Tackling Cancer: Non-Hodgkin Lymphoma's Biggest Current & Upcoming Players

As I noted seven 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 six weeks, we've looked at the six cancer types most expected to be diagnosed this year:

Today, we'll turn our attention to the projected seventh-most diagnosed cancer: non-Hodgkin lymphoma, or NHL.

The skinny on non-Hodgkin lymphoma
Approximately 79,000 cases of lymphoma -- a cancer of the lymphoid tissue and other autoimmune organs including the spleen -- are expected to be diagnosed this year. Of that total, 69,740 cases are expected to be labeled as non-Hodgkin lymphoma, which encompasses a wide variety of disease types, according to the American Cancer Society. The ACS is forecasting that 19,020 people will pass away this year because of NHL, making it the sixth most-likely cause of cancer-related death.

The good news for NHL sufferers is that survival rates are drastically improving, and it's a direct result of having better treatments available. NHL incidence rates have been declining since the late 1990s and dropped by 3% annually between 2005 and 2009. Five-year survival rates have improved from just 47% in 1975-1977 to 71% in 2005-2009, according to the ACS (link opens PDF file).


Source: Centers for Disease Control and Prevention, National Center for Health Statistics, U.S. Mortality Files. 

The unfortunate aspect of NHL is that there aren't too many precursors or warning signs that would signify whether someone's at risk or not. Outside of getting older, contracting HIV or T-cell leukemia virus type 1, or being given immune suppressants -- which are all shown to increase risk -- there isn't a test, rhyme, or reason to determining why people are unlucky enough to develop NHL.

The typical treatment regimen for NHL is chemotherapy. Occasionally radiation is used in combination with chemotherapy, but it's pretty rare since NHL tends to be a global problem. In very advanced cases where the disease has relapsed, physicians will occasionally turn to stem cell transplantation.

Where investment dollars are headed
As you might have figured, with NHL deaths expected to crest 19,000 in 2013, researchers are feverishly at work trying to bring revolutionary treatments to those who have this disease. In the meantime, here are some of the most common therapies currently associated with treating NHL.

  • Rituxan: Co-owned by Roche and Biogen Idec (NASDAQ: BIIB  ) in the U.S., Rituxan, a monoclonal antibody, is approved for multiple indications by the Food and Drug Administration to treat B-cell, CD20-positive NHL. Rituxan was first approved in February 2006 for large B-cell, CD20-positive NHL and, according to three clinical studies, demonstrated survival improvements of 9% to 11% on follow-ups compared to the placebo. One drawback, howver, is that Rituxan can lead to very serious side effects.
  • Zevalin: Developed by Spectrum Pharmaceuticals (NASDAQ: SPPI  ) , Zevalin is an antibody treatment that links to a radioactive atom (in this case Yttrium-90) and is administered intravenously, on an outpatient basis, over the course of nine days. It was first approved in March 2002 for the treatment of relapsed or refractory low-grade, follicular B-cell lymphoma, but gained the additional indication in 2009 for previously untreated follicular NHL in patients that achieved a partial or complete response to first-line chemotherapy. Not surprisingly, Zevalin is used in conjunction with Roche and Biogen's Rituxan.
  • Bexxar: GlaxoSmithKline's Bexxar is also an antibody linked to a radioactive isotope and was first approved by the Food and Drug Administration in 2003. Bexxar is targeted at CD20-positive, follicular NHL patients who are resistant to Rituxan and have relapsed following chemotherapy. However, like we saw with Rituxan, severe side effects can occur, including anaphylaxis, and no survival benefit has been clinically ascertained for those on the Bexxar therapeutic regimen, according to Bexxar's own website.  
  • Adcetris: Although Seattle Genetics' (NASDAQ: SGEN  ) Adcetris is focused primarily on Hodgkin's lymphoma, I figured it was worth mentioning since the FDA also approved it in August 2011 to treat a rare form of NHL known as systemic anaplastic large cell lymphoma, or ALCL. It is the only currently approved treatment specifically designed to treat ALCL. Of those ALCL patients treated with Adcetris in trials, 86% experienced a partial or complete response with a response average of 12.6 months. 
  • Folotyn: Another quick mention here for Folotyn, a drug developed by Allos Therapeutics and inherited by Spectrum when it purchased Allos last year. Folotyn was approved by the FDA to treat a rare form of NHL known as peripheral T-cell lymphoma, or PTCL. Like Adcetris, it's the only approved treatment for PTCL, which affects about 9,500 people annually.

Despite a landscape of improving survival rates, NHL trials haven't always gone according to plan. One prime example of this is Cell Therapeutics whose drug, Pixuvri, for the treatment of relapsed or refractory aggressive B-cell NHL, was recently turned down by England's governing medical body. Pixuvri has also failed on multiple occasions to be approved in the United States by the FDA.

What's coming down the pipeline
Now that you have a better understanding of some of the key treatments in NHL, let's have a look at a few promising treatments currently being tested in clinical trials. Keep in mind that with NHL being such a broad-reaching category, each of the following therapies may be very tightly defined with regard to its scope of treatment.

  • Ibrutinib: Currently being developed by Pharmacyclics (NASDAQ: PCYC  ) and partnered up with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, Ibrutinib is one of just a handful of drug hopefuls to receive the "breakthrough therapy" designation from the FDA. Being tested as a treatment for mantle cell lymphoma and chronic lymphocytic leukemia, ibrutinib has sailed through mid-stage trials thus far. In particular, ibrutinib induced a response rate in mantle cell lymphoma of 70% -- the highest ever recorded in an MCL clinical trial. Early estimates by analysts put the peak sales potential as high as $5 billion.
  • Epratuzumab: This is an experimental anti-CD22 monoclonal antibody currently in phase 2 development by Immunomedics (NASDAQ: IMMU  ) for the treatment of follicular lymphoma. In December 2010, Immunomedics presented its findings of epratuzumab in combination with Rituxan at the American Society of Hematology -- and the results were encouraging. Of the 57 evaluable patients, 84.2% had an objective response rate, and 23 of 30 patients that achieved a partial response were still achieving that partial response after the nine month period of testing .
  • Obinutuzumab (GA101): Aside from being impossible to pronounce, this experimental late-stage drug from Roche has demonstrated significant promise in treating chronic lymphocytic leukemia. GA101 is being tested in three late-stage trials, and, according to an announcement in late January from Roche, it met its initial primary endpoint in the first of those three trials while offering an encouraging glimpse into its progression-free survival potential.

Your best investment
With so many subtypes of cancer comprising non-Hodgkin lymphoma, it appears obvious to me that research and investment dollars are going to soar, while big profits are likely heading in the direction of biotech and big pharma companies.

If you were looking for a riskier investment with great growth potential, that would be Pharmacyclics. Understandably it'll be sharing its Ibrutinib revenue stream with J&J assuming it gains FDA approval for CLL and MCL. The data would point toward a strong likelihood of that happening -- as would its labeling as a breakthrough therapy -- but the stock has already come so far, so fast, in the past four years that I'm not certain how much upside is left.

As for the most intricately tied investment, I'm going to side with Biogen Idec. Sure, Rituxan may have a slew of potentially nasty side effects -- and I could very easily have chosen Roche, its co-owner, in this spot -- but its positive effects for those who can tolerate the medication are undeniable. Given that Rituxan is combined with other existing and pipeline medications, I'd call it the safest play, and investment, in non-Hodgkin lymphoma. It also doesn't hurt that Biogen Idec recently boosted its product portfolio with a new multiple sclerosis drug, Tecfidera.

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

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