-Author name in bold denotes the presenting author
-Asterisk * with author name denotes a Non-ASH member
Clinically Relevant Abstract denotes an abstract that is clinically relevant.

PhD Trainee denotes that this is a recommended PHD Trainee Session.

Ticketed Session denotes that this is a ticketed session.

2937 L-Mind: A Safety and Efficacy Analysis of Tafasitamab in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) Receiving Treatment for at Least 2 Years

Program: Oral and Poster Abstracts
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster II
Hematology Disease Topics & Pathways:
Research, clinical trials, Combination therapy, Clinical Research, Therapies
Sunday, December 11, 2022, 6:00 PM-8:00 PM

Johannes Duell, MD1*, Wojciech Jurczak2, Anna Marina Liberati3, Janusz Halka, MD4*, Esther Pena Carbó5*, Pau Abrisqueta Costa, MD, PhD6*, Kami J. Maddocks, MD7, Martin Dreyling, MD8, Andreas Rosenwald, MD9*, Abhishek Bakuli, PhD10*, Aasim Amin, PharmD10*, Konstantin Gurbanov, MD10* and Gilles Salles, MD, PhD11

1Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Bavaria, Germany
2MSC National Research Institute of Oncology, Krakow, Poland
3Università degli Studi di Perugia, Azienda Ospedaliera Santa Maria di Terni, Terni, Italy
4Department of Hematology, Warmian-Masurian Cancer Center of the Ministry of the Interior and Administration’s Hospital, Olsztyn, Poland
5Department of Haematology, Navarra University Clinic, Pamplona, Spain
6Department of Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Barcelona, Spain
7Ohio State University Hospital, Columbus, OH
8Ludwig-Maximilians-University Hospital, Munich, Germany
9Department of Pathology, University of Würzburg, Würzburg, Germany
10MorphoSys AG, Planegg, Germany
11Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York, NY


Tafasitamab, is a humanized, Fc-modified anti-CD19 monoclonal antibody that functions as an immunotherapy through direct cytotoxicity and antibody‑dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP). Based on data from the ongoing, open-label, multicenter, single-arm, Phase II L-MIND study (NCT02399085; Salles, et al. Lancet Oncol 2020), tafasitamab in combination with lenalidomide (LEN) was granted accelerated approval in the US (2020) and conditional/accelerated approval by the EMA (2021) and other regulatory authorities for the treatment of adult patients with R/R DLBCL not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are ineligible for autologous stem cell transplant (ASCT). It is a preferred regimen in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for this setting.

We have previously reported long-term, durable clinical activity for tafasitamab + LEN (Duell, et al. Haematologica 2021). Here, we report efficacy and safety data for tafasitamab + LEN in patients with R/R DLBCL enrolled on L-MIND who received treatment for ≥2 years and those in follow-up for ≥5 years.


Patients were aged ≥18 years with ASCT-ineligible R/R DLBCL, 1–3 prior systemic therapies (including ≥1 CD20-targeting regimen), and an Eastern Cooperative Oncology Group performance status of 0–2. Patients received 28-day cycles of tafasitamab (12 mg/kg IV), once weekly during Cycles 1–3, with a loading dose on Day 4 of Cycle 1, then every 2 weeks (Q2W) during Cycles 4–12. LEN (25 mg orally) was administered on Days 1–21 of Cycles 1–12. After Cycle 12, progression-free patients received tafasitamab Q2W until disease progression. Time-to-event, treatment response (Cheson 2007), and safety endpoints were assessed.


At data cut-off (February 15, 2022), of the 81 patients in the full analysis set, 30 patients completed 12 cycles of tafasitamab + LEN and 4 patients discontinued LEN before 12 cycles; 27 (34%) received treatment for ≥2 years (median: 4.3 years). The proportion of patients who were primary refractory, refractory to previous therapy, or who had received prior ASCT were similar between patients who received treatment for ≥2 years and the full analysis set (Table 1). Of the 27 patients who received treatment for ≥2 years, 23 are confirmed alive, one was lost to follow-up, one died by unknown cause, and two died following adverse events (AEs) unrelated to study treatment. Thirteen patients remained on treatment; reasons for tafasitamab discontinuation after ≥2 years were progressive disease (n=4), patient/physician decision (n=8), and non-treatment-related fatal AEs (n=2: one each for COVID-19 and cardiovascular AE). Twelve patients have been in follow-up for ≥5 years, of whom six are still on treatment, while 6 had discontinued treatment although still in response.

In patients who received treatment for ≥2 years, 23 had previously achieved a complete response (CR) as a best response and four had a partial response (PR), as assessed by the investigator (Figure 1); the 48-month overall survival (OS) rate was 92.6%; however, the median duration of response, progression-free survival, and OS have not been reached. In patients refractory to previous therapy line (n=12), 91.7% were in follow-up at 48 months. All of the primary refractory patients (n=4) are in follow-up at 60 months. Of the six patients who received treatment for ≥5 years, five achieved CR (one of whom had triple-hit R/R DLBCL) and one had a PR (investigator-assessed).

A lower incidence of AEs was reported during the tafasitamab monotherapy phase (Cycles 13–24 and Cycles ≥25) compared with the tafasitamab + LEN combination therapy phase (Cycles 1–12). The exposure-adjusted incidence of AEs showed that the majority were Grade 1–2.


Combination therapy with tafasitamab plus lenalidomide followed by tafasitamab monotherapy provided durable responses in patients with R/R DLBCL ineligible for ASCT. These long-term data suggest that this immunotherapy can achieve prolonged remission and survival of 5 years or longer in this patient population. The incidence of AEs decreased as patients transitioned from combination therapy to tafasitamab monotherapy, with long-term tafasitamab (up to 60 months) being well tolerated with no new safety signals.


MorphoSys AG

Disclosures: Duell: MorphoSys: Consultancy, Research Funding; Incyte: Consultancy; Regeneron: Research Funding. Jurczak: Beigene: Consultancy, Research Funding; AbbVie: Consultancy, Research Funding; Roche: Consultancy, Research Funding; Bayer: Research Funding; Celgene: Research Funding; TG Therapeutics: Research Funding; Loxo Oncology: Consultancy, Research Funding; Sandoz: Consultancy, Research Funding; Merck: Research Funding; Morphosys: Research Funding; Novo Nordisk: Research Funding; Lilly: Consultancy, Research Funding; Takeda: Research Funding; Mei Pharma: Research Funding; AstraZeneca: Consultancy, Research Funding; Janssen: Consultancy, Research Funding. Liberati: iQVIA: Research Funding; PSI: Research Funding; Verastem: Research Funding; Takeda: Research Funding; Secura Bio: Research Funding; Sanofi: Research Funding; Roche: Research Funding; Novartis: Research Funding; Morphosys: Research Funding; Janssen: Research Funding; DR REDDY’S LABORATORIES SPA: Research Funding; Celegene: Research Funding; BMS: Research Funding; Beigene: Research Funding; AbbVie: Research Funding; LOXO: Research Funding; MEI-PHARMA: Research Funding; EPZIME: Research Funding. Halka: Not applicable: Other: Not applicable. Carbó: Not applicable: Other: Not applicable. Abrisqueta Costa: Roche: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Speakers Bureau; Bristol-Myers-Squibb: Consultancy, Honoraria, Speakers Bureau; Sandoz: Speakers Bureau; Abbvie: Consultancy, Honoraria, Speakers Bureau; AstraZeneca: Consultancy, Honoraria, Speakers Bureau. Maddocks: Pharmacyclics: Consultancy, Research Funding; Lilly: Consultancy; Kite: Consultancy; Incyte: Consultancy; Gilead: Consultancy; ADC Therapeutics: Consultancy; Abbvie: Consultancy; Pfizer: Research Funding; Acerta: Consultancy; BMS: Consultancy, Research Funding; Janssen: Consultancy; Genentech: Consultancy; Morphosys: Consultancy; Genmab: Consultancy; Celgene: Consultancy; Beigene: Consultancy; AstraZeneca: Consultancy. Dreyling: Amgen: Honoraria; Lilly/Loxo: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead/Kite: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; BMS/Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bayer: Research Funding; Abbvie: Research Funding; Beigene: Consultancy. Rosenwald: Not applicable: Other: not applicable. Bakuli: MorphoSys AG: Current Employment, Other; Division of Infectious Diseases and Tropical Medicine, University Hospital, Ludwig-Maximilians-Universität Munch: Consultancy. Amin: MorphoSys AG: Current Employment; Paion AG: Current equity holder in private company. Gurbanov: Not applicable: Other. Salles: AbbVie, BeiGene, Bristol Myers Squibb, Celgene, Debiopharm, Epizyme, Genentech/Roche, Genmab, Incyte, Kite, a Gilead Company, Miltenyi, MorphoSys, Takeda, and VelosBio: Membership on an entity's Board of Directors or advisory committees; Roche/Genentech, Janssen, Celgene, Gilead Sciences, Novartis, AbbVie, MorphoSys AG, Amgen, Bayer, Epizyme, Regeneron, Kite, a Gilead Company: Honoraria; Roche/Genentech, Gilead Sciences, Janssen, Celgene, Novartis, MorphoSys AG, Epizyme, Alimera Sciences, Genmab, Debiopharm Group, Velosbio, Bristol Myers Squibb, BeiGene, Incyte, Miltenyi Biotec, Ipsen, Kite, a Gilead Company, Loxo, Rapt: Consultancy.

*signifies non-member of ASH