R & D Oncology Day
GlaxoSmithKline PLC
30 November 2005
Issued - Wednesday 30th November 2005
GlaxoSmithKline Presents Rapidly Expanding Pipeline Of Oncology
And Supportive Care Compounds
Philadelphia, PA, London, UK, November 30, 2005 - GlaxoSmithKline plc (NYSE:GSK)
today updated investors and financial analysts in New York on the Company's
rapidly expanding pipeline featuring innovative science that addresses a broad
range of patient needs for cancer prevention, treatment and supportive care.
Seminar Highlights
• GSK's substantial oncology and supportive care portfolio includes New Chemical Entities (NCEs), product
line extensions (PLEs) and oncology-related vaccines. Four NCEs highlighted in this seminar are expected to be in
phase III development in 2006: Tykerb (lapatinib), eltrombopag ('115), casopitant ('769), and pazopanib ('034).
• Tykerb - A targeted oral therapy with the potential to become an essential component in the treatment of
breast cancer:
o Latest data demonstrate promise as first-line treatment for advanced breast cancer, with 40% of
patients experiencing clinical benefit including tumor reduction or stable disease for at least 24
weeks.
o Tykerb's clinical program has been expanded:
• three new phase III trials are being initiated by January 2006, two in first-line therapy and
one in refractory breast cancer
• large phase II trial in the treatment of brain metastases associated with breast cancer started
in November 2005
• in mid-November, the Breast International Group and GSK agreed to collaborate on a large global
clinical trial to evaluate Tykerb as adjuvant therapy in early-stage breast cancer.
• Eltrombopag - New clinical data demonstrate the potential for eltrombopag to become the first oral platelet
growth factor for patients suffering from thrombocytopenia, a condition which can lead to uncontrolled bleeding,
significantly reduced life expectancy and compromised treatment for cancer or liver disease.
• Casopitant - New clinical data demonstrate the potential for casopitant when combined with Zofran as a new
and improved therapy for the prevention of nausea and vomiting associated with chemotherapy and after surgery.
• Pazopanib - Latest clinical data demonstrate prevention of tumor growth. Consequently an aggressive
clinical development program is expected to begin shortly in multiple cancer types including phase III trials in
renal cancer.
• Other GSK oncology assets highlighted at the seminar include Arranon for T-cell acute lymphoblastic
leukemia and lymphoma (launch in Q106), new indications for Hycamtin in relapsed cervical and relapsed small cell
lung cancer (filing Q405/2006), Avodart for reducing the risk of prostate cancer (phase III) and relacatib ('795) a
cathepsin-K inhibitor for the prevention and treatment of bone metastases (entering phase II in 2006).
"Today's seminar clearly shows the progress GSK has made in building its
oncology pipeline," said Tachi Yamada, GSK's Chairman of Research & Development.
"From modest beginnings, we now have a pipeline which is one of the largest in
our industry with seven major assets expected to be in phase III development in
the coming months, including the four NCEs highlighted today."
"Cancer remains an area of substantial unmet medical need. Our strategy is
focused on meeting all aspects of a cancer patient's treatment - from control,
reduction and prevention of tumors to novel medicines that will improve
supportive care for patients undergoing chemotherapy."
Paolo Paoletti, Senior Vice President of GSK's Oncology Medicine Development
Center, commented: "GSK is pursuing therapies targeting cancer at a molecular
level in order to block biochemical pathways that transform normal, healthy
human cells into cancer cells. We are particularly excited that the promising
efficacy of Tykerb, our targeted dual-kinase inhibitor, has led to support among
leading cancer experts for the initiation next year of a large study of Tykerb
in the treatment of early stage breast cancer."
Allen Oliff, Senior Vice President of GSK's Oncology Center for Excellence in
Drug Discovery, said: "We are very encouraged by the recent clinical data on
eltrombopag. This product clearly has the potential to be a significant advance
in the treatment of thrombocytopenia, a condition which has few therapeutic
options and can lead to sub-optimal treatment for patients suffering from a
number of conditions including cancer and liver disease."
Compounds reviewed at today's seminar include:
• Tykerb - a targeted oral therapy with the potential to become an
essential component in the treatment of breast cancer
World-wide, 400,000 women die each year as a result of breast cancer, and its
prevalence is increasing with approximately 1.5 million new cases diagnosed
every year. Tykerb, a dual-kinase inhibitor, is an oral once-daily treatment
currently being developed for breast cancer and other tumors. It works by
inhibiting two well-validated targets in oncology, the kinase components of
ErbB1 (EGFR) and ErbB2 receptors, which are associated with cancer-cell
proliferation and tumor growth.
Data presented at today's seminar, and at the recent European Cancer Conference
(ECCO) in Paris, illustrate the promising efficacy and safety profile of Tykerb.
Interim results from an international phase II trial of Tykerb as first-line
therapy in 40 patients with advanced or metastatic breast cancer (with ErbB2
overexpression) showed that 33% of patients had tumor reductions, with 40% of
patients experiencing clinical benefit (tumor reduction or stable disease for at
least 24 weeks). A further update will be presented at the San Antonio Breast
Cancer Symposium on 8th December.
Tykerb has also shown preliminary activity in the treatment of brain metastases,
which represents a significant unmet medical need for breast cancer patients.
Results were recently analyzed from a 416 patient phase II/III clinical trial in
the treatment of renal cancer. While the primary end-point was not met in the
full population, a preliminary analysis of the sub-group of 241 patients with
over-expression of EGFR demonstrated a statistically significant survival
benefit for patients receiving Tykerb. This data is expected to be presented at
ASCO in 2006.
In the 3,500 patients who are part of its clinical development program, Tykerb
to date has shown a low incidence of cardiotoxicity, a condition associated with
some breast cancer treatments. The most frequently reported adverse events
associated with Tykerb have been mild to moderate itching, rash, diarrhea, acne,
and dry skin.
Tykerb's clinical program has been expanded, with three new phase III trials
being initiated by January 2006, two in first-line therapy and one in refractory
breast cancer. A large phase II trial in the treatment of brain metastases
associated with breast cancer started in November 2005. In mid-November, GSK and
the Breast International Group - one of the world's premier cancer research
groups - agreed to collaborate on a large-scale global clinical trial to
evaluate Tykerb as adjuvant therapy in early-stage breast cancer.
GSK expects to file Tykerb for US Food and Drug Administration (FDA) approval at
the end of 2006 or in the first half of 2007.
• Eltrombopag ('115) demonstrates potential to become the first oral blood
platelet growth factor for patients suffering from thrombocytopenia
Eltrombopag is an orally administered small molecule that interacts with the
receptor for thrombopoietin (TPO), a protein in the body that is the primary
growth factor responsible for the production of blood platelets. By stimulating
the TPO receptor on megakaryocytes, eltrombopag increases the production of
platelets to help treat patients with thrombocytopenia (decreased platelet
count). As platelets are critically important in the first step of hemostasis,
patients with thrombocytopenia are at significant risk of uncontrolled bleeding.
Thrombocytopenia is prevalent in patients with many conditions such as those
with the autoimmune disease idiopathic thrombocytopenia purpura (ITP), cancer
patients being treated with chemotherapy, and patients suffering from liver
disease, including hepatitis C (HCV). In the case of cancer and HCV,
thrombocytopenia often becomes a complication that compromises therapy. In the
US alone there are approximately one to two million patients who suffer from
clinically significant thrombocytopenia each year. GSK is conducting clinical
trials with eltrombopag in a variety of these patient populations.
Most patients with ITP are treated with one of a number of 'broad' therapies
including steroids, intravenous immunoglobulin, splenectomy or platelet
transfusions which can be invasive or have unpleasant side effects. Patients
with CIT are managed by chemotherapy dose delays, dose reductions or platelet
transfusions. Consequently, eltrombopag has the potential to provide, in a
convenient oral formulation, a major advance for patients suffering from
thrombocytopenia.
Today the company presented data from a phase II dose-ranging clinical trial
that showed eltrombopag significantly raised platelet counts in adult patients
suffering from chronic ITP who had failed at least one prior therapy. In the
trial, eltrombopag produced significant response rates in 66% of patients
receiving the 50mg dose, and in 87% of patients receiving the 75mg dose,
compared to 13% receiving placebo. The frequency of side effects was comparable
between patients treated with placebo and those treated with eltrombopag.
An interim analysis of phase II data also showed an encouraging platelet
response in hepatitis C patients. A full analysis will be available during the
first half of 2006.
Current treatment options for thrombocytopenia, including immunosuppressive
agents, interleukins and blood platelet transfusions, have safety and efficacy
issues that limit their use. As the first oral treatment to increase the
production of platelets, eltrombopag potentially represents a significant
breakthrough for patients. GSK expects to file for approval of eltrombopag in
its initial indication (ITP) by the end of 2006 or in 2007, depending on
discussions with regulatory authorities.
Eltrombopag has been developed in collaboration with Ligand Pharmaceuticals.
• New data with casopitant ('769), demonstrate enhanced benefit over
existing therapy in the treatment of emesis associated with chemotherapy and
surgery
NK-1 antagonist, casopitant, is an anti-emetic medicine currently being
developed by GSK to prevent both chemotherapy-induced nausea and vomiting (CINV)
and post-operative nausea and vomiting (PONV).
There are more than 5 million patient visits per year in the US and EU for
highly or moderately emetogenic chemotherapy. Although almost all of these
patients are treated with 5-HT3 antagonists such as Zofran, more than 40% still
suffer from episodes of nausea and vomiting. New data from two phase II
dose-ranging studies (approximately 1,200 patients combined), presented at
today's seminar, showed that the use of casopitant in combination with Zofran
and dexamathasone produced a complete response rate in up to 86% of patients
receiving highly emetogenic chemotherapy, and in up to 85% of patients receiving
moderately emetogenic chemotherapy. These response rates were both significantly
higher (43% and 21% respectively) than treatment with Zofran and dexamethasone.
Casopitant also demonstrated significant activity in the prevention of
post-operative nausea and vomiting, a problem experienced by up to 50% of high
to moderate risk patients despite prophylactic treatment with 5-HT3 antagonists.
In a 700 patient phase II dose ranging study, casopitant, in combination with
Zofran, demonstrated a complete response rate at 24 hours that was up to 48%
higher than treatment with Zofran alone.
Side effects of casopitant plus Zofran both in the CINV and PONV trials were
similar to those seen in the control group. The most frequently observed side
effects in the CINV studies were nausea, vomiting, constipation, fatigue and
asthenia, and in the PONV studies were headache and dizziness.
Casopitant is expected to enter phase III development for CINV and PONV in 2006
with regulatory filing for both indications scheduled during 2007.
• Potent new medicine, pazopanib ('034), prevents tumor growth in early
clinical trials
Cancer tumors require the formation of new blood vessels (angiogenesis) to grow
and spread. Vascular endothelial growth factor (VEGF) stimulates angiogenesis.
The once-daily oral treatment pazopanib, a small molecule, potentially inhibits
blood vessel formation, thereby preventing subsequent tumor growth.
Early clinical data has demonstrated that pazopanib has strong anti-cancer
activity. In a 63 patient phase I study, 100% (6/6) of patients with renal cell
carcinoma who received a therapeutic dose of pazopanib had a clinical benefit
(tumor reduction or stable disease). Tumor shrinkage and prolonged stable
disease was also observed in a number of other cancer types, including
gastrointestinal, neuroendocrine, lung, thyroid and sarcomas. The most commonly
reported adverse events with pazopanib were hypertension and fatigue. Based on
these positive results and the substantial base of scientific knowledge of VEGF
inhibitors, GSK is pursuing an aggressive clinical development program for
pazopanib with global phase III trials in renal-cell cancer expected to begin
shortly.
Furthermore, in vitro studies have suggested there is an additive effect when
pazopanib is used in combination with Tykerb. Phase II trials to assess the use
of this combination are scheduled to begin next year. Pazopanib will also be
assessed in combination with other cancer treatments, including cytotoxic
agents.
GSK Pipeline Update
In conjunction with today's seminar, GSK issued an updated pipeline chart.
Currently GSK has 146 projects in the clinic including 97 NCEs, 18 vaccines and
31 PLEs. Of the 97 NCEs, 11 are in phase III/registration, 45 in phase II and 41
in phase I. This represents a near doubling of the number of NCEs since the time
of the GSK merger in 2001.
The new pipeline report is available on www.gsk.com.
S M Bicknell
Company Secretary
30th November 2005
About GlaxoSmithKline
GSK, one of the world's leading research-based pharmaceutical and healthcare
companies, is committed to improving the quality of human life by enabling
people to do more, feel better and live longer.
Under the safe harbor provisions of the US Private Securities Litigation Reform
Act of 1995, the company cautions investors that any forward-looking statements
or projections made by the company, including those made in this Announcement
and the Meeting presentation materials to which it relates, are subject to risks
and uncertainties that may cause actual results to differ materially from those
projected. Factors that may affect the Group's operations are described under
'Risk Factors' in the Operating and Financial Review and Prospects in the
GlaxoSmithKline Annual Report on Form 20-F for 2004.
Without limiting the foregoing, this Announcement and the Meeting presentation
materials to which it relates contain forward-looking statements regarding
ongoing drug discovery and development activities, the progress of which depends
in significant part on factors not fully within the Group's control, including
but not limited to the pace of clinical trial enrollment, the nature of the
results of pending and prospective preclinical and clinical trials, the
resolution of any unusual difficulties with drug formulation or manufacturing,
the outcome of review by regulatory authorities, changes in the prevailing legal
/regulatory climate, and the like. The Group's current expectations and other
information included in this Announcement and the related Meeting presentation
materials reflect data currently in hand, which may be preliminary in nature,
whereas the ultimate progress of investigational drugs through remaining stages
of development to regulatory submission, regulatory approval, and
commercialization may differ materially, given inherent risks and uncertainties.
Arranon, Hycamtin, Avodart, Tykerb and Zofran are trademarks of the
GlaxoSmithKline Group of companies.
Inquiries:
US Media inquiries: Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2319
Patricia Seif (215) 751 7709
Gaile Renegar (919) 483 2319
UK Media inquiries: Philip Thomson (020) 8047 5502
David Mawdsley (020) 8047 5502
Chris Hunter-Ward (020) 8047 5502
Alice Hunt (020) 8047 5502
US Analyst/ Investor inquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
European Analyst/Investor inquiries: Duncan Learmouth (020) 8047 5540
Anita Kidgell (020) 8047 5542
Jen Hill (020) 8047 5543
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