Incyte Corporation · NASDAQ:INCY
Incyte — ASCO 2026
20 slides from Incyte's conference presentation, 2026
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
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
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
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
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
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.
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
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
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
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
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
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)
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
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
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
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.
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
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
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
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