Incyte Corporation · NASDAQ:INCY

Incyte — ASCO 2026

20 slides from Incyte's conference presentation, 2026

  1. Slide 1: frontMIND: Phase 3 Study of Tafasitamab Plus Lenalidomide and R-CHOP in Newly Diagnosed DLBCL

    frontMIND: Phase 3 Study of Tafasitamab Plus Lenalidomide and R-CHOP for Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma Georg Lenz,1 Marek Trněný,2 John M. Burke,3 Grzegorz S. Nowakowski,4 Christopher P. Fox,5 Annalisa Chiappella,6 Johannes Duell,7 Young Woo Jeon,8 Chan Y. Cheah,9 Jason

  2. Slide 2: Background: Tafasitamab

    Background: Tafasitamab ● Tafasitamab, a monoclonal Tafasitamab + Lenalidomide Synergy in DLBCL* antibody, targets CD19 on Tafasitamab malignant B cells (Fc-modified, anti-CD19 mAb)1-5 Affinity-matured ● The engineered Fc region Lenalidomide CD19-binding site increases affinity to immune Direct cyto

  3. Slide 3: Background: DLBCL

    Background: DLBCL ● >40% of patients with high-risk DLBCL, are not cured with first-line R-CHOP1-3 ● Tafasitamab and lenalidomide doubled the historical ORR of lenalidomide monotherapy in R/R DLBCL leading to FDA approval of the regimen for patients with R/R DLBCL4,5 ● Tafasitamab plus lenalidomide

  4. Slide 4: Key Takeaway Points

    Key Takeaway Points 1 2 3 Tafa-Len-R-CHOP Point estimates suggested The incremental safety significantly prolonged trends toward PFS events observed with PFS compared with advantage with Tafa-Len-R-CHOP R-CHOP (HR 0.75) in Tafa-Len-R-CHOP in were well-managed and patients with previously key prespec

  5. Slide 5: frontMIND: Phase 3 Global Randomized Study Design

    frontMIND (NCT04824092): Phase 3, Global, Multicenter, Placebo-Controlled, Double-Blind, Randomized Study 21-day treatment cycles, 6 cycles Tafa-Len-R-CHOP Arm (Experimental Arm) Key Inclusion Criteria • Previously untreated DLBCL • Tafasitamab 12 mg/kg IV (days 1, 8, and 15) • Lenalidomide 25 mg/da

  6. Slide 6: Patient Disposition

    Patient Disposition Data cutoff: October 20, 2025 1229 Patients assessed for eligibility 330 Not randomized 294 Eligibility criteria not met 28 Withdrawal of consent 2 Investigator decision 6 Other reasons 899 Randomized 448 Assigned to receive Tafa-Len-R-CHOP 451 Assigned to receive R-CHOP 443 (98.

  7. Slide 7: Demographics and Baseline Disease Characteristics

    Demographics and Baseline Disease Characteristics Overall ITT population Tafa-Len-R-CHOP R-CHOP Total ITT Population (n=448) (n=451) (N=899) Median age, years (range) 65.0 (20, 80) 65.0 (18, 80) 65.0 (18, 80) Male sex 240 (53.6) 233 (51.7) 473 (52.6) Ann Arbor stage III or IV at enrollment 432 (96.4

  8. Slide 8: Tafa-Len-R-CHOP Significantly Improved PFS vs R-CHOP

    Tafa-Len-R-CHOP Significantly Improved PFS vs R-CHOP PFS by investigator assessment (primary endpoint) 100 90 HR 0.75* (P=0.0194) 95% CI: 0.59, 0.96 80 Probability of PFS, % Tafa-Len-R-CHOP 70 ● A 25% reduction in risk of 60 progression or death 50 R-CHOP demonstrated with 40 Tafa-Len-R-CHOP vs R-CH

  9. Slide 9: Tafa-Len-R-CHOP Significantly Improved EFS vs R-CHOP

    Tafa-Len-R-CHOP Significantly Improved EFS vs R-CHOP EFS by investigator assessment (key secondary) 100 90 HR 0.79* (P=0.0260) 95% CI: 0.64, 0.97 80 Probability of EFS, % 70 Tafa-Len-R-CHOP ● 2-year EFS: 60 65.0% with Tafa-Len-R-CHOP vs 50 56.7% with R-CHOP R-CHOP 40 30 ● 3-year EFS: 20 61.2% with T

  10. Slide 10: Interim Analysis of OS Demonstrated a Positive Trend

    Interim Analysis of OS Demonstrated a Positive Trend OS (key secondary) 100 90 HR 0.85* (P=0.2703) Tafa-Len-R-CHOP 95% CI: 0.63, 1.14 80 Probability of OS, % 70 R-CHOP ● 2-year OS: 60 84.1% with Tafa-Len-R-CHOP vs 50 80.5% with R-CHOP 40 30 ● 3-year OS: 20 81.1% with Tafa-Len-R-CHOP vs 10 77.8% with

  11. Slide 11: HR for PFS Improved in Centrally Confirmed Lymphoma Subtypes

    HR for PFS Improved in Centrally Confirmed Lymphoma Subtypes (n=773) 100 HR 0.68* (P=0.0035)† 90 95% CI: 0.52, 0.88 80 Probability of PFS, % 70 Tafa-Len-R-CHOP versus 60 Overall ITT population: R-CHOP 50 HR 0.75 (P=0.0194) 40 95% CI: 0.59, 0.96 30 20 ● 2-year PFS: 10 72.7% with Tafa-Len-R-CHOP vs Me

  12. Slide 12: Cell-of-Origin Molecular Subtypes

    Cell-of-Origin Molecular Subtypes Central GEP assessment Tafa-Len-R-CHOP R-CHOP Total ITT Population (n=448) (n=451) (N=899) Cell of origin (per GEP; central assessment), n 239 245 484 ABC-like 84 (35.1) 88 (35.9) 172 (35.5) GCB-like 131 (54.8) 117 (47.8) 248 (51.2) Unclassified 24 (10.0) 40 (16.3)

  13. Slide 13: Consistent Trends Toward PFS Benefit in Prespecified Subgroups

    Consistent Trends Toward PFS Benefit in Prespecified Subgroups Baseline Tafa-Len-R-CHOP R-CHOP Tafa-Len-R-CHOP R-CHOP Risk Factors Patient n/Event n Patient n/Event n Better Better HR* (95% CI) Overall 448/121 451/155 0.75 (0.59, 0.96) Cell of origin by central GEP ABC-like 84/27 88/44 0.59 (0.36, 0

  14. Slide 14: ORR and CR Rate by Investigator Assessment

    ORR and CR Rate by Investigator Assessment ORR (95% CI)*,† 80.4% 76.1% (76.4, 83.9) (71.8, 79.9) 100 NE 12.9% 11.8% PD 90 0.4% 6.3% 11.1% SD 80 1.1% PR 15.2% 10.9% 70 PET-negative CR 60 Percent 50 ● ORR (OR 1.29 [95% CI: 0.94, 1.78]‡; 40 P=0.1201§) and PET-negative CR 65.2% 65.2% 30 rate (OR 1.00 [9

  15. Slide 15: Overall Safety Summary

    Overall Safety Summary Tafa-Len-R-CHOP R-CHOP Variable (n=443) (n=447) Patients with ≥1 TEAE, n (%) Any TEAE 437 (98.6) 434 (97.1) Any treatment-related TEAE 423 (95.5) 407 (91.1) Grade ≥3 TEAE 384 (86.7) 340 (76.1) Serious TEAE 222 (50.1) 174 (38.9) Fatal TEAE 26 (5.9) 17 (3.8) TEAEs leading to dis

  16. Slide 16: Most Frequent TEAEs (≥12% in Any Group)

    Most Frequent TEAEs (≥12% in Any Group) Tafa-Len-R-CHOP (n=443), % R-CHOP (n=447), % Neutropenia 70.7 59.7 Anemia 46.3 34.5 Peripheral neuropathy* 40.6 39.1 Thrombocytopenia 38.8 26.6 Constipation 34.3 28.2 Nausea 26.4 31.3 Diarrhea 24.6 16.6 Hypokalemia 21.7 14.5 Fatigue 21.4 19.2 COVID-19 20.3 23.

  17. Slide 17: Tafa-Len Did Not Impact Delivery of R-CHOP

    Tafa-Len Did Not Impact Delivery of R-CHOP Tafa-Len-R-CHOP R-CHOP Median Relative Dose Intensities, % (Across 6 Cycles) (n=443) (n=447) R-CHOP component: rituximab, cyclophosphamide, doxorubicin, 100 100 prednisone/prednisolone R-CHOP component: vincristine 92.9 92.1 ● Median RDIs were high and the

  18. Slide 18: Summary and Conclusions

    Summary and Conclusions 1 2 3 4 Tafa-Len-R-CHOP Point estimates The incremental The results support significantly suggested trends safety events the use of prolonged PFS vs toward PFS observed with Tafa-Len-R-CHOP as R-CHOP (HR 0.75; advantage with Tafa-Len-R-CHOP a new standard 2-year PFS rate, Taf

  19. Slide 19: Manuscript Is Now Published Online in The Lancet

    Manuscript Is Now Published Online in The Lancet thelancet.com/journals/lancet/article/PIIS0140-6736(26)00866-4/fulltext 19

  20. Slide 20: Acknowledgments

    Acknowledgments ● The authors wish to thank the patients and their families, the investigators, Slovakia and the site personnel who Ukraine participated in this study Poland Russia UK ● The authors wish to also thank Canada Ireland Germany Marie-Laure Casadebaig, Susan Spitz, France Lin Zheng, and X

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