Forma Therapeutics Holdings Inc

Forma Therapeutics — Technical Presentation (December 2019)

14 slides from Forma Therapeutics's technical presentation, December 2019

  1. Slide 1: Olutasidenib (FT-2102), an IDH1m Inhibitor in AML Phase 1 Study

    Olutasidenib (FT-2102), an IDH1m Inhibitor as a Single Agent or in Combination With Azacitidine, Induces Deep Clinical Responses With Mutation Clearance in Patients With Acute Myeloid Leukemia Treated in a Phase 1 Dose Escalation and Expansion Study Justin M. Watts,1 Maria R. Baer,2 Jay Yang,3 Thoma

  2. Slide 2: Introduction

    Introduction • IDH1 mutations occur in 7-14% of patients with AML and approximately 3-5% of patients with MDS • Olutasidenib (FT-2102) is a highly potent, orally active, selective inhibitor of IDH1m Olutasidenib (FT-2102)

  3. Slide 3: Study Design

    Study Design Phase 1 Dose Expansion Key Inclusion Criteria Dose Escalation (RP2D) Objectives • AML or intermediate to very high risk MDS with IDH1- Olutasideniba R/R Monotherapy Olutasideniba R132 gene mutation 150 mg QD Primary 300 mg QD 150 mg BID • Relapsed/refractory (R/R) 150 mg BID • Safety an

  4. Slide 4: Demographics and Disease Characteristics

    Demographics and Disease Characteristics Olutasidenib Olutasidenib + AZA Characteristic (N = 32) (N = 46) Age, median (range), years 72 (35-87) 67 (31-88) Female 16 (50) 24 (52) ECOG PS - 0 / 1 / 2, % 28/50/22 28/57/15 AML, n 26 39 Primary AML (de novo) 21 (81) 23 (59) Secondary AML 5 (19) 16 (41) D

  5. Slide 5: Patient Disposition

    Patient Disposition Olutasidenib Olutasidenib + AZA Characteristic (N = 32) (N = 46) Treatment ongoing, n (%) 3 (9) 10 (22) Discontinued from study treatment, n (%) 29 (91) 36 (78) Transplant (HSCT) 4 (13) 10 (22) Disease progression 12 (38) 11 (24) Investigator decision 1 (3) 5 (11) Permanent withd

  6. Slide 6: Nonhematologic TEAEs (> 20%) Regardless of Causality

    Nonhematologic TEAEs (> 20%) Regardless of Causality Olutasidenib Olutasidenib + AZA TEAE, n (%) (N = 32) (N = 46) Any Grade Grade 3-4 Any Grade Grade 3-4 Nausea 15 (47) 0 32 (70) 4 (9) Fatigue 14 (44) 2 (6) 18 (39) 8 (17) Pyrexia 11 (34) 2 (6) 11 (24) 0 Diarrhea 8 (25) 1 (3) 21 (46) 2 (4) Pneumonia

  7. Slide 7: Hematologic TEAEs (> 20%) Regardless of Causality

    Hematologic TEAEs (> 20%) Regardless of Causality Olutasidenib Olutasidenib + AZA TEAE, n (%) (N = 32) (N = 46) Any Grade Grade 3-4 Any Grade Grade 3-4 Thrombocytopenia 9 (28) 9 (28) 21 (46) 19 (41) Neutropenia 3 (9) 2 (6) 14 (30) 13 (28) Leukocytosis 7 (22) 4 (13) 12 (26) 7 (15) Anemia 7 (22) 7 (22

  8. Slide 8: DLTs and AEs of Special Interest

    DLTs and AEs of Special Interest • No DLTs observed in the dose escalation cohorts • IDH differentiation syndrome (IDH-DS) • 4 monotherapy patients (13%; grade 3, 3; grade 2, 1) and 6 combination therapy patients (13%; grade 3, 3; grade 2, 1; grade 1, 2) experienced an IDH-DS AE • Most (7) were obse

  9. Slide 9: Clinical Response in Patients With AML

    Clinical Response in Patients With AML Monotherapy Combination Therapy T T T T T Response, n (%) R/R TN Response, n (%) R/R TN (n=22) (n=4) T T (n=26) (n=13) T T ORR 9 (41) 1 (25) T ORR 12 (46) 10 (77) CR 4 (18) 0 CR 3 (12) 7 (54) CRh 3 (14) 0 T CRh 1 (4) 0 CRi/MLFS 2 (9) 1 (25) CRi/MLFS 8 (31) 3 (2

  10. Slide 10: Survival in AML

    Survival in AML Median OS (95% CI), weeks 1.0 Monotherapy (R/R) 37.7 (10.7 - NR) Combination (R/R) 52.6 (18.3 - NR) 0.8 Combination (TN) NR (41.6 - NR) Survival Probability 0.6 0.4 Censored 0.2 Olutasidenib Monotherapy – R/R Olutasidenib + AZA Combination – R/R Olutasidenib + AZA Combination – TN 0.

  11. Slide 11: Mutational Analysis of AML Patients

    Mutational Analysis of AML Patients • Of the 59 patients with AML with both local and central IDH1m results, central testing confirmed the presence of IDH1m at study entry in 56 (95%) of patients • 57 of 59 patients (97%) had ≥ 1 co-mutation and 23 of 59 patients (39%) had ≥ 3 co-mutations IDH1 Vari

  12. Slide 12: IDH1 Mutation Clearance in AML

    IDH1 Mutation Clearance in AML • 25 patients achieving a clinical response had available longitudinal samples for analysis (VAF at ≥ cycle 3) • IDH1 mutation clearance/significant reduction (VAF to < 1%) is observed in 10 of 25 patients (40%) with an IWG response to olutasidenib Reduction of IDH1 VA

  13. Slide 13: Conclusions

    Conclusions • Olutasidenib is well tolerated as monotherapy and in combination with AZA • No DLTs in dose escalation; 150 mg BID is the RP2D based on optimal exposure and robust 2-HG response • Olutasidenib demonstrates clinical activity in a high-risk Phase 1 AML population • Olutasidenib induces I

  14. Slide 14: Acknowledgments

    Acknowledgments • The authors thank the patients and their families for participation in the study • This study was funded by FORMA Therapeutics, Inc., Watertown, MA • Olutasidenib (FT-2102) is an investigational drug; no efficacy or safety claim is intended or implied • Medical writing and editoria

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