Tafasitamab plus lenalidomide prolonged overall survival compared with systemic therapies in patients with relapsed/refractory diffuse large B-cell lymphoma, according to data from the retrospective RE-MIND2 study.
Patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) experienced prolonged overall survival (OS) following treatment with tafasitamab (Monjuvi) and lenalidomide (Revlimid), meeting the primary end point of the observational retrospective RE-MIND2 cohort study (NCT04697160).
Investigators compared tafasitamab and lenalidomide vs pooled systemic therapies; bendamustine/rituximab (Rituxan); and rituximab plus gemcitabine and oxaliplatin (R-GemOx). Median OS with tafasitamab plus lenalidomide was 34.1 months vs 11.6 months with pooled therapies (HR, 0.553; 95% CI, 0.358-0.855; P = .0068). When the tafasitamab regimen was compared with bendamustine and rituximab, the median OS was 31.6 months vs 9.9 months (HR, 0.418; 95% CI, 0.272-0.644; P <.0001). Lastly, the median OS was 31.6 months vs 11.0 months with R-GemOx (HR, 0.467; 95% CI, 0.305-0.714; P = .0003).
“In the context of current treatments, these data further highlight the clinical value of the tafasitamab plus lenalidomide combination in patients with relapsed/refractory DLBCL,” the investigators wrote.
RE-MIND2 examined 3454patients across 200 sites in North America, Europe, and the Asia-Pacific region from 2010 to 2020. Study sites included academic & public hospitals as well as private practices. Data were collected electronically using either Medidata RAVE electronic case report forms or Cardinal Health electronic survey tools, and a deduplication algorithm was employed to identify duplicate patient health records before statistical analysis.
Patients were required to have received at least 2 prior systemic anti-DLBCL treatment regimens, including at least 1 anti-CD20 therapy. Patients were excluded if they had central nervous system (CNS) involvement at initial diagnosis, underwent prior allogenic transplant, or prior first-line treatment with a CD19-targeted therapy or immunomodulatory drug, including thalidomide or lenalidomide. Most patients across all matched analysis sets were 70 years or older with Ann Arbor stage III or IV disease.
The study also assessed overall response rate (ORR), complete response (CR) rate, progression-free survival (PFS), duration of response (DoR), and time to next treatment (TTNT) as secondary end points.
Tafasitamab plus lenalidomide resulted in better ORR and CR rates vs systemic therapies pooled and R-GemOx; although the regimen also improved both measures vs bendamustine plus rituximab, the comparison did not reach statistical significance. Moreover, median DoR with tafasitamab plus lenalidomide was 26.1 months in all three matched comparisons vs 6.6, 9.2, and 9.5 months with systemic therapies pooled, bendamustine plus rituximab, and R-GemOx, respectively.
Investigators also observed a significant improvement in PFS with tafasitamab plus lenalidomide (12.1 months) vs systemic therapies pooled (5.8 months) and bendamustine rituxumab (7.9 months). The treatment also resulted in a PFS of 14.1 months vs 5.1 months with R-GemOx. In keeping with the other data, investigators also observed improvements in median TNTT for patients treated with tafasitamab plus lenalidomide vs pooled therapies (12.5 months vs 6.3 months), bendamustine rituximab (12.1 months vs 6.9 months), and with R-GemOx (12.5 months vs 5.7 months).
In the tafasitamab plus lenalidomide cohort, a total of 8 patients discontinued therapy due to adverse effects (AEs), representing 14.5%, 14.5%, and 15.1% of patients in the cohorts matched with systemic therapies pooled, bendamustine rituximab, and R-GemOx, respectively. This was in compared with the 6.8% in the pooled systemic therapies group, 2.8% in the bendamustine rituximab group, and 5.4% in the R-GemOx group. Death was less common in the tafasitamab plus lenalidomide cohort, in which 48% died, as compared with 64.5% in the systemic therapies pooled cohort, 70.7% in the bendamustine rituximab cohort, and 74.3% in the R-GemOx cohort. The most common cause of death across all cohorts was disease progression.
“Randomized controlled trials are generally considered by regulatory authorities to be the gold standard for establishing the causal relationship between treatments and patient outcomes,” investigators wrote. “However, the high costs, long duration, and limited generalizability of RCTs have prompted a need for alternative approaches to inform regulatory decision-making. RE-MIND2 demonstrates the use of real-world data to compare the efficacy outcomes of therapies used in routine clinical care for patients with relapsed/refractory DLBCL with those from a clinical trial population.”
Nowakowski GS, Yoon DH, Peters A, et al. Improved efficacy of tafasitamab plus lenalidomide versus systemic therapies for relapsed/refractory DLBCL: RE-MIND2, an observational retrospective matched cohort study. Clin Cancer Res. 2022;28(18):4003-4017. doi:10.1158/1078-0432.CCR-21-3648