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Bayer Halts Nexavar Trials Not good enough results!


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FRANKFURT (Reuters) - Bayer HealthCare, a U.S.-based unit of Bayer AG (BAYG.DE: Quote, Profile, Research), said on Monday it had stopped a late-stage trial of Nexavar in patients with non-small cell lung cancer, after an independent data monitoring committee said it would not meet the main goal of improved overall survival.

In the late-stage study, patients received Nexavar in combination with chemotherapeutic drugs carboplatin and paclitaxel.

Bayer said higher mortality was observed in a certain subset of patients treated with the combination of Nexavar and the chemotherapeutic drugs, versus those treated with carboplatin and paclitaxel alone.

Bayer had expected annual peak sales of around 750 million euros ($1.1 billion) from Nexavar in this indication. Bayer had hoped to launch Nexavar for non-small cell lung cancer in 2009.

Bayer and co-developer Onyx Pharmaceuticals Inc (ONXX.O: Quote, Profile, Research) will review the findings of the analysis to determine what, if any, impact they have on other ongoing Nexavar lung cancer trials.

Nexavar, also known as sorafenib, is approved in the United States and Europe for kidney cancer and liver cancer. The companies are studying the drug for treatment of a broad range of cancers, including breast cancer.

Bayer shares closed down 2.3 percent at 54.15 euros. Shares of Onyx closed down 1.1 percent at $44.98 on Friday. U.S. stock markets were closed on Monday.

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Thanks for this information!!!!

I'm actually on Bayer Nexavar trial, but I'm getting the Nexavar w/ Cisplatin and Gemzar. I asked about this (trial results) last week from the doc and she said that Bayer hasn't revealed any results so far about the trial. I guess they are running several trials at the same time with different combinations. Fingers crossed that my "combo platter" has some positive effects... =)


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"Nexavar is already approved in more than 30 countries for liver cancer and in more than 60 countries for the treatment of patients with advanced kidney cancer. But an additional indication for lung cancer would push it past the $1 billion sales mark."

The FDA easily approves a drug by “indication” (why is it that you’re going to take the drug). A drug company presents a drug and wants approval for two or three different indications. One may be really insignificant, affecting a very small number of people (lung cancer). The major indication might affect millions of people (liver and/or kidney cancer).

The drug doesn’t necessarily show efficacy for the lung cancer indication, but they’re able to get it approved for the liver and/or kidney cancer indication, while the FDA and the drug company both know the drug is going to be used for that all indications.

It’s going to be used “off-label" for lung cancer. The FDA should be intervening, but they don’t. The the FDA says that they don’t regulate the “off-label” use of drugs, and allows it to happen, and the “off-label” use of the drug becomes a public health threat. Nexavar, in combination with standard therapy, kills more patients than standard therapy alone.

Combination chemotherapy has not always produced greater degrees of clinical benefit than single agent therapy, as this clinical trial illustrates. When two or more drugs are given, there is a greater probability that at least one of the drugs will be active. There is then the potential for true synergery, where the whole is greater than the sum of the parts.

But most drug combinations are only additive or at most, minimally synergistc. However, some newer combinations show greater degrees of synergy, although apparently not in this study. True synergy is rather uncommon in most adult solid tumors. Most drug combinations in diseases are merely additive, where the whole equals the sum of its parts, and not synergistic. In hematologic neoplasms (leukemia, lymphoma, multiple myeloma), true synergy is very common.

In cases like this study, where drugs are only additive and not synergistic, nothing is learned by testing the drugs in combination compared to what is learned by testing them separately. Therefore, drugs in combination are only tested in cases where there is the realistic possiblitiy of seeing true synergy.

The best combinations are those in which there is true synergy and in which the toxicities of the drugs in the combination are non-overlapping, so that full doses of each drug may be given safely.

More emphasis should be put on matching treatment to patient, through the use of individualized genetic and cellular pre-testing, having more respect for minimal partial response or stable disease, when it can be achieved through use of the least toxic and mutagenic drug regimens, and reserve the use of higher dose therapy or aggressive combination chemotherapy to those patients with tumor biologies most amenable to attack and destroy by these aggressive treatments.

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Hey, I'm all in favor of the FDA approving any and all the drugs they want. However, the needed change in the war on cancer will not be on the types of drugs being developed, but on the understanding of the drugs we already have. The system is overloaded with drugs and underloaded with the wisdom and expertise for using them.

Pre-testing cancer cells before treatment, whether with chemotherapy or targeted therapies, would be more advantagous. There are molecular and cellular tests available to weed out those cancer patients that chemotherapy wouldn't have any benefit, what chemotherapy works the best for those that chemotherapy would benefit, and further monitor treatment success or disease progression.

Even these "smart" drugs, like all other chemotherapy drugs, do not work for everyone, they often have unwanted side effects, and they are extremely expensive. Patients, physicians, insurance carriers, and the FDA are all calling for predictive tests that allows for rational and cost-effective use of these drugs.

There is no proof beyond reasonable doubt for any approach to treating advanced cancer today. In life or death situations, one must make judgements based upon preponderance of available evidence as opposed to proof beyond reasonable doubt.

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