Roche’s RG7204 (a/k/a PLX4032) Shows OS/PFS Benefit in Metastatic Melanoma
[OS and PFS were co-primary endpoints of the phase-3 ‘BRIM3’ study. PLX4032 was featured in a series of articles in the NY Times (#msg-46899517, #msg-54567652).]
ZURICH, Jan 19 (Reuters) - Swiss drugmaker Roche's (ROG.VX) new treatment for advanced skin cancer helps patients live longer and also extends the period in which their disease does not get worse, a late-stage trial has shown.
The news should be a boost for Roche after its pipeline hit a number of setbacks last year, shaking investor confidence and lopping over a fifth off the stock's value in 2010.
Patients with previously untreated BRAF V600 mutation-positive metastatic melanoma taking RG7204, lived longer and for longer without their disease progressing compared to those taking dacarbazine, the current standard of care, Roche said on Wednesday.
"This clearly underlines that Roche/Genentech are a leader in oncology research and able to develop novel and highly targeted drugs," Vontobel analyst Andrew Weiss said. "It is a stepping stone in trying to rebuild confidence in valuing Roche's pipeline."
Roche has been developing the drug with privately held Plexxikon. Analysts estimate it will have peak sales of 500 million Swiss francs ($519 million) to 1 billion.
Melanoma is the deadliest form of skin cancer. Once it returns and spreads after initial treatment there are virtually no effective alternative treatments available.
The Roche/Plexxikon drug and ipilimumab, an experimental drug for advanced melanoma being developed by U.S. group Bristol-Myers Squibb (BMY.N), are providing the possibility of hope for patients who have previously had few options.
"The overall survival results came in somewhat earlier than expected and speak for the strength of the data which will probably be detailed at ASCO in June," said Helvea analyst Karl-Heinz Koch.
"Initially, the drug will have to share the market with ipilimumab though longer term the drugs may be used in combination. Hence, we believe there is upside to our 1 billion sales forecast for the drug," Koch said.‹
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