ASCO Policy Change Creates Massive Avalanche of Pre-Meeting Data

By Matthew Mahady
Published: Wednesday, Jun 09, 2010
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For a diverse spectrum of stakeholders, the annual American Society of Clinical Oncology (ASCO) meeting is one of the biggest, most significant events of the calendar year. Information disclosed at ASCO can move world financial markets, seriously affect the bottom lines of drug and biotech companies, capture the attention of government regulators, alter managed care company protocols and practice guidelines, change the way oncologists practice medicine, and offer new hope to struggling patients.

Thus, when ASCO decision-makers decided to revise the manner in which they disseminate eagerly anticipated clinical research data prior to this year’s recently adjourned 44th annual meeting held at the McCormick Place Convention Center in Chicago, from May 30 through July 3, 2008, the news made headlines and made reverberations that were felt throughout the worlds of oncology research, practice, finance, and investment.

In the past, ASCO members were granted an advance look at the data that were going to be presented at the upcoming annual meeting. Critics charged that ASCOs early disclosure policies enabled both ASCO members and well-positioned investors with ASCO membership contacts to leverage the advance information, thereby outmaneuvering their competitors and getting a valuable jump on the broader market. Over the past few years, for example, even casual market observers were able to ascertain which companies were going to release positive data and which companies were going to release negative data, simply by the watching the up or down movement of a given company’s share price in advance of the meeting.

In an effort to make the process of information access fairer and more uniform, ASCO has toughened its policy, eliminating the practice of early data disclosure to its membership. Instead of send- ing members a book of abstracts several weeks in advance, as it had done up until this year, ASCO made information available all at once, lifting its embargo at 9 o’clock P.M., Eastern Standard Time, on May 15, 2008, roughly two weeks before the commencement of its annual meeting on May 30.

The immediate result of ASCO’s new disclosure method was an almost overwhelming cascade of data from almost 5,000 clinical studies. Hidden within the tsunami of released data, are studies that will move the market, seemingly small details that could dramatically weight down or lift up per-share prices of large concerns, and endpoint results likely to determine the futures of several upstart, single-product biotechs.

Now that the smoke has settled and the gambles have been made, it is easier to determine the winners and losers of ASCO 2008. One effect of the ASCO policy change is that this year’s marketplace results, instead of being influenced by whispered nuggets of information between people ‘in-the-know,’ were based more on the actual clinical performance and quality of research produced. Measured by this yardstick, a mix of big industry players (such as Novartis, Amgen, and Genzyme) and smaller concerns (BioVex, Nektar) posted impressive accomplishments:

â–º Novartis

Novartis scored a major step forward in the realm of kidney cancer therapy. According to a phase III trial released with the rest of the ASCO data, product candidate RAD001 (everolimus) delayed progression of disease by a year, in nearly two-thirds of the study patients taking the oncedaily drug. This was a significantly better result than in those taking placebo (of whom 37% sustained disease-free progression for one year). The late-stage trial was stopped early because it met its main target.

Other RAD001 data were released at ASCO. In all, four oral sessions as well as several poster sessions featured RAD001.

Perhaps more impressive than any one positive study was the company’s overall commitment to the oncology sector as evidenced by the sheer scope and quantity of the research published by Novartis at the meeting. Novartis Oncology’s cancer therapies were the subject of more than 170 abstracts at ASCO. In addition, Novartis drugs were the subjects of seven oral presentations.

Also, the first efficacy results from the ABCSG-12 study, looking at the effect of Zometa (zoledronic acid) on disease-free survival in patients with early-stage breast cancer, were highlighted in a plenary session. Findings indicated that Zometa (zoledronic acid), prescribed to prevent fractures in breast cancer patients whose tumors have spread, may actually help slow the cancer itself. The study suggests the drug may be useful for more patients with breast cancer. According to researchers, 23% of women who received Zometa had tumor cells in the bone marrow after three months, compared with 36% of those who did not get the drug. “Tumor cells are continually being released from the primary tumor,” Rebecca Aft, MD, Barnes Jewish Hospital and Washington University, St. Louis, said in a statement. “It is thought that the bone marrow harbors these cells and that these cells are likely to evolve into metastatic disease. We think that zoledronic acid changes the bone marrow so that cancer cells are unable to lodge there.”

â–º Amgen

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