[Translation] A phase II clinical trial to evaluate the efficacy and safety of TQB2102 for injection combined with immunotherapy ± chemotherapy in patients with unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma

主要目的：评价注射用TQB2102联合贝莫苏拜单抗/派安普利单抗±卡培他滨在不可切除的局部晚期、复发性或转移性HER2阳性胃食管腺癌中的有效性。次要目的：评价注射用TQB2102联合贝莫苏拜单抗/派安普利单抗±卡培他滨在不可切除的局部晚期、复发性或转移性HER2阳性胃食管腺癌中的安全性；探索性目的：评价注射用TQB2102在不可切除的局部晚期、复发性或转移性HER2阳性胃食管腺癌的药代动力学（PK）特征和免疫原性；与疗效、作用机制、安全性和/或病理机制相关的生物标志物研究。

[Translation]

Primary objective: To evaluate the efficacy of TQB2102 for injection combined with bemosubinib/pembrolizumab ± capecitabine in unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma. Secondary objective: To evaluate the safety of TQB2102 for injection combined with bemosubinib/pembrolizumab ± capecitabine in unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma; Exploratory objective: To evaluate the pharmacokinetic (PK) characteristics and immunogenicity of TQB2102 for injection in unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma; Study of biomarkers related to efficacy, mechanism of action, safety and/or pathological mechanism.

Start Date14 Nov 2024

Sponsor / Collaborator

Nanjing Shunxin Pharmaceutical Co., Ltd.

NCT06516978

/ Not yet recruitingPhase 2IIT

A Prospective, Open-Label, Multicenter, Randomized Controlled Study Comparing the Efficacy and Safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Combined With Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.

Start Date01 Oct 2024

Sponsor / Collaborator

Jiangsu Provincial People's Hospital

CTR20242162

/ RecruitingPhase 2

评价TQB2916注射液联合化疗或派安普利单抗注射液在实体瘤中有效性和安全性的多中心、开放、单臂、多队列Ⅱ期临床试验。

[Translation] A multicenter, open, single-arm, multi-cohort Phase II clinical trial to evaluate the efficacy and safety of TQB2916 injection combined with chemotherapy or penpulimab injection in solid tumors.

队列1:探索软组织肉瘤受试者中，TQB2916 注射液联合多柔比星治疗的无进展生存期；队列2: 探索肉瘤和黑色素瘤受试者中，TQB2916 注射液联合派安普利单抗注射液治疗的客观缓解率。

[Translation]

Cohort 1: Explore the progression-free survival of TQB2916 injection combined with doxorubicin in subjects with soft tissue sarcoma; Cohort 2: Explore the objective response rate of TQB2916 injection combined with penpulimab injection in subjects with sarcoma and melanoma.

Start Date09 Jul 2024

Sponsor / Collaborator

Nanjing Shunxin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Penpulimab

100 Translational Medicine associated with Penpulimab

100 Patents (Medical) associated with Penpulimab

Literatures (Medical) associated with Penpulimab

01 Dec 2024·The Clinical Respiratory Journal

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

Review

Author: Zhang, Jinghang ; Liu, Yanting ; Zhao, Kelei ; Zhang, Jingjing ; Yuan, Xiaohan ; Wang, Yuanhang ; Zhang, Min ; Lu, Ping

ABSTRACTSMARCA4‐deficient undifferentiated tumor (SMARCA4‐UT) in the chest is a high‐grade malignant tumor that grows rapidly and often carries a poor prognosis. Unfortunately, there are currently no effective treatment available until now. Here, we report a case of SMARCA4‐UT in a patient who showed a swift response to a combination treatment of penpulimab, anlotinib, and chemotherapy. A 55‐year‐old man was diagnosed with thoracic SMARCA4‐UT along with metastases to multiple lymph nodes, the pleura, and bones. Immunohistochemical (IHC) testing indicated the absence of PD‐L1 expression in tumor cells. He was given sintilimab and anlotinib as first line treatment. However, a follow‐up chest CT revealed progressive disease (PD) after the first cycle treatment. Subsequently, the second line regimen was modified to etoposide and cisplatin (EP) combined with anlotinib and penpulimab. The effectiveness evaluation revealed partial remission (PR) following two cycles of the second‐line regimen treatment. 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.

01 Oct 2024·Cancer Pathogenesis and Therapy

Efficacy and safety of anlotinib plus penpulimab as second-line treatment for small cell lung cancer: A multicenter, open-label, single-arm phase II trial

Article

Author: Shi, Yuankai ; Wu, Kailiang ; Sun, Yan ; Wang, Rui ; Liu, Qiang ; Zhang, Changgong ; Wang, Jun ; Zhao, Jun ; Wu, Huijuan ; Mu, Xinlin ; Gao, Liying ; Bai, Chunmei ; Jia, Zhongyao ; Chen, Jianhua

BackgroundCurrently, the need for new therapeutic strategies involving programmed cell death protein-1 (PD-1) monoclonal antibodies in the second-line setting of small cell lung cancer (SCLC) is urgent. This study aimed to evaluate the efficacy and safety of anlotinib plus penpulimab as a second-line treatment for patients with SCLC who progressed after first-line platinum-based chemotherapy.MethodsThis study included the patients from Cohort 4 of a single-arm, open-label, multicenter, phase II clinical trial. A safety run-in phase was performed under anlotinib (10/12 mg quaque die [QD], days 1-14) plus penpulimab (200 mg intravenously [IV], day 1) in a 21-day cycle, followed by the formal trial in which the patients received anlotinib (12 mg QD, days 1-14) plus penpulimab (200 mg IV, day 1) in a 21-day cycle. The primary endpoint of the safety run-in phase was safety. The primary endpoint of the formal trial phase was the objective response rate (ORR).ResultsFrom April 28, 2020, to November 24, 2020, 21 patients were enrolled from 11 hospitals, including 2 in the safety run-in phase and 19 in the formal trial phase. In the formal trial phase, the ORR was 42.1% (8/19; 95% confidence interval [CI]: 17.7-66.6%). The median progression-free survival was 4.8 months (95% CI: 2.9-11.3 months), and the median overall survival was 13.0 months (95% CI: 4.6-not applicable [NA] months). The incidence of ≥grade 3 treatment-related adverse events (TRAEs) was 52.4% (11/21), and the incidence of treatment-related serious adverse events (AEs) was 28.6% (6/21). Two AE-related deaths occurred. The most common AEs were hypertension (57.1%, 12/21), hypothyroidism (42.9%, 9/21), and hypertriglyceridemia (38.1%, 8/21).ConclusionsIn patients with SCLC who progressed after first-line platinum-based chemotherapy, the second-line anlotinib plus penpulimab treatment demonstrates promising anti-cancer activity and a manageable safety profile, which warrants further investigation.Trial registrationNo. NCT04203719, https://clinicaltrials.gov/.

15 Jun 2024·Cancer

Phase 1b/2 study of penpulimab (AK105), an antiprogrammed cell death‐1 immunoglobulin G1 antibody, in advanced or metastatic solid tumors (AK105‐204)

Article

Author: Zhu, Jianqing ; Zheng, Yulong ; Xu, Nong ; Wang, Hong ; Xie, Yanru ; Xiong, Jianping ; Jiang, Ou ; Zhou, Yuefen

AbstractBackgroundPenpulimab, a new‐generation antiprogrammed cell death‐1 immunoglobulin G1 monoclonal antibody, was engineered to optimize receptor occupancy and eliminate fragment crystallizable γ‐mediated effector function. In this multicenter, phase 1b/2, multicohort study, the objective was to investigate the efficacy, safety, and immunogenicity of penpulimab in advanced solid tumors.MethodsPatients who had unresectable, advanced solid tumors were enrolled from six centers and received 200 mg penpulimab on day 1 every 2 weeks for up to 24 months. The primary end point was the objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors, version criteria 1.1.ResultsBetween September 2, 2019, and January 1, 2020, 65 patients were enrolled and received penpulimab. At the time of data cutoff (May 11, 2022), the median follow‐up was 12.6 months (range, 1.1–28.6 months). The ORR was 12.3 (95% confidence interval [CI], 5.5%–22.8%), with three (4.6%) complete responses and five (7.7%) partial responses. Twelve patients (18.5%) achieved stable disease, resulting in a disease control rate of 30.8% (95% CI, 19.9%–43.4%). The median duration of response was not reached (95% CI, 6.70 months to not estimable). In all cohorts, the median progression‐free survival was 1.74 months (95% CI, 1.41–2.69 months), and the median overall survival was 16.59 months (95% CI, 7.82–22.18 months). Grade 3 or greater treatment‐related adverse events and immune‐related adverse events occurred in 9.2% and 27.7% of patients, respectively. Positive antidrug antibody responses to penpulimab were observed in one patient (1.8%).ConclusionsPenpulimab showed promising antitumor activity with an acceptable safety profile, offering a potential new treatment approach for solid tumors. These findings supported the evaluation of penpulimab's durable activity and safety, as monotherapy or in combination therapy, in specific malignancies.

News (Medical) associated with Penpulimab

22 Nov 2024

·www.prnewswire.com

Akeso's Penpulimab Combination Therapy for First-line Treatment of Hepatocellular Carcinoma Accepted by NMPA

HONG KONG, Nov. 22, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the National Medical Products Administration (NMPA) of China has accepted its supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with anlotinib for the first-line (1L) treatment of advanced hepatocellular carcinoma (HCC). This marks penpulimab's fifth indication, following its approval for first line treatment of squamous non-small cell lung cancer, first line and third-line or further treatment for metastatic nasopharyngeal carcinoma, and third-line treatment of relapsed or refractory classical Hodgkin lymphoma. The differentiated clinical value of the penpulimab combination therapy is expected to offer a more effective solution for patients with liver cancer. The sNDA for this new indication is supported by the ALTN-AK105-III-02 study, a multicenter, randomized, open-label, parallel-controlled Phase III clinical trial. The study demonstrated positive outcomes in both progression-free survival (PFS) and overall survival (OS). These encouraging clinical results were featured as a "Late Breaking Abstract (LBA)" at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. Clinical data highlights: Penpulimab combined with anlotinib regimen reduced the risk of disease progression or death by 47% compared to the control group (median PFS: 6.9 months vs. 2.8 months, HR=0.53, P<0.0001); Penpulimab combined with anlotinib regimen reduced the risk of death by 31% compared to the control group (median OS: 16.5 months vs. 13.2 months, HR=0.69, P=0.0013). The combination of penpulimab and anlotinib significantly improved both PFS and OS in HCC patients compared to sorafenib, with no new safety signals. This makes the combination a promising first-line treatment option for advanced HCC. The ALTN-AK105-III-02 study marks the second global Phase III trial to achieve positive results for the combination of an immune checkpoint inhibitor and an oral multi-targeted tyrosine kinase inhibitor in the first-line treatment of advanced HCC. These encouraging findings pave the way for this combination therapy to become a superior treatment option for patients with advanced hepatocellular carcinoma. About Penpulimab Penpulimab is a differentiated PD-1 monoclonal antibody with an IgG1 subtype and modified Fc region, enhancing immunotherapy efficacy while minimizing adverse reactions. Developed by Akeso Biopharma, its commercialization is managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group, a subsidiary of Sino Biopharm. Penpulimab has been approved for the following indications: First-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) in combination with chemotherapy. Relapsed or refractory classical Hodgkin lymphoma (cHL) after at least two lines of systemic chemotherapy. Recurrent/metastatic nasopharyngeal carcinoma (NPC) who have failed to respond to two or more prior lines of systemic therapy. Penpulimab in combination therapy for the first-line treatment of metastatic NPC, has had its marketing application accepted by the NMPA and the FDA. Additionally, the marketing application for its monotherapy use in third-line or further treatment of metastatic nasopharyngeal carcinoma has also been accepted by the FDA. Ongoing late-stage clinical trials of penpulimab are progressing for liver cancer, gastric cancer, and other indications. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin, and X (formerly Twitter) SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3ImmunotherapyDrug ApprovalASCO

06 Sep 2024

·www.prnewswire.com

Akeso to Present Data from 13 Clinical Studies at ESMO 2024, Featuring its Internally Developed Cadonilimab, Ivonescimab, Ligufalimab, and other I/O Antibodies

HONG KONG, Sept. 5, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) will showcase promising results from 13 clinical studies on its internally developed PD-1/CTLA-4 bispecific antibody cadonilimab, PD-1/VEGF bispecific antibody ivonescimab, next-generation CD47 monoclonal antibody ligufalimab, and commercially available PD-1 monoclonal antibody penpulimab at the ESMO Congress 2024 from September 13th to 17th (CEST). These studies span advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies. Notably, ivonescimab's clinical results in combination with ligufalimab will be presented for the first time. Data on ivonescimab ± ligufalimab plus chemotherapy for mCRC and ivonescimab combined with chemotherapy for TNBC will be featured in the Mini Oral Session. Additionally, the Phase III study of anlotinib combined with penpulimab versus sorafenib for HCC will be presented as a late-breaking abstract in the Proffered Paper Session. Stay tuned for additional updates! Details of the Presentations: Colorectal Cancer Abstract Title: The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as first-line (1L) treatment for metastatic colorectal cancer (mCRC) Key Study Findings: For first-line treatment of MSS-type mCRC, previous immunotherapies have shown limited benefits. Ivonescimab has achieved meaningfully significant ORR, DCR, and PFS (although data is immature) in these mCRC patients. When combined with ligufalimab (CD47), the clinical outcome improved further, surpassing current standard treatments. These findings highlight the promising potential of ivonescimab, both alone and in combination with ligufalimab, for treating MSS-type mCRC. Session Type: Mini Oral Session Number: 514MO Presentation Presentation Time: Saturday, 14 September 15:50-15:55 (CEST) Speaker: Yanhong Deng, Sun Yat-sen University Sixth Affiliated Hospital Triple-Negative Breast Cancer Abstract Title: The safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC) Key Study Findings : Most patients were PD-L1 negative (53.3%). The proportion of patients who had previously received taxane-based neoadjuvant therapy (60%) was higher than in similar targeted drug studies. Ivonescimab demonstrated robust ORR and DCR. PFS results were meaningfully significant, even in patients with limited follow-up time and immature data. The safety profile of ivonescimab aligns with results from prior studies. Session Type: Mini Oral Session Number: 347MO Presentation Time: Monday, 16 September 08:30-08:35 (CEST) Speaker: Xiaojia Wang, Zhejiang Provincial Cancer Hospital Head And Neck Squamous Cell Carcinoma Abstract Title: Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC) Key Study Findings: PD-1 is the standard first-line treatment for CPS≥1 R/M HNSCC but has limited efficacy. Preliminary data from this study suggest that ivonescimab improves ORR and PFS for patients needing rapid tumor shrinkage. Ivonescimab combined with ligufalimab (CD47) further extends both ORR and PFS. Ivonescimab, both as monotherapy and in combination with ligufalimab, has yielded preliminary results that significantly outperform currently approved PD-1 treatments. A Phase III head-to-head trial against Keytruda is scheduled to initiate patient enrollment in the fourth quarter of 2024. Session Type: Poster Session Number: 876P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Neoadjuvant and Adjuvant AK104 in patients with recurrent, resectable squamous cell carcinoma of the head and neck: A phase II study Session Type: Poster Session Number: 866P Presentation Time: Saturday, 14 September 2024 (CEST) Hepatocellular Carcinoma Abstract Title: Primary results from the phase III ALTN-AK105-III-02 study: Anlotinib plus penpulimab versus sorafenib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC) Session Type: Proffered Paper Session Number: LBA40 Presentation Time: Friday,13 September 16:55-17:05 (CEST) Gynecological Oncology Abstract Title: A phase II study of cadonilimab plus chemotherapy in persistent recurrent/ metastatic cervical cancer patients who failed previous immuno/chemotherapy Session Type: Poster Session Number: 732P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer: a multicenter retrospective analysis in China Session Type: Poster Session Number: 727P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients : an open, prospective, single arm, phase II trial Session Type: Poster Session Number: 760P Presentation Time: Saturday, 14 September 2024(CEST) Nasopharyngeal Carcinoma Abstract Title: Combination of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) with chemotherapy in anti-PD-1 resistant recurrent or metastatic nasopharyngeal carcinoma: an open-label, single-arm, phase II clinical trial Session Type: Poster Session Number: 893P Presentation Time: Saturday, 14 September 2024(CEST) Biliary Tract Cancer Abstract Title: Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, single-arm clinical trial Session Type: Poster Session Number: 52P Presentation Time: Monday, 16 September 2024 (CEST) Gastric Cancer Abstract Title: Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer: A prospective, single-arm, phase II clinical trial Session Type: Poster Session Number: 1455P Presentation Time: Monday, 16 September 2024(CEST) Abstract Title: Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients Session Type: Poster Session Number: 1473TiP Presentation Time: Monday, 16 September 2024 (CEST) Esophageal Squamous Cell Carcinoma Abstract Title: Efficacy and safety of cadonilimab combined albumin-paclitaxel, cisplatin and fluorouracil (APF) in neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LAESCC): results from the CAPITAL trial Session Type: Poster Session Number: 1446P Presentation Time: Monday, 16 September 2024 (CEST) SOURCE Akeso, Inc.

Clinical ResultPhase 3Phase 2Immunotherapy

28 Feb 2024

·www.biospace.com

The promising results of a phase II clinical study for Akeso's Cadonilimab (PD-1/CTLA-4) combined standard treatment for first-line treatment of R/M cervical cancer has been published in Clinical Cancer Research

HONG KONG, Feb. 28, 2024 /PRNewswire/ -- Akeso (9926.HK) announced that the results of a phase II clinical trial for PD-1/CTLA-4 bispecific antibody（cadonilimab）combined with standard treatment (chemotherapy +/- bevacizumab) as first-line treatment for recurrent/metastatic cervical cancer had been published in the official journal of the American Association for Cancer Research (AACR), Clinical Cancer Research, with an impact factor of 11.5. The article comprehensively elaborates on the excellent therapeutic effects of cadonilimab as first-line treatment for the whole population of cervical cancer, demonstrating the good safety pro this treatment regimen. The publication of this article further enriches the evidence-based medicine evidence for the clinical application of cadonilimab. The study data published in Clinical Cancer Research this time continues to demonstrate the pronounced advantages presented in the data published at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, and with further extension of follow-up time, the efficacy advantage of cadonilimab combined with standard treatment for first-line treatment of recurrent/metastatic cervical cancer becomes more evident. Once again, it shows the clinical potential of cadonilimab for the entire population of recurrent/metastatic cervical cancer regardless of PD-L1 expression status, with the main research data superior to the data disclosed in current standard of care with immunotherapy-based combination therapy (non-head-to-head). Compared to the data disclosed at ASCO in 2022, the overall objective response rate (ORR) remains at a high level, with the disease control rate (DCR) increasing to 100%, and the complete response (CR) rate further increasing. 63.6% of patients experienced tumor reduction of more than 50%. The ORR of the 10mg/kg Q3W dose group (cadonilimab 10mg/kg Q3W + chemotherapy +/- bevacizumab) reached 79.3%, and when combined with bevacizumab, the ORR was as high as 92.3%. The population with PD-L1 CPS <1 accounted for 41.4%, and the ORR of this population was 75.0%, indicating that cadonilimab combined with standard treatment could provide clinical benefit for PD-L1-negative patients. Cadonilimab combined standard treatment brings excellent long-term survival benefits. The median follow-up time for the cadonilimab 15mg/kg Q3W + chemotherapy group was 20.24 months, the median progression-free survival (mPFS) was 11.10 months, the median overall survival (mOS) was not reached, and the 12-month OS rate was 93.3%. The median follow-up time for the cadonilimab 10mg/kg Q3W + chemotherapy group was 18.3 months, the mPFS was 7.06 months, the mOS was not reached, and the 12-month OS rate was 87.5%. The median follow-up time for the Cadonilimab 10mg/kg Q3W + chemotherapy + bevacizumab group was 15.01 months, and neither mPFS nor mOS was reached. The safety of cadonilimab combined with standard treatment is manageable, and no new safety signals have been observed. Reports indicate that in 2020, there were approximately 604,000 new cases of cervical cancer globally, with over 110,000 cases in China. It is estimated that by 2040, the number of deaths from cervical cancer in China will reach 75,000 cases, representing a 26.3% increase compared to 2020. The 5-year survival rate for advanced cervical cancer is only about 17.0%. In first-line treatment for advanced cervical cancer, chemotherapy+/-bevacizumab is the standard treatment regimen domestically, with limited efficacy and no approved immune combination therapy. Cadonilimab was approved by the China National Medical Products Administration (NMPA) in June 2022 for second-line treatment of recurrent/metastatic cervical cancer. Since its launch, Cadonilimab's outstanding clinical value and good safety pro been strongly validated in numerous clinical studies and real-world clinical applications. It has demonstrated prominent benefits for the entire population of patients with advanced cervical cancer, improving survival rates and quality of life, thus addressing the current important clinical need. In November 2023, an interim analysis of a randomized, double-blind, placebo-controlled phase III study of cadonilimab as first-line treatment for cervical cancer showed that the primary endpoint of progression-free survival (PFS) had been met. Soon, the population of patients with advanced cervical cancer in China will have access to immune combination therapy. Additionally, a randomized, double-blind, placebo-controlled Phase III study of cadonilimab combined with chemotherapy as first-line treatment for gastric cancer also met the primary endpoint of overall survival (OS) in the interim analysis, and a new drug application had been accepted by CDE. With positive results from registration trials of cadonilimab in first-line treatments of multiple tumor types, the population benefiting from cadonilimab will rapidly expand, better realizing the clinical value of this cadonilimab for tumor treatment and benefiting more patients. About Cadonilimab Cadonilimab is a first-in-class bispecific antibody targeting both PD-1 and CTLA-4 which is developed by Akeso. In Jun 2022, the China National Medical Products Administration (NMPA) approved cadonilimab for recurrent or metastatic cervical cancer. Cadonilimab has been included and recommended in multiple clinical practice guidelines such as CSCO. Cadonilimab has been engaged in more than 60 ongoing clinical trials including investigator-initiated studies. Currently, a phase III study of cadonilimab for first-line treatment of gastric cancer has met its endpoint of OS. A phase III study of cadonilimab has also met one of its primary endpoints of PFS for first-line treatment of recurrent/metastatic cervical cancer (R/M CC). About Akeso, Inc. Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception , we have established a distinctive and integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode. Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, NDAs for 4 drugs and 6 indications accepted, and 13 ongoing Phase III studies. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug to the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies. In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China's NMPA and granted Priority Review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited. Contact Akeso Public Relations: PR@akesobio.com Contact Akeso Business Development : bd@akesobio.com View original content: SOURCE Akeso, Inc. Company Codes: HongKong:09926, OTC-PINK:LNVGY, HongKong:9926

Clinical ResultPhase 3Phase 2License out/inDrug Approval

100 Deals associated with Penpulimab

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Nasopharyngeal Carcinoma	CN	Zhengda Tianqing Kangfang (Shanghai) Biomedical Technology Co., Ltd.	24 Apr 2024
Squamous non-small cell lung cancer	CN	Zhengda Tianqing Kangfang (Shanghai) Biomedical Technology Co., Ltd.	10 Jan 2023
Classical Hodgkin's Lymphoma	CN	Akeso Biopharma Co., Ltd.	03 Aug 2021
Classical Hodgkin's Lymphoma	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	03 Aug 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatocellular Carcinoma	NDA/BLA	CN	Nanjing Shunxin Pharmaceutical Co., Ltd.	21 Nov 2024
Hepatocellular Carcinoma	NDA/BLA	CN	Akeso Biopharma Co., Ltd.	21 Nov 2024
Nasopharyngeal Carcinoma	Phase 3	AU	Akeso Biopharma Co., Ltd.	16 Aug 2021
Nasopharyngeal Carcinoma	Phase 3	BR	Akeso Biopharma Co., Ltd.	16 Aug 2021
Advanced Hepatocellular Carcinoma	Phase 3	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	11 Aug 2020
metastatic non-small cell lung cancer	Phase 3	CN	Akeso Biopharma Co., Ltd.	27 Nov 2018
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	CN	Akeso Biopharma Co., Ltd.	12 Nov 2018
Adenocarcinoma	Discovery	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	20 May 2020
Advanced Gastric Adenocarcinoma	Discovery	CN	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	20 May 2020
squamous cell lung carcinoma	Discovery	CN	Akeso Biopharma Co., Ltd.	20 Dec 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05563480 (ESMO_IO2024) Manual	Phase 2	Nasopharyngeal Carcinoma	17	TQB2618 + Penpulimab	(kkoeapneyo) = kowjhqhvmh zjwimkyhcv (xhfoloerzh ) View more	Negative	12 Dec 2024
NCT04846634 (ALTER-L043, ESMO_IO2024) Manual	Phase 2	Locally Advanced Lung Non-Small Cell Carcinoma Adjuvant \| Neoadjuvant	90	Penpulimab + Chemotherapy + Anlotinib	(rjyznrhtea) = izwnhbdytf qqaeodjvvx (hrliebdjcj ) View more	Positive	12 Dec 2024
				Penpulimab + Chemotherapy	(rjyznrhtea) = lfgkqkmsav qqaeodjvvx (hrliebdjcj ) View more
NCT05894421 (ASH2024) Manual	Phase 1	Hodgkin's Lymphoma \| Mediastinal large B-cell lymphoma \| Diffuse Large B-Cell Lymphoma \| Lymphoma	21	TQB2223 + Penpulimab	(pqzcdskavh) = xvbkqjmdiy bidvhcmqpz (kjpuomukyj ) View more	Positive	08 Dec 2024
				TQB2223 + Penpulimab (HL patients previously treated with anti-PD-1/L1)	(pqzcdskavh) = dcmwndijaj bidvhcmqpz (kjpuomukyj ) View more
ALTER-UC-007 (NEWS) Manual	Phase 2	Bladder Cancer	6	吉西他滨+顺铂 or 派安普利单+安罗替尼	(xjwngnhfnz) = ltxcvzvpfa zmygtnhsng (xcmugspgcv )	Positive	30 Oct 2024
				吉西他滨+顺铂 or 派安普利单+安罗替尼 (受手术的患者)	(ezpmdtyhwu) = zhpawsgbvb hxjzeeooqr (wwvwrqhfmm )
NCT04203719 (Pubmed) Manual	Phase 2	Small Cell Lung Cancer Second line	21	Anlotinib 10/12 mg QD + Penpulimab 200 mg IV	(ussazjsfiy) = xqstvekoiy uxkktxllfn (aoqfliguek, 17.7 - 66.6) View more	Positive	01 Oct 2024
NCT05244993 (ESMO2024) Manual	Phase 2	Advanced Triple-Negative Breast Carcinoma First line	33	AK105, anlotinib, nab-P	(bcmaucpiww) = tericftwkg qywypmmocw (gtutxpxvcf, 60.65 - 93.45) View more	Positive	16 Sep 2024
ChiCTR2200062189 (keynote-564, ESMO2024) Manual	Phase 2	Renal Cell Carcinoma Adjuvant	63	Penpulimab 200 mg	(hjljvlnkkn) = fostbkruxn ncqafbbcpn (yqqsduvtkt ) View more	Positive	15 Sep 2024
				penpulimab (Observation)	(hjljvlnkkn) = ssjuhplswp ncqafbbcpn (yqqsduvtkt ) View more
NCT04344158 (ALTN-AK105-III-02, ESMO2024 \| PRNewswire) Manual	Phase 3	Advanced Hepatocellular Carcinoma First line	649	Anlotinib + Penpulimab	(eifbcmfhnu) = giqlrwztum kiwmpwqsob (hiskrlelut ) View more	Positive	13 Sep 2024
				Sorafenib	(eifbcmfhnu) = lsossxblgo kiwmpwqsob (hiskrlelut ) View more
WCLC2024 Manual	Phase 1	Non-Small Cell Lung Cancer	93	TQB2618 12Penpulimab	(ztsrxyllub) = gtagpwckgb izygtahsin (cabufupqsm ) View more	Positive	10 Sep 2024
				TQB2618 15penpulimab	(ztsrxyllub) = lcnwzfgpde izygtahsin (cabufupqsm ) View more
NCT05460481 (WCLC2024) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma Second line driver gene-negative	13	Anlotinibpenpulimab	(rxlilvbcpq) = wunleaessq kpsbaighmw (rlyfemcyfk ) View more	Positive	09 Sep 2024

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