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DRUG:

Anniko (penpulimab)

i
Other names: AK105, AK-105, AK 105
Company:
Akesobio, Sino Biopharm, Specialised Therap
Drug class:
PD1 inhibitor
Related drugs:
8d
A single-arm exploratory clinical study of penpulimab combined with anlotinib in the first-line treatment of advanced esophageal squamous cell carcinoma (ChiCTR2400089133)
P=N/A, N=30, Recruiting, The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University
New trial • Metastases
|
Focus V (anlotinib) • albumin-bound paclitaxel • Anniko (penpulimab)
20d
TQB2618-AK105-Ib-03: Clinical Trial to Evaluate the Safety and Effectiveness of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
P1/2, N=75, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2024 --> Dec 2024
Enrollment open • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • paclitaxel • Anniko (penpulimab) • TQB2618
2ms
New P2 trial • Metastases
|
Focus V (anlotinib) • albumin-bound paclitaxel • oxaliplatin • Anniko (penpulimab) • lobaplatin (D19466)
2ms
New P2 trial
|
Focus V (anlotinib) • Anniko (penpulimab)
3ms
Pianzumab Combined With AVD Regimen in the Treatment of Newly-diagnosed Advanced Classic Hodgkin Lymphoma (clinicaltrials.gov)
P2, N=108, Recruiting, Sun Yat-sen University | Not yet recruiting --> Recruiting | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Jun 2026 --> Sep 2026
Enrollment open • Trial completion date • Trial primary completion date • Metastases
|
Anniko (penpulimab)
3ms
TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. (clinicaltrials.gov)
P1, N=3, Terminated, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=114 --> 3 | Trial completion date: Mar 2028 --> Jul 2024 | Recruiting --> Terminated | Trial primary completion date: Jun 2026 --> Jul 2024; Based on the current status of the same target research and the company's overall layout in the field of tumors, the early termination was determined after full communication with the principal investigator of the group leader unit.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
|
Anniko (penpulimab)
4ms
New P2 trial
|
Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Epidaza (chidamide) • Yinuokai (orelabrutinib) • Anniko (penpulimab) • Polivy (polatuzumab vedotin-piiq)
4ms
Penpulimab Combined With GP ± Anlotinib as Neoadjuvant Therapy in Locoregionally Advanced Nasopharyngeal Carcinoma (clinicaltrials.gov)
P2, N=104, Active, not recruiting, Sun Yat-sen University | Not yet recruiting --> Active, not recruiting | Trial primary completion date: Jan 2024 --> Jan 2025
Enrollment closed • Trial primary completion date • Metastases
|
Focus V (anlotinib) • Anniko (penpulimab)
4ms
New P2 trial
|
doxorubicin hydrochloride • Anniko (penpulimab)
5ms
ZL-IRIAN: Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC (clinicaltrials.gov)
P2, N=44, Recruiting, Fudan University | Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Mar 2024 --> May 2025
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
Focus V (anlotinib) • irinotecan • Anniko (penpulimab)
6ms
TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. (clinicaltrials.gov)
P1, N=114, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
Enrollment open • Metastases
|
Anniko (penpulimab)
6ms
New P2 trial • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Focus V (anlotinib) • Anniko (penpulimab)
6ms
PAAG: A Study of Penpulimab and Anlotinib Plus Nab-paclitaxel and Gemcitabine for Metastatic Pancreatic Cancer. (clinicaltrials.gov)
P2, N=66, Completed, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting --> Completed | Trial completion date: Dec 2024 --> May 2024
Trial completion • Trial completion date • Combination therapy • Metastases
|
gemcitabine • Focus V (anlotinib) • albumin-bound paclitaxel • Anniko (penpulimab)
8ms
Trial primary completion date • Metastases
|
cisplatin • gemcitabine • Anniko (penpulimab)
8ms
AK105-301: A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer (clinicaltrials.gov)
P3, N=164, Terminated, Akeso | Trial completion date: Jun 2024 --> Dec 2023 | Active, not recruiting --> Terminated; corporate strategy adjustment
Trial completion date • Trial termination • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
|
carboplatin • Focus V (anlotinib) • pemetrexed • Anniko (penpulimab)
8ms
Trial completion
|
Anniko (penpulimab)
8ms
Trial completion
|
Focus V (anlotinib) • Anniko (penpulimab)
8ms
Trial completion
|
PD-L1 (Programmed death ligand 1)
|
carboplatin • paclitaxel • Anniko (penpulimab)
8ms
A Study of Penpulimab Combination Therapy in Patients With Advanced Nasopharyngeal Carcinoma (clinicaltrials.gov)
P2, N=28, Completed, Akeso | Recruiting --> Completed | N=90 --> 28 | Trial completion date: Jun 2023 --> Dec 2023
Trial completion • Enrollment change • Trial completion date • Combination therapy • Metastases
|
cisplatin • gemcitabine • Focus V (anlotinib) • Anniko (penpulimab)
8ms
New P2 trial
|
Focus V (anlotinib) • Anniko (penpulimab)
8ms
New P1 trial • Metastases
|
Anniko (penpulimab) • TQB2223
9ms
TQB2928 Injection Combined With Penpulimab in Treatment of Advanced Malignant Tumors. (clinicaltrials.gov)
P1, N=114, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
New P1 trial • Metastases
|
Anniko (penpulimab)
10ms
First-line penpulimab combined with paclitaxel and carboplatin for metastatic squamous non-small-cell lung cancer in China (AK105-302): a multicentre, randomised, double-blind, placebo-controlled phase 3 clinical trial. (PubMed, Lancet Respir Med)
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.
P3 data • Journal • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
carboplatin • paclitaxel • Anniko (penpulimab)
10ms
Enrollment open • Trial initiation date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Focus V (anlotinib) • Anniko (penpulimab) • TQB2618
11ms
A Study of Anti-PD-1 AK105 in Patients With Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
P2, N=130, Active, not recruiting, Akeso | Trial completion date: Dec 2023 --> Apr 2024
Trial completion date • Metastases
|
Anniko (penpulimab)
11ms
Penpulimab combined with anlotinib in patients with R/M HNSCC after failure of platinum-based chemotherapy: a single-arm, multicenter, phase Ⅱ study. (PubMed, ESMO Open)
Penpulimab combined with anlotinib demonstrated promising efficacy and manageable safety in R/M HNSCC patients after failure of platinum-based chemotherapy.
Journal
|
PD-1 (Programmed cell death 1)
|
Focus V (anlotinib) • Anniko (penpulimab)
12ms
New P2 trial
|
CD8 (cluster of differentiation 8)
|
Focus V (anlotinib) • temozolomide • Anniko (penpulimab)
12ms
ZL-IRIAN: Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC (clinicaltrials.gov)
P2, N=44, Recruiting, Fudan University | Trial completion date: Jan 2024 --> Sep 2024 | Trial primary completion date: Sep 2023 --> Mar 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF wild-type
|
Focus V (anlotinib) • irinotecan • Anniko (penpulimab)
1year
EXPLORING: XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma (clinicaltrials.gov)
P2, N=80, Recruiting, The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting --> Recruiting
Enrollment open • Circulating tumor DNA
|
Focus V (anlotinib) • capecitabine • oxaliplatin • Anniko (penpulimab)
1year
A case of pancreatic cancer treated with chemotherapy combined with immunotherapy and targeted therapy. (PubMed, Zhejiang Da Xue Xue Bao Yi Xue Ban)
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).
Journal • IO biomarker
|
CA 19-9 (Cancer antigen 19-9)
|
5-fluorouracil • Focus V (anlotinib) • irinotecan • leucovorin calcium • Anniko (penpulimab)
1year
Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN (clinicaltrials.gov)
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
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Erbitux (cetuximab) • Anniko (penpulimab)
1year
Penpulimab Combined With Chemotherapy for Neoadjuvant and Adjuvant Therapy in Patients With Resectable HNSCC (clinicaltrials.gov)
P2, N=72, Recruiting, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
New P2 trial
|
cisplatin • albumin-bound paclitaxel • Anniko (penpulimab)
1year
A case of pancreatic cancer treated with chemotherapy combined with immunotherapy and targeted therapy. (PubMed, Zhejiang Da Xue Xue Bao Yi Xue Ban)
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.
Journal • IO biomarker
|
CA 19-9 (Cancer antigen 19-9)
|
5-fluorouracil • Focus V (anlotinib) • irinotecan • leucovorin calcium • Anniko (penpulimab)
1year
Penpulimab combined with anlotinib and nab-paclitaxel plus gemcitabine (PAAG) as first-line treatment for advanced metastatic pancreatic cancer: A prospective, multicenter, single-arm, phase II study (ESMO Asia 2023)
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.
Clinical • P2 data • Metastases
|
IFNG (Interferon, gamma)
|
IFNG expression
|
gemcitabine • Focus V (anlotinib) • albumin-bound paclitaxel • Anniko (penpulimab)
1year
New P3 trial • Metastases
|
EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
|
EGFR mutation • EGFR positive
|
paclitaxel • Focus V (anlotinib) • Anniko (penpulimab)
1year
Penpulimab in Combination With Cetuximab as First-line Treatment in R/M SCCHN (clinicaltrials.gov)
P2, N=48, Recruiting, Eye & ENT Hospital of Fudan University | Active, not recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Erbitux (cetuximab) • Anniko (penpulimab)
1year
New P1 trial • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Focus V (anlotinib) • Anniko (penpulimab) • TQB2618
over1year
Pulmonary Blastoma is Successfully Treated with Immunotherapy and Targeted Therapy (IASLC-WCLC 2023)
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.
PD(L)-1 Biomarker • IO biomarker
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
|
PD-L1 expression • EGFR mutation • MET mutation
|
Focus V (anlotinib) • doxorubicin hydrochloride • cyclophosphamide • etoposide IV • Anniko (penpulimab)
over1year
New P2 trial
|
Anniko (penpulimab)
over1year
Penpulimab and anlotinib in an elderly patient with recurrent cervical cancer: a case report and literature review. (PubMed, Immunotherapy)
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.
Review • Journal
|
cisplatin • Focus V (anlotinib) • Anniko (penpulimab)
over1year
A case report and literature review of immune checkpoint inhibitor-associated pneumonia caused by penpulimab. (PubMed, Front Immunol)
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.
Review • Journal • Checkpoint inhibition
|
Anniko (penpulimab)
over1year
ZL-IRIAN: Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC (clinicaltrials.gov)
P2, N=44, Recruiting, Fudan University | Trial primary completion date: Jan 2023 --> Sep 2023
Trial primary completion date • Combination therapy • Metastases
|
KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
|
BRAF wild-type
|
Focus V (anlotinib) • irinotecan • Anniko (penpulimab)