Biotech Tracker News - Longer-Term Benefits of Zometa
April 30, 2003 Dr. Fred Saad and colleagues presented two posters supporting the continued use of Novartis’s (NYSE: NVS) Zometa for patients with prostate cancer-related bone disease. The presentations were held at a moderated poster session of The American Urological Association’s annual meeting. The posters featured data from a cohort of 643 patients, 186 of whom were entirely evaluable for the full duration of the investigation, with advanced, hormone-refractory prostate cancer and at least one bone metastasis who were randomized to Zometa 4 mg (over a 15-minute infusion) or placebo every 3 weeks for 24 months.  The posters showed that Zometa can provide durable palliation of bone pain for patients with prostate cancer metastatic to bone. They also confirmed Zometa’s ability to reduce skeletal complications associated with metastatic prostate cancer over the longer-term. Also solidified were agent’s reassuring safety and tolerability profiles for up to 24 months of use. The study further confirmed Zometa’s clinically significant magnitude of therapeutic effect regarding longer-term skeletal complication risk reduction.  A considerable proportion of patients affected by advanced prostate cancer develop bone metastases associated with severe bone pain. Although earlier generation bisphosphonates palliate pain over the short term in this clinical scenario, randomized, placebo-controlled trials have failed to show that etidronate, clodronate, and pamidronate can affect these pain outcomes, and other skeletal complications, over a longer-term. Therefore, the investigators sought to see whether Zometa could add longer-term pain reduction to its well-characterized ability to reduce skeletal complications for advanced prostate cancer patients over 15 months.  At 24 months, Zometa significantly reduced the proportion of patients experiencing a skeletal event such as a pathologic fracture, spinal cord compression, radiotherapy requirement, or surgical requirement. Zometa also significantly delayed the time to any first skeletal event by more than 5 months. Zometa consistently reduced bone pain over the study period. On a 0-10 composite pain scale, patients entered the investigation with mean scores of approximately 2 in both treatment groups. Zometa recipients experienced a diminished rate of pain intensity increase compared with placebo recipients, reaching statistical and clinical significance at 3 months (p = .003), 9 months (p = .03), 21 months (p = .014), and 24 months (p = .024). Quality of life and supplementary analgesia requirement profiles were reassuring. Statistically and clinically significant Zometa advantages included:  fewer recipients experienced a skeletal related event – 38% versus 49%  fewer recipients experienced a skeletal related event even when asymptomatic fractures were excluded from the analysis (p = .019)  time to first skeletal related event was longer (median of 488 versus 321 days; p= .009)  time to first pathologic fracture was reduced  skeletal morbidity rate was reduced (mean of 0.77 versus 1.47 events/year; p = .005)  reduced Brief Pain Inventory composite pain scores at 24 months (p = .024).  Zometa’s overall skeletal related event risk reduction was 36% (hazard ratio = 0.64; 95% confidence interval, 0.49, 0.85; p= .002). The median survival was 546 days in the Zometa group and 469 days in the placebo group.
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