GSK skin cancer drugs moves into phase III
pharmafile | January 25, 2011 | News story | Research and Development | BRAF V600 mutation, Cancer, Duchenne Muscular Dystrophy, GSK, GSK1120212, GSK2118436, GSK968, GlaxoSmithKline, melanoma, skin cancer
GlaxoSmithKline has begun late-stage trials of two new drugs for advanced or metastatic melanoma patients.
GSK2118436 and GSK1120212 are being studied to see if they stop or slow the progression of skin cancer in patients whose tumours contain a BRAF V600 mutation.
The mutation is believed to occur in 50-60% of all melanoma patients and would require a companion diagnostic tool to make the drug effective.
The BRF113683 phase III study will compare GSK’436, a BRAF inhibitor, to chemotherapy drug dacarbazine (DTIC) in previously untreated patients with BRAF V600 mutated advanced or metastatic melanoma.
The second study, METRIC, will compare MEK inhibitor GSK’212 to chemotherapy (DTIC or paclitaxel) in advanced or metastatic melanoma patients with a BRAF V600 mutation.
Paolo Paoletti, president of GSK oncology, said: “By focusing our research programme on patients with the V600 mutation, we are striving to understand how our investigational MEK and BRAF inhibitors can best be used to treat patients with metastatic melanoma.
“In addition to our ongoing research in metastatic melanoma, we are also studying GSK’212 and GSK’436, both alone and in combination with other agents, in other difficult to treat forms of cancers including pancreatic cancer, refractory or relapsed leukaemias and other solid tumours.”
The V600 mutation is also being targeted by Roche with its RG7204 candidate and the Swiss pharma company has already seen promising results in a recent phase III trial.
These drugs represent the future of personalised medicine whereby new oncology medicines are being designed to target specific cancer-causing mutations.
Muscular dystrophy trial gets go-ahead
Meanwhile, GSK has begun enrolling patients into a new phase III trial of boys with Duchenne Muscular Dystrophy (DMD) who have a dystrophin gene mutation amenable to an ‘exon 51 skip’. Up to 13% of boys with DMD have dystrophin gene mutation/deletions amenable to an exon 51 skip.
DMD’s severe symptoms are caused when certain exons, small sequences of genetic code, are mutated or deleted. GSK’s RNA-based therapeutic induces ‘exon skipping’ to avoid the effects of the defective exon and allow a novel dystrophin protein to be produced.
The randomised, placebo controlled study will enrol 180 patients, from up to 18 countries, and is currently the most advanced ongoing study for this rare, severely debilitating, neuromuscular disease.
The study is designed to assess the efficacy and safety of GSK968 6mg/kg, once weekly, compared to placebo, for 48 weeks in ambulant boys over 5 years of age with DMD.
The primary efficacy endpoint is a measure of muscle function using the six-minute walking distance test.
Dr Philippe Monteyne, head of development and chief medical officer for GSK Rare Diseases, said: “The commencement of this phase III study is an important milestone.
“Currently, there is no approved treatment to alter the course of DMD – a disease that puts boys in wheelchairs and often leads to death in early adulthood.”
Ben Adams
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