Another Oncology Win in Personalized Medicine

June 1st, 2009 by Accelrys Team

header09_r1_c12At the World Biomarker Congress in Philadelphia this past week, I had a chance to catch up with a colleague, now a senior executive at a European-based global pharma company. Our conversation inevitably turned to Personalized Medicine, a shared interest of ours.

He updated me on some pre-release data that will be shown at Sunday’s meeting of the American Society of Clinical Oncologists (ASCO), concerning Iressa, Astra Zeneca’s lung cancer medication. Previously thought to be a commercial and scientific failure, Iressa is now at the vanguard of therapies “rescued by targeting.” iressa_logo

Targeted therapies are drugs that are shown to have a particular effectiveness in a subset of the overall population. “Targetting” in this context refers to the identification of a genetic difference which corresponds to better clinical outcomes for a particular group of patients. In the case of Iressa, the data that will be presented tomorrow shows that cancer progression is halted for over nine months in patients with the mutation, compared with 6 months for patients receiving chemotherapy (median values).

About one in ten cancer patients has this mutation. Overall, lung cancer kills 1.3 million people per year.  

But what if a patient doesn’t have the mutation? Then Chemotherapy is the better treatment option, which can hold back the cancer progression for five months, compared to only 1 month for Iressa (again, median values).

logo-herceptinIf these results are confirmed, Iressa will join the growing list of personalized medicine success stories in Oncology, which began with world’s first targeted therapy, Genentech’s Herceptin, in 1998. Since Herceptin, we’ve seen other highly publicized therapies with genetic targeting, such as Erbitux.

imcloneBut why so much genetic targeting in cancer, and not (yet) in other indications? Is it the serious nature of the disease or the quality of the data (high compliance in large populations) or something else? The Iressa story gives us a clue.

Astra Zeneca didn’t give up on it, and pursued semi-anecdotal findings of efficacy in some patients, even though it was not effective in the larger clinical trial population. Because of the large potential revenues resulting from effective cancer treatments, it becomes economic for companies to invest in risky clinical trials for treatments that might only be effective in 10% of the population.

Rittenhouse Square

Rittenhouse Square

As my colleague summed it up during lunch at a café on Rittenhouse Square in Philadelphia, “It’s about the money, of course. Cancer kills, and so cancer treatments cost.”

 

Oncology is clearly the vanguard for targeted therapies. But as scientists and marketing executives become more familiar and comfortable with a development process that results in a fragmented market, the techniques will inevitably be replicated in treatments that can only demand lower prices because they treat less serious diseases.

 

And that will make us all winners, no matter what mutations we have.

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More Personalized Medicine Surprises at ASCO Meeting?

May 12th, 2009 by Accelrys Team

am09-general1The abstracts for the semi-annual meeting of the American Society of Clinical Oncologists (ASCO) go up on their website this Thursday, May 14 at 6PM EST. This is a scientific conference that consistently reverberates on Wall Street, because so much of pharmaceutical sales is driven by cancer indications. Many of the largest mergers over the last six months had oncology as the subtext, such as Roche & Genentech and Eli Lilly & ImClone.  

 

kras1At a recent ASCO conference in January, 2009, “personalized medicine” went from a theoretical concept from science to a genuine business reality. At that conference, ASCO recommended a genetic test for a mutation in a crucial gene on human chromosome 12, called “KRAS,” that regulates cell division via signal transduction. If a colorectal cancer patient had the mutation, entire groups of therapies, called “anti-EFGRs,” were no longer recommended. This is not a rare mutation, as an estimated 40% of patients have the mutation. 

The result? Profound, immediate changes in market share potential for pharma companies offering the anti-EFGR monoclonal antibody therapies cetuximab and panitumumab.

In terms of pharmaceutical revenue, this is a very big deal. Each therapy carries a price tag that reflects the critical nature of the cancer indication, generally over $2000 per month. There are 150,000 new cases diagnosed in the US every year (resulting in 50,000 deaths). So just a simple calculation of the market shows that about $1.5 billion annual new business disappeared for makers of anti-EGFRs (40% of patients x $2,000 per month per patient x 12 months x 150,000 new patients per year), which of course excludes revenues from the estimated 400,000 current colorectal cancer patients.

And in terms of fighting this nasty scourge, the ASCO announcement was a very big deal. It personalized the treatment for 60,000 new patients annually (40% x 150,000) who would have otherwise placed their hopes for survival on a therapy that simply wouldn’t work for them.

The trade name for Cetuximab is Erbitux(FDA approval 2004), which is marketed in the US by ImClone & BMS, and in the rest of the world by Merck. Panitumumab is marketed by Amgen globally as Vectibix (FDA approval 2006).

Based on the stock market dip over the last 18 months (called the “Global Financial Crisis”), it is hard to discern definitively what effect the ASCO recommendation had on the stock prices of the companies involved.

But the bigger change will likely be observed internally at these companies, as they continue to commit resources to biomarker discovery and qualification. Biomarker activities around KRAS might have identified the lack of efficacy in the mutant form, which corresponds to not being effective in 40% of patients.

When it comes to post-hoc personalized medicine for blockbuster drugs, the pharma industry clearly doesn’t like surprises. Biomarker activities and translating those activities into clinical trials push those surprises into the research phase, where they belong.

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