A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination with Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

Start Date31 Dec 2025

Sponsor / Collaborator

University of Maryland Baltimore

[+1]

NCT06724042

/ Not yet recruitingPhase 1

First-in-human Phase 1a/b, Open-Label, Multicenter, Dose Escalation, Optimization and Expansion Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors

This is a first-in-human Phase 1a/b, open-label, multicenter, dose escalation, optimization and expansion study of ISM5939 to evaluate the safety, tolerability, PK, PD, and preliminary antitumor activity of ISM5939 in patients with advanced or metastatic solid tumors.
The study will be conducted in 3 parts sequentially: Part 1 dose escalation ISM5939 monotherapy, Part 2 dose optimization to determine RP2D of ISM5939 monotherapy, and Part 3 dose expansion in 3 cohorts after initial safety run-in of ISM5939 combination therapy.

Start Date30 Dec 2025

Sponsor / Collaborator

InSilico Medicine Hong Kong Ltd.Startup

NCT06364904

/ Not yet recruitingPhase 3IIT

A Multicenter, III Stage, Randomized Controlled Trail on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma.

The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.

Start Date01 Oct 2025

Sponsor / Collaborator

Sun Yat-Sen Memorial Hospital

100 Clinical Results associated with Cisplatin

100 Translational Medicine associated with Cisplatin

100 Patents (Medical) associated with Cisplatin

122,235

Literatures (Medical) associated with Cisplatin

31 Dec 2025·ANNALS OF MEDICINE

Review

Author: Liu, Dequan ; Zheng, Xu ; Wang, Shijin ; Zheng, Zunwen ; Wu, Guangzhen ; Jiang, Bowen ; Che, Xiangyu ; Xie, Deqian ; Li, Guandu

Cisplatin is a platinum-based drug that is frequently used to treat multiple tumors. The anti-tumor effect of cisplatin is closely related to the tumor immune microenvironment (TIME), which includes several immune cell types, such as the tumor-associated macrophages (TAMs), cytotoxic T-lymphocytes (CTLs), dendritic cells (DCs), myeloid-derived suppressor cells (MDSCs), regulatory T cells (Tregs), and natural killer (NK) cells. The interaction between these immune cells can promote tumor survival and chemoresistance, and decrease the efficacy of cisplatin monotherapy. Therefore, various combination treatment strategies have been devised to enhance patient responsiveness to cisplatin therapy. Cisplatin can augment anti-tumor immune responses in combination with immune checkpoint blockers (such as PD-1/PD-L1 or CTLA4 inhibitors), lipid metabolism disruptors (like FASN inhibitors and SCD inhibitors) and nanoparticles (NPs), resulting in better outcomes. Exploring the interaction between cisplatin and the TIME will help identify potential therapeutic targets for improving the treatment outcomes in cancer patients.

31 Dec 2025·Animal Cells and Systems

Parvimonas micra -polarized M2-like tumor-associated macrophages accelerate colorectal cancer development via IL-8 secretion

Article

Author: Kim, Hyung-Sik ; Yang, Ji Won ; Seo, Yoojin ; Ahn, Ji-Su ; Yu, Jeong Hyun ; Park, Hee-Jeong ; Nguyen, Dang Khoa ; Lee, Hyeon Seo ; Oh, Su-Jeong ; Kim, Seong Hui ; Kang, Min-Jung ; Lee, Yunji

Parvimonas micra (Pm), a periodontal pathogen, has been implicated in the impairment of anti-tumor responses in colorectal cancer (CRC). The tumor microenvironment in CRC involves tumor-associated macrophages (TAMs), which are pivotal in modulating tumor-associated immune responses. The polarization of TAMs towards an M2-like phenotype promotes CRC progression by suppressing the immune system. However, the mechanisms by which Pm affects the progression of CRC remain inadequately elucidated. In this study, we explored the impact of Pm infection on CRC cell characteristics, including proliferation, chemoresistance, migration, and macrophage polarization. We found that Pm-infected THP-1-derived macrophages exhibited elevated interleukin-10 levels, a well-established M2 marker. Conditioned media from Pm-treated THP-1 cells significantly enhanced CRC cell proliferation, cisplatin resistance, and migration, and interleukin-8 was identified as a key factor. Consistent with the in vitro results, an azoxymethane/dextran sodium sulfate mouse model treated with oral Pm showed accelerated CRC tumor growth. These results offer mechanistic insights into the influence of Pm infection on tumor microenvironment in CRC through M2-like macrophage polarization. The identified pathways may serve as potential targets for therapeutic interventions for CRC.

31 Dec 2025·INTERNATIONAL JOURNAL OF HYPERTHERMIA

Article

Author: van Bochove, Gregor G. W. ; Rodermond, Hans M. ; Oei, Arlene L. ; Krawczyk, Przemek M. ; Stalpers, Lukas J. A. ; Franken, Nicolaas A. P. ; Scutigliani, Enzo M. ; Mei, Xionge ; Crezee, Johannes ; IJff, Marloes

Background: Efficacy of current treatment options for cervical cancer require improvement. Previous in vitro studies have shown the enhancing effects of the addition of PARP1-inhibitors to chemoradiotherapy and thermoradiotherapy. The aim of our present study was to test efficacy of different combinations of treatment modalities radiotherapy, cisplatin, hyperthermia and PARP1-inhibitors using in vitro tumor models, ex vivo treated patient samples and in vivo tumor models.Materials and Methods: In vitro clonogenic survival curves (0-6 Gy) show that PARP1-i (4-5 M Olaparib) enhances both chemoradiotherapy (0.3-0.5 µM cisplatin) and thermoradiotherapy (42 °C for 1 h) in SiHa, CaSki and HeLa cells. A cervical cancer mouse model and freshly obtained in-house developed patient-derived organoids were used to examine the effects of different treatment combinations. For the in vivo study, human cervical cancer (SiHa) cells were injected in the right hind leg of athymic nude mice. In vivo mouse experiments show that PARP1-i enhances thermoradiotherapy or chemoradiotherapy by reduction of tumor volumes. Five cycles of treatment were applied with the following doses per cycle: irradiation 3 Gy, hyperthermia 1 h at 42 °C, cisplatin at 2 mg/kg, and twice PARP1-i at 50 mg/kg.Results: Quadruple treatment, combining radiotherapy, hyperthermia, cisplatin and PARP1-i, was very effective but also lead to severe side effects causing severe weight loss and death. In contrast, thermoradiotherapy or chemoradiotherapy with addition of PARP1-i, were effective without serious side effects.Conclusion: The triple combinations are promising options for potentially more effective treatment of locally advanced cervical cancer without more toxicity.

1,109

News (Medical) associated with Cisplatin

25 Apr 2025

·www.prnewswire.com

Akeso Announces FDA Approval for Penpulimab-kcqx in Two BLA Indications for Comprehensive Treatment of Advanced Nasopharyngeal Carcinoma

HONG KONG, April 24, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior line of therapy. Penpulimab-kcqx was developed independently by Akeso, with further development and commercialization managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group. This milestone marks penpulimab-kcqx as Akeso's first internally developed innovative biologic to receive FDA approval. The approval underscores the robust clinical research behind penpulimab-kcqx and marks Akeso's successful entry into the United States regulatory system for the first time. This achievement highlights the company's innovative drug development capabilities and its commitment to adhering to the highest international standards in pharmaceutical quality management. The FDA's approval of penpulimab-kcqx validates Akeso's international drug development strategy and expansion capabilities. This approval lays a strong foundation for Akeso's continued clinical development efforts in the global therapeutics markets. Penpulimab-kcqx has been approved in China for two indications: 1. first-line treatment of advanced NPC, and 2. second or later line treatment of advanced NPC. The recent FDA approval of penpulimab-kcqx offers a new, immunotherapy option for advanced NPC patients in the US. The FDA approval is based on the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study, which supported the two Biologics License Application (BLA) for penpulimab-kcqx. These studies demonstrated the drug's clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC. AK105-304 is a randomized, double-blind, international Phase III trial that enrolled NPC patients of diverse ethnicities. The data will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Previously, the FDA granted penpulimab-kcqx Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for NPC treatment, highlighting the critical unmet need for this therapy. According to the WHO 2020 Global Cancer Statistics, over 133,000 new NPC cases are diagnosed annually worldwide, with more than 70% of the patients presented with locally advanced disease. Recurrent or metastatic NPC has a poor prognosis and limited survival. Penpulimab-kcqx's FDA approval will expand the number of NPC patients that can benefit from its treatment. Prof. Chaosu Hu, Principal Investigator of penpulimab-kcqx from Fudan University Shanghai Cancer Center, commented: "This milestone enhances international treatment guidelines for advanced NPC and extends the benefits of China's innovations to global patients, ultimately reshaping the treatment landscape for metastatic NPC worldwide." Prof. Xiaozhong Chen, Investigator of penpulimab-kcqx from Zhejiang Cancer Hospital, added: "The FDA approval of penpulimab-kcqx confirms its high efficacy and low toxicity, positioning China's innovative drug development in alignment with international standards." Dr. Yu Xia, Founder, Chairwoman, President & CEO of Akeso, expressed: "We are very excited by the approval of penpulimab-kcqx's approval in the US FDA for first line and later line NPC. Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the United States. The FDA approval of penpulimab-kcqx not only highlights the quality of our innovation but also underscores Akeso's focus on delivering treatments for difficult to treat cancers for patients around the world. We are deeply grateful to all the researchers, participants, and patients who have contributed to this success. Akeso will continue to advance first and best in class therapies, including bispecific antibodies and CD47 inhibitors, challenge global standards of care and unlocking the full potential of our pipeline for cancer patients everywhere." Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( 9926. HK) contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. There can be no assurance that penpulimab-kcqx or other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. Please see Prescribing Information for penpulimab-kcqx at when it is posted. 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, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available, and 4 new drugs with 4 new indications are 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. 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

Phase 3Clinical ResultDrug ApprovalFast TrackOrphan Drug

24 Apr 2025

·www.prnewswire.com

Kelun-Biotech to Present Results of Six Clinical Studies at 2025 ASCO Annual Meeting

CHENGDU, China, April 24, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) announced that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from May 30 to June 3. Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031). The abstracts for these studies will be published on the ASCO's official website on May 22, 2025, local time. Detailed information on the studies selected for ASCO 2025 are as follows: Title: Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study. Presentation Type: Oral Abstract Number: 8507 Session Date and Time: 6/1/2025 8:00 AM-11:00 AM CDT Title: Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study. Presentation Type: Oral Abstract Number: 6004 Session Date and Time: 5/31/2025 1:15 PM-4:15 PM CDT Title: Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase II OptiTROP-Breast05 study. Presentation Type: Rapid oral Abstract Number: 1019 Session Date and Time: 5/30/2025 2:45 PM-4:15 PM CDT Title: Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study. Presentation Type: Poster Abstract Number: 8529 Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT Title: Sacituzumab Tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study. Presentation Type: Poster Abstract Number: 8615 Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT Title: Results from a phase I study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer. Presentation Type: Poster Abstract Number: 6098 Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT About Sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as Non-small Cell Lung Cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the National Medical Products Administration (NMPA), and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. About Tagitanlimab Tagitanlimab is the first PD-L1 monoclonal antibody (mAb) globally to receive authorization for the first-line treatment of NPC. Previously, the National Medical Products Administration (NMPA) has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About KL590586 ( A400/EP0031) A400, a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. We are currently conducting pivotal clinical study for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China. In March 2021, we granted Ellipses Pharma, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031. In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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Phase 1Phase 2Clinical ResultPhase 3ASCO

24 Apr 2025

·www.fda.gov

FDA approves penpulimab-kcqx for non-keratinizing nasopharyngeal carcinoma

On April 23, 2025, the Food and Drug Administration approved penpulimab-kcqx (Akeso Biopharma Co., Ltd.) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.Full prescribing information for penpulimab-kcqx will be posted on Drugs@FDA.Efficacy and SafetyEfficacy of penpulimab-kcqx with cisplatin or carboplatin and gemcitabine was evaluated in Study AK105-304 (NCT04974398), a randomized, double-blind, multi-center trial in 291 patients with recurrent or metastatic NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease. Patients were randomized (1:1) to receive either penpulimab-kcqx with cisplatin or carboplatin and gemcitabine, followed by penpulimab-kcqx, or placebo with cisplatin or carboplatin and gemcitabine, followed by placebo. Chemotherapy regimens are described in the full prescribing information.The primary efficacy outcome measure was progression-free survival (PFS), as assessed by a Blinded Independent Review Committee according to RECIST v1.1. Overall survival (OS) was a key secondary endpoint. Median PFS was 9.6 months (95% CI: 7.1, 12.5) in the penpulimab-kcqx arm and 7.0 months (95% CI: 6.9, 7.3) in the placebo arm (hazard ratio [HR] 0.45 [95% CI: 0.33, 0.62], two-sided p-value <0.0001), with 31% and 11% of patients alive and progression-free after 12 months of follow-up in the penpulimab-kcqx and placebo arms, respectively. While OS results were immature, with 70% of pre-specified deaths for the final analysis reported, no detrimental trend was observed.Efficacy of single-agent penpulimab-kcqx was evaluated in Study AK105-202 (NCT03866967), an open-label, multicenter, single-arm trial conducted in a single country. The trial included a total of 125 patients with unresectable or metastatic non-keratinizing NPC who had disease progression after platinum-based chemotherapy and at least one other line of therapy. Patients received penpulimab-kcqx until disease progression or unacceptable toxicity, for a maximum of 24 months.The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) according to RECIST v1.1 as assessed by an Independent Radiology Review Committee. The ORR was 28% (95% CI: 20, 37) and median DOR was not reached (95% CI: 9.2, not estimable).Immune-mediated adverse reactions occurred with penpulimab-kcqx including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥20%) for penpulimab-kcqx with cisplatin or carboplatin and gemcitabine were nausea, vomiting, hypothyroidism, constipation, decreased appetite, decreased weight, cough, COVID-19 infection, fatigue, rash, and pyrexia. The most common adverse reactions (≥20%) for single-agent penpulimab-kcqx were hypothyroidism and musculoskeletal pain. Fatal adverse reactions occurred in 1% of patients, including a case each of pneumonitis, septic shock, colitis, and hepatitis.The recommended penpulimab-kcqx dose with cisplatin or carboplatin and gemcitabine is 200 mg every three weeks until disease progression or unacceptable toxicity, for a maximum of 24 months. The recommended single-agent penpulimab-kcqx dose for previously treated NPC is 200 mg every two weeks until disease progression or unacceptable toxicity, for a maximum of 24 months.Expedited ProgramsThis review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.This application was granted fast track designation, breakthrough designation, and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X: @FDAOncology.

Clinical ResultFast TrackOrphan DrugDrug Approval

100 Deals associated with Cisplatin

External Link

KEGG	Wiki	ATC	Drug Bank
D00275	Cisplatin	L01XA01	DB00515

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Biliary Tract Neoplasms	Japan	Nippon Kayaku Co., Ltd.	22 Feb 2012
Malignant Pleural Mesothelioma	Japan	Nippon Kayaku Co., Ltd.	04 Jan 2007
Childhood Malignant Solid Neoplasm	Japan	Nippon Kayaku Co., Ltd.	15 Sep 2005
Lymphoma	Japan	Nippon Kayaku Co., Ltd.	15 Sep 2005
Bone Cancer	Japan	Nippon Kayaku Co., Ltd.	14 Feb 2005
Endometrial Carcinoma	Japan	Nippon Kayaku Co., Ltd.	14 Feb 2005
Germinoma	Japan	Nippon Kayaku Co., Ltd.	31 May 2004
Hepatocellular Carcinoma	Japan	Nippon Kayaku Co., Ltd.	29 Jan 2004
Osteosarcoma	Japan	Nippon Kayaku Co., Ltd.	21 Dec 1999
Small Cell Lung Cancer	Japan	Nippon Kayaku Co., Ltd.	21 Dec 1999
Solid tumor	China	Dezhou Deyao Intelligent Pharmacy Co., Ltd.	01 Jan 1995
Solid tumor	China	Dezhou Bocheng Pharmaceutical Technology Co., Ltd.	01 Jan 1995
Solid tumor	China	Yunnan Phytopharmaceutical Co. Ltd.	01 Jan 1995
Solid tumor	China	Kunming Guiyan Pharmaceutical Co., Ltd.	01 Jan 1995
Solid tumor	China	Qilu Pharmaceutical Co., Ltd.	01 Jan 1995
Stomach Cancer	Japan	Nippon Kayaku Co., Ltd.	03 Jun 1990
Esophageal Carcinoma	Japan	Nippon Kayaku Co., Ltd.	30 May 1988
Neuroblastoma	Japan	Nippon Kayaku Co., Ltd.	30 May 1988
Uterine Cervical Cancer	Japan	Nippon Kayaku Co., Ltd.	30 May 1988
Head and Neck Neoplasms	Japan	Nippon Kayaku Co., Ltd.	28 Aug 1986

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Fallopian Tube High Grade Serous Adenocarcinoma	Phase 3	United States	GSK Plc	08 Mar 2024
Primary peritoneal carcinoma	Phase 3	United States	GSK Plc	08 Mar 2024
Metastatic gastric adenocarcinoma	Phase 3	United States	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Japan	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Argentina	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Belgium	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Canada	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Czechia	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Denmark	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	Finland	Eli Lilly & Co.	20 Jan 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04602078 (AUREA \| SOGUG-AUREA, CTgov)	Phase 2	Urothelial Carcinoma of the Urinary Bladder \| Locally Advanced Urothelial Carcinoma \| Metastatic urothelial carcinoma	82	Cisplatin 70 mg/m2+Gemcitabine 1000 mg/m2+Atezolizumab 1200 mg/m2	ypcqfsevsq = axkzvupstg veljyobfgm (hpyacjpzzl, hwaziyhkgd - decqotbvyl) View more	-	24 Apr 2025
NCT02365766 (GU14-188 \| HCRN GU14-188, CTgov)	Phase 1/2	Urothelial Carcinoma of the Urinary Bladder \| Bladder Cancer \| Non-Muscle Invasive Bladder Neoplasms ... View more	83	Cisplatin+Pembrolizumab (Phase 1b Cohort I: Cisplatin-eligible - Pembrolizumab 200 mg)	wdrkjuzmhx = ohovpgsbfv fgsbnixozb (mwkxvpczxn, omrxvhizom - atinxvafrj)	-	18 Mar 2025
				Cisplatin+Pembrolizumab (Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg)	lolcxsfdgh = wbetsewfml fwtnzcqhis (afjwtyqvxn, khpnccbzxk - pbhuygzmzp) View more
NCT04158141 (CTgov)	Phase 3	Malignant Pleural Mesothelioma	16	Pleurectomy+Carboplatin+Pemetrexed+cisplatin+Pemetrexed Disodium (Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment))	ptorkueisv = ywpulgslkj lvkfrgzntq (uxlhujmpuv, zeozlpiuja - xtylegfsuh) View more	-	19 Feb 2025
				Intensity-Modulated Radiation Therapy+Carboplatin+Pemetrexed+cisplatin+Pemetrexed Disodium (Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS))	ptorkueisv = xjrtroglzz lvkfrgzntq (uxlhujmpuv, riufoalrec - omnykgzeek) View more
NCT02662062 (ANZUP 1502 \| PCR-MIB, CTgov)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	28	Radiotherapy+cisplatin+pembrolizumab	okcfgbapko = uobtecuabx jpxtrbhssi (nzmqekakbn, jjvacfzfqn - afxhwufmxk) View more	-	27 Jan 2025
ASCO_GI2025 Manual	Not Applicable	Locally Advanced Esophageal Squamous Cell Carcinoma	23	docetaxel (DTX), cisplatin (CDDP), and 5-fluorouracil (5-FU) (DCF) therapy + nivolumab	eduasywgpa(etpcahlqnk) = rnpwaaczaw elzidohdyg (vfjgdpjdgy ) View more	Positive	23 Jan 2025
JPRN-jRCTs031180006 (JCOG1301C \| Trigger, ASCO_GI2025) Manual	Phase 2	HER2-positive gastric cancer \| HER2 positive Gastroesophageal Junction Adenocarcinoma Adjuvant HER2 Positive	46	S-1/cisplatin	ekvnagzuec(lfhgycyplv) = lznoihcqck cxswdynngx (kuabceohge ) View more	Positive	23 Jan 2025
				S-1/cisplatin + Trastuzumab	ekvnagzuec(lfhgycyplv) = xgcebtdblj cxswdynngx (kuabceohge ) View more
NCT00478699 (GECP-SCAT \| SCAT Ph III Trial \| SCAT Trial, CTgov)	Phase 3	Non-small cell lung cancer stage IIIA	500	Docetaxel+Cisplatin (Control Arm)	tzltlxrhkx = zuiuqojdvn nvjqwjfysh (spvmnkzglr, dcxeshzsbd - bzoiamsnqn) View more	-	12 Dec 2024
				gemcitabine+docetaxel+cisplatin (Experimental Arm)	tzltlxrhkx = vitklpipow nvjqwjfysh (spvmnkzglr, icmdfdjidm - uzxirprqzy) View more
NCT02754726 (CTgov)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma	35	nivolumab+albumin-bound paclitaxel+Gemcitabine+Paricalcitol+cisplatin	ttllwhmers = yfmzxmlqlk ydnxwpvfnq (fxgdhrszbp, quozmafspx - jjjsdzbqlp) View more	-	10 Dec 2024
ESMO_ASIA2024 Manual	Not Applicable	Head and Neck Neoplasms	104	Docetaxel plus Cisplatin	eqtinshibt(rvaracofus) = dtzwvuwkcb wluxehyxzo (pzdvhnueiv ) View more	Similar	07 Dec 2024
				Paclitaxel plus Carboplatin	eqtinshibt(rvaracofus) = oujhynwktc wluxehyxzo (pzdvhnueiv ) View more
NCT01554397 (CTgov)	Phase 2/3	Uterine Cervical Cancer	101	PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)+cisplatin	jnkzsupejh = rdbvmhggnc seuhgxzdao (xxnikeabye, uehasmuvxy - eteicucbzl) View more	-	29 Nov 2024

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