When overall response does not translate into clinical benefit (TTP and survival), but there is some pts who will benefit. Take that currently they do not have ANY option, maybe Rubi will become one?
Press Release Source: SuperGen Inc.
SuperGen Reports Results of Phase III Study of Orathecin(TM) In Patients With Advanced Pancreatic Cancer
Friday May 30, 5:06 pm ET
Responses noted in highly refractory patients
DUBLIN, Calif., May 30 /PRNewswire-FirstCall/ -- SuperGen Inc. (Nasdaq: SUPG - News) today reported results in the company's Phase III clinical study of Orathecin(TM) (rubitecan) capsules, an investigational oral, topoisomerase I-inhibiting chemotherapeutic compound, as a treatment for refractory or resistant pancreatic cancer. The study randomized 409 patients, most of whom had previously failed two or more chemotherapies, to Orathecin or 'best choice'. Approximately ninety percent of patients in the 'best choice' group received a chemotherapeutic agent such as gemcitabine, 5-FU, mitomycin C, capecitabine, or docetaxel. The primary study end-point was overall survival with secondary end-points of tumor response and time to disease progression.
The results of this Orathecin study were presented at a satellite symposium entitled, "Evolving Strategies -- Management of Pancreatic Cancer," by Dr. Howard Burris, Director of Drug Development at the Sarah Cannon Cancer Center in Nashville, Tenn. The symposium -- chaired by Dr. Daniel Haller, Professor of Medicine at the University of Pennsylvania School of Medicine, underwritten by SuperGen through an unrestricted educational grant and reviewed and approved by the American Society of Clinical Oncology (ASCO) -- was held in Chicago one day prior to the opening of ASCO's 39th Annual Meeting.
Dr. Burris highlighted several clinical findings:
-- Seven percent (13/196) of patients randomized to Orathecin experienced
either a complete or partial tumor response (shrinkage of tumor by 50%
or more), versus less than 1 percent (1/211) for patients receiving
'best choice'. This finding is statistically significant and
independently verified.
-- Median time to disease progression was 57 days for patients receiving
Orathecin, versus 47 days for patients receiving 'best choice'. This
finding is statistically significant.
-- Median survival time for patients receiving Orathecin was 108 days
versus 93 days for patients receiving 'best choice'. This difference in
the primary end-point was numerically superior but not statistically
significant. The results were confounded by the fact that approximately
half of the patients randomized to the 'best choice' treatment received
Orathecin when they failed 'best choice'. As a result of this 'rescue
therapy', 74 percent (302/409) of all patients received Orathecin.
-- Among the 13 patients receiving Orathecin who experienced a complete or
partial response, the median survival time was 336 days, and the median
time to disease progression was 246 days.
Dr. Burris also presented an overview of the observed toxicities, which were generally manageable for patients with advanced stage pancreatic cancer. Less that 5 percent of patients in either arm discontinued therapy for drug related toxicity. Severe or most frequent adverse events with an incidence greater than 5 percent in patients who received Orathecin versus the 'best choice' included: asthenia (20% vs. 18%), abdominal pain (17% vs. 12%), pain (5% vs. 6%), sepsis (5% vs. 7%), deep thrombophlebitis (5% vs. 5%), nausea (14% vs. 9%), anorexia (6% vs. 10%), diarrhea (9% vs. 5%), vomiting (12% vs. 8%), leucopenia (22% vs. 13%), anemia (16% vs. 9%), thrombocytopenia (9% vs. 10%), dehydration (15% vs. 12%), bilirubinemia (7% vs. 2%) and dyspnea (8% vs. 6%), respectively.
"There are currently no approved treatments for refractory pancreatic cancer patients in the third-line setting," said Dr. Burris. "The patients enrolled in this study were very ill and had few viable treatment options. Any compound that demonstrates an impact in time to tumor progression and objective response is an important finding for patients.
"As these data indicate, Orathecin will not help everyone," added Dr. Burris. "However, in those who do respond, there is an improvement in survival approaching one year."
"We are actively finalizing the third and last section of our New Drug Application for the FDA, which should be completed shortly," said Dr. Joseph Rubinfeld, Chairman and Chief Executive Officer of SuperGen.
"Refractory or resistant pancreatic cancer patients currently have no therapeutic alternatives. The results from the Phase III study indicate that Orathecin may be of clinical benefit to this disadvantaged patient population, especially given its oral administration," added Dr. David Alberts, Director, Cancer Prevention and Control at the Arizona Cancer Center (University of Arizona) and Chairman of the Scientific Advisory Board of the Pancreatic Cancer Action Network (PanCAN). "Pancreatic cancer is perhaps the most feared of all cancers, with patients having an average life expectancy after diagnosis of only three-to-six months." |
