Anniko (penpulimab)

P3, N=298, Recruiting, Akeso | Trial primary completion date: Dec 2023 --> Feb 2025

P3, N=164, Terminated, Akeso | Trial completion date: Jun 2024 --> Dec 2023 | Active, not recruiting --> Terminated; corporate strategy adjustment

P1/2, N=94, Completed, Akeso | Unknown status --> Completed

P2, N=31, Completed, Akeso | Active, not recruiting --> Completed

P3, N=350, Completed, Akeso | Unknown status --> Completed

P2, N=28, Completed, Akeso | Recruiting --> Completed | N=90 --> 28 | Trial completion date: Jun 2023 --> Dec 2023

P2, N=33, Recruiting, The First Affiliated Hospital of Zhengzhou University

P1, N=34, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

P1, N=114, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Penpulimab plus chemotherapy significantly improved progression-free survival in patients with advanced squamous non-small-cell lung cancer compared with chemotherapy alone. The treatment was safe and tolerable. Penpulimab combined with paclitaxel and carboplatin is a new option for first-line treatment in patients with this advanced disease.

P1, N=75, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Sep 2023 --> Jan 2024

P2, N=130, Active, not recruiting, Akeso | Trial completion date: Dec 2023 --> Apr 2024

Penpulimab combined with anlotinib demonstrated promising efficacy and manageable safety in R/M HNSCC patients after failure of platinum-based chemotherapy.

P2, N=164, Recruiting, The First Affiliated Hospital of Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-Sen University

P2, N=44, Recruiting, Fudan University | Trial completion date: Jan 2024 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Mar 2024

P2, N=80, Recruiting, The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting --> Recruiting

The patient received two cycles of modified FOLFIRINOX plus immune checkpoint inhibitor (penpulimab)...Three cycles of combined therapy were adopted after surgery followed by maintenance therapy with anlotinib plus penpulimab. There was no evidence of tumor recurrence during the follow-up (nearly 19 months since diagnosis).

P2, N=48, Recruiting, Eye & ENT Hospital of Fudan University | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Jan 2024 --> Dec 2024

P2, N=72, Recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

The patient received two cycles of modified FOLFIRINOX plus immune checkpoint inhibitor (Penpulimab)...Three cycles of combined therapy were adopted after surgery followed by maintained therapy with anlotinib plus Penpulimab. There was no evidence of tumor recurrence 19 months since diagnosis.

Conclusions PAAG as first-line treatment demonstrated a promising efficacy and manageable AEs for mPC. Biomarkers identified in this study possessed the potential to guide the precise clinical application of PAAG.

P3, N=52, Not yet recruiting, Degan Lu

P2, N=48, Recruiting, Eye & ENT Hospital of Fudan University | Active, not recruiting --> Recruiting

P1, N=75, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

We summarized and analyzed the literature reports on Pubmed from 2000 to the present, using the keywords 'pulmonary blastoma', and found 78 different cases of PB, using chemotherapy including cyclophosphamide, doxorubicin, etoposide, and others...With consultation of the multidisciplinary team and full communication and informed consent from the patient, she later had 8 cycles of anlotinib(a new oral multikinase inhibitor) and penpulimab(a humanized anti-PD-1 monoclonal antibody) in the department of oncology... To our knowledge, this is the first study to combine immunotherapy and targeted therapy for PB. This study shows the combination of immunotherapy and multi-targeting tyrosine kinase inhibitors can produce a more significant clinical response in pulmonary blastoma, or maybe a synergistic effect. As a potential therapeutic strategy for pulmonary blastoma, immunotherapy in combination with targeted therapy should be considered.

P2, N=108, Not yet recruiting, Sun Yat-sen University

The patient was diagnosed with poorly differentiated stage III C1r cervical squamous cell carcinoma and received standard cisplatin-sensitized chemoradiotherapy, subsequently achieving a good treatment effect of complete response. It has been maintained for more than 17 months, and as of April 2023 the patient is still maintaining her response. Our case suggests that penpulimab combined with anlotinib has promising efficacy in the treatment of elderly patients with recurrent cervical cancer.

The incidence of CIP is very low, and its diagnosis should be combined with clinical manifestations and previous drug use. mNGS can provide certain value in the exclusion of severe infections, so as to provide basis and reference for the early identification, diagnosis and treatment of severe CIP.

P2, N=44, Recruiting, Fudan University | Trial primary completion date: Jan 2023 --> Sep 2023

P1/2, N=29, Recruiting, Peking Union Medical College Hospital | Not yet recruiting --> Recruiting | Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Feb 2023 --> Feb 2024

P1, N=92, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

P2, N=5, Recruiting, Peking Union Medical College Hospital

P3, N=480, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Our preliminary results suggested that the 9p24.1/PD-L1/PD-L2 copy number alterations were less than reported,but Pen-RMA also achieved excellent responses in newly diagnosed PCNSL patients with mild toxicity. CSF ctDNA could be leveraged to overcome the limitations of tissue biopsies for diagnosis and assessed more sensitively compared with imageology-based response evaluation. Figure 1.

P1/2, N=75, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

P2, N=20, Not yet recruiting, West China Hospital

P3, N=298, Recruiting, Akeso | Trial completion date: Oct 2025 --> Sep 2026 | Trial primary completion date: Jul 2023 --> Dec 2023

The induction treatment of Pen-RMA has shown excellent responses in newly diagnosed PCNSL patients with mild hematologic toxicity. Our preliminary results also suggested that CSF-based ctDNA could facilitate diagnosis when tissue was inaccessible and show higher sensitivity than imageology in assessing the depth of remission.

P3, N=164, Active, not recruiting, Akeso | Unknown status --> Active, not recruiting | N=360 --> 164 | Trial completion date: Nov 2021 --> Jun 2024 | Trial primary completion date: Nov 2020 --> Jun 2023

P2, N=55, Not yet recruiting, Ruijin Hospital

P2, N=110, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

P2, N=100, Recruiting, Nanfang Hospital of Southern Medical University | Not yet recruiting --> Recruiting | Initiation date: Mar 2022 --> Sep 2022