Novartis' Myeloma Drug Adds 4-Month PFS In Trial

Novartis announced new data from the Phase 3 trial of panobinostat (LBH589) showing that the drug increased median progression free survival by 4 months when added to two other drugs in patients with relapsed and/or refractory multiple myeloma.

Panobinostat is a pan-DAC inhibitor and epigenetic regulator that may help in restoring cell programming in multiple myeloma. The compound was given priority review by the U.S. Food and Drug Administration (FDA). Regulatory applications in other countries are currently undergoing review.

Findings from the Phase 3 PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) trial showed that panobinostat plus bortezomib and dexamethasone achieved a clinically relevant 4-month improvement in median PFS. Addition of panobinostat to the combination therapy also increased complete and near complete response rates as well as duration in response across all patient subgroups.

“The PANORAMA-1 study is the first Phase 3 trial to show the superiority of LBH589 plus bortezomib and dexamethasone over one of the standard two-drug regimens for patients with relapsing and/or refractory multiple myeloma. These results show that by adding a new mechanism of action, pan-DAC inhibition, there is a significant benefit for this patient population,” said lead study investigator Jesus San-Miguel, Director of Clinical and Translational Medicine, Clínica Universidad de Navarra in Pamplona, Spain.

Multiple myeloma is the second leading cancer of the blood and is incurable at present. Most patients with myeloma will relapse or become refractory to standard treatments.

Alessandro Riva, Global Head of Novartis Oncology Development and Medical Affairs, said, “The PANORAMA-1 results provide strong evidence of the potential impact LBH589 could have for the multiple myeloma community. We are committed to working with regulatory authorities to make this treatment available to patients as soon as possible.”

Earlier this year, the company presented its findings for panobinostat at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago. Novartis published the study results in the journal The Lancet Oncology.