And The Early Winner Is...

The American Society of Clinical Oncology’s annual meeting began this past weekend, and so far the early winner appears to be Genentech (DNA | Quote | Chart | News | PowerRating) on many fronts. The company released full late-phase clinical data on its new drug Avastin to treat advanced colorectal cancer, and the results look real. Avastin is a new class of anti-cancer agent that inhibits the growth of new blood vessels to growing cancers by blocking a protein called Vascular Endothelial Growth Factor (VEGF | Quote | Chart | News | PowerRating). The bottom line was the Avastin-treated patient group appeared to have a 50% higher survival advantage over the conventional chemotherapy patient group. This is a significant survival difference particularly in regard to treating this difficult, advanced cancer. With this survival difference, the study far exceeded its primary and secondary endpoints. In addition, the safety profile of the drug was very acceptable. Genentech’s next step with Avastin is to make preparations for filing with the FDA for potential approval sometime late this year or early next year.

Along with Avastin, Genentech also released positive preliminary data on its other targeted drug Tarceva -- with OSI Pharmaceuticals (OSIP | Quote | Chart | News | PowerRating) -- to treat advanced lung cancer and malignant glioma (brain cancer). Tarceva, like Avastin, is monoclonal antibody. However, this drug blocks a different cancer growth stimulant protein called EGF. Genentech is testing both Avastin and Tarceva against a variety of other cancers with the hope of broadening the potential use of both drugs. The company also released preliminary data on a new class of monoclonal antibody (Omnitarg) they're testing against a variety of solid cancers. With good news coming out of ASCO and plans in place to market recently approved Xolair for asthma and Raptiva for psoriasis, Genentech is burning on all cylinders.

ImClone (IMCLE | Quote | Chart | News | PowerRating) also released much-anticipated data on its new drug, Erbitux. Erbitux has a mechanism of action similar to Tarceva’s, by blocking a protein (EGF) that stimulates the growth of cancer cells. ImClone’s data involving the addition of Erbitux to conventional chemotherapy to treat patients with advanced metastatic colorectal cancer did show considerable shrinkage of tumors when compared to conventional chemotherapy alone (23% vs. 11%). However, despite showing efficacy, overall survival of patients treated with Erbitux was not significantly influenced. Erbitux also appears to show effectiveness in shrinking tumors in patients with advanced lung cancer.

Dendreon (DNDN | Quote | Chart | News | PowerRating) and Antigenics (AGEN | Quote | Chart | News | PowerRating), two companies involved in developing vaccines to treat cancer, also presented positive early clinical data on their patented vaccines. The vaccine approach focuses on stimulating the body’s own immune system to fight off a developing cancer. Dendreon’s vaccine is being tested against a variety of cancers and appears to have potential in stimulating the body’s immune system to fight off cancer. Antigenics also presented positive phase I clinical data on its new vaccine to treat a type of chronic leukemia or CML. Both companies plan to advance their vaccines into late-stage clinical trials.

Other less high-profile companies also presented positive clinical data on their developing cancer drugs over the weekend at ASCO. Vical (VICL | Quote | Chart | News | PowerRating) reported positive phase II results on its high-dose Allovectin study to treat advanced melanoma. In addition, Telik (TELK | Quote | Chart | News | PowerRating) reported positive phase II results from a study testing its new drug Telcyta in patients with advanced lung cancer. The company is also testing this drug in advanced clinical trials against ovarian cancer.

What’s Ahead This Week?

Despite the upbeat weekend presentations, there are several more companies ready to present data today and tomorrow at ASCO. Look for Millennium Pharmaceuticals (MLNM | Quote | Chart | News | PowerRating) to make a big splash today and tomorrow when the company presents clinical data on the use of its recently approved drug Velcade to treat a variety of other cancers. Velcade was recently approved by the FDA to treat multiple myeloma, a fatal bone marrow cancer. Cell Therapeutics (CTIC | Quote | Chart | News | PowerRating) and Medarex (MEDX | Quote | Chart | News | PowerRating) will also gain some attention this week with presentations summarizing clinical data on their perspective new cancer drugs.

For the next several days, I believe investors will still be in a euphoric state over the results coming out of ASCO despite the impressive anticipatory gains experienced by many of these companies over the last several weeks.

Good Luck,

Paul Ruggieri MD