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e-Poster Display Session

31P - Integrated safety analysis of anti-programmed cell death-1 (PD-1) antibody penpulimab in advanced solid tumour or lymphoma

Date

09 Dec 2020

Session

e-Poster Display Session

Presenters

Nong Xu

Citation

Annals of Oncology (2020) 31 (suppl_7): S1428-S1440. 10.1016/annonc/annonc391

Authors

N. Xu1, B. Han2, S. Jiao3, C. Hu4, A. Mislang5

Author affiliations

  • 1 The First Affiliated Hospital of Zhejiang University Medical College, Hangzhou/CN
  • 2 Shanghai Chest Hospital, Shanghai/CN
  • 3 Chinese PLA General Hospital, Beijing/CN
  • 4 Shanghai Cancer center, Shanghai/CN
  • 5 Adelaide Cancer Centre, Kurralta Park/AU
More

Abstract 31P

Background

Penpulimab is a humanized IgG1 mAb that blocks PD-1 binding to PD-L1, Penpulimab is engineered to eliminate FcγR binding and ADCC/ADCP completely, as compared to majority of marketed IgG4 PD-1 antibodies with ADCC/ADCP activity. Penpulimab demonstrats a slower PD-1 antigen binding off-rate than marketed PD-1 antibodies, which results in better cellular activity and higher receptor occupancy. Penpulimab also shows numerous contacts with N58 glycosylation on the BC loop of PD-1 which could be an advantage to facilitate interaction of PD-1 antibody. These structural differentiations offer more robust biological effect and enhance anti-tumor activity of Penpulimab.

Methods

This integrated safety analysis includes data from 422 patients (pts) treated with monotherapy or combination therapy of Penpulimab from 6 clinical trials: one dose-escalation and expansion study [AK105-101(in advanced solid tumor) treated with single dose of 1.0, 3.0, 10 mg/kg and 200mg Q2W] in Australia and 5 studies [AK105-201 (in R/R cHL), AK105-202 (in NPC) and AK105-204 (in advanced solid tumor) treated with 200mg Q2W monotherapy; AK105-203 (in HCC) treated with Penpulimab 200mg Q3W combined with Anlotinib 8mg d1-14 Q3W; AK105-301( in non-squamous NSCLC) treated with Penpulimab 200mg Q3W combined with chemotherapy] in China. In this analysis, immune-related adverse events (irAEs) of Penpulimab is based on suspected irAEs confirmed by medical review.

Results

As of Jan 10 2020, a total of 422 patients (pts) [monotherapy: combo therapy= 329:93] received a median of 8 doses [1-52] of Penpulimab. Main types of tumor (≥10 pts) in this analysis include: R/R cHL (N=94), NPC (N=89), NSCLC (N=56), HCC (N=53), gastric/GEJ cancer (N=21), ovarian cancer (N=20), pancreatic cancer(N=11), esophageal cancer (N=11) and biliary duct carcinoma (N = 11). irAEs occurred in 23.0% of pts (G3 in 2.6%, no G4 or G5, serious in 0.7%, treatment discontinuation in 0.7%). Most common irAEs (≥1%) were hypothyroidism (9.2%), hyperthyroidism (4.3%), increased TSH (2.8%) and rash (2.4%).

Conclusions

Penpulimab demonstrates impressive safety profile with relatively lower incidence rate of ≥ Grade 3 immune-related adverse events.

Clinical trial identification

NCT03352531, NCT03722147, NCT03866967, NCT04172571, NCT04172506, NCT03866980.

Legal entity responsible for the study

Akeso, Inc.

Funding

Akeso, Inc.

Disclosure

Y. Xia, D. Xia, X. Jin, Z.M. Wang, B. Li: : Honoraria (self): Akeso, Inc. All other authors have declared no conflicts of interest.

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