Encouraging First Data On New Targeted Treatment For Patients With Melanoma - The Deadliest Form Of

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1st June 2009, 10:30pm - Views: 818

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Encouraging First Data on New Targeted Treatment for Patients With Melanoma -

the Deadliest Form of Skin Cancer

BASEL, June 1/ PRNewswire-AsiaNet/ --


    - PLX4032 (R7204) Phase I Results Offer Hope of First Highly Effective

      Drug in Melanoma Along With Companion Diagnostic

    - For Non-US Media Only

    Roche announced today results from a Phase I study with PLX4032 (R7204) a

new, highly selective and promising treatment for patients with advanced

melanoma whose cancer harbours the BRAF mutation (known as mutation-positive

). Patients treated with PLX4032 lived for a median of at least six months

without their disease getting worse and experienced shrinkage of their

tumours; this included patients where the cancer had spread to the liver,

lung and bone[i]. Historically, metastatic melanoma patients live less than

two months before their disease progresses.

    To view the Multimedia News Release, please click:

    PLX4032 works in a highly innovative way by selectively inhibiting the

cancer-causing BRAF mutation, and is being developed in parallel with a

companion diagnostic to identify mutation-positive patients. These data

represent a significant development in the treatment of melanoma for which

there are few treatment options.

    Following these initial positive findings, Roche and its partner

Plexxikon will evaluate the activity of PLX4032 in larger trials to support a

potential registration program beginning later this year. If successful, it

is expected to launch with a tissue based companion diagnostic test,

representing another step forward in personalising cancer treatment. The two

companies in their strong partnership are co-developing PLX4032 for potential

use in a number of cancers harbouring the BRAF mutation. They are also

co-developing the diagnostic test to select mutation-positive patients for

clinical trials, and ultimately, for treatment with PLX4032.

    "PLX4032 has shown both tumour shrinkage and delay in tumour progression

in patients whose tumours harbour a BRAF mutation, as well as improved

quality of life for symptomatic patients," stated Keith T. Flaherty, M.D.,

assistant professor at the Abramson Cancer Center of the University of

Pennsylvania and principal investigator for the PLX4032 phase I clinical

trial. "Seven years after BRAF mutations were first identified we have

validation that this mutation is a cancer driver and therapeutic target. In

addition to a new and important chapter in the story of targeted therapy

development in cancer, we are especially excited for our melanoma patients

for whom there are few treatment options."

    PLX4032 works by targeting and destroying tumour cells carrying the BRAF

mutation. BRAF is an important mediator of cell growth and division, but when

mutated is known to cause 60% of melanomas, the most deadly form of skin

cancer, and approximately eight percent of all solid tumours. PLX4032's

potency and selectivity is expected to result in a treatment that is both

effective and well tolerated.

    Malignant melanoma is the most serious type of skin cancer, with about

160,000 new cases diagnosed worldwide each year. Melanoma is treatable if

caught early but patients who develop metastatic disease are rarely cured

with available treatments. Only a small proportion of people (<2%) live more

than two years once systemic metastases become evident[i].

    About the study

    ASCO Abstract #9000: Monday 1 June 2009, 16:30-18:00, EDT Level 4,

Valencia Room, W415A

    Promising preliminary findings reported in BRAF mutation-positive

melanoma patients include:


    - PLX4032 has been well tolerated at therapeutic doses

    - Partial responses in nine mutation-positive melanoma patients and

      minor responses in four mutation-positive melanoma patients have 

      been observed

    - Regression of metastatic lesions in every site to which melanoma

      commonly spreads, including to the liver, lung and bone

    - Disease control lasting up to 14 months with continuous therapy,

      with many responding patients still receiving treatment

    - Interim median progression-free survival of at least six months

    By contrast, no treatment response was observed in a small group of

patients without the BRAF mutation, and progression-free survival was less

than two months, consistent with historical data.

    Drug-related adverse events, including rash and photosensitivity, have

been classified as mild in grade. Serious adverse events, including diagnosis

of cutaneous squamous cell carcinoma, were observed in some patients after

chronic treatment; however the safety profile has been warranted favourable

for this population and the trial authorised to proceed to the next stage of


    The PLX4032 data not only represent an important step forward in

understanding and treating malignant melanoma, but also represent a

significant advance in the use of biomarkers and diagnostic tools and the

potential benefits of tailoring cancer treatment to individual patients.

    About Plexxikon

    Plexxikon is a leader in the structure-guided discovery and development

of novel small molecule pharmaceuticals to treat human disease. The company's

clinical stage programs include PLX4032 for the treatment of melanoma and

colorectal cancer, PLX5568 for the treatment of polycystic kidney disease and

PLX204 for the treatment of diabetes. Among the company's preclinical

development programs, candidates are being developed for the treatment of

rheumatoid arthritis, multiple sclerosis and other autoimmune diseases as

well as for the treatment of pancreatic and metastatic breast cancer.

    Plexxikon's proprietary Scaffold-Based Drug Discovery(TM) platform

integrates multiple state-of-the-art technologies, including structural

screening as one key component that provides a significant competitive

advantage over other drug discovery approaches. To date, the company has

discovered a portfolio of clinical and preclinical stage compounds being

Community Health Roche 2 image

developed to address significant unmet medical needs in cardio-renal disease,

CNS disorders, inflammatory and neuro-inflammatory diseases and oncology. For

more information: http://www.plexxikon.com.

    About Roche

    Headquartered in Basel, Switzerland, Roche is a leader in

research-focused healthcare with combined strengths in pharmaceuticals and

diagnostics. Roche is the world's largest biotech company with truly

differentiated medicines in oncology, virology, inflammation, metabolism and

CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based

cancer diagnostics and a pioneer in diabetes management. Roche's personalised

healthcare strategy aims at providing medicines and diagnostic tools that

enable tangible improvements in the health, quality of life and survival of

patients. In 2008, Roche had over 80'000 employees worldwide and invested

almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion

Swiss francs. Genentech, United States, is a wholly owned member of the Roche

Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more

information: http://www.roche.com.

    All trademarks used or mentioned in this release are protected by law.

    [i] ASCO 2009, Abstract #9000: "Phase 1 study of PLX4032:

Proof-of-concept for V600E BRAF mutation as a therapeutic target in human


    [ii] Boyle P, et al. World Cancer report. IARC Press, Lyon,


    Further information:


    - Backgrounder Oncology:

    Source: Roche

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