Abstract 157P
Background
Upper gastrointestinal (UGI) cancers are a group of highly aggressive malignancies with poor prognoses. Immunotherapy is emerging as an effective treatment option for some of these cancers. Penpulimab, a new generation anti-PD-1 monoclonal antibody, was engineered to optimize receptor occupancy by improving duration of drug binding, and to eliminate Fc-mediated effector function that compromises anti-tumor immune cell function. Here, we present the preliminary antitumor and safety data on Penpulimab in patients (pts) with advanced UGI malignancies.
Methods
Pts with advanced cancers, relapsed or refractory to standard therapy but naïve to immune checkpoint inhibitors (ICIs), were enrolled in two phase I trials of Penpulimab (NCT03352531 and NCT04172506). Pts received Penpulimab IV at 1-10 mg/kg Q2W or 200mg Q2W until disease progression or unacceptable toxicity. Antitumor activity was investigator-assessed per RECIST v1.1 criteria.
Results
As of 1st July 2020, 67 pts with UGI cancers received Penpulimab for a median of 6 (1–64) doses. The antitumor activity of Penpulimab in the 60 pts evaluable for efficacy is shown below. 11/13 (85%) responders had ongoing responses at data cutoff date. Table: 157P
Pancreatic cancer (PCA), n=9 | Cholangiocarcinoma (CCA), n=9 | Gastric/ gastroesophageal junction (GEJ) cancer, n=19 | Hepatocellular carcinoma, (HCC), n=23 | |
ORR, % (95% CI) | 11.1 [0.3, 48.2] | 22.2 [2.8, 60.0] | 26.3 [9.1, 51.2] | 21.7 [7.5, 43.7] |
DCR, % (95% CI) | 33.3 [7.5, 70.1] | 44.4 [13.7, 78.8] | 42.1 [20.3, 66.5] | 52.2 [30.6, 73.2] |
Median DoR, months (range) | 22.1+ | 21.1 [0.03+, 21.1] | NR [3.7+, 14.8+] | NR [3.7+, 23.0+] |
Treatment-related adverse events (TRAEs) occurred in 44.8% of pts. There were no discontinuations due to drug-related AEs or drug-related deaths. Grade ≥3 TRAEs occurred in 5 pts (7.5%) – raised liver enzymes (n=2), adrenal insufficiency (n=1) and hyponatraemia (n=1) in the same pt, intestinal obstruction (n=1), and hypertension (n=1).
Conclusions
Penpulimab was well tolerated and demonstrated encouraging antitumor activity with durable response in pts with advanced UGI cancers, including PCA and CCA, which are generally resistant to single agent ICI. Penpulimab in combination with anlotinib, a multi-targeted receptor tyrosine kinase inhibitor, is being evaluated in phase III studies for 1L HCC (NCT04344158) and 2L Gastric/GEJ (NCT04385550).
Clinical trial identification
NCT03352531; NCT04172506.
Editorial acknowledgement
Legal entity responsible for the study
Akeso Biopharma Inc.
Funding
Akeso Biopharma Inc.
Disclosure
A.R.A. Mislang: Honoraria (self): BMS. A. Cooper: Honoraria (self): MSD; Travel/Accommodation/Expenses: Merck Sharp & Dohme; Travel/Accommodation/Expenses: Roche. X. Jin, K.Y. Kwek: Shareholder/Stockholder/Stock options, Full/Part-time employment: Akeso Biopharma. B. Li, M. Wang, D. Xia: Y. Xia: Shareholder/Stockholder/Stock options, Full/Part-time employment, Officer/Board of Directors: Akeso Biopharma. A. Prawira: Research grant/Funding (institution), Non-remunerated activity/ies: Akeso Biopharma; Research grant/Funding (institution), Non-remunerated activity/ies: Beigene; Research grant/Funding (institution), Non-remunerated activity/ies: Corvus; Research grant/Funding (institution), Non-remunerated activity/ies: CStone; Research grant/Funding (institution), Non-remunerated activity/ies: Macrogenics; Research grant/Funding (institution), Non-remunerated activity/ies: Five Prime; Research grant/Funding (institution), Non-remunerated activity/ies: Virogin; Research grant/Funding (institution), Non-remunerated activity/ies: QBiotics; Research grant/Funding (institution): Arcusbio; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Bayer; Research grant/Funding (institution): Roche/Genentech; Research grant/Funding (institution): BMS; Research grant/Funding (institution): Apollomics; Research grant/Funding (institution): ENB Therapeutics; Research grant/Funding (institution): Henlius; Research grant/Funding (institution): Eli Lilly; Research grant/Funding (institution): INXMed; Research grant/Funding (institution): Merck/MSD; Research grant/Funding (institution): Janssen. All other authors have declared no conflicts of interest.
Resources from the same session
313P - Diagnostic value of micro RNA (miRNA) in renal cell cancer: A meta-analysis and systemic review
Presenter: Jestoni Aranilla
Session: e-Poster Display Session
314P - Comprehensive microbial signatures and genomic profiling in tumour samples using next generation sequencing
Presenter: Mei Qi Yee
Session: e-Poster Display Session
315P - High-penetrance breast and/or ovarian cancer susceptibility genes in Filipinos
Presenter: Frances Victoria Que
Session: e-Poster Display Session
316P - Implementation of Vela Analytics to accelerate comprehensive interpretation and reporting of next-generation sequencing-based oncology testing in clinical diagnostic laboratories
Presenter: Yingnan Yu
Session: e-Poster Display Session
317P - Genomic profiling and molecular pathology of Chinese glioma patients
Presenter: yuanli Zhao
Session: e-Poster Display Session
320P - Psychometric interplay of the perception of the real-life impact of COVID-19 pandemic: A cross-sectional survey of patients with newly diagnosed malignancies
Presenter: Kelvin Bao
Session: e-Poster Display Session
321P - Impact of COVID-19 and lockdown on adherence to treatment schedule among cancer patients
Presenter: Krishnamani Kalpathi
Session: e-Poster Display Session
322P - Challenged faced by cancer patients during the COVID-19 pandemic
Presenter: mithra Krishnamani
Session: e-Poster Display Session
323P - Oncology care in the Republic of Kazakhstan during COVID-19
Presenter: Dilyara Kaidarova
Session: e-Poster Display Session
324P - COVID era: Perception of oncologists from a developing nation
Presenter: Rakesh Roy
Session: e-Poster Display Session