Retired PepsiCo executive David Scherb was in bad shape 15 months ago. Kidney cancer had spread to his lungs and one tumor became so big it ate through his sternum and bulged right through the surface of his skin. It was so painful he couldn't wear a shirt.
But last April, he started on a clinical trial of a new experimental kidney cancer drug from Novartis (nyse: NVS - news - people ) called RAD001. The pain declined, and by summer of 2007 the tumor was no longer visible. A full year later, the tumor remains in check. "If it wasn't for this drug, I don't feel like I would be here," Scherb says.
Novartis is emerging as the surprise winner at this year's annual meeting of the American Society of Clinical Oncology, the year's biggest cancer conference. The company looks to have a sure-fire new drug for kidney cancer patients who have failed other options. Its bone drug Zometa was unexpectedly shown to reduce risk of breast cancer recurring by 35%. And perhaps most intriguing of all, the same kidney drug seems to have big potential for treating advanced breast cancer.
The most immediate sales impact could come from the surprise finding that the company's bone-boosting drug Zometa slashed the recurrence of breast cancer in pre-menopausal women by about 35% in an 1,800 person trial, when combined with standard treatment. That could yield new sales for a drug that now has been used merely as supportive care to prevent fractures in patients with cancer bone metastases. The new study shows it may actually prevent new metastases. The mechanisms aren't entirely clear, but may be because the drug inhibits blood vessel formation in the bone.
The current data is in only one small set of breast cancer patients. Novartis is conducting a big study to see whether the dug can also prevent relapse in the much bigger group of postmenopausal women with breast cancer. But with little downside to giving the drug, many doctors probably won't wait, predicts Julie Gralow of the University of Washington.
"There will be great uptake," says Gralow. "People will say, 'Why not?" I'm losing bone, my insurance will pay, there is hardly any toxicity and it may decrease recurrence.' " The drug is given as a twice-yearly infusion.
In another study at the meeting, researchers reported RAD001 delays progression of kidney cancer by about two months in tough cases that had failed with other treatments. While not a huge effect, the results are all but certain to lead to approval of the drug, doctors said. It could establish RAD firmly as the agent of choice for those who have failed Pfizer's (nyse: PFE - news - people ) Sutent, the drug mostly commonly used for initial kidney cancer therapy.
This could cut into sales for Onyx Pharmaceuticals (nasdaq: ONXX - news - people ) and Bayer's (nyse: BAY - news - people ) Nexavar drug for kidney cancer. Wyeth (nyse: WYE - news - people ) also sells a kidney cancer drug that is similar to RAD001.
"There are a lot of treatment options for patients now," says Memorial Sloan-Kettering Cancer Center's Robert Motzer, who led the study. Together, the various new kidney cancer drugs "have changed the prognosis."
But kidney cancer may be "the tip of the iceberg" for RAD001, says David Epstein, president of Novartis' cancer unit. The drug, which hits a key growth-promoting molecule inside cells, called mTOR, is also showing surprising preliminary promise in treating advanced breast cancer patients. It appears to restore the effectiveness of Genentech's (nyse: DNA - news - people ) Herceptin drug after that drug has failed.
In one small trial from doctors in France of 13 patients who had failed on Herceptin, tumors shrank dramatically in six when RAD001 was added to the mix; in three the tumors vanished entirely. In another study of RAD in breast cancer, three out of of 22 patients had big tumor shrinkage, while the disease stabilized in another 13 for prolonged periods.
"The percentage of responses is dramatic. We usually don't see that," says UCLA oncologist Dennis Slamon, who played a pivotal role in developing Herceptin. He says mTOR may be a key resistance mechanism that cells use to evade the effects of Herceptin.
The results are highly preliminary. But Novartis' Epstein is so excited by the data he is considering jumping right from these trials into a large final-stage tests. "I tell people I want to be involved in one more drug like Gleevec" before retiring, Epstein says, referring to Novartis' breakthrough leukemia pill. He hopes RAD001 is it.
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