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Tackling Cancer: Kidney Cancer's Biggest Current and Upcoming Players

By Sean Williams - May 5, 2013 at 4:00PM

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Cancer research is big business, and it pays to know where research dollars are headed.

As I noted nine weeks ago, cancer statistics are both staggering and disappointing. Although cancer deaths per 100,000 people have been on the downswing since 1991 thanks to access to more effective medications and better awareness about the negative health effects of smoking, there is still a lot of research and progress yet to achieve. My focus in this 12-week series is to bring to light both the need for continued research in these fields, as well as highlight ways you can profit from the biggest current and upcoming players in each area.

Over the past eight weeks, we've looked at the eight cancer types most expected to be diagnosed this year:

Today, we'll turn our attention to the projected ninth-most diagnosed cancer: kidney cancer -- specifically, renal cell cancer.

The skinny on kidney cancer
This year, nearly 60,000 people will be diagnosed with renal cell cancer. While less than thyroid cancer in number of new diagnoses, the chance of death directly from kidney cancer is considerably higher. In fact, more than 13,000 people are projected to die from some form of renal cell carcinoma this year.

If there is a positive light to be shed from a renal cell cancer diagnosis, it's that 62% of all cases are diagnosed in a localized state, which, according to the American Cancer Society (link opens PDF file), results in a five-year survival rate of 91%. Also, better treatments and better awareness about smoking have helped boost the overall five-year survival rate of kidney cancer from 50% in 1975-1977 to 72% as of 2002-2008.

Conversely, there aren't any current tests that help screen for early-stage kidney cancer, and diagnoses actually rose by an average of 3.1% between 2005 and 2009 despite a 0.5% average annual decrease in death rates.

Sources: Surveillance, Epidemiology, and End Results Program and National Center for Health Statistics. 

Multiple factors, including smoking, hypertension, chronic renal failure, exposure to certain chemicals, and genetic factors have been shown to increase a person's chance of acquiring kidney cancer.

Where investment dollars are headed
Similar to what we saw last week with regard to treating thyroid cancer, surgery is a common option used to treat localized kidney cancer. In some cases ablation (using extreme heat or cold to destroy the tumor) can be used with success. ACS notes that radiation and chemotherapy tend to not have a huge effect on many stages of kidney cancer, but you'll find no shortage of anti-cancer therapies targeted at metastatic renal cell carcinoma. Here are a few of the most popularly prescribed therapies.

  • Nexavar: Co-developed by Onyx Pharmaceuticals (NASDAQ: ONXX) and Bayer, Nexavar has been approved to treat advanced renal cell carcinoma, or RCC, since Dec. 2005. In trials, Nexavar doubled progression-free survival to 167 days compared to the placebo which delivered a PFS of just 84 days. Slightly less than two years later Nexavar gained the added indication to treat unresectable hepatocellular carcinoma, a type of liver cancer. Sales of the drug totaled $861.4 million worldwide in 2012, excluding sales in Japan.
  • Avastin: I believe I've been quite clear in my assessment that Roche's Avastin is a wonder drug. Currently approved for four separate disease indications, Avastin was approved in combination with interferon alfa to treat metastatic RCC in July 2009. Avastin, as a reminder, is a monoclonal antibody that binds to VEGF-receptors and inhibits blood vessel growth, essentially starving solid tumors. In trials, Avastin plus interferon alfa delivered a PFS of 10.2 months compared with just 5.4 months for the interferon alfa with the placebo.
  • Inlyta: Approved in January 2012, Pfizer's (PFE 0.22%) Inlyta is designed to treat advanced RCC after the failure of one prior chemotherapy. An twice-daily oral medication similar to Nexavar, Inlyta was pitted against Nexavar in trials and came out on top in terms of PFS. The data showed the Inlyta arm delivered PFS of 6.7 months whereas the Nexavar-arm delivered a PFS of just 4.7 months.
  • Sutent: Also developed by Pfizer, Sutent was approved to treat metastatic RCC in January 2006. The once-daily tablets -- which are also approved to treat pancreatic neuroendocrine tumors and gastrointestinal stromal tumors -- were pitted against interferon-alfa in trials and demonstrated a better-than-doubling of median progression-free survival (47.3 weeks compared with 22 weeks). Sutent was Pfizer's ninth best-selling drug in 2012 with $1.24 billion in sales. 
  • Afinitor: Developed by Novartis, Afinitor was approved in March 2009 as a second-line treatment for advanced RCC after patients experienced progression or failed to respond to Sutent or Nexavar. In trials, Afinitor provided a median PFS of 4.9 months as compared with the placebo, which provided only 1.9 months of median PFS. Further, the objective response rate for Afinitor was 2% and 0% for the placebo.
  • Votrient: Finally, GlaxoSmithKline's (GSK 0.89%) oral medication, Votrient, was approved in October 2009 as a first-line treatment for advanced RCC. Like all previous therapies before it, Votrient delivered a significant improvement in median PFS (9.2 months versus 4.2 months) relative to the placebo. Similarly, the objective response rate was an impressive 30% for Votrient and just 3% for the placebo. 

Despite this seemingly endless parade of advanced RCC treatments, there have also been some notable failures -- perhaps none more fresh than AVEO Pharmaceuticals' (AVEO -0.63%) implosion this past week. AVEO's lead drug, Tivozanib, provided a statistically significant median PFS advantage over Nexavar in late-stage trials, but it failed to produce a median overall survival gain compared to Nexavar. That confusing stat prompted the FDA's panel to vote 13-1 against recommending Tivozanib for approval. While not dead, it's going to take at least another trial it seems to justify Tivozanib's benefits.

What's coming down the pipeline
Now that you have a better idea of the half-dozen important metastatic RCC treatments, let's have a look at two other potentially game-changing treatments coming down the pipeline.

  • BMS-936558: This is an early stage clinical treatment from Bristol-Myers Squibb (BMY -0.54%) that is being targeted at a broad range of cancers, including advanced RCC. Most tumors, including those found in advanced RCC, overexpress the PD-L 1 ligand, which this compound helps to suppress. In early studies, 27% of RCC patients had at least a partial response to BMS-936558, and a good two-thirds of those patients had durable responses lasting longer than a year.
  • Tivozanib: That's right, call me crazy, but I think there's a statistically significant PFS advantage to Tivozanib. However, AVEO will need to be extremely careful when it runs an additional late-stage trial with how it switches patients over from Nexavar to Tivozanib once their disease progresses if it hopes to gain a positive review from the FDA panel. I'd cautiously look for Tivozanib to make it back before the FDA panel sometime in 2015.

Your best investment
The good news for kidney cancer sufferers is that there's a small army of late-stage treatments available that have proven successfully in extended patient quality of life. On the flipside, kidney cancer doesn't have a lot going on in the pipeline beyond AVEO's late-stage drug, meaning your best investment is likely to be found in an existing treatment.

From an investing perspective, while I like the steady growth I've seen from Pfizer's Sutent, I prefer Onyx Pharmaceuticals with Nexavar. Onyx is right in the biotechnology acquisition sweet spot -- being valued at $6.5 billion it's neither too small to be untrusted nor too big for a slow-growth big pharmaceutical company to purchase. Onyx's additional drugs (Stivarga and Kyprolis) provide supplementary sources of revenue that make it an attractive option over the long term.

Stay tuned next week, when we tackle the current and upcoming therapies for the treatment of endometrial cancer in this "Tackling Cancer" series.

Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.

Try any of our Foolish newsletter services free for 30 days. We Fools don't all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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