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
244P - Optimization of early diagnostics of cervical intraepitelial neoplasies and cervical cancer
Presenter: Zakhirova Nargiza
Session: e-Poster Display Session
245P - Clinicopathological features including response to platinum-based chemotherapy in endometrial carcinomas involving SWI/SNF complex inactivation.
Presenter: Izumi Tanimoto
Session: e-Poster Display Session
246P - Impact of genetically predicted elevated concentrations of C-reactive protein on ovarian cancer risk: A Mendelian randomization study
Presenter: Haoxin Peng
Session: e-Poster Display Session
247P - The role of p53 gene suppressor and bcl-2 oncoprotein in non-epithelial ovarian tumor prognosis determination among child and adolescent patients
Presenter: Anvar Shukullaev
Session: e-Poster Display Session
248P - The effect of progesterone on ALA-based PDT efficacy in uterine sarcoma cells
Presenter: Ellie Chu
Session: e-Poster Display Session
249P - A Retrospective Study on the Treatment Response of Locally Advanced Cervical Cancer Patients to Combination Chemoradiotherapy
Presenter: Siti Nabihah Sahralidin
Session: e-Poster Display Session
250P - Health-related Quality of Life in Women with Cervical Cancer
Presenter: Almagul Zhabagina
Session: e-Poster Display Session
251P - Tendency of morbidity and mortality in cervical cancer in the last 10 years in the Republic of Uzbekistan
Presenter: Mirzagaleb Tillyashaykhov
Session: e-Poster Display Session
252P - Secondary data analysis of newly diagnosed advanced ovarian cancer in South Korea
Presenter: Soo Young Jeong
Session: e-Poster Display Session
253P - Non-Epithelial Tumours of Ovary, An Experience from Qatar
Presenter: Ammar Madani
Session: e-Poster Display Session