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