In the absence of a direct head-to-head clinical trial, study may help inform treatment selections for stem cell transplant-ineligible patients.
According to results from the PEGASUS study, patients with newly diagnosed multiple myeloma who were treated with a combination regimen including daratumumab (Darzalex, Janssen) showed a longer estimated progression-free survival (PFS) and significantly reduced risk of progression or death.
Daratumumab was approved in combination with lenalidomide-dexamethasone in June 2019 for the treatment of patients with newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplant. According to the study authors, the bortezomib-lenalidomide-dexamethasone combination (VRd) has become a preferred regimen for patients with sufficient fitness for triplet therapy.
The PEGASUS study indirectly compared PFS among patients who participated in the phase 3 MAIA clinical trial, which investigated daratumumab plus lenalidomide and dexamethasone in patients who received commonly prescribed bortezomib-containing regimens. In the absence of a direct head-to-head clinical trial, these results may help inform treatment selections for transplant-ineligible patients, according to a press release.
“As we noted in the publication, the PEGASUS study, which indirectly compared patient data from a clinical trial to data from an electronic health database, may potentially help inform decisions for this patient population in multiple myeloma,” said co-author Saad Usmani, MD, MBA, FACP, in a press release.
Investigators used data from the Flatiron Health electronic health record-derived de-identified database to indirectly compare MAIA dexamethasone data with 2 other standard-of-care regimens: VRd and bortezomib, and dexamethasone alone (Vd). According to a press release, the regimen including daratumumab was associated with a 32% lower risk of disease progression or death compared with VRd and a 52% reduction compared with Vd.
These PEGASUS findings build on the MAIA study, which found a 44% reduction in the risk of disease progression or death with daratumumab compared with lenalidomide and dexamethasone alone over a mean follow-up of 28 months.
“With the availability of more data from real-world clinical practice and analytical tools, we were able to compare treatment regimens and assess patient outcomes to gain further insight into the treatment landscape in transplant-ineligible newly diagnosed multiple myeloma, including the use of Darzalex as an important treatment option for this patient population,” concluded Beth Barber, PhD, in a press release.
Real-world evidence study finds better patient outcomes with Janssen’s daratumumab than bortezomib in multiple myeloma [email]. Received October 12, 2020. Accessed October 12, 2020.