ASCO's Take-Home and the Oncology Market

The American Society of Clinical Oncology (ASCO) held its annual confab last weekend to the tune of 40,000 participants, ranging from researcher luminaries to down-home family docs. Financial analysts were at the meetings, generally hogging the first rows of seats with laptops open and cell phones on. But you can’t blame them: The breaking data on cancer drugs in late-stage trials resonates on Wall Street, kicking drugmaker stock values up or down.

Pharm Exec asked two top pharmaceutical analysts who specialize in oncology, Clair Gricks and Ramya Kollipara, both of Decision Resources, to review ASCO’s highlights-and then crystal-ball the cancer market’s outlook.

1. Erbitux, ImClone’s anti-EGFR monoclonal antibody, was a big winner.
• In the FLEX trial, which included patients with all types of non-small-cell lung cancer (NSCLC), Erbitux plus two chemotherapies (vinorelbine and cisplatin) improved overall survival compared to the two chemos alone (11.3 months vs. 10.1 months).
These results indicate that Erbitux will be approved as a first-line treatment in all metastatic NSCLCs. Notably, it will also offer a second treatment option after Genentech’s Avastin for patients with nonsquamous NSCLC.
NSCLC is one of the most common cancer groups.
• In the CRYSTAL trial, which included patients with colorectal cancer who carry the K-RAS biomarker, Erbitux was effective in those who had wild-type K-RAS, while those who had K-RAS mutations saw little benefit.
Already approved in the US for both K-RAS biomarkers, Erbitux will soon be marketed in Europe only for wild-type patients.
“This is a great example of personalized medicine,” Clair Gricks said. “There’s a huge drive-from both a cost and care perspective-to characterize the genetic profile of patients in order to preselect who the drug will work for.”
• The trend in cutting-edge cancer treatment is increasingly toward combining two or more monoclonal antibodies or targeted therapies. But the cost is almost prohibitively expensive, Gricks said. So the more trials and data that are done, the better doctors know what does and doesn’t work.
In the CAIRO trial, involving patients with metastatic colorectal cancer, the Erbitux/Avastin combo didn’t work-compared to the standard Avastin/Xelox

2. Avastin, Genenetech’s anti-VEGF monoclonal antibody, racks up more targets, more indication, more moolah.
• In the AVADO trial, involving patients with metastatic HER2-negative breast cancer, Avastin in combination with Sanofi’s Docetaxel, met its goal of slowing tumor growth and improving progression-free survival.
“Avastin is already approved for indications in breast cancer,” Gricks said. “But even an additional application in a small subset such as this can be very lucrative because the breast cancer market is so big.”

3. Novartis’ Zometa, currently approved for bone metastases, was the shock of the confab-in a good way.
• In the ABCS12 trial, which includes patients with early-stage recurring breast cancer, a combination of Zometa and endocrine (hormonal) therapy was effective in preventing a recurrence of the cancer itself-and not just in cutting its spread to the bones.

4. Pfizer’s Sutent, a small molecule RTK-inhibitor, cemented its claim to first-line status in renal cell carcinoma.
• Having been approved based on surrogate endpoints, Pfizer’s trial measured overall survival: 26.4 months for the Sutent crowd vs. 21.8 months for the interferon-a crowd. Among patients who received no subsequent treatment, the Sutent group lived twice as long as the interferon-a group, 28.1 months vs. 14.1 months.

5. Novartis’ everolimus, an immunosuppressant approved as a cancer treatment in Europe, got a boost toward an FDA OK.
• In patients whose advanced-stage renal cancer has progressed despite prior treatments, everolimus produced a four-month progression-free survival compared with the 1.9 months for patients on placebo.

Got all that? Now, Gricks and Kollipara ran this brand-new data through Decision Resources' algorithmic models (or something) and came up with he following predictions.
• Total Oncology Market Sales: 2007: $59 billion; 2012: $80 billion
• Avastin, already a major player with four cancer indications, will aim to expand its label into the very large and lucrative market of early-stage disease.
Total Sales: 2006: $2.4 billion; 2011: $7.2 to $9.6 billion
• With two indications already under its belt, Erbitux will grow its market with an application for non-small-cell lung cancer.
• Over the next five years, lung cancer is likely to be the fastest-growing cancer market, with new treatments and new combinations of current treatments vying for share.
• Breast cancer, the largest market, is stable-early detection has led to early diagnosis and early-stage treatment, plus it is well served by Herceptin, Avastin, Tykerb and other drugs. Ditto for colorectal cancer.
• Renal cancer will remain a fast-growing niche market.
• Leukemias and ovarian cancers will see a big jump in sales as new treatments arrive. Check back at the 2009 ASCO affair.
To search the thousands of abstracts presented at 2008 ASCO, go to http://www.abstract.asco.org/.