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GlaxoSmithKline: Data from Tykerb investigational phase III studies 2010.12.11

London, UK and Philadelphia, USA - December 10, 2010 - Topline results were presented today from two Phase III studies examining the effect of Tykerb (lapatinib) in the neo-adjuvant setting of HER2-positive breast cancer. The combination of lapatinib and trastuzumab, with standard chemotherapy, was compared to standard chemotherapy plus either lapatinib or trastuzumab in a trial called NeoALTTO.

Courtesy of the American Association for Cancer Research / YouTube
 

London, UK and Philadelphia, USA - December 10, 2010

Data from Tykerb investigational phase III studies in neo-adjuvant HER2-positive breast cancer presented at breast cancer symposium


Topline results were presented today from two Phase III studies examining the effect of Tykerb (lapatinib) in the neo-adjuvant setting of HER2-positive breast cancer.

The combination of lapatinib and trastuzumab, with standard chemotherapy, was compared to standard chemotherapy plus either lapatinib or trastuzumab in a trial called NeoALTTO.

Courtesy of the American Association for Cancer Research / YouTube
 
In another trial, known as GeparQuinto, lapatinib plus standard chemotherapy was compared to trastuzumab plus standard chemotherapy.

The studies were conducted and presented by international cooperative groups, with research being funded in part by GlaxoSmithKline.

 
 
Data findings from both trials were presented at the 33rd annual meeting of the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held in San Antonio, Texas (8-12 December 2010).

Each year, the CTRC-AACR San Antonio Breast Cancer Symposium attracts academic and private physicians and researchers, as well as other health care professionals focused on curing breast cancer, to discuss and learn about new and late-breaking research including experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and pre-malignant breast disease, as well as new findings from clinical trials.
Courtesy of the American Association for Cancer Research
 
The primary endpoint for NeoALTTO and GeparQuinto was pathological complete response (pCR) defined as the absence of invasive cancer cells in the breast at surgery.

Paolo Paoletti, M.D., Head of Oncology Research and Development, GSK.
Photo: GSK
 
“In NeoALTTO, a higher level of complete pathological response was obtained by the dual inhibition of the HER2 pathway using an antibody, trastuzumab, and a small molecule tyrosine kinase inhibitor, lapatinib, compared with either agent alone. This is an important scientific finding,” said Paolo Paoletti, M.D., Head of Oncology Research and Development, GSK.
“Although lapatinib is not currently approved in this setting, we are committed to further researching the potential of this combination in this aggressive form of breast cancer.”


NeoALTTO


The Neo-Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Trial (NeoALTTO) randomised 455 patients with HER2-positive primary breast cancer to receive lapatinib (L) plus paclitaxel or trastuzumab (T) plus paclitaxel or a combination of lapatinib and trastuzumab (L+T) plus paclitaxel.

The study was led by the Breast International Group (BIG) - in particular by its partners the SOLTI cooperative group and the Breast European Adjuvant Study Team (BrEAST) - and was funded by GlaxoSmithKline.

The primary endpoint for NeoALTTO was pathological complete response defined as the absence of invasive cancer cells in the breast at surgery or only non-invasive in-situ cancer in the breast.

Topline results showed the pCR rate was 51.3 percent in the lapatinib plus trastuzumab combination arm compared to a rate of 24.7 percent for the lapatinib arm and 29.5 percent for the trastuzumab arm.
The difference in pCR between the lapatinib plus trastuzumab arm compared to the trastuzumab arm was statistically significant, p=0.0001.
The pCR difference between the lapatinib and trastuzumab arms was not statistically significant, p=0.34.

Grade 3 adverse events presented for L,T and L+T respectively were: diarrhoea (23 percent, 2 percent and 21 percent), neutropenia (16 percent, 3 percent and 9 percent), hepatic (13 percent, 1 percent and 9 percent), and skin disorders (7 percent, 3 percent, and 7 percent).

No deaths occurred during the treatment phase of the neo-adjuvant setting of the study, and no major cardiac dysfunction occurred during the neo-adjuvant phase of the study.
There was one patient death immediately after the end of treatment.

Courtesy of GlaxoSmithKline
 
Results presented at SABCS 2010 reflect findings from the 18 weeks of therapy prior to surgery, a very important window in the treatment of early breast cancer.
Analysis of primary endpoint efficacy and safety findings is ongoing.
The study is continuing for secondary endpoints, which include overall survival, disease-free survival and safety.


GeparQuinto


GeparQuinto is an open-label Phase III trial led by the German Breast Group which evaluated patients with HER2-negative and HER2-positive breast cancer.

In the HER2-positive setting 620 patients were randomised to receive neo-adjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel in combination with either trastuzumab or lapatinib.
The lapatinib dosing used in the study was lower than the dose in the currently approved label for lapatinib.

The study employed pathological complete response as the primary endpoint defined as the absence of tumour residuals (invasive and non-invasive) in the breast and lymph nodes at the time of surgery.

Study results show that both the lapatinib and trastuzumab therapies demonstrated an ability to reduce the presence of tumour residuals in breast and nodes at the time of surgery.
The pCR rate in the trastuzumab arm was 31.3 percent compared to the lapatinib arm of 21.7 percent, p<0.03.

The topline presentation of the results at SABCS contained limited safety data. Categories of frequently occurring serious adverse events, all grades, included: gastrointestinal, blood disorders and infections.
Analysis of primary endpoint efficacy and safety findings is ongoing.
The study is ongoing for secondary endpoints, which include overall survival, disease-free survival and safety.


About NeoALTTO


NeoALTTO is a multinational, randomised, Phase III study in primary breast cancer.
In the study, 455 patients with HER2 -positive primary breast cancer were randomised to one of three treatment arms; Patients were randomised to receive either lapatinib 1500 mg/d, or trastuzumab four mg/kg IV loading dose followed by two mg/kg IV weekly, or lapatinib 1000 mg/d with trastuzumab four mg/kg IV loading dose followed by two mg/kg IV weekly for a total of six weeks.

Courtesy of GlaxoSmithKline
 
After this biological window, patients continued on the same targeted therapy plus weekly paclitaxel 80 mg/m² for a further 12 weeks, until definitive surgery (total neo-adjuvant therapy duration of 18 weeks).
Paclitaxel was initiated at week four if there was evidence of disease progression at that time. In NeoALTTO, the primary endpoint was pCR defined as no invasive cancer in the breast or only non-invasive in-situ cancer in the breast specimen.


About GeparQuinto


GeparQuinto is a neo-adjuvant Phase III study, planned to include more than 2,500 patients that were HER2-positive and HER2-negative.
The HER2-positive
cohort of the study included 620 HER2-positive breast cancer patients and compared lapatinib versus trastuzumab given concomitantly with anthracycline–taxane-based therapy.
Both groups received trastuzumab post surgery.

The primary end point was pathological complete response defined as no invasive or non-invasive tumour residuals in breast and nodes, i.e. patients with some residual disease.
The trial was led and presented by the GBG (German Breast Group) who are responsible for data management and the trial database.

The trial was supported by GSK, Roche, Novartis and Sanofi.


About Tykerb (lapatinib)


In the United States, lapatinib is indicated in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that over expresses the HER2 receptor for whom hormonal therapy is indicated.

Tykerb in combination with an aromatase inhibitor has not been compared to a trastuzumab-containing chemotherapy regimen for the treatment of metastatic breast cancer.

Lapatinib is also FDA approved in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumours over express HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.3

In Europe, lapatinib, in combination with an aromatase inhibitor (AI), is indicated for the treatment of post-menopausal women with hormone receptor (HR)-positive, HER2 (ErbB2) over-expressing metastatic breast cancer and for whom chemotherapy is currently not intended.

In Europe, lapatinib is also approved in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumours over-express HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.

Lapatinib is approved in 91 countries including the U.S., Europe, Australia, India, Brazil, Russia, Turkey, South Korea and other countries around the world.

Registration dossiers have been filed in Canada, China, Japan, Mexico and a number of countries in Asia, Latin America and the Middle East.


US FDA boxed warning and important safety information for Tykerb


Hepatotoxicity has been observed in clinical trials and postmarketing experience.
The hepatotoxicity may be severe and deaths have been reported.
Causality of the deaths is uncertain.

Patients with known severe hypersensitivity to TYKERB or any of its components should not take TYKERB.
Also, patients may experience decreased left ventricular ejection fraction, hepatotoxicity, diarrhoea, interstitial lung disease/pneumonitis, QT prolongation, and risk of fetal harm in pregnant women.
If TYKERB is to be administered to patients with severe hepatic impairment, dose reduction should be considered.

The most common adverse reactions (≥20%) during therapy with TYKERB plus letrozole compared to letrozole were diarrhoea (64%, 20%), rash (44%, 13%), nausea (31%, 21%), and fatigue (20%, 17%).

The most common adverse reactions (>20%) during therapy with TYKERB plus capecitabine versus capecitabine alone were diarrhoea (65%, 40%), palmar-plantar erythrodysesthesia (53%, 51%), nausea (44%, 43%), rash (28%, 14%), vomiting (26%, 21%), and fatigue (23%, 25%).


About GlaxoSmithKline


GlaxoSmithKline – 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.

 
 
For further information please visit
www.gsk.com  


GlaxoSmithKline enquiries:

UK Media enquiries:

David Mawdsley
(020) 8047 5502

Claire Brough
(020) 8047 5502

Stephen Rea
(020) 8047 5502

Alexandra Harrison
(020) 8047 5502

Jo Revill
(020) 8047 5502


European Analyst/Investor enquiries:

Sally Ferguson
(020) 8047 5543

Gary Davies
(020) 8047 5503

Ziba Shamsi
(020) 8047 3289


SOURCE:
http://www.gsk.com/media/  

NOTE:
This release may not have been issued in every market in which GSK operates.


Research and develop


“The drugs discovered in the labs are not replacing the value of those medicines losing patent protection”

Andrew Witty, CEO of GlaxoSmithKline,
calls on the pharmaceutical industry to do more with less - and still be innovative


Andrew Witty, CEO of GlaxoSmithKline
Photo: GlaxoSmithKline
 
The past 50 years have seen the pharmaceutical industry deliver a constant flow of innovation.
This helped to increase life expectancy and reduce morbidity in very large population groups suffering from a wide variety of common and not-so-common diseases and illnesses.

The business model clearly worked - and up until 2001, ironically at about the time of the human-genome breakthroughs, most would have expected this trend to continue.
It has not. So now we are having to reinvent our industry.

It is an error to believe that the pharmaceutical industry is somehow not subject to market forces. It is. These forces simply operate over ultra-long cycles and are mitigated for periods of time by the existence of patents.
The power of these market forces is becoming clear as a number of factors come together.

The industry is witnessing increased competition from generic drugs as an unprecedented number of branded medicines lose patent protection.

This “patent cliff” has been estimated to be worth a staggering $200 billion over the period 2008-12.
Unfortunately, these losses have coincided with a decline in r&d productivity: the drugs discovered in the labs are not replacing the value of those medicines losing patent protection.
The reasons are complex.
The cyclical nature of scientific discovery has played its part, as has the industry’s misguided belief that it could “industrialise” the r&d process.
Decoding the human genome has also not yet led to the wave of new medicines originally hoped for.

In addition to these pressures, the industry faces a consolidation of purchasing power, via private-sector and governmental health-care reforms, putting unprecedented pressure on prices.
At the same time, regulatory standards, and caution, keep rising.

Hence the key question for 2011: how does the industry maintain long-term, high-risk investment in r&d against such a challenging backdrop?

As long as a gap remains between the number of medicines losing patent protection and the number of new medicines produced through r&d, it is clear that the size of the industry will continue to contract in the drive for efficiency.

For some players, more mergers and acquisitions are likely, but others will plan to shrink, and all parts of the value chain from r&d through to production and sales and marketing will be affected.

A critical dimension to determine success for the future will be getting r&d right.
In particular, we need to reverse the decline in productivity, improve success rates for regulatory approval and deliver medicines that add more than incrementally to a physician’s capabilities.

In the past the problem of r&d in big pharmaceutical companies has been “fixed” by spending more and by using scale to “industrialise” the research process.
These are no longer solutions: shareholders are not prepared to see more money invested in r&d without tangible success.
If anything, based on a rational allocation of capital, r&d should now be consuming less resource. Instead I believe the focus needs to be on two key issues.


Art, not just science


First, we need to recapture the ability to empower creative talent in the discovery phase of r&d by creating an environment in the labs that reflects the fact that discovering a drug is as much an art as it is a process.
But this needs to be combined with a more rigorous method for allocating resources only to where the prospects for success are greatest.

Second, we need to streamline the development phase, in part by ending earlier the development of drugs which do not offer the prospect of being truly distinctive.

In addition, I foresee more innovative partnerships emerging in r&d.
Pharmaceutical companies are increasingly partnering with smaller specialist firms and academia. This spreads risk with lower up-front costs.
There is also a need for big pharmaceutical firms to work together.
The decision of Pfizer and gsk to pool our hiv products to create ViiV Healthcare, a specialised hiv/aids company, is an example of this.

The industry in five years’ time will look very different from today.
Companies will need to put a premium on management and human capital, while operating in an increasingly complex social, legal, scientific and political environment.

As for governments, they will have to recognise the enormous industrial transformation that is under way and ensure that the incentive the industry needs - a fair reward for innovation - is not extinguished.

The pharmaceutical industry is hugely innovative.
But it now must apply that innovation to its own business model.
If governments work to support, not stifle, innovation, the industry will deliver the next era of revolutionary medicine.

http://www.gsk.com/media/downloads/economist-world-in-2011-gsk-witty.pdf  



Andrew Witty

Chief Executive Officer of GlaxoSmithKline

Andrew Witty
Photo: GlaxoSmithKline
 
Andrew Witty assumed the position of Chief Executive Officer on 21 May 2008.
He is a member of the Board and Corporate Executive Team and previously held the role of President, Pharmaceuticals Europe.

Andrew joined Glaxo in 1985 and held a variety of roles in the UK business.
He was a Sales Representative for the Respiratory business, held a variety of Marketing roles and was Director of Pharmacy and Distribution.

He has worked in the Company’s International New Products groups, both in the Respiratory and HIV/Infectious disease fields and has been involved in multiple new product development programmes.

In 1993, Andrew was appointed Managing Director of Glaxo South Africa and later Area Director for GlaxoWellcome, South and East Africa.
Subsequently he moved to North Carolina as Vice President and General Manager, Marketing for GlaxoWellcome Inc., the group’s US subsidiary.

Andrew then moved to Singapore and led the Group’s operations in Asia as Senior Vice President, Asia Pacific prior to his appointment to the Corporate Executive Team as President of GSK Europe in 2003.

Andrew has served in numerous advisory roles to Governments around the world including South Africa, Singapore, Guangzhou China and the UK.

Andrew is President of the EFPIA, a position he took up on 1 January 2010.

Andrew has a Joint Honours BA in Economics from the University of Nottingham.

http://www.gsk.com/about/bio-witty-cet.htm  



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