Slide 1: POD1UM-202: Phase 2 Study of Retifanlimab in Squamous Carcinoma of the Anal Canal
POD1UM-202: Phase 2 Study of Retifanlimab in Patients With Squamous Carcinoma of the Anal Canal Who Progressed Following Platinum-Based Chemotherapy Sheela Rao,1 Jaume Capdevila,2 Duncan Gilbert,3 Stefano Kim,4 Laetitia Dahan,5 Talal Kayyal,6 Marwan Fakih,7 Anne Demols,8 Lars H. Jensen,9 Karen-Lise
Slide 2: Disclosures
Disclosures • S Rao has served as an advisor for or received honoraria from Amgen, Bayer, Celgene, and Shire; and received travel grants from Bayer, Celgene, and Incyte • This study was sponsored by Incyte Corporation (Wilmington, DE)
Slide 3: Background
Background • The incidence of SCAC is increasing worldwide, especially in women1 − SCAC shares common etiologic features with other HPV-related malignancies, including cervical cancer and HNSCC2 − Risk is markedly increased with concurrent HIV infection1 − Median survival in advanced/metastatic dise
Slide 4: POD1UM-202: Phase 2, Open-label, Single-arm, Multicenter Study of Retifanlimab
POD1UM-202: Phase 2, Open-label, Single-arm, Multicenter Study of Retifanlimab (NCT03597295) Patients Treatment • ≥18 years with confirmed locally advanced or metastatic • Retifanlimab 500 mg IV infusion Q4W (28-day cycle) for SCAC up to 2 years • Disease progression on or after platinum-based thera
Slide 5: Patient Characteristics
Patient Characteristics Characteristic N = 94 Age, median (range), y 64 (37–94) ≥65 46 (49) ≥75 10 (11) Female, n (%) 61 (65) Race, n (%) White 72 (77) Other/Missing 22 (23) ECOG PS, n (%) 0 39 (42) 1 55 (59) Prior therapy, n (%) Chemoradiation therapy 69 (73) Radiotherapy (no chemotherapy) 16 (17)
Slide 6: Summary of Overall Responses (RECIST v1.1)
Summary of Overall Responses (RECIST v1.1) Objective Responses by ICR Variable N = 94 ORR (95% CI), % 13.8 (7.6–22.5) Best overall response, n (%) CR 1 (1.1) PR 12 (12.8) SD 33 (35.1) PD 43 (45.7) Missing 5 (5.3) DCR, n (%) 46 (48.9) • Median (95% CI) duration of response was 9.5 (5.6–not estimable)
Slide 7: Kaplan-Meier Estimate of PFS by ICR and OS
Kaplan-Meier Estimate of PFS by ICR and OS PFS OS 1.0 Number of patients evaluable 94 1.0 Number of patients evaluable 94 0.9 Events, n (%) 71 (75.5) 0.9 Events, n (%) 37 (39.4) Censored, n (%) 23 (24.5) Censored, n (%) 57 (60.6) 0.8 Median PFS (95% CI), months 2.3 (1.9, 3.6) 0.8 Median OS (95% CI),
Slide 8: Summary of Adverse Events
Summary of Adverse Events Patients With AE, n (%) All Patients (N = 94) Any treatment-related AE 55 (58.5) Grade ≥3 11 (11.7) Led to treatment discontinuation 4 (4.2) Any immune-related AE* 24 (25.5) Grade ≥3† 6 (6.4) Led to treatment discontinuation 2 (2.1) Infusion reactions (none grade ≥3) 4 (4.3
Slide 9: Conclusions
Conclusions • Retifanlimab has promising activity in patients with platinum-refractory SCAC, including those known to be HIV-positive − ICR-assessed ORR of 14% is comparable to that seen previously with PD-1 inhibitors in other HPV- driven malignancies1–6 − Median DOR of 9.5 months compares favorabl
Slide 10: Acknowledgments
Acknowledgments • The authors wish to thank the patients and their families, the investigators, and the site personnel who participated in this study • Clinical trial management was provided by Tristan Richard (Incyte Corporation) • Medical writing assistance was provided by Kakuri Omari, PhD, CMPP,