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news.Phase III data shows reduced risk of disease progression by 66% in advanced NET patients
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New data published by Novartis, show that patients with advanced neuroendocrine tumors (NET) of the midgut who were treated with Sandostatin LAR Depot (octreotide acetate for injectable suspension) experienced a 66% reduction in risk of disease progression versus placebo. The data was published in in the Journal of Clinical Oncology. Sandostatin LAR is indicated to treat the diarrhea and flushing episodes associated with advanced carcinoid tumors.
These data are from the phase IIIb study PROMID. In the study, patients receiving octreotide LAR more than doubled time without tumor progression for a median of 14 months compared with a median of six months for those who received placebo.
Prof Rudolf Arnold, lead investigator of PROMID at Philipps-University, Marburg, Germany, said: “PROMID is a placebo-controlled, randomised trial that showed octreotide LAR can control tumor growth in all patients with NET of the midgut whether or not they experience symptoms. These are promising data for patients with NET who face limited treatment options.”
The PROMID study showed antitumor benefit in patients with functioning and non-functioning tumors resulting from treatment with octreotide LAR. In an analysis of patients with non-functioning tumors, time to tumor progression for patients receiving octreotide LAR was 28.8 months versus 5.9 months for those on placebo (hazard ratio=0.25 [95% confidence interval 0.10-0.59]). For patients with functioning tumors, time to tumor progression for patients receiving octreotide LAR was 14.3 months and 5.5 months for those on placebo (hazard ratio=0.23 [95% confidence interval 0.09 to 0.57]).
David Epstein, president and CEO of Novartis Oncology at Novartis Molecular Diagnostics, said: “For more than a decade, octreotide LAR has been a cornerstone of NET treatment for the symptoms of flushing and diarrhea associated with carcinoid syndrome. The findings of the PROMID trial are critical because they show octreotide LAR also has the potential to control tumor growth and provide the benefit of treatment to even more patients with an unmet medical need.”