New combination therapy yields faster response in myeloma study

Treating multiple myeloma with a Darzalex (daratumumab)-based combination may lead to a faster and longer-lasting response than a standard combination regimen using lenalidomide (sold as Revlimid and generics), a study found.

The results may “inform updated clinical guidelines to standardize [newly diagnosed myeloma] management and advance overall myeloma treatment strategies,” the researchers wrote.

An early-access version of the study, “Superior 12-month progression-free survival with frontline DVd versus VRd in patients with newly diagnosed multiple myeloma: a multicenter propensity score-matched analysis,” was published in the Journal of Translational Medicine. Johnson & Johnson, the company that sells Darzalex, was not involved in the research.

Myeloma is a form of blood cancer marked by the uncontrolled growth of plasma cells, a type of immune cell, in the bone marrow.

A standard initial treatment for myeloma is the so-called VRd regimen, which includes three medications: the immunomodulatory agent lenalidomide, the proteasome inhibitor bortezomib (sold as Velcade and generics), and the steroid medication dexamethasone.

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Standard has limitations

Although the VRd regimen has long been a staple of initial myeloma treatment, it has notable limitations. This regimen isn’t effective for everyone, and it carries safety risks.

An alternative combination therapy called DVd, which uses the anti-CD38 antibody therapy Darzalex in combination with bortezomib and dexamethasone, is approved in the U.S. for myeloma that has not been adequately controlled after one line of treatment.

A team of scientists in China conducted a clinical trial (ChiCTR2500102869) to see if the DVd regimen might offer better results than the standard VRd regimen in people with newly diagnosed myeloma. More than 200 patients were enrolled across a dozen centers in China. Roughly half of the patients were given each therapy regimen.

The researchers noted that the two treatment groups were not equally balanced for well-established risk factors: Patients in the DVd group were generally older and had cancers with high-risk genetic mutations.

Results showed that most participants responded to treatment, meaning their cancer burden decreased following therapy. Overall response rates were 97.9% with DVd and 94.1% with the standard VRd, with no statistically significant difference between the groups.

However, participants treated with the DVd regimen achieved a response significantly sooner, “despite worse [initial] characteristics,” the researchers wrote. Most DVd-treated patients achieved a response in less than two months, while response times for those on standard VRd were more than two months.

Rates of participants testing negative for minimal residual disease — defined as a very small number of cancer cells that remain in the body during or after treatment — were comparable between the DVd and VRd groups (5.3% vs. 4.9%).

Over a median follow-up time of 17 months (nearly 1.5 years), most participants did not experience disease progression. At one year, 92.8% of patients given DVd had no progression, whereas 79% of those on VRd were progression-free. This reflects a significantly lower risk — 71% — of progression with the DVd regimen.

Participants treated with DVd were also significantly more likely to have a treatment response that lasted for at least one year (92.5% vs. 74.6%).

Similar results were observed among several high-risk patient groups.

To account for pre-treatment differences between the two groups, the researchers used a technique called propensity score matching, which compares outcomes between patients matched as closely as possible on pre-treatment characteristics.

This analysis showed results broadly in line with the main findings: overall response rates were similar between DVd and VRd, but DVd treatment generally resulted in a faster and longer-lasting response.

Safety data were broadly similar with both DVd and VRd; most participants on either regimen experienced adverse events. The researchers noted, however, that patients on DVd tended to have lower rates of serious reactions, including severe reductions in blood cell counts, extreme fatigue, muscle cramps, and serious nausea.

“DVd yielded equivalent short-term remission rates to VRd, but delivered superior long-term disease control with manageable toxicities, supporting its capacity to sustain deep responses,” the researchers wrote. “These real-world data support DVd as a frontline option for [newly diagnosed multiple myeloma] patients.”