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Can Pfizer Inc. Recover From Its Latest Lung Cancer Setback?

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Over the past several years, Pfizer (NYSE: PFE  ) has taken bold steps to streamline its operations and improve profitability after a wave of patent expirations. Focusing on the company's emerging oncology segment seemed like a great plan, until the recent failures of a lung cancer candidate with high expectations.

Dacomitinib is an epidermal growth factor receptor tyrosine kinase inhibitor, one of many tumor fighting drugs more commonly referred to as EGFR inhibitors. This experimental drug was expected to eventually put its non-small cell lung cancer (NCLSC) competitors on the ropes. Unlike Tarceva from Roche (NASDAQOTH: RHHBY  ) and Iressa from partners AstraZeneca (NYSE: AZN  ) and Teva (NYSE: TEVA  ) , Pfizer's unique therapy is irreversible and acts on multiple receptor types. Let's take a look at just how far this will set back the restructured pharma giant.

The prize
Combined, Tarceva and and Iressa racked up about $2 billion worldwide in 2012. Dacomitinib wasn't expected to be a blockbuster on the scale of a drug like Lipitor, which was Pfizer's most successful drug and formerly the top-selling drug in the world. However, dacomitinib's failed trials would sting much less if they occurred during earlier stages of development.

What went wrong
Not long ago, dacomitinib had the competition shaking in their boots. Results from a 188 patient trial released at the end of 2012 showed significantly stronger responses when compared to Tarceva. The problem with the drug wasn't safety or response rates, but long term survival. In the ARCHER 1009 trial, about 800 patients were given either Tarceva or dacomitinib. After 10 months the patients given dacomitinib did not show significant improvement in progression-free survival compared to patients that received Tarceva.

In the BR.26 trial, advanced lung cancer patients that had been treated previously with either Tarceva or Iressa, were given placebo or dacomitinib. At three and a half years, the overall survival rate of patients given dacomitinib was not significantly higher than those given placebo.

As awful as these failures seem, they do not necessarily seal dacomitinib's fate. It is possible that patients in certain subsets responded more strongly to the therapy. Pfizer hasn't disclosed every detail yet. There is still a possibility that the therapy is more effective for groups of patients that don't respond to available drugs.

Some background
To get a sense of how Pfizer can salvage something from its dacomitinib program, it helps to understand some history behind EGFR inhibitors. AstraZeneca and Teva's Iressa won an accelerated approval for second-line treatment of NCLSC way back in 2003. Because of the unmet need at the time, the FDA approved its use based on tumor response rates. Underwhelming long-term survival rates in follow-up studies later resulted in a limited indication.

In 2004, Roche's Tarceva won approval for the same indication as Iressa. But Tarceva won the old fashioned way, with improved survival data compared to existing treatments.

Pfizer hasn't released all the data yet, so it is difficult to make direct comparisons with existing therapies. The important takeaway is that dacomitinib didn't fail because it's not effective at all, but rather because it wasn't better at lengthening survival rates among a wide range of patients.

It's personal
In May of last year, Tarceva won an expanded approval for first-line treatment of NCLSC in patients with specific mutations. The indication was approved together with Roche's companion diagnostic that screens for those mutations.

More recently, Boehringer Ingelheim scored a similar NCLSC approval with Gilotrif and a companion diagnostic from Qiagen. The FDA has made it clear that it supports personalized cancer treatments for difficult to treat lung cancers and beyond.

Dacomitinib might not win an approval for the entire range of mutations it was intended to treat. But odds are decent that within the hundreds of patients treated in late stage trials, there's a group with unmet need that showed a significant response.

Complete results from the failed trials should be released later this year. Also, a third phase 3 trial for first-line treatment of NCLSC patients with EGFR mutations is expected next year. It's a long shot, but Pfizer's latest trial failures might not be a total loss after all.

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Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On February 01, 2014, at 3:53 AM, entheogenius wrote:

    Here's an excerpt from my journal and upcoming book "Psychopathic Psychotronics"

    Here's another one of the ideas used against me. It was used as a basis for one of my psychiatric commitments and was made a part of my medical record. Thanks Regions Hospital!

    At age 17 I read about Laetrile and Trophoblasts. Trophoblasts are supposedly a type of cell that play a crucial role in fetal development. Once that jobs done they just lay around in your body like a time bomb. If something comes along and wakes them up, they go into blastic replication and become cancer. Laetrile also known as Vitamin B-17 is a chemical sandwich with a cyanide molecule in the middle. To a non trophoblast cell laetrile is harmless, but to a trophoblast it's deadly because they produce the enzyme Beta-Glucoaronidase which is supposedly able to activate the cyanide in the laetrile delivering it right to the cancer cell or so that's the theory. It turned out to be b.s. or so they say. But it got me thinking about how some cancers are formed by viral activity. Cervical cancer from Human Papilloma Virus is a good example of this. It's my understanding that only a trophoblast can become cancerous.

    My idea was to make a virus that can only infect and replicate in a trophoblast by making them require the enzyme beta-glucoaronidase to initiate infection and replication. When a virus infects a cell it replaces its DNA with its RNA destroying the cell. Such a virus could theoretically cure cancer and vaccinate against it as well.

    I once told part of my theory to the resident psychiatrist at Hazelden rehab center in 1993. He wrote it down and bitched me out for keeping it a secret. About 18 months later in the news of the world of medicine section in the Readers Digest I read about a novel new cancer therapy involving injecting herpes viruses into brain tumors in rats and with promising results. By the way no one thought of me as having any mental illness at Hazelden.

    Cancer is expected to make around $160,000,000,000 per year by 2020 do you think anyone that's in on the profit wants to be replaced with an injection that may cost $20 to make per dose or less? How does that sound for being unable to differentiate between reality and fantasy?

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Cory Renauer

Cory is a long-term minded analyst mainly focused on the biotechnology and pharmaceuticals. He genuinely enjoys cutting through the industry's complexities to help everyday investors make better decisions. You can contact Cory on Twitter @coryrenauer

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