Real world data from multiple myeloma patients in Hungary supports the use of a triple combination regimen — Ninlaro (ixazomib), Revlimid (lenalidomide), and dexamethasone — in people already heavily treated for this disease.
The study, “Real World Efficacy and Safety Results of Ixazomib Lenalidomide and Dexamethasone Combination in Relapsed/Refractory Multiple Myeloma: Data Collected from the Hungarian Ixazomib Named Patient Program,” was published Pathology and Oncology Research.
After promising results from the TOURMALINE-MM1 Phase 3 trial (NCT01564537), regulatory agencies in the U.S. and Europe approved Ninlaro in combination with Revlimid and dexamethasone to treat myeloma patients who had at least one prior therapy.
In addition to extending the time to disease progression or death, this all-oral triple combination had a good safety profile in patients with multiple myeloma, including those in the high-risk category.
But while clinical trials show the combination to be safe and effective, data from clinical trials may not necessarily reflect real-world outcomes. For this reason, it is vital for researchers to study real-world data surrounding newly approved treatments.
Researchers in Hungary set out to assess the clinical characteristics and survival of relapsed multiple myeloma patients — all having already used one to three therapies — who received this combo treatment between December 2015 and April 2017.
The study included 77 patients treated across seven centers in Hungary. Most (67.1%) responded to the therapy, with researchers reporting 12.3% complete responses, 11% very good partial responses, and 43.8% partial responses. Stable disease was noted in additional 17.8%.
The overall progression-free survival, which measures the length of time during and after the treatment that a patient lives without the disease progressing, was 11.4 months.
Results also showed that patients given one prior treatment had a longer progression-free survival than those with two or more prior treatments.
Importantly, researchers found that the combination was equally effective across both the standard and high-risk group of patients.
Adverse events were found to usually be mild, with none severe enough to permanently stop taking the drug.
Overall, there were five deaths, three from infections and two from pulmonary embolism, when a blood clot gets caught in one of the blood vessels that go from the heart to the lung.
As expected, results from this study were different from those reported in the clinical trial. While a similar proportion of patients responded to treatment — 78.8%, including 14% complete responses and 36% very good partial responses — the estimated progression-free survival in TOURMALINE-MM1 was 20.6 months, which is 9.6 months longer that in the real world.
“Compared to the TOURMALINE study results, the PFS [progression-free survival] of our cohort is somewhat inferior, [which] is not unusual when real life patient data are compared to randomized controlled study results,” the researchers said.
They concluded that “[o]ur real word data support the use of Ixazomib-Revlimid-Dexamethasone as a highly effective and well tolerated oral treatment protocol for relapsed myeloma.”