Roche impresses at ASCO with vemurafenib
pharmafile | June 6, 2011 | News story | Research and Development, Sales and Marketing | ASCO, Roche, skin cancer, vemurafenib
Roche’s vemurafenib has proven one of the stars of the ASCO cancer conference by increasing overall survival in skin cancer patients.
The late-stage BRIM3 study showed vemurafenib significantly improved overall survival in patients with previously untreated BRAF V600 mutation-positive metastatic melanoma, compared to chemotherapy alone.
In the study, the risk of death was reduced by an unprecedented 63% for those taking vemurafenib, compared to patients on the chemotherapy arm.
Roche said that median overall survival (OS) rates couldn’t yet be estimated because of the small number of patients in long-term follow-up.
However, it has released median OS estimates from an earlier BRIM3 study in January, which saw patients receiving vemurafenib living 9.2 months compared to 7.8 months for those receiving chemotherapy.
After an additional two months of follow-up, median OS increased to 10.5 months for patients receiving vemurafenib, while the median OS estimate for patients receiving chemotherapy remained at 7.8 months.
Further data will be released later this year after the long-term follow up study is completed.
Roche expects both US and European regulatory decisions on the drug before the end of the year, and analysts have forecast annual vemurafenib to achieve annual sales of $452 million by 2015.
In addition to OS, vemurafenib also significantly increased progression-free survival, a co-primary endpoint, by 74% compared to chemotherapy alone.
Side effects from the drug included skin rashes and joint pain – more serious adverse events were recorded however, with around 12% of patients developing squamous cell carcinoma, a low-grade form of skin cancer.
The data was shown at the high profile ASCO conference in Chicago, which showcases new and innovative cancer treatments.
The drug was watched closely at the event because melanoma is the deadliest of the three forms of skin cancer – causing around 40,000 deaths globally every year – and currently has few successful treatment options.
Personalised approach
The drug is being developed alongside a bespoke diagnostic kit – the cobas 4800 BRAF V600 mutation test – to help identity those patients who can benefit from vemurafenib.
This is a truly personalised approach that represents the future of oncology treatments, and is being developed in-house by Roche’s diagnostics business.
Paul Brown, head of Roche molecular systems, said: “The joint development of the investigational cobas BRAF test and vemurafenib exemplify how our personalised healthcare approach is one step closer to becoming a reality for patients.
“In BRIM3 our investigational test enabled rapid and accurate identification of eligible patients with metastatic melanoma.”
Vemurafenib is an investigational, oral, small molecule that is designed to selectively inhibit a cancer-driving mutated form of the BRAF protein.
The drug is being co-developed under a 2006 license and collaboration agreement between Roche and Plexxikon, a member of the Daiichi Sankyo Group.
If approved the drug will have to compete with BMS’ melanoma drug Yervoy (ipilimumab) that was approved by the FDA in March and is expected to make $1.26 billion in peak annual sales.
BMS and Roche announced last week a collaboration to evaluate the combination of Yervoy and vemurafenib as a therapy for metastatic melanoma.
Roche is also planning a number of extra studies with vemurafenib that includes combinations with other medicines, such as Yervoy, as well as studies in other tumour types.
One of these will be a phase II study exploring the efficacy safety of vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma that has spread to the brain.
Ben Adams
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