Pomalyst Triple Combo Delays Disease Progression in Relapsed or Refractory Myeloma Patients, Phase 3 Data Show

Adding Pomalyst (pomalidomide) to a combination of Velcade (bortezomib) and dexamethasone significantly extended the time until disease worsening or death in patients with relapsed or refractory multiple myeloma, updated Phase 3 trial data shows.

The trial, called OPTIMISMM (NCT01734928), assessed if the triple combination was better than Velcade and dexamethasone in patients who had received prior Revlimid (lenalidomide) treatment. 

Findings are being presented Friday in the poster, “Pomalidomide (POM), bortezomib, and low‐dose dexamethasone (PVd) vs bortezomib and low-dose dexamethasone (Vd) in lenalidomide (LEN)-exposed patients (pts) with relapsed or refractory multiple myeloma (RRMM): Phase 3 OPTIMISMM trial,” during the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Pomalyst (marketed as Imnovid in Europe) is an immunomodulatory agent analogue to thalidomide. The medicine is indicated, in combination with dexamethasone, for patients with multiple myeloma whose disease became worse after at least two prior anti-myeloma treatments, including Revlimid and a proteasome inhibitor — such as Velcade, Kyprolis or Ninlaro.

OPTIMISMM is now studying the safety and effectiveness of adding Pomalyst to a combo therapy of Velcade (bortezomib) and low-dose dexamethasone in relapsed or refractory myeloma patients who previously received one to three treatments, including Revlimid.

The study enrolled 559 adults, randomly assigned the Pomalyst combination or Velcade and low-dose dexamethasone alone. Most participants had failed to respond to their last anti-myeloma treatment.

After a median follow-up of 16 months, Pomalyst significantly improved the length of time patients lived without disease worsening from 7.10 to 11.2 months, reducing the risk of disease progression or death by 39%, compared with the combo without Pomalyst.

Adding Pomalyst seemed to particularly benefit patients who had had only one line of anti-myeloma treatment prior to the study, reducing their risk of disease progression or death by 46%.

Adverse effects remained manageable and were consistent with prior data on regimens with Pomalyst. Data on overall survival is not yet available.

So far, this is the only Phase 3 study reporting a significant and clinically meaningful improvement in progression-free survival in patients who failed to respond to Revlimid.

At this year’s ASCO annual meeting, Celgene — Pomalyst’s maker — is also presenting data from many other anti-cancer therapies currently under investigation by the company, including updated data from the first clinical study of bb2121, a CAR T-cell therapy for multiple myeloma (NCT02658929).

“Cancer research is at a critical point where advances in cellular immunotherapy may be able to drive previously unattainable advancements,” Nadim Ahmed, Celgene’s president of hematology and oncology, said in a press release.

“The studies being shared at ASCO this year reinforce our position of being at the forefront of discoveries that can accelerate our understanding of disease mechanisms with the opportunity to harness a patient’s own immune system to maximize the potential of new therapeutic options for patients,” he said.