Tafasitamab plus lenalidomide versus standard of care as second‐line (2L) therapy for patients with R/R DLBCL: A post hoc internal 2L analysis of L‐MIND (IN 2L‐MIND)
Bibliographic record
Abstract
Background: Tafasitamab (tafa) is an anti-CD19 immunotherapy that enhances antibody-dependent cellular cytotoxicity and phagocytosis. L-MIND (NCT02399085), a phase 2 single-arm study, demonstrated efficacy of tafa plus lenalidomide (tafa/len) in autologous stem cell transplantation (ASCT)–ineligible adult patients (pts) with relapsed or refractory (R/R) DLBCL, and led to tafa/len accelerated approval in the US and conditional approval in Canada and Europe. Using the L-MIND 35-month follow-up data (October 30, 2020 data cutoff), the IN 2L-MIND post hoc analysis assessed 2L clinical outcomes in pts evaluated in 2 cohorts: pts treated with tafa/len as 2L therapy during the study (tafa/len cohort) and pts who received 2L systemic therapy prior to entering L-MIND (SOC cohort). Methods: Methodology for L-MIND as well as independent review committee– and investigator (INV)-assessed outcomes have been previously published (Salles et al., Lancet Oncol 2020). The primary endpoint of IN 2L-MIND was INV-assessed progression-free survival (PFS) after 2L treatment (defined as the time from initiation of 2L therapy [index date] until disease progression or death from any cause); secondary endpoints included objective response rate (ORR) and duration of response (DOR). Observable time was defined as time from initial DLBCL diagnosis until initiation of 2L treatment. Primary refractory pts enrolled in L-MIND prior to protocol amendment had disease that relapsed or progressed between 3 and 6 months after completing 1L therapy. Results: Total of 80 pts (tafa/len, n = 40; SOC, n = 40) were analyzed. Pt characteristics for the tafa/len and SOC cohorts were as follows: median age at diagnosis was 70 and 67 years, and male pts comprised 52.5% and 55.0%, respectively; 35 pts (87.5%) in each cohort had confirmed DLBCL diagnosis. In the tafa/len and SOC cohorts, median total observable time was 18.96 and 22.60 months, 6 and 9 pts had primary refractory disease, and 20 and 16 pts relapsed within 12 months of 1L therapy, respectively. Based on 35-month data, median PFS in the IN 2L-MIND analysis was 16.2 months (95% CI, 7.0-not evaluable [NE]) in the tafa/len cohort and 7.2 months (95% CI, 4.1–11.4) in the SOC cohort (Figure), and median DOR was 43.9 months (95% CI, 6.5-NE) and 7.9 months (95% CI, 3.2–13.8), respectively. ORR was 75.0% in the tafa/len cohort and 52.5% in the SOC cohort (CR, 37.5% vs. 25.0%; PR, 37.5% vs. 27.5%, respectively). PFS and ORR results were similar in a sensitivity analysis excluding pts without confirmed DLBCL diagnosis. The research was funded by: Incyte Corporation Keywords: Aggressive B-cell non-Hodgkin lymphoma, Chemotherapy, Combination Therapies Conflicts of interests pertinent to the abstract. L. H. Sehn Consultant or advisory role: AbbVie, Acerta, Apobiologix, AstraZeneca, Celgene, Debiopharm, Genentech, Genmab, Gilead Sciences, Incyte Corporation, Janssen, Karyopharm Therapeutics, Kite Pharma, Lundbeck, Merck, MorphoSys, Novartis, Sandoz, Takeda, TG Therapeutics, Verastem Oncology, Teva, Roche, Seattle Genetics Research funding: Teva Other remuneration: Roche, Seattle Genetics J. Kuruvilla Consultant or advisory role: AbbVie, Antengene, BMS, Gilead, Karyopharym, Merck, Roche, Seattle Genetics Honoraria: AbbVie, Amgen, AstraZeneca, BMS, Gilead, Incyte, Janssen, Karyopharm, Merck, Novartis, Pfizer, Roche, Seattle Genetics Research funding: Roche, AstraZeneca, Merck G. Salles Consultant or advisory role: AbbVie, Atbtherapeutics, Bayer, Beigene, BMS/Celgene, Debiopharm, Epizyme, Genentech/Roche, Genmab, Incyte, Ipsen, Janssen, Kite/Gilead, Loxo/Lilly, Molecular Partners, MorphoSys, Nordic Nanovector, Novartis, Regeneron, Takeda Stock ownership: Owkin K. J. Maddocks Honoraria: Pharmacyclics, Celgene, Seattle Genetics, MorphoSys AG, Bristol Myers Squibb, Karyopharm Therapeutics, Kite Pharma/Gilead Company, ADC Therapeutics and Genmab, Genentech, Lilly, Epizyme, Incyte, AbbVie, AstraZeneca Research funding: Pharmacyclics, Merck, Bristol Myers Squibb, AbbVie, AstraZeneca C. Koch Employment or leadership position: Incyte Corporation Stock ownership: Incyte Corporation Z. Xue Employment or leadership position: Incyte Corporation Stock ownership: Incyte Corporation T. Amoloja Employment or leadership position: Incyte Corporation Stock ownership: Incyte Corporation A. Amin Employment or leadership position: MorphoSys AG J. Duell Research funding: MorphoSys, Regeneron, Incyte Other remuneration: Incyte, MorphoSys
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.006 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.007 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".