Actual-world knowledge from the U.S. confirms the effectiveness of Monjuvi for treating relapsed or refractory diffuse massive B-cell lymphoma (DLBCL).
The true-world effectiveness of Monjuvi (tafasitamab-cxix) in U.S. sufferers with relapsed or refractory diffuse massive B-cell lymphoma (DLBCL) was confirmed, together with components related to survival, in response to knowledge from a retrospective medical chart assessment introduced on the 2024 ASH Annual Assembly.
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 within the total inhabitants (181 sufferers), and the real-world total survival (OS) was 24.8 months. The true-world total response charge (ORR) to the agent was 73.5%, which comprised a whole response (CR) charge of 23.2% and a partial response (PR) charge of fifty.3%. Within the sufferers who achieved a real-world CR or PR with the agent (133 sufferers), the real-world period of response (DOR) was 9.6 months.
An evaluation confirmed that components considerably linked with elevated threat of development included receiving the agent within the third to fifth line (51 sufferers) versus the second line (130 sufferers), having Ann Arbor stage 3 to 4 illness (169 sufferers) versus stage 1 to 2 (10 sufferers), rising Charlson Comorbidity Index scores (181 sufferers) and ponderous (36 sufferers) versus non-bulky (145 sufferers) illness.
Furthermore, components considerably related to elevated threat of mortality included receiving Monjuvi within the third to fifth line versus the second line, rising age, ECOG efficiency standing of two or increased versus under 2 and ponderous versus non-bulky illness.
Glossary:
Development-free survival (PFS): time with out illness worsening.
Total survival (OS): time till demise from any trigger.
Total response charge (ORR): proportion of sufferers with tumor discount.
Full response (CR): no detectable most cancers.
Partial response (PR): tumor discount, however not full.
Period of response (DOR): time response lasts.
Secure illness (SD): most cancers neither grows nor shrinks.
Ann Arbor stage: system to categorise lymphoma unfold.
Charlson Comorbidity Index scores: predicts mortality based mostly on comorbidities.
Cumbersome illness: massive tumor mass.
Non-bulky illness: small or no massive tumor mass.
ECOG efficiency standing: measures a affected person’s skill to carry out each day actions, with scores from 0 (absolutely lively) to five (useless). Larger scores point out higher impairment.
“The extra follow-up from the preliminary knowledge assortment allowed for a extra sturdy analysis of the real-world effectiveness of [Monjuvi] in sufferers with relapsed or refractory DLBCL, predominantly in the neighborhood apply setting,” lead examine writer Dr. Kim Saverno of Incyte Company, in Wilmington, Delaware, mentioned in a poster presentation of the info. “These outcomes help a real-world scientific profit for [Monjuvi], with the best profit noticed when [the agent] was obtained in second versus later strains of remedy.”
Extra therapy consequence knowledge confirmed that in those that obtained Monjuvi within the second line (130 sufferers), the real-world ORR was 78.5%; this was comprised of a CR charge of 27.7% and a PR charge of fifty.8%. For this group, the steady illness (SD) charge was 8.5%, the progressive illness (PD) charge was additionally 8.5%, and 4.6% of sufferers didn’t have these knowledge out there. Within the group of sufferers who obtained the immunotherapy within the third line (43 sufferers), the real-world ORR was 62.8%; this comprised a CR charge of 11.6% and a PR charge of 51.2%. On this subset, the SD and PD charges had been 18.6% and 11.6%, respectively; 7% of sufferers didn’t have these knowledge out there.
In sufferers who skilled a real-world CR as a finest response to Monjuvi (42 sufferers), the median real-world DOR was 19.2 months. In those that achieved a real-world PR as a finest response to the agent (91 sufferers), the median real-world DOR was 8.5 months.
The CD19-targeted immunotherapy Monjuvi was authorised by the FDA in July 2020 to be used together with Revlimid (lenalidomide) in grownup sufferers with relapsed or refractory DLBCL not in any other case specified, together with DLBCL arising from low-grade lymphoma and who usually are not candidates to bear autologous stem cell transplant. Up to now, few research have evaluated the agent in a US real-world setting, in response to Saverno. She added that knowledge from a real-world examine had been beforehand shared, however had a restricted follow-up time of 6.5 months, which “precluded sturdy evaluations of the scientific effectiveness” of the agent.
For sufferers to be thought of eligible for the evaluation, they should have began therapy with Monjuvi with or with out concomitant Revlimid for relapsed or refractory illness on or following Oct. 21, 2020; be no less than 18 years previous on the time therapy with the agent was began; and have undergone no less than 4 months of follow-up since therapy began. Those that died throughout this four-month interval had been nonetheless permitted. If sufferers obtained the agent as a part of an interventional scientific trial, they had been excluded.
A complete of 181 sufferers had been included within the examine; 144 of those sufferers had been nonetheless alive finally follow-up of preliminary knowledge assortment which had occurred between Feb. 22, 2023, and March 29, 2023. Of these sufferers, 137 sufferers had further follow-up knowledge out there and underwent further knowledge assortment between Dec. 18, 2023, and Jan. 31, 2024. A complete of 106 sufferers had been alive finally follow-up.
“Over 70% of sufferers obtained [Monjuvi] within the second line, and 71% of sufferers had discontinued [Monjuvi] on the final follow-up, principally as a result of illness development,” Saverno famous. “Over half of the sufferers had been nonetheless alive on the final follow-up, and among the many sufferers nonetheless alive, half [were] nonetheless receiving [Monjuvi] on the time of the newest follow-up.”
Within the 181 whole sufferers, the median age on the time of Monjuvi initiation was 71.1 years. Most sufferers had been White (64.1%), and greater than half of sufferers had been male (56.4%). Relating to Ann Arbor stage at time of therapy initiation, 5.5% had stage 1 or 2 illness, 93.4% had stage 3 or 4 illness; this info was unknown for 1.1% of sufferers. ECOG efficiency standing on the time of therapy initiation was 0 to 1 for 52.5% of sufferers and a couple of or increased for 47.5% of sufferers. Revised Worldwide Prognostic Index for Diffuse Giant B-cell Lymphoma was 3 to five for 80.5% of sufferers and 1 to 2 for 19.5% of sufferers.
“This examine is impacted by limitations inherent to real-world research, corresponding to unobserved and lacking knowledge,” Saverno concluded. “The variety of collaborating oncologists was small and thus could not mirror the therapy patterns of all US oncologists managing sufferers with DLBCL.”
Reference:
“Actual-world effectiveness of tafasitamab (tafa) for the therapy of relapsed/refractory diffuse massive B-cell lymphoma (R/R DLBCL) in the USA.” By Dr. Kim Saverno et al, Blood.
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