Slide 1: Neoadjuvant Pepinemab in Combination with Nivolumab and/or Ipilimumab in Resectable Stage III Melanoma
Exhibit 99.1 Neoadjuvant Pepinemab in Combination with Nivolumab and/or Ipilimumab in Resectable Stage III Melanoma NCT03769155 Michael Lowe, MD, MA, FACS, FSSO Associate Professor of Surgery Emory University School of Medicine Atlanta, GA, USA 09.12.2022
Slide 2: Declaration of Interests
DECLARATION OF INTERESTS Michael Lowe Research Funding: Amgen,BMS, Delcath, Merck, Regeneron, Stryker,Vaccinex Advisory Board: BMS Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Slide 3: Background
Background Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Slide 4: Background
Background No treatment Patient 1 Patient 2 Patient 3 Pepinemab Pre- Treatment On- Treatment CD8+ T cells Tumor (Cytokeratin+) Tumor CD8+ T cells MSS Colorectal cancer metastasis to liver Tumor margin Winship Cancer Institute, Emory University Content of this presentation is copyright and responsibi
Slide 5: Trial Design
Trial Design Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.
Slide 6: Trial Design
Trial Design • Primary Objective: • Effect of pepinemab on T cell infiltrate into the tumor microenvironment in lymph nodes and blood • Secondary Objectives: • Assess safety and tolerability of the combination of pepinemab with checkpoint inhibitors in patients with resectable stage III melanoma • D
Slide 7: Pathologic Responses
Pathologic Responses Cohort Drug N pCR* pMR^ A Nivolumab/pepinemab 8 25.0% 37.5% B Ipilimumab/pepinemab 8 12.5% 12.5% C Nivolumab/ipilimumab/pepinemab 8 62.5% 75.0% D Nivolumab 7 28.5% 42.9% *Pathologic complete response: No viable tumor ^ Major pathologic response: pCR plus near pCR (<10% viable tu
Slide 8: Recurrence-free Survival Kaplan-Meier Plot
K Ka ap pl la an n- -M Me ei ie er r P Pl lo ot t Recurrence-free Survival W Wi it th h N Nu um mb be er r o of f S Su ub bj je ec ct ts s a at t R Ri is sk k 1 1..0 0 + Censored Logrank p=0.0097 Nivolumab/pepinemab 0 0..8 8 Ipilimumab/pepinemab 0 0..6 6 Nivolumab/ipilimumab/ 0 0..4 4 pepinemab 0 0.
Slide 9: Recurrence-free Survival by Response
Recurrence-free Survival by Response K Ka ap pl la an n- -M Me ei ie er r P Pl lo ot t W Wi it th h N Nu um mb be er r o of f S Su ub bj je ec ct ts s a at t R Ri is sk k 1 1..0 0 + Censored Logrank p=0.0129 0 0..8 8 0 0..6 6 0 0..4 4 0 0..2 2 0 0..0 0 1 18 8 1 13 3 7 7 5 5 3 3 2 2 2 2 0 0 N No o Y
Slide 10: Toxicity
Toxicity • All patients safely underwent surgery without delay • Grade 3 adverse events: • Nivolumab/pepinemab: 1/8 (arthralgias) • Ipilimumab/pepinemab: 3/8 (AI, thrombocytopenia, transaminitis) • Nivolumab/ipilimumab/pepinemab: 5/8 (dermatitis, colitis, enteritis, nephritis, AI) • Nivolumab: 1/8 (
Slide 11: Conclusions
Conclusions • Pepinemab is well-tolerated and adds no additional toxicity to PD-1 and CTLA-4 inhibitors in the neoadjuvant setting • The triple combination of nivolumab, ipilimumab and pepinemab shows excellent response rates and with short follow up prolonged RFS compared to doublet therapies • Fur
Slide 12: Thank you to the Congress organizers and the Discussant
Thank you to the Congress organizers and the Discussant Michael Lowe mlowe3@emory.edu European Society for Medical Oncology (ESMO) Via Ginevra 4, CH-6900 Lugano T. +41 (0)91 973 19 00 esmo@esmo.org esmo.org