Slide 1: REDIRECT: A Phase 2 study of AFM13 in R/R CD30-positive PTCL
REDIRECT: A Phase 2 study of AFM13 in patients with CD30-positive relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) Won Seog Kim, MD Sungkyunkwan University School of Medicine, Seoul, Republic of Korea Footnotes
Slide 2: Disclosure Information
Disclosure Information Won Seog Kim I have the following relevant financial relationships to disclose: Grant/Research support from: Sanofi, Beigene, Boryong, Roche, Kyowa-Kirin, Donga Footnotes
Slide 3: There is high unmet need in R/R PTCL
There is high unmet need in R/R PTCL PTCLs are a heterogeneous group of aggressive lymphomas with generally poor prognoses1 Many patients do not PTCL accounts for 10–15% Median OS of most PTCL respond to frontline therapy; of all new cases of NHL subtypes is 1–3 years; the no standard-of-care worldw
Slide 4: AFM13: Enhancing the innate immune response to target CD30+ tumor cells
AFM13: Enhancing the innate immune response to target CD30+ tumor cells AFM13 AFM13 mechanism of action3 AFM13 is a tetravalent, bispecific CD30/CD16A, designed to redirect and Augmenting innate immunity with AFM13 may provide an enhance NK cell-mediated effective treatment approach for patients ADC
Slide 5: Previous studies with AFM13 demonstrate proof-of-concept for targeting CD30+ lymphomas
Previous studies with AFM13 demonstrate proof-of-concept for targeting CD30+ lymphomas AFM13 monotherapy in patients with CD30+ R/R HL1 and R/R lymphomas with cutaneous presentation2 • AFM13 exhibited targeted lysis of CD30+ tumor cells, with ORRs of 11.5%–42.0% • A well-managed safety profile was o
Slide 6: The REDIRECT study (NCT04101331)
The REDIRECT study (NCT04101331) A Phase 2 open-label, global, multicenter, registration-directed study in patients with CD30+ R/R PTCL Inclusion criteria Exclusion criteria Non-PTCL subtypes of lymphoma: T-PLL, Histologically confirmed CD30+ R/R PTCL by T-LGL, CLPD-NK, ANKL, ENKTCL, Ber-H2 targeted
Slide 7: The REDIRECT study (NCT04101331) design and endpoints
The REDIRECT study (NCT04101331) 200 mg AFM13 was administered IV Q1W until disease progression, unacceptable toxicity, termination at the investigator’s discretion, or withdrawal of consent Primary Endpoint: Cohort A: ORR by IRC assessed by FDG-PET CD30 expression ≥10% (N=20) Interim Secondary Endp
Slide 8: Patient and tumor characteristics (N=108)
Patient and tumor characteristics (N=108) Median (range) age, years Prior lines, N (%) 21 63 93 Mean: 2.7 1 23 (21.3) Sex, N (%) 2 35 (32.4) ≥3 50 (46.3) Male 66 42 Female (61.1) (38.9) PTCL subtypes, N (%) Auto- Prior BV: PTCL-NOS 41 (38.0) transplant: 50 (46.3) 42 (38.9) AITL 30 (27.8) sALCL 26 (2
Slide 9: Exposure to study treatment (N=108)
Exposure to study treatment (N=108) Number of infusions Relative dose intensity Patients with at least one Patients who received (mean) (mean) dose reduction* 200 mg at all infusions 9 (median) 116 1 16 91% 11% 85% Footnotes *The dose was reduced to 100 mg AFM13 as per the protocol, in the case of r
Slide 10: AFM13 exhibited a tolerable safety profile (N=108)
AFM13 exhibited a tolerable safety profile (N=108) No new or unexpected safety findings were observed Summary of adverse events, N patients (%) Summary of AFM13-related TEAEs by Grade (≥5% patients), N patients (%) All AFM13-related Grade 1/2 Grade 3/4 Overall Any TEAE 46 (42.6) 33 (30.6) 79 (73.1)
Slide 11: AFM13 exhibited clinical efficacy in a heavily pre-treated cohort (N=108)
AFM13 exhibited clinical efficacy in a heavily pre-treated cohort of patients (N=108) ORR CRR Metabolic responses were determined by 32.4% 10.2% FDG-PET per (23.7, 42.1) (5.4, 18.1) IRC assessment Footnotes ORR, CRR, and DCR (95% CI) values are presented. CI, confidence interval; CRR, complete respo
Slide 12: Tumor shrinkage was observed in over half of evaluable patients (N=82)
Tumor shrinkage was observed in over half of evaluable patients (N=82) Greatest percentage tumor change from baseline in SPD based on CT per IRC assessment in individual patients* 200 180 160 140 Most patients exhibiting a PR or CR 120 100 showed responses during the first cycle 80 of treatment with
Slide 13: Patients with AITL exhibited the highest ORR and CRR
Patients with AITL exhibited the highest ORR and CRR ORR, % CRR , % (95% CI) (95% CI) 22 2.4 (10.6, 37.6) (0.1, 12.9) 53.3 26.7 (34.3, 71.7) (12.3, 45.9) 23.1 3.8 (9.0, 43.6) (0.1, 19.6) 36.4 9.1 (10.9, 69.2) (0.2, 41.3) 32.4 10.2 (23.7, 42.1) (5.2, 17.5) AITL, angioimmunoblastic T-cell lymphoma; CI
Slide 14: No meaningful differences in response by CD30 expression level
No meaningful differences in response amongst patients stratified by CD30 expression level ORR, % CD30 expression level (95% CI) 26.7 ≥1–<5% (7.8, 55.1) 30.8 ≥5%–<10% (9.1, 61.4) 35.9 ≥10%–<50% (21.2, 52.8) 30.6 ≥50% (16.4, 48.1) Footnotes CI, confidence interval; FDG-PET, fluorodeoxyglucose-positro
Slide 15: Duration of responses
Duration of responses Kaplan-Meier Plot of Duration of Response by IRC for FDG-PET 1.0 Cohort DoR, N=35 0.9 DoCR, N=11 0.8 0.7 Patients censored, N 13 Probability 0.6 0.5 Median DoR, months 2.3 0.4 0.3 (95% CI) (1.9, 6.5) 0.2 0.1 Median DoCR, months 3.6 0.0 (95% CI) (1.9, NE) 0 3 6 9 12 15 18 21 24
Slide 16: Progression-free survival
Progression-free survival Kaplan-Meier Plot of Progression-free Survival by IRC for FDG-PET 1.0 Cohort N=108 0.9 0.8 Patients censored, N 46 0.7 Probability 0.6 Median PFS, months 3.5 0.5 (95% CI) (1.9, 3.6) 0.4 0.3 0.2 0.1 0.0 0 3 6 9 12 15 18 21 24 27 30 Duration of Survival (months) Number of Sub
Slide 17: Overall survival
Overall survival Kaplan-Meier Plot of Overall Survival Cohort 1.0 N=108 0.9 0.8 Patients censored, N 62 0.7 Probability 0.6 Median OS, months 13.8 0.5 (95% CI) (5.0, NE) 0.4 0.3 0.2 0.1 0.0 0 3 6 9 12 15 18 21 24 27 30 33 Duration of Survival (months) Number of Subjects at Risk: Cohort 108 79 55 36
Slide 18: Conclusion
Conclusion AFM13 exhibited clinical efficacy in a heavily pre-treated cohort with CD30+ R/R PTCL; the greatest ORR was observed in patients with AITL AFM13 showed a tolerable safety profile; no new or unexpected safety findings were observed compared with previous AFM13 clinical studies Enhancing th
Slide 19: Acknowledgements
Acknowledgements We would like to thank all of the patients, caregivers, investigators and trial site staff who participated in the REDIRECT study I would also like to take this opportunity to thank my fellow co-authors and investigators for their valued contribution to this trial: • Jake Shortt • A
Slide 20: Acknowledgements for the patients, caregivers and trial staff at the following sites
Acknowledgements for the patients, caregivers and trial staff at the following sites: Australia Poland Turkey § Royal Adelaide Hospital § Szpitale Pomorskie Sp. z o.o.. Szpital Morski im. PCK, Oddzial § Ankara University Faculty of Medicine, Department of Internal § Flinders Medical Centre Hematolog
Slide 21: Thank you for listening
Thank you for listening Footnotes