Roche has been boosted by late-stage data which shows that a new personalised treatment being developed with partner Plexxikon improves survival in patients with advanced skin cancer.
The drug in question, RG7204, showed a significant survival benefit in people with previously untreated BRAF V600 mutation-positive metastatic melanoma. Study participants who received the treatment have improved overall survival rates and also lived longer without their disease getting worse compared to those on dacarbazine, the current standard of care. Full data will be presented at a medical meeting later this year.
RG7204 is designed to selectively inhibit the mutated BRAF protein found in about half of all cases of metastatic melanoma, the deadliest form of skin cancer. Roche noted that the safety profile was generally consistent with previous RG7204 studies.
The Swiss major's chief medical officer, Hal Barron, said that “for the first time, a personalised investigational medicine has shown a significant survival benefit in metastatic melanoma". He added that "this is an important advance" for people with the BRAF V600 mutation-positive form of the disease "who have had extremely limited treatment options".
Based on these results, patients on the control arm of the study will have the option to crossover to receive RG7204. Roche added that it is now working closely with global health authorities to expand the recently announced early access programme for the drug.
Response to FDA over Avastin mBC withdrawal proposal
Meantime, Roche's Genentech unit has submitted its response to the US Food and Drug Administration's proposal to withdraw approval of the metastatic breast cancer indication for the blockbuster Avastin (bevacizumab).
In December, the agency said it plans to pull Avastin as a first-line treatment for metastatic HER2-negative breast cancer combined with paclitaxel. The response from Genentech lays out the information on which it intends to rely at a hearing to demonstrate why Avastin should remain an FDA-approved option for women in the USA with HER2-negative mBC.
Specifically, the company has proposed conducting a new confirmatory trial of Avastin plus paclitaxel, the chemotherapy combined with Avastin in the study that led to accelerated approval. It would have a biomarker component "with the intent of identifying people who may be more likely to derive a greater benefit from Avastin", Genentech says.