The real-world effectiveness of Monjuvi (tafasitamab-cxix) in U.S. patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) was confirmed, along with factors associated with survival, according to data from a retrospective medical chart review presented at the 2024 ASH Annual Meeting.
At a median follow-up time of 14.7 months from Monjuvi initiation, the real-world progression-free survival (PFS) with Monjuvi was 11.3 months in the overall population (181 patients), and the real-world overall survival (OS) was 24.8 months. The real-world overall response rate (ORR) to the agent was 73.5%, which comprised a complete response (CR) rate of 23.2% and a partial response (PR) rate of 50.3%. In the patients who achieved a real-world CR or PR with the agent (133 patients), the real-world duration of response (DOR) was 9.6 months.
An analysis showed that factors significantly linked with increased risk of progression included receiving the agent in the third to fifth line (51 patients) versus the second line (130 patients), having Ann Arbor stage 3 to 4 disease (169 patients) versus stage 1 to 2 (10 patients), increasing Charlson Comorbidity Index scores (181 patients) and bulky (36 patients) versus non-bulky (145 patients) disease.
Moreover, factors significantly associated with increased risk of mortality included receiving Monjuvi in the third to fifth line versus the second line, increasing age, ECOG performance status of 2 or higher versus below 2 and bulky versus non-bulky disease.
Glossary:
Progression-free survival (PFS): time without disease worsening.
Overall survival (OS): time until death from any cause.
Overall response rate (ORR): percentage of patients with tumor reduction.
Complete response (CR): no detectable cancer.
Partial response (PR): tumor reduction, but not complete.
Duration of response (DOR): time response lasts.
Stable disease (SD): cancer neither grows nor shrinks.
Ann Arbor stage: system to classify lymphoma spread.
Charlson Comorbidity Index scores: predicts mortality based on comorbidities.
Bulky disease: large tumor mass.
Non-bulky disease: small or no large tumor mass.
ECOG performance status: measures a patient's ability to perform daily activities, with scores from 0 (fully active) to 5 (dead). Higher scores indicate greater impairment.
“The additional follow-up from the initial data collection allowed for a more robust evaluation of the real-world effectiveness of [Monjuvi] in patients with relapsed or refractory DLBCL, predominantly in the community practice setting,” lead study author Dr. Kim Saverno of Incyte Corporation, in Wilmington, Delaware, said in a poster presentation of the data. “These results support a real-world clinical benefit for [Monjuvi], with the greatest benefit observed when [the agent] was received in second versus later lines of therapy.”
Additional treatment outcome data showed that in those who received Monjuvi in the second line (130 patients), the real-world ORR was 78.5%; this was comprised of a CR rate of 27.7% and a PR rate of 50.8%. For this group, the stable disease (SD) rate was 8.5%, the progressive disease (PD) rate was also 8.5%, and 4.6% of patients did not have these data available. In the group of patients who received the immunotherapy in the third line (43 patients), the real-world ORR was 62.8%; this comprised a CR rate of 11.6% and a PR rate of 51.2%. In this subset, the SD and PD rates were 18.6% and 11.6%, respectively; 7% of patients did not have these data available.
In patients who experienced a real-world CR as a best response to Monjuvi (42 patients), the median real-world DOR was 19.2 months. In those who achieved a real-world PR as a best response to the agent (91 patients), the median real-world DOR was 8.5 months.
The CD19-targeted immunotherapy Monjuvi was approved by the FDA in July 2020 for use in combination with Revlimid (lenalidomide) in adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma and who are not candidates to undergo autologous stem cell transplant. To date, few studies have evaluated the agent in a US real-world setting, according to Saverno. She added that data from a real-world study were previously shared, but had a limited follow-up time of 6.5 months, which “precluded robust evaluations of the clinical effectiveness” of the agent.
For patients to be considered eligible for the analysis, they must have started treatment with Monjuvi with or without concomitant Revlimid for relapsed or refractory disease on or following Oct. 21, 2020; be at least 18 years old at the time treatment with the agent was started; and have undergone at least four months of follow-up since treatment started. Those who died during this four-month interval were still permitted. If patients received the agent as part of an interventional clinical trial, they were excluded.
A total of 181 patients were included in the study; 144 of these patients were still alive at last follow-up of initial data collection which had occurred between Feb. 22, 2023, and March 29, 2023. Of those patients, 137 patients had additional follow-up data available and underwent additional data collection between Dec. 18, 2023, and Jan. 31, 2024. A total of 106 patients were alive at last follow-up.
“Over 70% of patients received [Monjuvi] in the second line, and 71% of patients had discontinued [Monjuvi] at the last follow-up, mostly due to disease progression,” Saverno noted. “Over half of the patients were still alive at the last follow-up, and among the patients still alive, half [were] still receiving [Monjuvi] at the time of the most recent follow-up.”
In the 181 total patients, the median age at the time of Monjuvi initiation was 71.1 years. Most patients were White (64.1%), and more than half of patients were male (56.4%). Regarding Ann Arbor stage at time of treatment initiation, 5.5% had stage 1 or 2 disease, 93.4% had stage 3 or 4 disease; this information was unknown for 1.1% of patients. ECOG performance status at the time of treatment initiation was 0 to 1 for 52.5% of patients and 2 or higher for 47.5% of patients. Revised International Prognostic Index for Diffuse Large B-cell Lymphoma was 3 to 5 for 80.5% of patients and 1 to 2 for 19.5% of patients.
“This study is impacted by limitations inherent to real-world studies, such as unobserved and missing data,” Saverno concluded. “The number of participating oncologists was small and thus may not reflect the treatment patterns of all US oncologists managing patients with DLBCL.”
Reference:
“Real-world effectiveness of tafasitamab (tafa) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in the United States.” By Dr. Kim Saverno et al, Blood.
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