GSK pushes two melanoma drugs into crowded Ph3 arena

GlaxoSmithKline ($GSK) is moving two of its melanoma drugs into late-stage trials designed to identify a target population most likely to benefit from the drugs. Investigators plan to recruit patients with a BRAF V600 mutation, narrowing the group to slightly more than half of the patients suffering from skin cancer.

As Reuters notes, GSK will be moving into a late-stage melanoma arena which already includes closely-watched drugs from Roche and Plexxikon (RG7204) as well as Bristol-Myers Squibb's ipilimumab.

The BRF113683 Phase III study compares GSK'436, a BRAF inhibitor, to dacarbazine in previously untreated patients with BRAF V600 mutated advanced or metastatic melanoma. The METRIC study compares GSK'212, a MEK inhibitor, to chemotherapy in advanced or metastatic melanoma patients with a BRAF V600 mutation.

"By focusing our research on patients with the V600 mutation, we are striving to understand how our ... inhibitors can best be used to treat patients with metastatic melanoma," said Paolo Paoletti, president of GSK Oncology. "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 leukemias and other solid tumors."

- see the GSK release
- check out the Reuters report