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6-K Filing
argenx SE (ARGX) 6-KCurrent report (foreign)
Filed: 7 Jul 17, 12:00am
Exhibit 99.2
A phase 1b study of ARGX-111 in patients with advanced cancers over-expressing the MET protein Anna Hultberg1, Philippe Aftimos2, Christian Rolfo3, Sylvie Rottey4, Philippe Barthelemy5, Christophe Borg6, Keunchil Park7, Do-Youn Oh8, Sang-We Kim9, Natalie De Jonge1, Valérie Hanssens1, Karen Zwanenpoel3, Torsten Dreier1, Luc Van Rompaey1, Hans de Haard1, Patrick Pauwels3, Samson Fung1, Alain Thibault1, Nicolas Leupin1 and Ahmad Awada2 1argenx BVBA, Zwijnaarde (Ghent), Belgium,2Institut Jules Bordet, Brussels, Belgium, 3University Hospital Antwerp, Edegem, Belgium,4University Hospital Ghent, Ghent, Belgium, 5Centre Paul Strauss, Strasbourg, France, 6Hôpital Jean Minjoz, France, 7Samsung Medical Center, Seoul, South Korea, 8Seoul National University Hospital, Seoul, South Korea, 9Asan Medical Center, Seoul, South Korea 4 modes of action to attack MET+ tumor cells Phase 1b clinical trial overview Results Patient demographics and baseline characteristics MET overexpression (IHC) and MET gene amplification (FISH) ARGX-111 shows a favorable safety profile IHC FISH • No clinically relevant differences regarding these characteristics were Disease control rate of 42% with > 6 months stabilization of disease in several patients Partial response and 75% CTC reduction in a MET gene amplified gastric cancer patient CTC by Veridex 1 2 0 1 0 0 8 0 6 0 4 0 2 0 0 S c r e e n p r e C 6 18F-FDG-PET/CT shows mixed response in lesions (selection) ARGX-111 conclusions and future perspectives ARGX-111 is a unique MET-selective mAb combining complete blockade of MET signalling with enhanced tumor cell killing ARGX-111 has a favorable safety and tolerability profile Dose of 3 mg/kg q2w selected based on MTD and pharmacokinetics Preliminary anti-tumor activity at all dose levels in heavily pretreated patients with advanced MET+ malignancies Acknowledgments We would like to thank all the patients and their families for participating in this study. We would also like to thank all staff at sites, vendors and argenx that have contributed to the study. • • • • C T C / 7 . 5 m l b l o o d 7 5 % d e c r e a s e • Patient had mixed response (PD) after two doses of 0.3 mg/kg q3w ARGX-111 • Increased to 1 mg/kg C3-C9 at which patient showed PR at C5-C9 • Patient had a 75% decrease of CTC at C6 • 42% DCR with 1/24 PR and 9/24 SD, 60% DCR in the safety expansion (3 mg/kg q2w) • 3 patients had intra patient dose escalation at C3, 2 patients had dose reduction from 10-3 mg/kg due to DLT • Mean duration of treatment was 12 weeks • Demographic characteristics varied slightly across the treatment groups observed when comparing the treatment groups • All patients were stage IV • IRR were most common, but manageble with premedication • 5 CTCAE grade 3 toxicities (IRR, pain and fatigue) were considered related to ARGX-111 of which two (IRR) were considered DLTs at 10 mg/kg • 7 grade 5 toxicities were reported, none related to ARGX-111 • 43% IHC positive (>50%, >2+ intensity) • Gastric and colon had high expression levels • 12-12.5% MET amplified in lung and gastric • Overall 3% (15/501) of patients were MET gene amplified (MET:CEP7 >2) Archived biopsy