GTx, Inc. (NASDAQ: GTXI) announced today in a Phase IIb clinical trial evaluating Ostarine™ (GTx-024), a selective androgen receptor modulator, for the treatment of muscle wasting in patients with cancer, Ostarine™ treatment improved physical function and overcame the negative prognostic effect of severe weight loss on overall survival in patients with non-small cell lung cancer.
These additional study results from GTx's Phase IIb clinical trial will be presented June 4th and 5th in Chicago at the Annual Meeting of the American Society of Clinical Oncology.
"Non-small cell lung cancer patients with severe muscle loss have poorer treatment outcomes and shorter overall survival," said Mitchell S. Steiner, MD, CEO of GTx. "This wasting and associated decline in function may have detrimental consequences early in the course of a patient's malignancy, underscoring the importance of treating this condition at an early stage."
Abstract # 9022: Effect of GTx-024, a selective androgen receptor modulator (SARM), on physical function in patients with non-small cell lung cancer (NSCLC) with cancer cachexia.
Location: Room S102, Poster Board 6
Time: June 5th, 8 - 12 p.m.
Moderated poster discussion: 11:30 - 12:30 in room S100BC
Lead Author: Steiner, M
In the Phase IIb Ostarine™ clinical trial evaluating 159 cancer patients with either non-small cell lung cancer (NSCLC), colorectal cancer, breast cancer, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia, physical function was evaluated by the Stair Climb Test as a key secondary endpoint. A subsequent analysis defined clinical benefit as a 10% improvement in stair climb power. Among the 61 patients with NSCLC enrolled in the study, 28 had stair climb power assessed at baseline and again at the conclusion of the study at 16 weeks. Seventy-eight percent (78%) of these patients who were treated with Ostarine™ demonstrated clinical benefit, as compared to 30% of the patients receiving placebo (p=0.02).
Abstract # 9117: The impact of less than 8% weight loss on overall survival in subjects with non-small cell lung cancer (NSCLC) treated in a Phase IIb trial of GTx-024.
Location: Hall A, Poster Board 51D
Time: June 4th, 2 - 6 p.m.
Lead Author: Dodson, S
The Phase IIb Ostarine™ clinical trial enrolled 159 patients with non-small cell lung cancer (NSCLC), colorectal cancer, breast cancer, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia. Among the entire study population receiving placebo, overall survival was significantly reduced in patients with >8% weight loss at baseline compared to patients with ≤8% weight loss (P=0.003, log rank). In the same analysis of the 61 patients with NSCLC, patients receiving placebo with >8% weight loss at baseline demonstrated a similar survival disadvantage when compared to patients with ≤8% baseline weight loss (P=0.04), with 4 month Kaplan-Meier estimates 100% vs 49% ±14.8%. Ostarine™ treatment overcame the negative prognostic effect of severe baseline weight loss. In both the overall study population and in the NSCLC patient group, there was no difference in overall survival between Ostarine™ treated patients with >8% weight loss at baseline compared to Ostarine™ treated patients with ≤8% weight loss.
About Ostarine™
Ostarine™ is a selective androgen receptor modulator that GTx is developing for the prevention and treatment of muscle wasting, a cancer related symptom. Muscle loss is an independent predictor of performance status, tolerability to cancer treatment, progression free survival and overall survival.
To date, GTx has evaluated Ostarine™ in eight clinical trials involving approximately 600 subjects including three efficacy studies. In the third quarter of 2011, GTx expects to initiate two pivotal Phase III clinical trials evaluating Ostarine™ for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.
Source:
GTx, Inc.