Genentech to file an application to the FDA to start marketing the product.
There are a couple interesting points to note about this drug. The product is developed specifically for about half of melanoma patients (those with the mutated form of BRAF) and the trials were designed to use a companion diagnostic to screen out the patients who were unlikely to benefit. This is the sort of personalized medicine that Genentech popularized over a decade ago with trastuzumab (Herceptin), which has rarely been duplicated since. Now that insurers are increasingly balking at paying high prices for cancer drugs that only stand to help a small percentage of patients, Genentech is bound to play up the personalized aspect of this therapy in its meetings with doctors.
Also, look for plenty of questions about what happens when patients develop resistance to the heralded new drug. Genentech has noticed that a protein known as MEK is often overexpressed in patients who develop resistance to the BRAF inhibitor. So it has developed a new MEK inhibitor that it is testing in combination with the new Plexxikon drug, which it hopes will keep patients in remission for longer periods of time.
“This program highlights the power of the scientific group we have at Genentech,” Bishop says. “I’m excited about the biology we are learning from samples we’ve collected, and what we’re seeing in terms of clinical observation.”
—New opportunities for erlotinib (Tarceva). This is the drug for non-small cell lung cancer that has been put in a box of sorts, as a second- or third-line treatment—and one that doesn’t work for a majority of patients. The most benefit seen prior to this year’s ASCO has been seen in Asian populations.
Now Genentech is hoping to combat some of that perception with results from a new pivotal stage study, called EURTAC, which it says is the first to show the drug can be effective in patients getting their first round of treatment for lung cancer, and that it works for a Western population of people. The study, of more than 140 patients, randomly assigned patients to get either the Genentech drug by itself, or standard chemotherapy. The abstract of this study on the ASCO website is #7503, and the company says more data will come out at the meeting in early June.
“It’s an important finding,” Bishop says. “You have a targeted agent that is better than the standard of care for these patients.”
—While ASCO is a meeting mainly for clinicians who actually treat patients with cancer, it’s occasionally a showcase for stuff that a true scientist can appreciate. This will be the coming out party for something called MetMab, which is a one-armed antibody drug. Gene jockeys out there know
