An Open-label Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab + Chemotherapy in Patients With Advanced Solid Tumors - Cohort A

This trial is part of a multicenter, open-label Phase Ib/II clinical study evaluating the efficacy, safety, and tolerability of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors. Phase Ib of Cohort A1 determines the dose of LM-108 in combination with penpulimab + oxaliplatin + capecitabine. Phase II explores the efficacy and safety of LM-108 in combination with anti-tumor therapy in patients with advanced solid tumors.

Start Date01 Mar 2025

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT06821503

/ Not yet recruitingPhase 1/2

An Open Label Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab Plus Chemotherapy in Patients With Advanced Solid Tumors - Cohort C

This trial is the cohort C part of a multicenter, open label Phase Ib/II clinical study evaluating the preliminary efficacy, safety, and tolerability of LM-108 combined with anti-tumor therapy in patients with advanced solid tumors. The dose of LM-108 combined with penpulimab, albumin paclitaxel, and gemcitabine is recommended in Phase Ib.Explore the efficacy and safety of LM-108 combined with anti-tumor therapy in patients with advanced pancreatic cancer in Phase II.

Start Date01 Feb 2025

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20243929

/ RecruitingPhase 2

评价注射用TQB2102联合免疫±化疗在不可切除的局部晚期、复发性或转移性HER2阳性胃食管腺癌患者中有效性和安全性的Ⅱ期临床试验

[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±化疗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±化疗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 ± chemotherapy 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 ± chemotherapy 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.

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: Zhao, Kelei ; Liu, Yanting ; Zhang, Jinghang ; 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 ; Wu, Huijuan ; Zhao, Jun ; 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/.

30 Jun 2024·Annals of Coloproctology

Venous thromboembolism among Asian populations with localized colorectal cancer undergoing curative resection: is pharmacological thromboprophylaxis required? A systematic review and meta-analysis

Review

Author: Tan, Emile Kwong-Wei ; Sultana, Rehena ; Seow-En, Isaac ; Tan, Shih Jia Janice ; Ng, Yvonne Ying Ru ; Allen, John Carson ; Chok, Aik Yong ; Mathew, Ronnie

Purpose: We compared the incidence of venous thromboembolism (VTE) among Asian populations with localized colorectal cancer undergoing curative resection with and without the use of pharmacological thromboprophylaxis (PTP).Methods: A comprehensive literature search was undertaken to identify relevant studies published from January 1, 1980 to February 28, 2022. The inclusion criteria were patients who underwent primary tumor resection for localized nonmetastatic colorectal cancer; an Asian population or studies conducted in an Asian country; randomized controlled trials, case-control studies, or cohort studies; and the incidence of symptomatic VTE, deep vein thrombosis, and/or pulmonary embolism as the primary study outcomes. Data were pooled using a random-effects model. This study was registered in PROSPERO on October 11, 2020 (No. CRD42020206793).Results: Seven studies (2 randomized controlled trials and 5 observational cohort studies) were included, encompassing 5,302 patients. The overall incidence of VTE was 1.4%. The use of PTP did not significantly reduce overall VTE incidence: 1.1% (95% confidence interval [CI], 0%–3.1%) versus 1.9% (95% CI, 0.3%–4.4%; P = 0.55). Similarly, PTP was not associated with significantly lower rates of symptomatic VTE, proximal deep vein thrombosis, or pulmonary embolism.Conclusion: The benefit of PTP in reducing VTE incidence among Asian patients undergoing curative resection for localized colorectal cancer has not been clearly established. The decision to administer PTP should be evaluated on a case-bycase basis and with consideration of associated bleeding risks.

News (Medical) associated with Penpulimab

17 Mar 2025

·www.prnewswire.com

Akeso's Penpulimab Receives NMPA Approval for First-Line Treatment of Nasopharyngeal Cancer

HONG KONG, March 16, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) announced that its innovative, self-developed anti-PD-1 monoclonal antibody, penpulimab, has been officially approved by the National Medical Products Administration (NMPA) for the first-line treatment of recurrent or metastatic nasopharyngeal cancer (NPC) in combination with chemotherapy. Previously, penpulimab was approved for use as a third-line treatment for advanced NPC. With this new approval, penpulimab now provides comprehensive treatment coverage across all stages of NPC, offering patients a continuous immunotherapy option from first-line to third-line therapy. This marks the fourth approved indication for penpulimab. In addition to the two NPC indications, penpulimab is also approved for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) when combined with chemotherapy, as well as for monotherapy in patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have previously received at least two lines of systemic chemotherapy. Furthermore, a supplemental New Drug Application (sNDA) for penpulimab in combination with anlotinib for first-line treatment of advanced hepatocellular carcinoma (HCC) is currently under review. Professor Hu Chaosu, one of the principal investigators of penpulimab at Fudan University Shanghai Cancer Center, said: "In China, there remains a significant unmet clinical need for NPC. As the only IgG1 subtype anti-PD-1 monoclonal antibody globally, penpulimab has demonstrated robust efficacy in clinical studies, enhancing the effectiveness of immunotherapy for NPC. The approval for first-line treatment marks a major milestone, as it provides a comprehensive treatment regimen for clinicians and patients, benefiting a large population of NPC patients in China, from first-line to third-line therapy." Professor Chen Xiaozhong, one of the principal investigators of penpulimab at Zhejiang Cancer Hospital, said: "Nasopharyngeal cancer (NPC) is a highly prevalent malignancy in certain regions, and patients with recurrent or metastatic NPC typically face a poor prognosis. Penpulimab has demonstrated a significantly high response rate and prolonged survival benefits in both first-line treatment of NPC and in patients with metastatic NPC who have failed multiple lines of prior therapy. Additionally, it has shown a favorable safety profile, with a low incidence of immune-related adverse events. " Dr. Xia Yu, Founder, Chairwoman, CEO, and President of Akeso, said: "We want to extend our sincere gratitude to all the researchers, clinical trial participants, and NPC patients who have contributed to this milestone. With its differentiated design, penpulimab has gained widespread recognition among clinicians and patients for its efficacy and safety in treating diseases like non-small cell lung cancer (NSCLC), Hodgkin lymphoma, and nasopharyngeal cancer. The approval for first-line treatment of advanced NPC will allow more patients in China to benefit from this new PD-1 monoclonal antibody, further improving survival outcomes." "As key drugs like cadonilimab, ivonescimab, and penpulimab receive approval for a wide range of indications, Akeso's commitment to innovation and excellence in drug development—from discovery to clinical application—is clearly demonstrated. These advancements are not only improving patient outcomes but also reaffirming our dedication to transforming global healthcare. Moving forward, Akeso will continue to pioneer breakthrough therapies with the potential to set new standards of care, driving positive change in treatment paradigms and improving the lives of patients worldwide." 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

Drug ApprovalImmunotherapy

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

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	China	Zhengda Tianqing Kangfang (Shanghai) Biomedical Technology Co., Ltd.	24 Apr 2024
Squamous non-small cell lung cancer	China	Zhengda Tianqing Kangfang (Shanghai) Biomedical Technology Co., Ltd.	10 Jan 2023
Classical Hodgkin's Lymphoma	China	Akeso Biopharma Co., Ltd.	03 Aug 2021
Classical Hodgkin's Lymphoma	China	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	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	21 Nov 2024
Hepatocellular Carcinoma	NDA/BLA	China	Akeso Biopharma Co., Ltd.	21 Nov 2024
Nasopharyngeal Cancer, Recurrent	Phase 3	China	Akeso Biopharma Co., Ltd.	16 Aug 2021
Nasopharyngeal Carcinoma	Phase 3	Canada	Akeso Biopharma Co., Ltd.	16 Aug 2021
Advanced Hepatocellular Carcinoma	Phase 3	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	11 Aug 2020
metastatic non-small cell lung cancer	Phase 3	China	Akeso Biopharma Co., Ltd.	27 Nov 2018
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	China	Akeso Biopharma Co., Ltd.	12 Nov 2018
Adenocarcinoma	Discovery	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	20 May 2020
Advanced Gastric Adenocarcinoma	Discovery	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	20 May 2020
squamous cell lung carcinoma	Discovery	China	Akeso Biopharma Co., Ltd.	20 Dec 2018

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04846634 (ALTER-L043, ESMO_IO2024) Manual	Phase 2	Locally Advanced Lung Non-Small Cell Carcinoma Adjuvant \| Neoadjuvant	90	Penpulimab + Chemotherapy + Anlotinib	(zujaugopzn) = eyntszdrvj pfnaxerwvu (redzdfedtg ) View more	Positive	12 Dec 2024
				Penpulimab + Chemotherapy	(zujaugopzn) = urmlmrkqlu pfnaxerwvu (redzdfedtg ) View more
NCT05563480 (ESMO_IO2024) Manual	Phase 2	Nasopharyngeal Carcinoma	17	TQB2618 + Penpulimab	(aafiocvaeg) = ustynlrald yatfwfsnpl (xfhfxmttnr ) View more	Negative	12 Dec 2024
NCT05894421 (ASH2024) Manual	Phase 1	Hodgkin's Lymphoma \| Mediastinal large B-cell lymphoma \| Diffuse Large B-Cell Lymphoma \| Lymphoma	21	TQB2223 + Penpulimab	(kltnkigqcz) = biszczvolj iaulcfarzz (xdezsrdtyx ) View more	Positive	08 Dec 2024
				TQB2223 + Penpulimab (HL patients previously treated with anti-PD-1/L1)	(kltnkigqcz) = lzqborzxnx iaulcfarzz (xdezsrdtyx ) 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	(lhrpleyzyl) = ywyanqjtab uadzqlhcfy (bfbufzuhzp )	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)	(xyokyegvmd) = gmylsftjie ecwuptdqbg (xiwnsinjnq )
NCT04203719 (Pubmed) Manual	Phase 2	Small Cell Lung Cancer Second line	21	Anlotinib 10/12 mg QD + Penpulimab 200 mg IV	(rgorxlapjz) = pfvmingvnb vmniwdvqzs (ulsctqkuwl, 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	(caqizicgmt) = whhchvzjyt utmrtizhvl (ltznxszovv, 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	(ebrmbkwypc) = wdbdycowym wsojscwusg (gofshwtwvd ) View more	Positive	15 Sep 2024
				penpulimab (Observation)	(ebrmbkwypc) = cgqgqicozp wsojscwusg (gofshwtwvd ) View more
NCT04344158 (ALTN-AK105-III-02, ESMO2024 \| PRNewswire) Manual	Phase 3	Advanced Hepatocellular Carcinoma First line	649	Anlotinib + Penpulimab	(shnmhcazrn) = awzmmomrjf rzwviaaoni (izlordgxmc ) View more	Positive	13 Sep 2024
				Sorafenib	(shnmhcazrn) = tmvgknoexd rzwviaaoni (izlordgxmc ) View more
WCLC2024 Manual	Phase 1	Non-Small Cell Lung Cancer	93	TQB2618 12Penpulimab	(vjyesrwslb) = fihxhjgnmn zdkqckujrx (pwbtlsfire ) View more	Positive	10 Sep 2024
				TQB2618 15penpulimab	(vjyesrwslb) = nislcovwny zdkqckujrx (pwbtlsfire ) View more
NCT05460481 (WCLC2024) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma Second line driver gene-negative	13	Anlotinibpenpulimab	(amnmikabtm) = ghfftbzfmg yaksxpckvm (owmbiwwlwd ) View more	Positive	09 Sep 2024

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Accelerate your research with the latest regulatory approval information.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis