Welcome to this month’s issue of OncoFacts. We appreciate your interest in this newsletter. You are invited to participate in Quick Poll (see left-hand margin of this page) which features the issue of prophylaxis for venous thromboembolism in hospitalized medical patients.

CME – accredited educational activities scheduled for the second half of 2007:

The 3rd Annual Oncology Highlights meeting, jointly-sponsored by the Georgia Cancer Foundation and the Winship Cancer Institute of Emory University, will be held on July 20 and July 21 at the Grand Hyatt Buckhead in Atlanta, Georgia. We invite you to visit our Web site (www.asoncology.com) for additional information and online registration.

Great Debates^SM in Hematology is scheduled for September 28 and September 29, 2007 at the Westin River North in Chicago. The meeting will feature thought leaders (one presenting the “pro” viewpoint and one presenting the “con” viewpoint) debating important controversial issues in the field of hematology. Chairpersons for the meeting are James Armitage, MD, Hagop Kantarjian, MD, and Robert Orlowski, MD. Visit our Web site for additional information and online registration.

On March 13, 2007 the FDA approved GlaxoSmithKline’s (GSK) lapatinib (Tykerb^®) to be used in combination with capecitabine for the treatment of patients with HER2-positive, advanced, metastatic breast cancer (MBC) that had been previously treated with other cancer drugs, including an anthracycline, a taxane, and trastuzumab. Lapatinib is a once-daily orally administered small molecule dual receptor (EGFR and HER2) tyrosine kinase inhibitor. The approval was based on the positive results of a randomized clinical trial of 392 patients with HER2-positive advanced MBC treated with either lapatinib + capecitabine or capecitabine alone that demonstrated a statistically significant improvement in the time-to-progression (TTP), the primary endpoint, favoring the combination arm (TTP with HR 0.49, p≤0.001; median TTP 8.4 months vs 4.4 months with p<0.001). The tumor response rate was higher in patients treated with the combination arm (24% vs 14%). The survival data is not yet mature. This improvement in outcome was achieved without an increase in serious toxic effects or symptomatic cardiac events.

The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee has recommended to the FDA that there is substantial evidence of the efficacy and safety of Dendreon’s sipuleucel-T (Provenge^®) as a treatment for patients with asymptomatic, metastatic, androgen-independent (hormone-refractory) prostate cancer. The company’s biologics license application (BLA) for the active cellular immunotherapy had been assigned priority review status by the FDA in January 2007. If approved for marketing by the FDA, Provenge would become the first active cellular immunotherapy and the first biologic approved to treat prostate cancer. The BLA is based primarily on a statistically significant 4.5 month improvement in overall survival (OS) achieved by Provenge compared to placebo (25.9 months vs 21.4 months) in a phase III trial (D9901). The FDA will now review the advisory committee’s recommendations with an anticipated decision by May 15, 2007.

On March 16, the FDA granted approval to Alexion Pharmaceuticals, Inc.’s eculizumab (Soliris™) for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Eculizumab is the first FDA-approved medication indicated for the treatment of any PNH manifestation. In PNH, patients develop red blood cells (PNH cells) that are abnormally sensitive to complement. The complement-mediated destruction (lysis) of these PNH cells creates intravascular hemolysis. Eculizumab is a monoclonal antibody that inhibits the terminal components of complement, thereby reducing hemolysis and improving hemoglobin levels. The approval was based on the results of a placebo-controlled trial of 87 PNH patients with at least 4 red blood cell transfusions in the last 12 months. Co-primary endpoints, hemoglobin stabilization and reduction in number of transfused units, were significantly improved (p<0.01 for both) with IV infusions of eculizumab.

On April 5, 2007 the FDA confirmed that it has extended the review of Wyeth Pharmaceuticals’ NDA for temsirolimus (Torisel™), an investigational treatment for patients with advanced renal cell carcinoma (RCC). The NDA was originally submitted on October 5, 2006 and was granted priority review status. The company recently submitted additional information on tumor evaluation, as requested by the FDA as part of the ongoing review. The action date for the NDA has been extended by 3 months, to July 2007, to allow the agency time to complete a full review of these analyses. The pivotal study of temsirolimus, an mTOR (mammalian target of rapamycin) inhibitor, showed that in patients with advanced RCC and poor prognostic features who had no prior systemic therapy, temsirolimus significantly increased the median OS (the primary endpoint) by 49% compared to interferon-alpha.

The FDA has granted fast-track designation to Cell Therapeutics’ paclitaxel poliglumex (Xyotax™) for the first-line treatment of advanced non-small cell lung cancer (NSCLC) in female patients with poor performance status. The company recently filed a special protocol assessment (SPA) with the FDA for the design of its phase III trial of paclitaxel poliglumex in women with advanced NSCLC. The trial, PGT306, will focus exclusively on women with normal estrogen levels – the subset where paclitaxel poliglumex demonstrated the greatest survival advantage in the STELLAR trials. The trial is expected to enroll 300 patients.(Back)

Preliminary results of a large, randomized, phase III trial conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG) have shown that use of a low dose of dexamethasone in combination with lenalidomide (Revlimid^®, Celgene Corporation) is associated with improved survival when compared to a treatment regimen with lenalidomide and a higher, standard dose of dexamethasone in patients with newly-diagnosed multiple myeloma. The Data Monitoring Committee overseeing the trial recommended that the survival results from a recent interim analysis be made public because of early differences being seen in OS rates. Patients who received low-dose dexamethasone and lenalidomide had a one-year survival of 96% compared to 86% for those treated with standard-dose dexamethasone and lenalidomide. In addition, there were fewer side effects associated with the low-dose dexamethasone + lenalidomide regimen. Detailed results from this trial will be presented at the American Society of Clinical Oncology annual meeting in Chicago from June 1 to 5, 2007.(Back)