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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:
    3d
    ANSWER: Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=100, Recruiting, Nanfang Hospital, Southern Medical University | Trial completion date: Sep 2027 --> Sep 2028 | Trial primary completion date: Jun 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • Focus V (anlotinib) • albumin-bound paclitaxel • Anniko (penpulimab)
    27d
    Rapid Response to Penpulimab Combined With Anlotinib and Chemotherapy in a Thoracic SMARCA4-UT Without PD-L1 Expression: A Case Report and Review of Literature. (PubMed, Clin Respir J)
    He was given sintilimab and anlotinib as first line treatment...Subsequently, the second line regimen was modified to etoposide and cisplatin (EP) combined with anlotinib and penpulimab...Notably, the patient's progress-free survival (PFS) exceeds 7 months and the overall survival up to 12 months. Our case implies that a combination of chemotherapy, anlotinib, and penpulimab might offer a promising therapeutic approach for PD-L1-negative thoracic SMARCA4-UT.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4)
    |
    PD-L1 expression • PD-L1 negative
    |
    cisplatin • Focus V (anlotinib) • Tyvyt (sintilimab) • etoposide IV • Anniko (penpulimab)
    1m
    ALTN-AK105-III-02: A Phase III Clinical Trial of AK105 Injection Combined With Anlotinib Hydrochloride Capsules Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC) (clinicaltrials.gov)
    P3, N=648, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Jun 2024 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date • Metastases
    |
    sorafenib • Focus V (anlotinib) • Anniko (penpulimab)
    1m
    TQB2223-AK105-Ib-01: Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. (clinicaltrials.gov)
    P1, N=34, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Anniko (penpulimab) • TQB2223
    2ms
    ANSWER: Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=100, Recruiting, Nanfang Hospital, Southern Medical University | Trial completion date: Jul 2024 --> Sep 2027 | Trial primary completion date: Mar 2023 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • Focus V (anlotinib) • albumin-bound paclitaxel • Anniko (penpulimab)
    2ms
    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)
    2ms
    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
    4ms
    EASOPCWAAC: Efficacy and Safety of Penpulimab Combined With Anlotinib and Chemotherapy (clinicaltrials.gov)
    P2, N=194, Recruiting, Xijing Hospital
    New P2 trial • Metastases
    |
    Focus V (anlotinib) • albumin-bound paclitaxel • oxaliplatin • Anniko (penpulimab) • lobaplatin (D19466)
    4ms
    A clinical study on the efficacy and safety of Penpulimab and Anlotinib combined with Platinum-Doublet Chemotherapy in the first-line treatment of pulmonary sarcomatoid carcinoma (ChiCTR2400086977)
    P2, N=20, Not yet recruiting, Nanjing Drum Tower Hospital; Nanjing Drum Tower Hospital
    New P2 trial
    |
    Focus V (anlotinib) • Anniko (penpulimab)
    5ms
    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)
    5ms
    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)
    6ms
    A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL (clinicaltrials.gov)
    P2, N=528, Not yet recruiting, The First Affiliated Hospital with Nanjing Medical University
    New P2 trial
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • vincristine • prednisone • Epidaza (chidamide) • Inokai (orelabrutinib) • Anniko (penpulimab) • Polivy (polatuzumab vedotin-piiq)
    6ms
    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)
    6ms
    TQB2916 Injection Combined With Chemotherapy or Penpulimab Injection in the Treatment of Solid Tumors (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P2 trial
    |
    doxorubicin hydrochloride • Anniko (penpulimab)
    6ms
    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)
    7ms
    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)
    7ms
    First-line Anlotinib Combined With Penpulimab for Advanced Pheochromocytoma: A Single-arm, Multicenter, Prospective Phase II Study (clinicaltrials.gov)
    P2, N=22, Recruiting, Sun Yat-sen University
    New P2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Focus V (anlotinib) • Anniko (penpulimab)
    8ms
    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)
    9ms
    A Study of Penpulimab (AK105) in the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=298, Recruiting, Akeso | Trial primary completion date: Dec 2023 --> Feb 2025
    Trial primary completion date • Metastases
    |
    cisplatin • gemcitabine • Anniko (penpulimab)
    9ms
    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)
    9ms
    AK105-201: A Study of Anti-PD-1 AK105 in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=94, Completed, Akeso | Unknown status --> Completed
    Trial completion
    |
    Anniko (penpulimab)
    9ms
    AK105-203: A Study of the Combination of Anti-PD-1 AK105 and Anlotinib in First-line Hepatocellular Carcinoma (HCC) (clinicaltrials.gov)
    P2, N=31, Completed, Akeso | Active, not recruiting --> Completed
    Trial completion
    |
    Focus V (anlotinib) • Anniko (penpulimab)
    9ms
    A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=350, Completed, Akeso | Unknown status --> Completed
    Trial completion
    |
    PD-L1 (Programmed death ligand 1)
    |
    carboplatin • paclitaxel • Anniko (penpulimab)
    9ms
    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)
    9ms
    Anlotinib Combined With Penpulimab as Front-line Treatment in Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=33, Recruiting, The First Affiliated Hospital of Zhengzhou University
    New P2 trial
    |
    Focus V (anlotinib) • Anniko (penpulimab)
    10ms
    Clinical Study of TQB2223 Injection Combined With AK105 Injection in the Treatment of Advanced Hepatocellular Carcinoma. (clinicaltrials.gov)
    P1, N=34, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1 trial • Metastases
    |
    Anniko (penpulimab) • TQB2223
    10ms
    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)
    11ms
    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)
    12ms
    A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer. (clinicaltrials.gov)
    P1, N=75, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Not yet recruiting --> Recruiting | Initiation date: Sep 2023 --> Jan 2024
    Enrollment open • Trial initiation date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Focus V (anlotinib) • Anniko (penpulimab) • TQB2618
    1year
    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)
    1year
    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)
    1year
    South China Nervous Tumor 00002-2301: The efficacy of anlotinib or penpulimab in patients with progression after concurrent chemoradiotherapy in new diagnosed glioblastoma:a Bayesian adaptive randomized designed phase II stduy (ChiCTR2300074437)
    P2, N=164, Recruiting, The First Affiliated Hospital of Sun Yat-sen University; The First Affiliated Hospital of Sun Yat-Sen University
    New P2 trial
    |
    CD8 (cluster of differentiation 8)
    |
    Focus V (anlotinib) • temozolomide • Anniko (penpulimab)
    1year
    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)
    over1year
    A Single Center, Single Arm Clinical Study on the Treatment of Advanced Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations and Failed EGFR TKIs With the Combination of Enrotinib and Paclitaxel Monoclonal Antibody (clinicaltrials.gov)
    P3, N=52, Not yet recruiting, Degan Lu
    New P3 trial • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene)
    |
    EGFR mutation • EGFR positive
    |
    paclitaxel • Focus V (anlotinib) • Anniko (penpulimab)
    over1year
    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)
    over1year
    A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer. (clinicaltrials.gov)
    P1, N=75, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P1 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Focus V (anlotinib) • Anniko (penpulimab) • TQB2618