is estimated at 8.4 months. To date, the one-year survival rate is 48% for the 31 patients who have been in the study for at least one year, officials said.

The objective response rate, progression-free survival, median survival and one-year survival rates compare favorably to the historical docetaxel data from three randomized, independent phase 3 clinical trials. In these historical trials, about 96% of all patients had failed only a first-line treatment while 4% had failed both first- and second-line treatment.

By contrast, in the talabostat/docetaxel combination trial, 64% of patients had failed first-line treatment while 36% had failed both first- and second-line treatment.

Additionally, about 75% of the patients in the talabostat study had received a prior platinum-based combination treatment with either docetaxel or another taxane, officials said.

"It is important to note that of the five responders, two had a complete response, which is very unusual and quite significant in a second- or third-line setting in advanced non-small cell lung cancer. We also saw a clinically meaningful increase in progression-free survival, which is the primary clinical endpoint for regulatory approval in talabostat's phase 3 non-small cell lung cancer trials," said Dr. Casey Cunningham, an oncologist at Mary Crowley Medical Research Center in Dallas and a member of Point's Clinical Advisory Board.

The research was presented Wednesday at the AACR-EORTC-NCI International Conference on Molecular Targets and Cancer Therapeutics in Philadelphia.

Point is a Boston-based biopharmaceutical company developing a family of dipeptidly peptidase inhibitors for use in cancer, type 2 diabetes and as vaccine adjuvants.

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