Encouraging First Data on New Targeted Treatment for Patients With Melanoma - the Deadliest Form of Skin Cancer

    BASEL, Switzerland, June 1 /CNW/ -

    -   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 ((less than)2%) live
more than two years once systemic metastases become evident(ii).

    About the study

    ASCO Abstract No. 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

    -   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
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 No.9000: "Phase 1 study of PLX4032: Proof-of-
    concept for V600E BRAF mutation as a therapeutic target in human cancer".

    (ii) Boyle P, et al. World Cancer report. IARC Press, Lyon, 2008

    Further information:

    -   Backgrounder Oncology:

    -   Roche at ASCO: http://www.roche.com/media/events/med-asco2009.htm

For further information:

For further information: Roche Group Media Relations: Phone:
+41-61-688-8888, e-mail: basel.mediaoffice@roche.com; Daniel Piller (Head);
Alexander Klauser, Martina Rupp, Claudia Schmitt, Nina Schwab-Hautzinger,
Christine McMenamin, Roche, Tel: +41-79-618-7671,
christine.mcmenamin@roche.com; Kathleen Sereda Glaub, Plexxikon Inc., Tel:
(510) 647-4009, kglaub@plexxikon.com; Anne Cameron, Galliard Healthcare, Tel:
+44-759-0711-190, acameron@galliardhealth.com

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