Gemzar and Alimta: Although Eli Lilly & Co. (NYSE:LLY)‘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 Inc (USA) (NASDAQ:ONTY) and Merck KgaA’s Stimuvax failed to improve overall patient survival. In October, ArQule, Inc. (NASDAQ:ARQL) 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, Inc. (NASDAQ:AMGN) 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 AG (ADR) (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 Co. (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 Corporation (NASDAQ:CELG) 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 Inc. (NYSE:PFE). 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.
The article Tackling Cancer: Lung Cancer’s Biggest Current and Upcoming Players originally appeared on Fool.com.
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.
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