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.

Authors

null

Johannes Duell

Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany

Johannes Duell , Pau Abrisqueta , Martin H. Dreyling , Gianluca Gaidano , Eva González Barca , Wojciech Jurczak , Kami J. Maddocks , Tobias Menne , Olivier Tournilhac , Abhishek Bakuli , Aasim Amin , Konstantin Gurbanov , Gilles A. Salles , Zsolt Nagy

Organizations

Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany, Department of Hematology, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Barcelona, Spain, Ludwig-Maximilians-University Hospital, Munich, Germany, Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy, Institut Català d'Oncologia, Hospital Duran i Reynals, IDIBELL, Universitat de Barcelona, Barcelona, Spain, Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Kraków, Poland, Department of Internal Medicine, Arthur G James Comprehensive Cancer Center, Ohio State University Wexner Medical Center, Columbus, OH, Freeman Hospital, The Newcastle Upon Tyne Hospitals, Newcastle upon Tyne, United Kingdom, CHU de Clermont-Ferrand, Clermont Ferrand, France, MorphoSys AG, Planegg, Germany, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, Semmelweis University, Budapest, Hungary

Research Funding

Pharmaceutical/Biotech Company
MorphoSys AG

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 Nov, 2022 in the full analysis set (FAS; n=80), ORR was 56.2% [95% CI: 44.7–67.3]. 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: 43.7 mo [29.9–58.4]). 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). Conclusions: 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. Clinical trial information: NCT02399085.

NORR, %
[95% CI]
PFS* OS* DoR*
FAS8056.2
[44.7–67.3]
36.1
[23.7–48.6]
(9)
40.3
[29.0–51.3]
(21)
58.7
[39.9–73.4]
(5)
Age≤70 yr3560.0
[42.1–76.1]
40.8
[22.4–58.4]
(4)
45.9
[27.9–62.2]
(9)
63.8
[35.3–82.3]
(3)
>70 yr4553.3
[37.9–68.3]
32.6
[16.7–49.5]
(5)
35.8
[21.8–50.1]
(12)
55.5
[30.2–74.8]
(2)
IPI score0–24065.0
[48.3–79.4]
57.0
[38.2–72.0]
(7)
58.0
[40.9–71.8]
(17)
80.3
[54.5–92.4]
(4)
3–54047.5
[31.5–63.9]
12.2
[2.7–29.3]
(2)
20.3
[8.6–35.4]
(4)
29.5
[8.7–54.3]
(1)
Bulky disease (≥7.5 cm)Yes1442.9
[17.7–71.1]
27.7
[5.3–57.0]
(1)
33.4
[9.3–60.2]
(2)
NE
(0)
No6560.0
[47.1–72.0]
37.4
[23.6–51.1]
(8)
42.3
[29.7–54.3]
(19)
58.9
[38.4–74.6]
(5)
Time to progression after 1L therapy<12 mo2050.0
[27.2–72.8]
38.8
[17.0–60.2]
(3)
44.9
[21.9–65.6]
(8)
70.0
[32.9–89.2]
(1)
≥12 mo2080.0
[56.3–94.3]
46.2
[19.5–69.4]
(4)
57.0
[32.0–75.8]
(6)
51.4
[21.2–75.2]
(2)

*5-yr rate estimate, % [95% CI] (5-yr n at risk). Pts with 1 prior line of therapy.Includes primary refractory. NE, not estimable.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Non-Hodgkin Lymphoma

Clinical Trial Registration Number

NCT02399085

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr e19522)

DOI

10.1200/JCO.2023.41.16_suppl.e19522

Abstract #

e19522

Abstract Disclosures