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As I noted three 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.
Thus far, we've examined the two most oft-diagnosed cancer types: prostate cancer and breast cancer. This week we'll be shifting our focus to lung cancer -- a type of cancer with a much grimmer prognosis in terms of survival rates than prostate or breast cancer.
The skinny on lung cancer
This year, an estimated 228,190 people are going to be diagnosed with some form of lung or bronchus cancer. I wish I could say that advancements have been swift in treating this disease, but abstinence and awareness as to the effects of cigarette smoking have been front and center in helping to reduce instances of lung cancer over the past two decades. Between 2005 and 2009, the incidence of lung cancer in men has decreased by an average of 1.9% annually. For women, this trend only recently began to reverse, with diagnoses falling by just 0.3% annually between 2005 and 2009.
However, the sad reality is that five-year survival rates for lung cancer have improved from just 12% in 1975-1977 to 17% in 2002-2008, according to the American Cancer Society (link opens PDF). Lung cancer is an effective and swift killer, accounting for more deaths among men and women than any other cancer, and has left patients and physicians scrambling for solutions for the better part of 40 years.
This relates back to the fact that only 15% of all lung cancer diagnoses come with the cancer in a localized stage, and advanced-stage lung cancer carries only a 4% survival rate of five years or beyond. The majority of diagnoses are for non-small-cell lung cancer (about 84%) with the remainder being small-cell lung cancer. The typical treatment for localized lung cancer is surgery often followed by chemotherapy. In advanced stages of the disease, surgery isn't typically an option, and rounds of chemotherapy or radiation are often prescribed by physicians.
Where investment dollars are headed
Unlike prostate or breast cancer, which have growing five-year survival rates and hormonal therapies that keep the disease at bay, lung cancer has few tools that slow down the progression of the disease for a meaningful amount of time. In short, investment dollars are streaming into lung cancer research from both an early- and late-stage perspective, and physicians couldn't be happier to have so many companies focused on the next revolutionary lung cancer treatments.
The National Cancer Institute alone lists 29 drugs currently approved by the FDA to fight non-small-cell lung cancer, or NSCLC. I'll cover the most pertinent ones below. I should also note that I'm going to focus almost entirely on NSCLC treatments as opposed to small cell lung cancer, or SCLC, as SCLC has a considerably better response rate to standard chemotherapy and radiation than does NSCLC.
- Avastin: Developed by Roche (NASDAQOTH: RHHBY ) , Avastin is a multi-cancer wonder drug. It's approved to treat metastatic colorectal and kidney cancer, glioblastomas (an aggressive brain cancer), and metastatic lung cancer where surgery has been ruled out. Avastin was approved in 2006 in combination with chemotherapy agents Paclitaxel and carboplatin following a clinical trial in which the Avastin arm's median overall survival improved to 12.3 months from just 10.3 months in the Paclitaxel and Carboplatin-only control arm. However, Avastin may also be losing some of its allure. In 2011, the FDA revoked its approval for its use in breast cancer after it discovered that its risks outweighed its benefits. In addition, a study conducted by researchers at the Stony Brook University School of Medicine found that death risk actually rose for patients when Avastin was combined with chemotherapy agents.
- Tarceva: Owned by Roche and Astellas Pharma, Tarceva is a pill designed as a second or third-line treatment for NSCLC. Patients receiving Tarceva have either gone through a round of chemotherapy that's kept the disease at the same level, or it has progressed. Tarceva was first approved by the FDA in 2004, but received the additional indication of "maintenance treatment" in April 2010. For its 2004 approval, Tarceva demonstrated median overall survival of 6.7 months as compared to just 4.7 months for the control arm.
- Xalkori: Developed by Pfizer (NYSE: PFE ) (yes, we broke the Roche streak dating back to last week), Xalkori is a twice-daily pill dedicated to patients with metastatic NSCLC that's caused by a defect in a gene called anaplastic lymphoma kinase, or ALK. Xalkori was granted an accelerated approval by the FDA in August 2011 after two arms of the same clinical trial demonstrated objective response rates of 50% and 61%. Keep in mind, however, that this trial was not designed to measure overall survival, and Pfizer even states on the Xalkori webpage that "It is not known whether Xalkori will improve symptoms or help patients with this disease live longer."
- Abraxane: Celgene's (NASDAQ: CELG ) Abraxane is used as a first-line treatment in metastatic cases of NSCLC where neither surgery or radiation are a viable option. It received approval from the FDA just last October after clinical trials showed an 8% increase in overall response rate and a 0.9-month median response duration improvement with the Abraxane patient pool as compared to those just taking Paclitaxel.
- Gemzar and Alimta: Although Eli Lilly's Gemzar came off patent a few years ago, it's still worth mentioning as a key combination chemotherapy agent in the fight against lung cancer. It is most often combined with Cisplatin and administered intravenously as a first-line therapy for NSCLC patients. Similarly, Alimta was a big player until 2011 when it came off patent.
Unfortunately, 29 compounds simply aren't enough for us to be anywhere near knocking down this disease. The failure rate for lung cancer drug hopefuls has been maddeningly high. In December, Oncothyreon and Merck KgaA's Stimuvax failed to improve overall patient survival. In October, ArQule imploded after the independent data monitoring committee saw no chance of tivantinib meeting its survival endpoints. Just a month before that, Eli Lilly's Alimta when combined with Roche's Avastin failed to improve overall survival in a late-stage study despite demonstrating a progression-free survival improvement in the Alimta control arm. In March 2011, even Amgen and Takeda Pharmaceuticals (two huge biotech behemoths) failed to meet their clinical endpoint with motesanib in late-stage trials.The point here is that this is an incredibly difficult disease to fight off, and many of the experimental drugs currently in the pipeline won't make it to market.
What's coming down the pipeline
Following such depressing news that many of these lung cancer drugs will fail, I even admit it can be difficult to pick out a few upcoming drug hopefuls that could change the game for lung cancer sufferers. Here are three experimental drugs worth keeping your eyes on.
- LDK378: This is an oral ALK inhibitor currently in the mid-stage trials and being developed by Novartis (NYSE: NVS ) . Just last week, it received the extremely rare designation of being called a "breakthrough therapy" by the FDA. The drug is designed to treat patients whose cancer grew while using Xalkori, or who couldn't tolerate Xalkori. Early-stage results concluded that a complete response, partial response, or unconfirmed partial response was witnessed in 80% of the 88 patient treatment group. Assuming that response rate remains well above the average and LDK378 proves to have minimal side effects, it should be approved sometime next year.
- Afatinib: This drug is currently being targeted at multiple types of advanced cancer -- including breast, head, and neck cancer, in addition to NSCLC. Specifically, Afatinib, which is being developed by Boehringer Ingelheim, targets the T790M mutation and is under an accelerated review by the FDA for epidermal growth factor receptor, or EGFR mutation-positive NSCLC. In clinical trials, Afatinib delivered progression-free survival of a whopping 11.1 months as compared to just 6.9 months for the pemetrexed/cisplatin control arm. With results like this, I could easily see Afatinib gaining FDA approval and improving patients' quality of life.
- Nivolumab: This drug being developed by Bristol-Myers Squibb (NYSE: BMY ) may have the longest shot of all to gain approval, but I believe it's taking the correct approach to fighting lung cancer. Nivolumab utilizes and enhances the body's own immune system to seek out and destroy the cancer through anti-PD-1 immunotherapy. In early stage clinical trials, Nivolumab demonstrated a response rate ranging from 6% to 32% in NSCLC, and, according to Bristol-Myers' press release, the results appear durable. Nivolumab is currently in late-stage trials.
Your best investment
As you can see, there really are a ton of treatment choices for lung cancer; but which one makes the best investment?
If you're looking for a company with a bright future and perhaps a dose of risk, I'd give that to Celgene with Abraxane. I don't feel that Abraxane's improvements in median response duration were truly eye-popping, but the simple fact that it's approved as a first-line treatment should give it an edge over many of its competitors -- not to mention that Abraxane is approved to treat way more than just NSCLC.
However, the most stable company here that looks poised to deliver demonstrable returns from a financial perspective for shareholders is Pfizer. Xalkori is perhaps the first specialized NSCLC drug that targets a mutation and delivers a markedly higher response rate than the previous standard treatment. Xalkori has been assigned a high-end peak sales estimate of $2.5 billion by analysts, which I feel could be quite achievable given its outperformance in existing studies.
Stay tuned next week when we tackle the current and upcoming therapies for the treatment of colon and rectal cancer in this Tackling Cancer series.
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