Tous Actualités
Suivre
Abonner Roche Pharmaceuticals

Roche Pharmaceuticals

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

Basel, Switzerland (ots/PRNewswire)

- 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:
http://www.prnewswire.com/mnr/roche/38645
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[ii].
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 investigation.
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 #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:
      http://www.roche.com/media_backgrounder/media_oncology.htm
    - Roche at ASCO: http://www.roche.com/media/events/med-asco2009.htm

Contact:

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: +1-510-647-4009, kglaub@plexxikon.com; Anne Cameron, Galliard
Healthcare, Tel: +44-759-0711-190, acameron@galliardhealth.com

Plus de actualités: Roche Pharmaceuticals
Plus de actualités: Roche Pharmaceuticals