Favorable word from the news-spewing European Cancer Conference (ECCO) in Barcelona, Spain, on two of Amgen Inc.'s compounds helped offset less happy doings at the company - namely, the start of previously disclosed layoffs, due to reimbursement trouble for the firm's anemia drugs.
Amgen this week made public its plan to let go 675 employees from its Thousand Oaks, Calif.-based headquarters as part of the dismissal of as many as 2,600 from the total staff of about 20,000. (See BioWorld Today, Aug. 17, 2007.)
Results disclosed at ECCO involved a compound important in Amgen's pair of erythropoietin stimulating agents, Aranesp (darbepoetin alfa). A Phase II study showed that extended dosing when paired with chemotherapy treatment (every two or every three weeks depending on the chemo regimen) appeared to be efficacious with respect to changes in hemoglobin, with no unexpected adverse events observed when compared to weekly dosing.
Also, results from two combined patient-level analyses suggested that patients treated with Aranesp experienced a decrease in blood transfusions and improvement in hematologic response, and the examinations do not suggest a negative impact on overall survival or progression-free survival between patients receiving chemo with Aranesp and those who didn't get the drug.
Amgen's a granulocyte colony stimulating factor Neulasta (pegfilgrastim), used to decrease infection in chemo patients, also was the subject of talk at the meeting. Results from an integrated analysis showed that primary prophylactic use of the compound decreased febrile-neutropenia hospitalizations by more than half (4 percent vs. 10 percent) when compared to current practice neutropenia management and reduced chemo dose reductions by nearly two-thirds (9 percent vs. 24 percent).
Shares of Amgen (NASDAQ:AMGN) closed Wednesday at $56.08, up $1.20.
In other news from ECCO:
• Pfizer Inc., of New York, said preliminary results from a new Phase II study provide data on the antitumor activity and tolerability of Sutent (sunitinib) in patients with advanced gastric cancer. Also, data from Phase I studies provided information on Sutent's tolerability and safety in combination with current standard-of-care chemo in the treatment of hormone-refractory prostate cancer and advanced breast cancer. The multi-kinase inhibitor Sutent was approved by the FDA in January 2006 for two indications: gastrointestinal stromal tumors and advanced kidney cancer.
• L. Hoffmann-La Roche Ltd., of Basel Switzerland, reported that data from a Phase III study showed that the addition of Herceptin (trastuzumab) to chemotherapy prior to breast cancer surgery completely eradicated tumors in nearly three times as many women with inflammatory HER2-positive breast cancer compared with chemotherapy alone. HER2-positive disease is diagnosed in up to 30 percent of all breast cancer cases. In the trial, known as the NeOAdjuvant Herceptin (NOAH), patients were assigned to one of two cohorts depending on HER2 status. All patients received neoadjuvant chemotherapy before surgery consisting of three cycles of doxorubicin-paclitaxel, four cycles of paclitaxel and three cycles of cyclophosphamide/methotrexate/5-fluorouracil. Patients with HER2-positive disease were randomized to receive concomitant Herceptin for one year or chemotherapy only. Out of 228 evaluable patients with HER2-positive breast cancer, 61 had inflammatory breast cancer. Of the 99 evaluable patients with HER2-negative breast cancer, 14 had IBC. Thirty-one patients with HER2-positive IBC received Herceptin in addition to chemotherapy. Herceptin is marketed in the U.S. by Genentech, in Japan by Chugai and internationally by Roche.