Trial success for Roche’s personalised skin cancer drug
pharmafile | January 19, 2011 | News story | Research and Development | BRAF V600, Cancer, RG7204, Roche, personalised medicine, skin cancer
A promising Roche drug has helped previously untreated patients with advanced skin cancer to live longer without their disease getting worse in a phase III trial.
“For the first time, a personalised investigational medicine, RG7204, has shown a significant survival benefit in metastatic melanoma,” says Hal Barron Roche’s chief medical officer.
“This is an important advance for people with the BRAF V600 mutation-positive form of the disease who have had extremely limited treatment options,” he added.
Co-developed by Roche and Plexxikon, the investigational, oral, small molecule is designed to selectively inhibit a cancer-causing mutated form of the BRAF protein.
This is found in about half of all cases of metastatic melanoma, which is the most aggressive form of skin cancer, with life expectancy following diagnosis usually measured in months.
RG7204 had already impressed in phases I and II, and in the phase III study BRIM3 it increased overall survival and progression-free survival compared to participants who received current standard of care dacarbazine.
Full data will be presented at a medical meeting later this year but analyst Jefferies International, which has predicted peak sales of $1 billion for RG7204, called the headline results “very encouraging”.
They pointed out that Roche’s success could be bad news for Bristol-Myers Squibb’s Yervoy (ipilimumab), which is set to receive a decision from the FDA in March.
BMS’ cytotoxic T-lymphocyte antigen 4 (CTLA-4) drug is an immune therapy directed against T-cells, and has shown improved overall survival in patients with unresectable stage III/IV melanoma for whom previous treatment had failed.
Meanwhile, Lilly was forced to halt phase III trials of its own melanoma candidate tasisulam in December due to serious safety concerns after 12 people died during the study.
Patients on the control arm of Roche’s BRIM3 will now have the option to receive RG7204 and the company says it is “working closely” with global health authorities to expand the RG7204 early access programme.
There are an estimated 40,000 deaths worldwide from the disease, with the number of cases in developed countries predicted to double from 138,000 a year to 227,000 by 2019.
Roche hopes RG7204, like its investigational compound GDC-0449 (a ‘Hedgehog pathway’ inhibitor), will be part of a new generation of cancer medicines.
Roche’s oncology pipeline currently includes 22 new medicines, five of which are expected to be submitted for approval by 2013.
Adam Hill
Related Content
Central nervous system cancer metastases – the evolution of diagnostics and treatment
The current forms of immunotherapy, how T cell therapy works and what the future holds
Roche receives CE Mark for blood test to help rule out Alzheimer’s
Roche has been granted CE Mark approval for its Elecsys pTau181 test, the first in …
BioMed X and Servier launch Europe’s first XSeed Labs to advance AI-powered antibody design
BioMed X and Servier have announced the launch of Europe’s first XSeed Labs research project, …
