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Jun 5 2006, 8:30 AM EST

New Data on Lung Cancer Trials with Targretin(R) is Presented at ASCO; Biomarker Data Analysis Supports Benefit in Subsets of Patients in 1st and 3rd Line NSCLC

News source: Business Wire

Ligand Pharmaceuticals Incorporated (Pink Sheets:LGND) (the "Company" or "Ligand") -- Results of retrospective analysis in large trials in first line NSCLC and final analysis of a 3rd line NSCLC trial were presented Sunday, June 4th at the annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta. Lung cancer data presented yesterday include:

-- A retrospective analysis of SPIRIT I and II phase III trials describing components of Metabolic Syndrome in patients benefiting from Targretin(R).

-- Biomarker identification and correlation with prolonged survival in a subset of NSCLC patients in SPIRIT I and II.

-- Final data analysis of a large phase II trial with Targretin monotherapy in 3rd line NSCLC.

-- A preclinical study on Targretin prevention or reversal of gemcitabine resistance in NSCLC.

"Collectively, the results presented at ASCO this year further strengthen, with the use of selective biomarker analysis, the potential benefit of Targretin therapy added to chemotherapy in a first line setting, or as monotherapy in third line, heavily pretreated patients, in an important group of NSCLC patients," said Andres Negro-Vilar, Executive Vice President, R&D and Chief Scientific Officer, Ligand Pharmaceuticals. "The identified patients in the subgroups most benefiting from Targretin (males, smokers, greater weight loss, stage IV disease) are among those with the poorest prognosis and have not been shown so far to derive benefit from other targeted therapies. Collectively, identification and characterization of a predictive biomarker in these studies has been instrumental to define a prospective pathway to confirm the utility and seek registration for Targretin capsules in first and third line NSCLC."

Retrospective analysis of SPIRIT I and II trials shows that baseline Metabolic Syndrome risk factors are associated with high sensitivity to Targretin and prolonged survival

A poster presented by lead author Z. Dziewanowska, Vice President, Clinical Research at Ligand Pharmaceuticals conducted a retrospective pooled analysis of 1,213 patients in SPIRIT I and II phase III trials to evaluate the presence of biomarker correlates of prolonged survival. High sensitivity to Targretin, as defined by high increases in triglycerides (34% of patients, N=194) resulted in a statistically significant (P=0.003) better median survival of 12.4 months vs. 9.5 months in the pooled chemo control group (N=618).

Further analysis of these subpopulations of high responders was conducted to identify their demographics and other baseline risk factors that may contribute to their different sensitivity to Targretin. Patients with particularly prolonged survival in this subgroup include males, smokers, stage IV disease and patients with greater weight loss prior to treatment, all risk factors associated with worst prognosis in NSCLC.

An evaluation of metabolic syndrome risk factors showed that the Targretin-sensitive subgroup showing better survival had at baseline a significant (p less than 0.001) cluster of risk factors associated with Metabolic Syndrome, i.e., greater body mass index, higher total cholesterol/HDL ratio, higher total cholesterol and triglycerides and higher uric acid, than either control group patients or those Targretin patients with no/low triglyceride elevations. All these parameters analyzed during treatment also showed similar statistical correlations (p less than 0.001) either individually or as part of a composite risk score analysis.

The report concludes that baseline and in-treatment triglycerides and key Metabolic Syndrome risk factors are important biomarker predictors of the beneficial survival impact of Targretin in first-line NSCLC.

Biomarker correlates of survival in NSCLC: Role of RXR-Beta and associated receptors in mediating Targretin i

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