Axitinib Shows Trend Toward Prolonged Overall Survival In Advanced Pancreatic Cancer When Combined With Standard Of Care Chemotherapy
July 3, 2007 – 1:07 pm | posted in Cancer / Oncology, GastroIntestinalAxitinib (AG-013736), an investigational oral, selective inhibitor of VEGFR 1, 2, 3 (vascular endothelial growth factor receptors 1, 2, 3) combined with gemcitabine showed a trend towards prolonged overall survival (OS) in patients with advanced pancreatic cancer, compared with gemcitabine alone, according to interim data from a randomized Phase II trial being presented this week at the 9th World Congress on Gastrointestinal Cancer (WCGC).
“Pancreatic cancer continues to be one of the most life-threatening and difficult-to-treat solid tumors,” said lead study investigator Jean-Philippe Spano, MD, PhD, Hopital La Piti-Salpetriere. “Seeing an agent with this level of activity and tolerability at this stage in development is encouraging news for patients. These findings suggest that axitinib has anti-tumor activity in advanced pancreatic cancer and provide the basis for a Phase III program to further evaluate the potential benefits of this agent in pancreatic cancer patients.”
About the Study
In the Phase II study, 103 previously untreated patients with advanced pancreatic cancer were randomized (2:1) to receive axitinib in combination with gemcitabine (AG + GEM)or gemcitabine alone (GEM). The primary endpoint of the study was to determine the overall survival of patients who received AG + GEM compared to those who received GEM. Secondary endpoints included objective response rate, progression-free survival and the safety of AG + GEM.
Interim results of the Phase II study showed median overall survival with axitinib plus gemcitibine of 6.9 months compared with 5.6 months with gemcitabine alone. AG + GEM reduced the risk of death by 26 percent compared with GEM (hazard ratio = 0.74; CI 0.427 - 1.284). Additionally, in the subset of 94 patients with better performance status (ECOG PS 0 or 1), AG + GEM reduced the risk of death by 33% (hazard ratio of 0.67) compared to GEM alone.
Additional study findings include: (UPDATE BASED ON INTERIM DATA]
– AG + GEM prolonged progression free survival (PFS) compared with GEM (median 130 days vs. 113 days).
– Objective response was observed in 7 percent of patients receiving AG + GEM compared with 0 percent taking GEM.
– Eighteen percent of patients in the GEM arm experienced a best response of progressive disease compared with only 10 percent in the AG + GEM arm.
– AG + GEM can be combined at 5mg and 1000 mg/m2, respectively. The most common adverse events among both treatment arms were diarrhea, fatigue, nausea and vomiting.
Based on the results of this study, a randomized, double-blind Phase III study is planned to evaluate axitinib in combination with gemcitabine compared with gemcitabine plus placebo in previously untreated patients with advanced pancreatic cancer. The primary endpoint is overall survival.
About Axitinib
Axitinib is an oral, selective inhibitor of VEGFR 1, 2, 3 (vascular endothelial growth factor receptors 1, 2, 3), which has been shown to induce tumor regression as a single-agent and in combination with chemotherapy. Inhibiting VEGF binding plays a key role in anti-angiogenesis - or blocking blood vessel formation which starves tumors of the blood and nutrients needed for growth.
Axitinib is an investigational agent and has not yet been approved by the U.S. Food and Drug Administration or other global regulatory agencies.
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