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Ixazomib plus lenalidomide-dexamethasone improves PFS, OS in multiple myeloma

Audrey Abella
07 Sep 2017

Combining ixazomib with lenalidomide and dexamethasone improved progression-free survival (PFS) and overall survival (OS) over lenalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) previously treated with one to three treatments, according to the China Continuation study.

A total of 115 Chinese patients were randomized to receive ixazomib 4.0 mg (n=57) or placebo (n=58) on days 1, 8, and 15, plus lenalidomide 25 mg (days 121) and dexamethasone 40 mg (days 1, 8, 15, and 22) in 28‑day cycles. [J Hematol Oncol 2017;doi:10.1186/s13045-017-0501-4]

The ixazomib-lenalidomide-dexamethasone combination was superior to the lenalidomide-dexamethasone combination in terms of PFS (median 6.7 vs 4.0 months; hazard ratio [HR], 0.598, 95 percent confidence interval [CI], 0.3670.972; p=0.035) after a median follow-up of 7.4 and 6.9 months for the respective groups.

There was also a significant OS benefit favouring the ixazomib-lenalidomide-dexamethasone combination over lenalidomide-dexamethasone (median 25.8 vs 15.8 months; HR, 0.419, 95 percent CI, 0.2420.726; p=0.001) after a median follow-up of 20.2 and 19.1 months, respectively.

“[The] OS findings are indicative of a treatment effect rather than an effect driven by imbalances between arms in patient subgroups, subsequent therapies, or non-MM-related deaths,” said the researchers.

Grade 3 adverse events (AEs) were reported by 67 and 74 percent of participants in the ixazomib-lenalidomide-dexamethasone and lenalidomide-dexamethasone arms, respectively.

This study was a separate regional extension of the global TOURMALINE-MM1* study. [N Engl J Med 2016;374:1621-1634] However, despite identical eligibility criteria and dosing regimens, median PFS in the current study was lower compared with the global trial.

“[S]ubsequent therapy in China is different from Western populations … [The] differences are likely attributable to the fact that Chinese MM patients present with more advanced stage disease … than patients in other regions,” said the researchers.

Overall, the 4.0 mg/week ixazomib dose combined with lenalidomide-dexamethasone demonstrated a favourable benefit-risk profile in Chinese patients with RRMM, noted the researchers. “[The present] findings provide supportive evidence for the activity, tolerability, and safety of the all-oral triplet regimen of [ixazomib-lenalidomide-dexamethasone] … as a treatment option for patients with RRMM around the world,” they said.

Despite the introduction of advanced treatment options over the last two decades, MM remains incurable. [Leukemia 2014;28:1122-1128] Furthermore, there has been an increasing incidence of MM in Asia, hence the need for further evaluation of new treatment alternatives. [Am J Hematol 2014;89:751-756; Lancet 2016;387:251-272; N Engl J Med 2014;371:906-917; J Clin Oncol 2015;33:3459-3466]

“[S]pecific investigation of … therapies in Asian populations is important in the context of differences in the clinical profile of MM and treatment patterns compared with [therapies] in North America and Europe,” said the researchers.

 

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Most Read Articles
Elvira Manzano, 3 days ago
Bisphosphonates have proven antifracture efficacy and remain to be the cornerstone of osteoporosis treatment. However, a drug holiday is of particular importance with bisphosphonates due to some signals with long-term use of the drug, including rare incidence of atypical femoral fracture (AFF) and osteonecrosis of the jaw (ONJ), says a leading endocrinologist at AFOS 2017.
11 hours ago
Breast cancer patients have notably different microbiomes in the local breast tissue and urinary tract, a recent study reveals. Particularly, species in the Methylobacterium genus are reduced in the local breast tissue while the urinary tract is enriched in gram-positive bacteria.
Pearl Toh, 13 Oct 2017
Women with higher plasma tryptophan concentrations were less likely to have poor sleep quality during pregnancy, especially among those with anxiety symptoms, according to the GUSTO* study.
Tristan Manalac, 13 hours ago
Statin use, particularly in smokers, obese patients and nondiabetics, has a strong and dose-dependent association with decreasing risk of pancreatic ductal adenocarcinoma (PDAC), according to a new study.