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Credit: NIH
Adding panobinostat to treatment with bortezomib and dexamethasone can improve progression-free survival (PFS) in previously treated patients with multiple myeloma, results of the PANORAMA-1 trial suggest.
The combination conferred a 4-month improvement in median PFS when compared to bortezomib and dexamethasone plus placebo.
There was no significant difference in overall survival between the treatment groups, but researchers said these data are not mature.
“The PANORAMA-1 study is the first phase 3 trial to show the superiority of [panobinostat] plus bortezomib and dexamethasone over one of the standard 2-drug regimens for patients with relapsing and/or refractory multiple myeloma,” said lead study investigator Jesus San-Miguel, MD, of Clínica Universidad de Navarra in Pamplona, Spain.
Dr San-Miguel and his colleagues reported the results of PANORAMA-1 in The Lancet Oncology. The trial was sponsored by Novartis Pharmaceuticals, the company developing panobinostat.
The trial included 768 patients with relapsed or relapsed and refractory multiple myeloma who had failed at least 1 prior treatment.
Three-hundred and eighty-seven patients were randomized to treatment with panobinostat, bortezomib, and dexamethasone. And 381 patients were randomized to receive placebo, bortezomib, and dexamethasone.
The median follow up was 6.47 months in the panobinostat arm 5.59 months in the placebo arm.
The study’s primary endpoint was PFS. And the median PFS was significantly longer in the panobinostat arm than the placebo arm—11.99 months and 8.08 months, respectively (P<0.0001).
The median overall survival, on the other hand, was similar between the treatment arms. It was 33.64 months in the panobinostat arm and 30.39 months in the placebo arm (P=0.26).
Likewise, the overall response rate was similar between the treatment arms—60.7% with panobinostat and 54.6% with placebo (P=0.09). But the rate of complete or near-complete response was higher with panobinostat—27.6% and 15.7%, respectively (P=0.00006).
The rate of serious adverse events was 60% in the panobinostat arm and 42% in the placebo arm.
The most common grade 3/4 adverse events were thrombocytopenia (67% and 31%, respectively), lymphopenia (53% and 40%, respectively), neutropenia (35% and 11%, respectively), diarrhea (26% and 8%, respectively), and neuropathy (18% and 15%, respectively).
Based on these data, panobinostat was granted priority review by the US Food and Drug Administration in May. Priority review is given to therapies that may offer major advances in treatment. 
Credit: NIH
Adding panobinostat to treatment with bortezomib and dexamethasone can improve progression-free survival (PFS) in previously treated patients with multiple myeloma, results of the PANORAMA-1 trial suggest.
The combination conferred a 4-month improvement in median PFS when compared to bortezomib and dexamethasone plus placebo.
There was no significant difference in overall survival between the treatment groups, but researchers said these data are not mature.
“The PANORAMA-1 study is the first phase 3 trial to show the superiority of [panobinostat] plus bortezomib and dexamethasone over one of the standard 2-drug regimens for patients with relapsing and/or refractory multiple myeloma,” said lead study investigator Jesus San-Miguel, MD, of Clínica Universidad de Navarra in Pamplona, Spain.
Dr San-Miguel and his colleagues reported the results of PANORAMA-1 in The Lancet Oncology. The trial was sponsored by Novartis Pharmaceuticals, the company developing panobinostat.
The trial included 768 patients with relapsed or relapsed and refractory multiple myeloma who had failed at least 1 prior treatment.
Three-hundred and eighty-seven patients were randomized to treatment with panobinostat, bortezomib, and dexamethasone. And 381 patients were randomized to receive placebo, bortezomib, and dexamethasone.
The median follow up was 6.47 months in the panobinostat arm 5.59 months in the placebo arm.
The study’s primary endpoint was PFS. And the median PFS was significantly longer in the panobinostat arm than the placebo arm—11.99 months and 8.08 months, respectively (P<0.0001).
The median overall survival, on the other hand, was similar between the treatment arms. It was 33.64 months in the panobinostat arm and 30.39 months in the placebo arm (P=0.26).
Likewise, the overall response rate was similar between the treatment arms—60.7% with panobinostat and 54.6% with placebo (P=0.09). But the rate of complete or near-complete response was higher with panobinostat—27.6% and 15.7%, respectively (P=0.00006).
The rate of serious adverse events was 60% in the panobinostat arm and 42% in the placebo arm.
The most common grade 3/4 adverse events were thrombocytopenia (67% and 31%, respectively), lymphopenia (53% and 40%, respectively), neutropenia (35% and 11%, respectively), diarrhea (26% and 8%, respectively), and neuropathy (18% and 15%, respectively).
Based on these data, panobinostat was granted priority review by the US Food and Drug Administration in May. Priority review is given to therapies that may offer major advances in treatment.
Credit: NIH
Adding panobinostat to treatment with bortezomib and dexamethasone can improve progression-free survival (PFS) in previously treated patients with multiple myeloma, results of the PANORAMA-1 trial suggest.
The combination conferred a 4-month improvement in median PFS when compared to bortezomib and dexamethasone plus placebo.
There was no significant difference in overall survival between the treatment groups, but researchers said these data are not mature.
“The PANORAMA-1 study is the first phase 3 trial to show the superiority of [panobinostat] plus bortezomib and dexamethasone over one of the standard 2-drug regimens for patients with relapsing and/or refractory multiple myeloma,” said lead study investigator Jesus San-Miguel, MD, of Clínica Universidad de Navarra in Pamplona, Spain.
Dr San-Miguel and his colleagues reported the results of PANORAMA-1 in The Lancet Oncology. The trial was sponsored by Novartis Pharmaceuticals, the company developing panobinostat.
The trial included 768 patients with relapsed or relapsed and refractory multiple myeloma who had failed at least 1 prior treatment.
Three-hundred and eighty-seven patients were randomized to treatment with panobinostat, bortezomib, and dexamethasone. And 381 patients were randomized to receive placebo, bortezomib, and dexamethasone.
The median follow up was 6.47 months in the panobinostat arm 5.59 months in the placebo arm.
The study’s primary endpoint was PFS. And the median PFS was significantly longer in the panobinostat arm than the placebo arm—11.99 months and 8.08 months, respectively (P<0.0001).
The median overall survival, on the other hand, was similar between the treatment arms. It was 33.64 months in the panobinostat arm and 30.39 months in the placebo arm (P=0.26).
Likewise, the overall response rate was similar between the treatment arms—60.7% with panobinostat and 54.6% with placebo (P=0.09). But the rate of complete or near-complete response was higher with panobinostat—27.6% and 15.7%, respectively (P=0.00006).
The rate of serious adverse events was 60% in the panobinostat arm and 42% in the placebo arm.
The most common grade 3/4 adverse events were thrombocytopenia (67% and 31%, respectively), lymphopenia (53% and 40%, respectively), neutropenia (35% and 11%, respectively), diarrhea (26% and 8%, respectively), and neuropathy (18% and 15%, respectively).
Based on these data, panobinostat was granted priority review by the US Food and Drug Administration in May. Priority review is given to therapies that may offer major advances in treatment.