Five‐year subgroup analysis of tafasitamab + lenalidomide from the Phase II L‐MIND study in patients with relapsed or refractory diffuse large B‐cell lymphoma
Year: 2023
Type: article
Abstract: Background: The Phase II L-MIND study led to accelerated US approval and EU conditional authorization of the CD19-targeted immunotherapy, tafasitamab, + lenalidomide (LEN) followed by tafasitamab monotherapy for patients (pts) with R/R DLBCL ineligible for autologous stem cell transplant (ASCT). Long-term L-MIND data further support the regimen. Here we present exploratory analyses of final 5-year (yr) efficacy in subgroups of interest. Methods: Pts (≥18 years) with ASCT-ineligible R/R DLBCL, 1–3 prior systemic therapies (incl. ≥1 targeting CD20) and ECOG PS 0–2 received tafasitamab for ≤12 28-day cycles (+ LEN), then alone until disease progression. Primary endpoint was objective response rate (ORR). Secondary endpoints included duration of response (DoR), progression-free survival (PFS) and overall survival (OS). Exploratory subgroup analyses including by International Prognostic Index (IPI) and time to progression after 1L (in pts with only 1 prior line) used Kaplan-Meier estimates of 5-yr endpoints. Results: As of 14 November 2022 in the full analysis set (FAS; n = 80), ORR was 57.5% [95% CI: 45.9–68.5]. Median treatment duration was 9.0 months (mo) [0.5–73.6] and median follow-up (mFU) for OS was 65.6 mo [59.9–70.3]). Median DoR was not reached (mFU: 44.0. mo [29.9–57.0]). Of 18 patients in follow-up for ≥5 years, 9 received tafasitamab until end of study per protocol, 9 discontinued while in remission. RR and 5-yr rates for DoR, PFS and OS showed long-term clinical activity in all pt subgroups (Table). Conclusion: In this 5-yr subgroup analysis, a long-term clinical benefit with tafasitamab + LEN followed by tafasitamab monotherapy was observed in all subgroups of clinical interest, including pts with poor prognosis risk factors. These data suggest this immunotherapy may have curative potential, which is being explored in further studies. Encore Abstract - previously submitted to ASCO 2023 The research was funded by: MorphoSys AG Keyword: Aggressive B-cell non-Hodgkin lymphoma Conflicts of interests pertinent to the abstract. J. Duell Research funding: MorphoSys AG, Regeneron P. Abrisqueta Consultant or advisory role: Janssen, Celgene, AbbVie, AstraZeneca Honoraria: Janssen, Celgene, AbbVie, AstraZeneca, Gilead Other remuneration: Speakers’ bureau: Janssen, Celgene, AbbVie, AstraZeneca, Gilead M. Dreyling Consultant or advisory role: AstraZeneca, BeiGene, BMS/Celgene, Gilead/Kite, Janssen, Lilly/Loxo, Novartis, Roche Research funding: AbbVie, Bayer, Celgene, Gilead/Kite, Janssen, Roche Other remuneration: Speakers' honoraria: AstraZeneca, BeiGene, Gilead/Kite, Janssen, Lilly, Novartis, Roche G. Gaidano Consultant or advisory role: AbbVie, AstraZeneca, BeiGene, Incyte, Janssen, Roche Other remuneration: Speaker’s Bureau: AbbVie, Janssen E. G. Barca Consultant or advisory role: Janssen, AbbVie, Gilead, Kiowa, EUSAPharma, Incyte, Lilly, BeiGene Educational grants: Janssen, AbbVie, EUSAPharma Other remuneration: Speakers' bureau: Janssen, AbbVie, Takeda, Kiowa, Roche, EUSAPharma, Incyte, BeiGene W. Jurczak Consultant or advisory role: MEI Pharma, Debiopharm, Loxo, Takeda, AstraZeneca, BeiGene Research funding: GSK, Acerta, BeiGene, Nordic Nanovector, Debiopharm, Incyte, Genentech, Janssen, Loxo, MEI Pharma, MorphoSys AG, Takeda, TG Therapeutics K. J. Maddocks Honoraria: Pharmacyclics, MorphoSys AG, Bristol-Myers Squibb, Karyopharm Therapeutics, Kite Pharma/Gilead Company, ADC Therapeutics, AbbVie, AstraZeneca, BeiGene, Genmab, Genentech, Janssen, Lilly, Incyte Research funding: Pharmacyclics, Merck, Bristol-Myers Squibb T. Menne Consultant or advisory role: Kite/Gilead, Amgen, Novartis, Pfizer, Celgene/BMS, Daiichi Sankyo, Atara, Roche, Janssen Research funding: Janssen, AstraZeneca, Novartis Educational grants: Amgen, Jazz, Pfizer, Bayer, Kyowa Kirin, Celgene/BMS, Kite/Gilead, Janssen, Takeda Other remuneration: Honoraria for lectures: Kite/Gilead, Takeda, Janssen, Roche, Servier, Novartis, Celgene/BMS, Pfizer Z. Nagy Consultant or advisory role: Takeda, Janssen, AbbVie, Roche, Amgen, Servier, Astellas O. Tournilhac Consultant or advisory role: Takeda, AstraZeneca, BeiGene, Incyte, Janssen, Gilead, AbbVie, Roche, Sandoz, Blueprint A. Bakuli Employment or leadership position: MorphoSys AG Other remuneration: statistical consultancy: Ludwig-Maximilians-University Hospital, Munich, Germany A. Amin Employment or leadership position: MorphoSys AG Stock ownership: Paion AG K. Gurbanov Employment or leadership position: MorphoSys AG G. Salles Consultant or advisory role: Roche/Genentech, Gilead Sciences, Janssen, Celgene, Novartis, MorphoSys AG, Epizyme, Alimera Sciences, Genmab, Debiopharm Group, VelosBio, Bristol-Myers Squibb, BeiGene, Incyte, Miltenyi Biotec, Ipsen Honoraria: Roche/Genentech, Janssen, Celgene, Gilead Sciences, Novartis, AbbVie, MorphoSys AG
Source: Hematological Oncology
DOI: 10.1002/hon.3164_324
Institutions: Universitätsklinikum Würzburg, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institute of Oncology, Ludwig-Maximilians-Universität München, Università degli Studi del Piemonte Orientale “Amedeo Avogadro”, Institut d'Investigació Biomédica de Bellvitge, Institut Català d'Oncologia, Duran i Reynals Hospital, Universitat de Barcelona, The Maria Sklodowska-Curie National Research Institute of Oncology, The Ohio State University Wexner Medical Center, The Ohio State University, Freeman Hospital, Semmelweis University, Centre Hospitalier Universitaire de Clermont-Ferrand, MorphoSys (Germany), Memorial Sloan Kettering Cancer Center
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4380079400