OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) today announced further results
from the Phase III SATURN study showing that Tarceva® (erlotinib)
extended the survival of patients with advanced non-small cell lung
cancer (NSCLC) when used as single agent, maintenance therapy in
patients who did not progress following first-line treatment with
platinum-based chemotherapy. As previously announced, the safety results
in this study were consistent with what has been seen previously and
there were no new or unexpected safety signals. Overall survival was a
key secondary endpoint of the study and these new data were presented
today at the 13th World Conference on Lung Cancer being held
in San Francisco.
“Based on the data presented today, Tarceva is the first oral cancer
therapy to show a survival benefit in the first-line maintenance NSCLC
setting. Assuming approval, when used immediately after chemotherapy,
Tarceva will provide a new, convenient, non-chemotherapy treatment
option for patients - allowing doctors to continue treating a patient’s
disease without exposing them to the continuous burden and lifestyle
constraints of long-term chemotherapy," stated Gabe Leung, President,
Pharmaceutical Business of OSI Pharmaceuticals.
The study showed that patients with NSCLC treated with Tarceva had a 23
percent improvement in overall survival compared with patients who
received placebo (hazard ratio=0.81; p-value=0.0088). The hazard ratio,
which assesses risk in the overall trial population, is widely
recognized as the best measure of overall benefit in large randomized
clinical trials. A hazard ratio of less than one for survival indicates
a reduced risk of death. The median survival (a single point estimate of
benefit) for patients receiving Tarceva was 12 months versus a median
survival of 11 months for patients receiving placebo.
The study confirmed that a broad spectrum of patients with advanced
NSCLC experienced a survival benefit from Tarceva. Specific analysis of
patients in the study whose tumors were confirmed not to have genetic
mutations in their epidermal growth factor receptor (EGFR “wild-type”)
showed that this group experienced a 30 percent improvement in survival
(hazard ratio = 0.77; p-value = 0.0243). The majority of patients with
NSCLC are EGFR wild-type. Full data analysis for various sub-groups is
still on-going. However, available data also showed that the hazard
ratio for overall survival in patients with tumors expressing the EGFR
gene by Immunohistochemistry (IHC) was also 0.77 (p-value = 0.0063).
As presented previously, the hazard ratio for progression-free survival
(the time patients live without their disease worsening) in patients
with EGFR mutations was 0.10 (p-value <0.0001). Overall survival for
this patient sub-group is still immature with the median survival not
yet being reached in patients with EGFR mutations receiving Tarceva.
Determination of the overall survival benefit in this sub-group was
further confounded by the fact that two-thirds of the patients with EGFR
mutations who received placebo crossed over to receive Tarceva or
another EGFR therapy. An ongoing Phase III trial evaluating how Tarceva
compared to traditional chemotherapy for first-line treatment in
patients whose tumors had an EGFR mutation is expected to provide more
insight.
