Roche’s melanoma candidate impresses in phase II trials
pharmafile | November 5, 2010 | News story | Research and Development | BRAF protein, Cancer, Phase II, Plexxikon, RG7204, Roche
Roche’s mid-stage melanoma candidate has produced positive results in a difficult to treat cancer.
RG7204 is an investigational, first-in-class molecule designed to selectively inhibit a cancer-causing, mutated form of the BRAF protein found in around half of all melanoma patients.
It is being trialled in advanced melanoma patients as a second-line treatment. These patients’ survival rates are only measured in months and there are currently few treatment options available.
The BRIM2 phase II study is a single-arm, multi-centre, open-label phase II study that enrolled 132 patients with previously treated BRAF V600E mutation-positive advanced melanoma.
The primary endpoint of the study was overall response rate (ORR) as assessed by an independent review committee.
Secondary endpoints of the study included duration of response, progression-free survival (PFS), and overall survival (OS).
Just over half of the patients (52%) had tumours decrease in size by 30% or more for at least two consecutive scans as assessed by an independent review committee.
People who participated in the trial had a median PFS of 6.2 months and the median duration of response was 6.8 months. Median OS has not yet been reached.
The drug is being co-developed under a 2006 license agreement with US biotech firm Plexxikon.
At the same time Roche’s own diagnostics business is developing a test kit for RG7204 to help indentify those patients carrying the BRAF gene.
This kind of personalised approach is see as the future for a number of cancer treatments and the diagnostics kit could help Roche during the regulatory process.
Jeffrey Sosman, an oncologist at the Tennessee, US-based Vanderbilt-Ingram Cancer Centre, presented the data at the seventh International Melanoma Research Congress of the Society for Melanoma Research in Sydney, Australia.
He said: “We are pleased by the RG7204 study results in advanced melanoma, one of the top causes of cancer deaths in young adults.
“We now have additional data that confirm promising clinical activity in previously treated patients with BRAF V600E mutation-positive metastatic melanoma.”
Hal Barron, head of global product development and chief medical officer at Roche, said: “We are very encouraged by these data and based on the phase II findings we are working to open an expanded access programme.
“This would make RG7204 available to people with BRAF-mutation positive advanced melanoma who have had at least one prior medicine.”
Currently, Bristol Myers Squibb is developing its own skin cancer drug ipilimumab, but this has been hit by a regulatory delay after the FDA said it needs more time to review its data.
A phase III study (BRIM3) of the drug and its diagnostic test kit is currently ongoing.
Additional information about the clinical trials is available at the Roche clinical trials registry.
Ben Adams
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