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Dec 6, 2013

Phase III Endpoints Met by Novartis, GSK/Theravance

  • Positive Phase III results were reported today for compounds designed to fight multiple myeloma and asthma.

    Novartis said its investigational compound LBH589 (panobinostat) in combination with bortezomib and dexamethasone met the primary endpoint of significantly extending progression-free survival (PFS) in patients with relapsed or relapsed and refractory multiple myeloma compared to bortezomib and dexamethasone alone. LBH589 is a pan-deacetylase (pan-DAC) inhibitor that works by blocking a key cancer cell enzyme that ultimately results in cellular stress and death of these cells.

    "Given its mechanism of action, LBH589 has the potential to be an important treatment option for multiple myeloma," said Alessandro Riva, global head of oncology development and medical affairs at Novartis.

    The company cited PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA), a trial designed to evaluate LBH589 in patients with relapsed or relapsed and refractory multiple myeloma. Novartis said PANORAMA-1 results showed LBH589 delivering “significant” clinical benefit, supporting the company’s quest to market the drug as the first in its class of anticancer agents available to patients with multiple myeloma.

    Details were not immediately released. Full results from PANORAMA-1, according to Novartis, continue to be evaluated and will be presented at an upcoming medical congress and discussed with regulatory authorities.

    Earlier data showed that oral LBH589, when combined with bortezomib and dexamethasone, recaptures responses in heavily pretreated and bortezomib-refractory multiple myeloma patients, thereby providing these patients with a potential new option after failing prior standard treatments.

    Benefits and risks of LBH589 are also being explored in additional hematologic malignancies through ongoing clinical trials, the company said.

    Separately, GlaxoSmithKline (GSK) and Theravance said the combination of ICS fluticasone furoate (FF) and the long-acting beta2 agonist vilanterol (VI) met its primary endpoint in a Phase III efficacy and safety study to support a new asthma indication for the chronic obstructive pulmonary disease (COPD) compound.

    The companies said the combined 100/25 mcg dosage of FF/VI met its primary endpoint of statistically significant improvement in lung function compared with 100 mcg of FF alone. Lung function was defined for the study as 0–24-hour weighted mean forced expiratory volume in one second.

    The 12-week study evaluated 990 patients with moderate to severe persistent asthma. Patients were randomized to one of three treatments taken once-daily in the evening—two dosages of FF/VI inhalation powder, 100/25 mcg and 200/25 mcg, and 100 mcg FF inhalation powder alone. The primary comparison was FF/VI 100/25 mcg versus FF 100mcg. The primary endpoint was weighted mean serial FEV1 at the end of the 12-week treatment period.

    “We are pleased to see the results delivered by FF/VI in the treatment of asthma,” Dave Allen, head of GSK’s respiratory therapy area unit, R&D, said in a statement. “We have undertaken a large and comprehensive clinical program providing data on the efficacy and safety profile for FF/VI in asthma. With these additional data, we will consider our next steps in relation to an asthma filing in the United States."

    The most common reported side-effects included headache, nasopharyngitis, upper respiratory tract infection, and influenza. Incidences of any on-treatment serious adverse events were similar across all treatment arms.

    FF/VI—administered via a dry powder inhaler (DPI) called Ellipta®—is approved in the United States under the brand name Breo® Ellipta as an inhaled long-term, once-daily for maintenance treatment of airflow obstruction in patients with COPD, as well as chronic bronchitis and/or emphysema, as well as for reducing COPD exacerbations in patients with a history of exacerbations.



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