Genentech, Inc. (NYSE:DNA) and OSI Pharmaceuticals, Inc. (Nasdaq:OSIP)
today announced that a randomized Phase III study (BeTa Lung) evaluating
Avastin®
(bevacizumab) in combination with Tarceva®
(erlotinib) in patients with advanced non-small cell lung cancer (NSCLC)
whose disease had progressed following platinum-based chemotherapy did
not meet its primary endpoint of improving overall survival compared to
Tarceva in combination with placebo. However, there was clear evidence
of clinical activity with improvements in the secondary endpoints of
progression-free survival (PFS) and response rate when Avastin was added
to Tarceva compared to Tarceva alone in this study.
Median survival was similar in both arms of BeTa Lung. No new or
unexpected safety signals for either Avastin or Tarceva were observed in
the study, and adverse events were consistent with those observed in
previous NSCLC clinical trials evaluating the agents. The companies are
further analyzing the study results and will submit the data for
presentation at the 2008 Chicago Multidisciplinary Symposium in Thoracic
Oncology in Chicago, Ill., November 13-15.
“We are disappointed this study did not show
an improvement in survival for patients with advanced lung cancer who
have a poor prognosis and a disease that is extremely difficult to
treat. We are, however, encouraged to see the combination of Avastin and
Tarceva had clear evidence of biological activity, and will fully
analyze the data so that we can apply the insights to our ongoing lung
cancer research,” said Hal Barron, M.D.,
Genentech’s senior vice president, Development
and chief medical officer. “The results of
this study do not affect Avastin or Tarceva’s
approved indications in advanced non-small cell lung cancer.”
Avastin is currently approved as first-line treatment in combination
with carboplatin and paclitaxel chemotherapy for patients with locally
advanced, non-squamous, NSCLC based on a 25 percent improvement in
overall survival compared to chemotherapy alone (hazard ratio 0.80).
Tarceva is currently approved as a treatment for patients with advanced
NSCLC who have progressed following treatment with at least one prior
chemotherapy regimen, based on a 37 percent improvement in overall
survival compared to placebo (hazard ratio 0.73).
“The data from this study continue to support
the role of Tarceva as an important treatment option for advanced lung
cancer patients,” said Gabriel Leung,
President, OSI Oncology. “Median survival in
the Tarceva and placebo group in this second-line study was 9.2 months.
As expected, this exceeded the median survival of 6.7 months seen in the
Tarceva registration study, BR.21, that included patients treated in
both the second- and third-line settings. We look forward to results of
SATURN, a Phase III trial evaluating single-agent Tarceva as a
first-line maintenance therapy in NSCLC patients whose disease has not
progressed following treatment with chemotherapy.”
A second study (ATLAS) is evaluating the combination of Avastin and
Tarceva as a potential first-line maintenance therapy for advanced
non-small cell lung cancer patients whose disease has not progressed
following initial treatment with Avastin in combination with
chemotherapy. Results are expected in the first half of 2009.
About BeTa Lung
BeTa Lung is a global, multicenter, placebo-controlled, randomized,
double-blinded Phase III study that enrolled 636 patients with advanced
NSCLC. Patients must have experienced disease progression during or
following first-line standard chemotherapy or chemoradiotherapy.
