Bristol-Myers Squibb Company BMY today announced results from a pooled
analysis of survival data for 12 studies (n=1,861) in patients with metastatic
or locally advanced or unresectable melanoma who were treated with Yervoy^®
(ipilimumab) at different doses and regimens. A plateau in the survival curve
begins at approximately three years, with follow-up of up to ten years in some
patients. Approximately 22% of patients were alive at three years. The data
will be presented at the 2013 European Cancer Congress on September 28 at 1:00
p.m. CEST and were highlighted at a Congress press briefing (Abstract # 24LBA,
“Pooled analysis of long-term survival data from Phase 2 and Phase 3 trials of
ipilimumab in metastatic or locally advanced, unresectable melanoma”).
Safety data were not included in this analysis. However, safety data from
these individual studies have been reported. Overall, the types of adverse
events (AEs) attributed to Yervoy are generally mechanism
(immune)-based. Yervoy can result in severe and fatal immune-related adverse
reactions due to T-cell activation and proliferation. In these clinical
trials, adverse events associated with Yervoy were managed with
protocol-specific guidelines, including the administration of systemic
corticosteroids, dose interruption/discontinuation and/or other
immunosuppressants.
“This pooled analysis reinforces the long-term survival data seen in the
individual studies and provides additional insight into the overall survival
of metastatic melanoma patients treated with Yervoy,” said Brian Daniels,
senior vice president, Global Development and Medical Affairs. “The durability
and consistency of long-term survival observed in this analysis is encouraging
as we continue to advance the research and development of our immuno-oncology
portfolio.”
“In this analysis, approximately 26% of treatment-naïve and 20% of
previously-treated patients were alive at three years after being treated with
an ipilimumab regimen,” said F. Stephen Hodi, M.D., Department of Medicine,
Harvard Medical School, Dana-Farber Cancer Institute. “This pooled analysis is
encouraging, particularly when considering that metastatic melanoma is one of
the most aggressive forms of cancer and historically, average survival was
just six to nine months.”
About The Analysis
This pooled analysis was conducted to provide a more precise estimate of the
long-term survival effect of Yervoy in patients with metastatic melanoma. It
is comprised of patient-level data from 12 prospective and retrospective
studies, including two Phase 3 trials (n=790), eight Phase 2 trials (n=821),
and two retrospective, observational studies (n=250), which have been or will
be reported on as individual studies. Three studies included overall survival
follow-up in some patients for up to ten years.
The analysis included both previously-treated (n=1,257) and previously
untreated patients (n=604) who received Yervoy at different doses and
regimens. The majority of patients received Yervoy 3 mg/kg (n=965) or 10 mg/kg
(n=706). Yervoy was given every 3 weeks for 4 doses, and most studies included
the option to receive either Yervoy retreatment or Yervoy maintenance therapy
for eligible patients.
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