By Turna Ray
Simultaneous commercialization of a drug and diagnostic product is the key to capturing the most value for all companies involved in Rx/Dx co-development, Karl Mahler, Roche's head of investor relations, said at the 2009 UBS Life Sciences Conference in New York this week.
According to Mahler, a primary focus at the company is launching drug/diagnostic combination treatments through its personalized healthcare franchise, since such products are differentiated from others on the market, may go through regulatory approval and penetrate the market faster, and justify higher pricing.
Furthermore, in discussions with the US Food and Drug Administration, the regulatory agency is "requesting simultaneous drug/diagnostic submissions," Mahler noted.
One of the most promising Rx/Dx products in the company's pipeline is PLX4032, an investigational melanoma drug that has been shown in early clinical trials to be efficacious in those with BRAF V600E mutations, representing approximately 50 percent of melanoma patients. Roche and Plexxikon have an agreement to co-develop and market PLX4032 and its companion diagnostic.
After reporting promising results at this year's annual meeting of the American Society of Clinical Oncology, Plexxikon and Roche are planning to begin larger clinical trials later this year to support the regulatory submission for PLX4032. The companion diagnostic is currently being used to identify best responders in clinical trials for the drug [see PGx Reporter 06-03-2009].
Stefan Frings, head of Roche's HER2 franchise, said at the meeting that based on the fact that PLX4032 is a novel drug that has shown efficacy in BRAF V600E mutation-positive melanoma patients, the company would seek to fast-track the product's approval through the FDA.
In addition to the BRAF mutation test, Roche also has in late-stage development tests detecting anti-CCP antibodies and rheumatoid factor, which may be companion diagnostics for several rheumatoid arthritis drugs in Phase III trials, including Genentech's monoclonal antibody ocrelizumab. Genentech is a subsidiary of Roche.
In terms of companion diagnostics, Roche markets tests developed by Dako and PathVysion that gauge HER2 mutations for Genentech's breast cancer drug Herceptin; DxS' KRAS mutation test for gauging responsiveness to monoclonal antibodies such as Amgen's Vectibix and Bristol-Myers Squibb's Erbitux; as well as the CYP450 AmpliChip test, based on he Affymetrix microarray platform, which is used to gauge responsiveness to several marketed drugs.
For the next two years, Roche will also focus on broadening Avastin's market, Mahler noted. Avastin, an anti-VEGF monoclonal antibody developed by Genentech, is currently approved in the US for the treatment of metastatic colorectal cancer; locally advanced, recurrent or metastatic non-small cell lung cancer; for previously untreated advanced HER2-negative breast cancer; and for the treatment of kidney cancer.
By 2011, the company plans to report results from seven Phase III trials investigating Avastin in other indications, including gastric, ovarian, and prostate cancers.
At the earliest, results from a study looking at Avastin as a second-line treatment for HER2-negative breast cancer is expected in the third quarter of 2010. Additionally, a Phase III trial looking at the Avastin/Herceptin combination treatment for metastatic HER2-positive breast cancer is slated to report results by 2011.