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Caelyx Delays Time to Disease Progression as Maintenance Therapy in,Patients with Metastatic Breast Cancer

CHICAGO - June 3, 2007 - Schering-Plough Corp. announced results from a Phase III study that showed maintenance chemotherapy with Caelyx (pegylated liposomal doxorubicin hydrochloride) significantly prolonged time to progression (TTP) in patients with metastatic breast cancer with infrequent and manageable clinical toxicity after first-line chemotherapy. These data were presented today at the 43rd Annual Meeting of the American Society of Clinical Oncology.

"While standard chemotherapy has proven effective for patients with metastatic breast cancer, their response is short-lived and the time to progression is brief," said Emilio Alba, M.D., professor at Hospital U. Virgen de la Victoria, in Malaga, Spain and lead investigator for the
study. "The results from this study showed a significantly improved time to progression (13.2 months) in patients treated with CAELYX versus the observational arm (10.2 months)."
The Spanish Cooperative Group, Grupo Espanol de Investigacion en Cancer de Mama (GEICAM) conducted the multi-center, Phase III study at seven different sites throughout Spain.

Of the 288 patients with metastatic breast cancer registered for the trial, 155 subjects who had responded to initial therapy or had stable disease were randomized either to receive CAELYX or to observation. Patients receiving therapy were given a regimen of CAELYX at 40 mg/m2 once every four weeks for 6 cycles of therapy. Patients in the CAELYX arm experienced a median improvement in time to progression of three months (13.2 months versus the observational arm of 10.2 months; p=0.0005).

The patients in the study had a median age of 57, and had adequate bone marrow, renal, hepatic and cardiac function. These patients had experienced either complete response, partial response or had stable disease. Patients received induction chemotherapy with three cycles of
anthracycline followed by three cycles of taxane, and were then randoml
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