Roche Holdings Ltd. (RHHBY) recently presented encouraging data from a phase III trial (BRIM 3) on BRAF V600 mutation-positive metastatic melanoma candidate, vemurafenib (RG7204, PLX4032), at the annual meeting of the American Society of Clinical Oncology (ASCO).
The BRIM 3 study was conducted to compare vemurafenib with dacarbazine (chemotherapy) in patients with previously untreated BRAF V600 mutation-positive, unresected, locally advanced or metastatic melanoma (skin cancer).
Upon comparison with chemotherapy, the study results demonstrated that patients on vemurafenib experienced a significant improvement in overall survival, with the risk of death reducing by 63%. The study also met the co-primary endpoint of reducing the risk of disease aggravation by 74% compared with chemotherapy.
Last month, Roche submitted a new drug application (NDA) to the US Food and Drug Administration (FDA), for the use of vemurafenib to treat patients with BRAF V600 mutation-positive metastatic melanoma. Roche also submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA), for similar use of the drug.
Roche is developing vemurafenib under a license and collaboration agreement with Plexxikon, which was recently acquired by Daiichi Sankyo. We note that the drug has priority review status in the US.
Besides vemurafenib data, Roche also reported positive data on Tarceva (erlotinib) and Avastin (bevacizumab) at ASCO.
Data from the phase III trial (EURTAC) on Tarceva showed that compared with placebo, the first-line use of Tarceva almost doubled survival rates in patients with a genetically distinct type of advanced non-small cell lung cancer (NSCLC) and even decreased the risk of the disease becoming worse by 63%.
Meanwhile, data from Avastin’s late-stage trial (OCEANS) demonstrated that women with recurrent platinum-sensitive ovarian cancer, who were dosed with Avastin experienced a 52% decline in the risk of disease progression compared with those on chemotherapy.
Avastin, which is currently marketed worldwide for the treatment of colorectal cancer, breast cancer, NSCLC, kidney cancer and glioblastoma (a type of brain cancer), faces competition from Eli Lilly & Co.’s (LLY) Erbitux.
Tarceva primarily faces competition from Eli Lilly’s Alimta, Sanofi-Aventis’ (SNY) Taxotere and AstraZeneca’s (AZN) Iressa.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
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