Professor Gilles Salles from Memorial Sloan Kettering Cancer Center speaks about the ASCO 2021 Abstract – Long-term analyses from L-MIND, a phase II study of tafasitamab (MOR208) combined with lenalidomide (LEN) in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
Link to Abstract:
https://meetinglibrary.asco.org/record/197097/abstract
Description:
L-MIND (NCT02399085) is an open-label Phase II trial of tafasitamab (MOR208), an Fc-modified, humanized anti-CD19 monoclonal antibody, in patients with R/R DLBCL who are ineligible for ASCT. We previously reported primary analyses and 2-year efficacy results; now we give an updated efficacy analysis with a 35-month follow-up (cut-off: October 30, 2020).
Methodologies:
Pts were 18 years old and had ASCT-ineligible R/R DLBCL. They had had 1–3 previous systemic treatments (Tx), including at least one CD20-targeting regimen, and had an ECOG status of 0–2. Pts were given tafasitamab (12 mg/kg IV) in 28-day cycles (C), once weekly during C1–3, with a loading dose on Day 4 of C1, and then every two weeks (Q2W) during C4–12. On Days 1–21 of C1–12, LEN (25 mg PO) was given. Patients who did not develop after C12 were given tafasitamab Q2W until disease progression. IRC examined the primary endpoint, which was the objective response rate (ORR). The duration of response (DoR), progression-free survival (PFS), and overall survival were also secondary goals (OS).
Outcomes:
Eighty of the 81 patients who were recruited in the study were given tafasitamab + LEN and were included in the complete analysis set (1 previous Tx, n=40; 2+ prior Tx, n=40). The total ORR was 57.5 percent (n=46/80) at the data cut-off, with full responses (CR) in 40% of points (n=32/80) and partial responses (PR) in 17.5 percent (n=14/80) (Table). Median DoR=43.9 months (95 percent CI: 26.1–not reached [NR]), and NR in pts who achieved a CR (95 percent CI: 43.9–NR); median PFS=11.6 months (95 percent CI: 6.3–45.7), with median follow-up 33.9 months; median OS=33.5 months (95 percent CI: 18.3–NR), with median follow-up 42.7 months; median OS=33.5 months (95 percent There were no unexpected side effects or new warning signs.
Observations:
In patients with R/R DLBCL who were not candidates for ASCT, combination Tx with tafasitamab + LEN followed by tafasitamab monotherapy showed sustained responses with a tolerable safety profile. These long-term results suggest that tafasitamab + LEN, followed by extended tafasitamab monotherapy, has the potential to prolong remission and improve survival in this patient group, particularly at first relapse.
Clinical trial information: NCT02399085:
http://clinicaltrials.gov/show/NCT02399085
