CON - 1 Conclusions C David R. Parkinson Vice President, Global Head, Clinical Research and Development Novartis Pharmaceuticals Corporation.

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Presentation transcript:

CON - 1 Conclusions C David R. Parkinson Vice President, Global Head, Clinical Research and Development Novartis Pharmaceuticals Corporation

C CON - 2 ZOMETA ® for the Treatment of Patients With Bone Metastases  Consequences of bone metastases are serious events for cancer patients  Current therapy does not meet clinical needs of this broad population  Preclinical data suggest superior potency of ZOMETA in inhibiting osteoclast activity compared to the range of other bisphosphonates, pamidronate included  The current treatment program was designed to test the efficacy of ZOMETA across a broad range of tumors

C CON - 3 ZOMETA ® for the Treatment of Patients With Bone Metastases  Data have been presented from 3 large, international, controlled, double-blind, randomized clinical trials – These trials included > 3,000 patients with breast cancer, myeloma, prostate cancer, and other solid tumors – This represents the largest clinical trial program ever conducted to evaluate the efficacy and safety of bisphosphonates in patients with metastatic cancer to bone

C CON - 4 Safety  Initial experience with higher doses and/or shorter infusion times revealed renal events characteristic of i.v. bisphosphonates  Increasing the infusion time to 15 minutes and using the 4-mg dose of ZOMETA ® have yielded a renal safety profile similar to pamidronate  The safety profile is consistent with those typically seen with i.v. bisphosphonates

C CON - 5 Summary of Efficacy Breast Cancer and Multiple Myeloma (010)  The effectiveness of ZOMETA ® compared to pamidronate has been reliably established in preplanned analyses of SREs with a noninferiority design

C CON - 6 Summary of Efficacy Solid Tumors –PC/BC (011)  Consistent benefit across SRE analyses, with a relative reduction of 14% of the proportion of patients having an SRE  Important extension of the median time to first SRE by 67 days, with a 27% reduction in relative risk, in this poor-prognosis patient population  First clinical trial demonstration of bisphosphonate benefit in these patient populations

C CON - 7 Summary of Efficacy Prostate Cancer (039)  Clear demonstration of efficacy, both in terms of a 25% relative reduction of SREs, and an extension of the time to the first SRE by more than 100 days, representing a 33% relative risk reduction, compared to placebo  First demonstration of such a benefit in patients with prostate cancer, and an important addition to therapy for prostate cancer

C CON - 8 Conclusions  Confirmation of the activity of ZOMETA ® in breast cancer and myeloma, where pamidronate has been shown to be effective  Demonstrated clinical benefit to patients with a range of other solid tumors metastatic to bone  Consistency of this efficacy is an important characteristic of the drug; across 3 trials, multiple tumor types, and multiple endpoints  In addition, efficacy is observed in patients with bone lesions varying from osteolytic to osteoblastic in radiologic appearance  This efficacy is observed with a safety profile similar to pamidronate, and with a more convenient administration time