Pomalyst Combo Delays Disease Progression in Relapsed or Refractory Myeloma Patients in Phase 3 Trial

José Lopes, PhD avatar

by José Lopes, PhD |

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survival and ASCT

A combination treatment including Pomalyst (pomalidomide) significantly extended the time until disease progression or death in patients with relapsed or refractory multiple myeloma who were treated in a Phase 3 trial.

That result was announced by Celgene, Pomalyst‘s maker, regarding the OPTIMISMM trial (NCT01734928), which assessed if adding Pomalyst to Velcade (bortezomib) and low-dose dexamethasone was better than a combination of Velcade plus dexamethasone in patients who already had received a prior Revlimid regimen.

OPTIMISMM is the only Phase 3 study analyzing a triple combination in these patients, the company said.

The study enrolled 559 adult participants whose disease progressed during or after their last anti-myeloma treatment. Pomalyst was taken orally on days 1-14 of a 21-day treatment cycle, along with a subcutaneous dose of Velcade and an oral dose of dexamethasone.

Treatment with Pomalyst induced a significant and clinically relevant increase in progression-free survival — the study’s primary goal — which is defined as the length of time after treatment that patients do not exhibit disease worsening.

The triple-combo therapy also showed a safety profile consistent with prior data.

Additional study goals are overall survival (up to five years), overall response rate – defined as the percentage of patients who respond to treatment – and duration of response.

Celgene said it will present detailed results from its Phase 3 study at future medical meetings. The company estimates study completion by April, 2022.

“The OPTIMISMM results confirm the expanding role of pomalidomide in previously treated multiple myeloma patients,” Paul Richardson, MD, the study’s principal investigator, said in a press release. The triple combination, Richardson added, is “an important step in improving care, and especially for patients previously treated with lenalidomide in this setting.”

Celgene’s Pomalyst is a derivative of thalidomide that inhibits the process of new blood vessel formation, called angiogenesis. Tumors require new vessels to match the increasing blood supply needed for their growth.

Pomalyst is indicated currently in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least two prior therapies, including Revlimid and an inhibitor of proteasomes — cellular complexes that break down proteins — and have exhibited disease progression within 60 days of completion of the last therapy.

A combo treatment with Pomalyst, dexamethasone, and the immunotherapy Darzalex (daratumumab) was approved by the U.S. Food and Drug Administration (FDA) as a multiple myeloma treatment in 2017.