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

121,970

Literatures (Medical) associated with Cisplatin

31 Dec 2025·Human Vaccines & Immunotherapeutics

Review

Author: Marchetti, Andrea ; Mollica, Veronica ; Mottaran, Angelo ; Piazza, Pietro ; Rosellini, Matteo ; Danielli, Linda ; Ricci, Costantino ; Schiavina, Riccardo ; Tassinari, Elisa ; Massari, Francesco ; Santoni, Matteo

In recent years, several clinical trials focused on the potential role of immune-checkpoint inhibitors (ICIs) in the adjuvant treatment of muscle-invasive urothelial cancer (UC). Heretofore, only the anti-programmed death protein 1 (anti-PD1) nivolumab received European Medical Agency (EMA) approval for cisplatin-unfit patients. In our work, we deeply analyzed the results of the three pivotal studies in view of the rapidly evolving therapeutic advanced UC's scenario. Furthermore, there are several ongoing research to investigate ICIs and other emerging immune agents in this setting; results are awaited. Additionally, current efforts have been made to assess the role of these agents in earlier disease settings, particularly in high-risk non-muscle-invasive bladder cancer (NMIBC). In our review, we analyzed the potential role of predictive and/or prognostic biomarkers that may improve patient selection and treatment efficacy. To conclude, we highlighted the upcoming changes that could redefine the standard of care for patients with early-stage UC.

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 ; Ahn, Ji-Su ; Seo, Yoojin ; Yu, Jeong Hyun ; Nguyen, Dang Khoa ; Park, Hee-Jeong ; Lee, Hyeon Seo ; Kim, Seong Hui ; Oh, Su-Jeong ; 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.

1,105

News (Medical) associated with Cisplatin

04 Apr 2025

·pipelinereview.com

Imfinzi-based perioperative regimen approved in the EU for resectable non-small cell lung cancer

Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone LONDON, UK I April 04, 2025 I AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the European Union (EU) for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine . Each year in Europe, there are more than 450,000 people diagnosed with lung cancer. 1 Around 25-30% of all patients with NSCLC, the most common form of lung cancer, are diagnosed at an early stage to have surgery with curative intent. 2-3 However, the majority of patients with resectable disease will develop recurrence and only 36-46% of patients with Stage II disease will survive for five years. 4-5 This decreases to 24% for patients with Stage IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high unmet medical need. 4 Professor Martin Reck, Head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf, Germany, member of the AEGEAN Steering Committee and investigator in the trial, said: “Today’s approval provides an important new treatment option that should become a backbone combination approach for patients in Europe with resectable non-small cell lung cancer, who have historically faced high rates of recurrence and a poor prognosis. When added to neoadjuvant chemotherapy, perioperative durvalumab meaningfully improved outcomes in this curative-intent setting, significantly extending the time patients lived without their cancer returning.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Today’s approval marks an important step towards improving outcomes for patients in Europe with resectable non-small cell lung cancer, enabling more patients to access this important immunotherapy-based regimen. This new indication builds on the established role of Imfinzi in unresectable disease and underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure.” Results from a planned interim analysis of event-free survival (EFS) showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus neoadjuvant chemotherapy alone in patients treated with the Imfinzi -based perioperative regimen (32% data maturity; EFS hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.53-0.88; p=0.003902). In a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6). Additionally, interim overall survival (OS) results presented at the 2024 World Conference on Lung Cancer showed a favourable trend with the Imfinzi- basedperioperative regimen (35% data maturity; median OS: not reached [NR] versus 53.2 months; HR=0.89; 95% CI 0.70-1.14). The OS data were not tested for statistical significance at this interim analysis and will continue to be assessed as a key secondary endpoint at final analysis. Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients’ ability to complete surgery versus chemotherapy alone. Imfinzi is approved in the US, China and several other countries in this setting based on the AEGEAN results. Regulatory applications are currently under review in Japan and additional countries in this indication. Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease as not progressed after chemoradiotherapy (CRT) based on the PACIFIC Phase III trial. Notes Lung cancer Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 6-7 Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% of patients diagnosed with NSCLC. 8-9 An estimated 28,000 people are treated for resectable NSCLC across the five major European countries each year. 10 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition. 11-12 The majority of patients with resectable disease eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy. 5 AEGEAN AEGEAN is a randomised, double-blind, multi-centre, placebo-controlled global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage IIA-IIIB (Eighth Edition AJCC Cancer Staging Manual) NSCLC, irrespective of PD-L1 expression. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 802 patients were randomised to receive a 1500mg fixed dose of Imfinzi plus chemotherapy or placebo plus chemotherapy every three weeks for four cycles prior to surgery, followed by Imfinzi or placebo every four weeks (for up to 12 cycles) after surgery. Patients with known EGFR or ALK genomic tumour aberrations were excluded from the primary efficacy analyses. In the AEGEAN trial, the primary endpoints were pCR, defined as no viable tumour in the resection specimen (including lymph nodes) following neoadjuvant therapy, and EFS, defined as the time from randomisation to an event like tumour recurrence, progression precluding definitive surgery, or death. Key secondary endpoints were major pathologic response, defined as residual viable tumour of less than or equal to 10% in the resected primary tumour following neoadjuvant therapy, disease-free survival, OS, safety and quality of life. The final pathologic response analyses were performed after all patients had the opportunity for surgery and pathology assessment per the trial protocol. The trial enrolled participants from 264 centres in more than 25 countries including in the US, Canada, Europe, South America and Asia. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses. In addition to its indications in resectable, early-stage (IIA-IIIB) NSCLC and unresectable, Stage III NSCLC, Imfinzi is also approved for use in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage SCLC in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC. Imfinzi is also approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of EFS in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers. Imfinzi is also approved as a perioperative treatment in combination with neoadjuvant chemotherapy for muscle-invasive bladder cancer in the US. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan. Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi . As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi and Imjudo ; Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca . References 1. Ferlay J, et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer . 2018;103:356-387. 2. Cagle PT, et al. Lung Cancer Biomarkers: Present Status and Future Developments. Arch Pathol Lab Med . 2013;137(9):1191-1198. 3. Le Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell Lung Cancer: Where is it Going? Ann Oncol . 2010;21(suppl 7):vii196-198. 4. Goldstraw P, et al. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol . 2007;2(8):706-14. 5. Pignon JP, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol . 2008;26(21):3552-3559. 6. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf . Accessed April 2025. 7. World Health Organization. International Agency for Research on Cancer. All Cancers Fact Sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf . Accessed April 2025. 8. LUNGevity Foundation. Types of Lung Cancer. Available at: https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer . Accessed April 2025. 9. Cheema PK, et al. Perspectives on treatment advances for stage III locally advanced unresectable non-small-cell lung cancer. Curr Oncol . 2019;26(1):37-42. 10. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html . Accessed April 2025. 11. Sethi S, et al. Incidental Nodule Management – Should There Be a Formal Process? J Thorac Dis . 2016:8(Suppl 6);S494-S497. 12. LUNGevity Foundation. Screening and Early Detection. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection . Accessed April 2025. SOURCE: AstraZeneca

Clinical ResultPhase 3ImmunotherapyDrug Approval

04 Apr 2025

·www.astrazeneca.com

Imfinzi-based perioperative regimen approved in the EU for resectable non-small cell lung cancer

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been approved in the European Union (EU) for the treatment of adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the pivotal AEGEAN trial, which were published in The New England Journal of Medicine. Each year in Europe, there are more than 450,000 people diagnosed with lung cancer.1 Around 25-30% of all patients with NSCLC, the most common form of lung cancer, are diagnosed at an early stage to have surgery with curative intent.2-3 However, the majority of patients with resectable disease will develop recurrence and only 36-46% of patients with Stage II disease will survive for five years.4-5 This decreases to 24% for patients with Stage IIIA disease and 9% for patients with Stage IIIB disease, reflecting a high unmet medical need.4 Professor Martin Reck, Head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf, Germany, member of the AEGEAN Steering Committee and investigator in the trial, said: “Today’s approval provides an important new treatment option that should become a backbone combination approach for patients in Europe with resectable non-small cell lung cancer, who have historically faced high rates of recurrence and a poor prognosis. When added to neoadjuvant chemotherapy, perioperative durvalumab meaningfully improved outcomes in this curative-intent setting, significantly extending the time patients lived without their cancer returning.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Today’s approval marks an important step towards improving outcomes for patients in Europe with resectable non-small cell lung cancer, enabling more patients to access this important immunotherapy-based regimen. This new indication builds on the established role of Imfinzi in unresectable disease and underscores our commitment to transforming care in the early stages of lung cancer where there is the greatest potential for cure.” Results from a planned interim analysis of event-free survival (EFS) showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus neoadjuvant chemotherapy alone in patients treated with the Imfinzi-based perioperative regimen (32% data maturity; EFS hazard ratio [HR] 0.68; 95% confidence interval [CI] 0.53-0.88; p=0.003902). In a final analysis of pathologic complete response (pCR), treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone (difference in pCR 13.0%; 95% CI 8.7-17.6). Additionally, interim overall survival (OS) results presented at the 2024 World Conference on Lung Cancer showed a favourable trend with the Imfinzi-basedperioperative regimen (35% data maturity; median OS: not reached [NR] versus 53.2 months; HR=0.89; 95% CI 0.70-1.14). The OS data were not tested for statistical significance at this interim analysis and will continue to be assessed as a key secondary endpoint at final analysis. Imfinzi was generally well tolerated, and no new safety signals were observed in the neoadjuvant and adjuvant settings. Further, adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not compromise patients' ability to complete surgery versus chemotherapy alone. Imfinzi is approved in the US, China and several other countries in this setting based on the AEGEAN results. Regulatory applications are currently under review in Japan and additional countries in this indication. Imfinzi is the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease as not progressed after chemoradiotherapy (CRT) based on the PACIFIC Phase III trial. Notes Lung cancer Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.6-7 Lung cancer is broadly split into NSCLC and small cell lung cancer (SCLC), with 80-85% of patients diagnosed with NSCLC.8-9 An estimated 28,000 people are treated for resectable NSCLC across the five major European countries each year.10 Early-stage lung cancer diagnoses are often only made when the cancer is found on imaging for an unrelated condition.11-12 The majority of patients with resectable disease eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy.5 AEGEAN AEGEAN is a randomised, double-blind, multi-centre, placebo-controlled global Phase III trial evaluating Imfinzi as perioperative treatment for patients with resectable Stage IIA-IIIB (Eighth Edition AJCC Cancer Staging Manual) NSCLC, irrespective of PD-L1 expression. Perioperative therapy includes treatment before and after surgery, also known as neoadjuvant/adjuvant therapy. In the trial, 802 patients were randomised to receive a 1500mg fixed dose of Imfinzi plus chemotherapy or placebo plus chemotherapy every three weeks for four cycles prior to surgery, followed by Imfinzi or placebo every four weeks (for up to 12 cycles) after surgery. Patients with known EGFR or ALK genomic tumour aberrations were excluded from the primary efficacy analyses. In the AEGEAN trial, the primary endpoints were pCR, defined as no viable tumour in the resection specimen (including lymph nodes) following neoadjuvant therapy, and EFS, defined as the time from randomisation to an event like tumour recurrence, progression precluding definitive surgery, or death. Key secondary endpoints were major pathologic response, defined as residual viable tumour of less than or equal to 10% in the resected primary tumour following neoadjuvant therapy, disease-free survival, OS, safety and quality of life. The final pathologic response analyses were performed after all patients had the opportunity for surgery and pathology assessment per the trial protocol. The trial enrolled participants from 264 centres in more than 25 countries including in the US, Canada, Europe, South America and Asia. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. In addition to its indications in resectable, early-stage (IIA-IIIB) NSCLC and unresectable, Stage III NSCLC, Imfinzi is also approved for use in combination with a short course of Imjudo (tremelimumab) and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved for limited-stage SCLC in patients whose disease has not progressed following concurrent platinum-based CRT; and in combination with chemotherapy (etoposide and either carboplatin or cisplatin) for the treatment of extensive-stage SCLC. Imfinzi is also approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of EFS in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers. Imfinzi is also approved as a perioperative treatment in combination with neoadjuvant chemotherapy for muscle-invasive bladder cancer in the US. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1st-line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan. Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi and Imjudo; Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. Ferlay J, et al. Cancer incidence and mortality patterns in Europe: Estimates for 40 countries and 25 major cancers in 2018. Eur J Cancer. 2018;103:356-387. 2. Cagle PT, et al. Lung Cancer Biomarkers: Present Status and Future Developments. Arch Pathol Lab Med. 2013;137(9):1191-1198. 3. Le Chevalier T. Adjuvant Chemotherapy for Resectable Non-Small-Cell Lung Cancer: Where is it Going? Ann Oncol. 2010;21(suppl 7):vii196-198. 4. Goldstraw P, et al. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours. J Thorac Oncol. 2007;2(8):706-14. 5. Pignon JP, et al. Lung Adjuvant Cisplatin Evaluation: A Pooled Analysis by the LACE Collaborative Group. J Clin Oncol. 2008;26(21):3552-3559. 6. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed April 2025. 7. World Health Organization. International Agency for Research on Cancer. All Cancers Fact Sheet. Available at: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf. Accessed April 2025. 8. LUNGevity Foundation. Types of Lung Cancer. Available at: https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Accessed April 2025. 9. Cheema PK, et al. Perspectives on treatment advances for stage III locally advanced unresectable non-small-cell lung cancer. Curr Oncol. 2019;26(1):37-42. 10. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html. Accessed April 2025. 11. Sethi S, et al. Incidental Nodule Management – Should There Be a Formal Process? J Thorac Dis. 2016:8(Suppl 6);S494-S497. 12. LUNGevity Foundation. Screening and Early Detection. Available at: https://lungevity.org/for-patients-caregivers/lung-cancer-101/screening-early-detection. Accessed April 2025. Adrian Kemp Company Secretary AstraZeneca PLC Oncology Corporate and financial

Clinical ResultImmunotherapyPhase 3Drug Approval

02 Apr 2025

·www.globenewswire.com

Helsinn Group submits a new formulation of AKYNZEO® to the European Medicines Agency (EMA)

Lugano, Switzerland – April 2, 2025 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of nearly fifty years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, today announced the submission of a new formulation for AKYNZEO® to the European Medicines Agency (EMA). AKYNZEO® is indicated for the prevention of acute and delayed nausea and vomiting associated with both highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy. Once approved, this new innovative formulation may offer benefits to cancer patients in addition to the already approved formulations. The new AKYNZEO® formulation is expected to be launched in H1 2026. Roberta Cannella, Chief Technical Officer, commented: “This submission brings us closer to offering patients a new option for AKYNZEO®. It not only demonstrates our commitment to enhancing patients’ quality of life but also our dedication to innovation in supportive care.” About AKYNZEO® AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed dose combination approved in adults for the prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy. For additional information please see the EU Summary of Product Characteristics. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and a consolidated network of partners to reach out to patients in more than 190 countries worldwide. Established in 1976, Helsinn is a fourth-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com

Drug 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


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)	pajxeqjzxt = fzagntnqhx drhkflhedd (rnqzcuzjup, qafnszvplc - kzaanzazxm)	-	18 Mar 2025
				Cisplatin+Pembrolizumab (Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg)	hyolihchqr = nancljckxv lzjqkjtgvd (rlrlkytxiz, dmoygqjhml - ruywdzumvi) 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))	inqafvesik = xieolvuccs fmkwcirmyl (rpxxdpsqvf, nsvdvymlij - ccdculryku) 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))	inqafvesik = cnktumaqys fmkwcirmyl (rpxxdpsqvf, wootusiqmo - ddtsfykxya) View more
NCT02662062 (ANZUP 1502 \| PCR-MIB, CTgov)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	28	Radiotherapy+cisplatin+pembrolizumab	tnrprknmcl = vutyhpxggl oblxkrfdzl (lxdddijbnj, umsqcuksid - yzwpmdjvxf) 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	jpestfxapd(ilbsjkelyi) = lkmwhmniku oevmzszbaw (fxtqnwqxmh ) 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	nhbhhpzjlk(ypxcxrusax) = nhtiwygctq kugrcuopzj (gcztrcspmz ) View more	Positive	23 Jan 2025
				S-1/cisplatin + Trastuzumab	nhbhhpzjlk(ypxcxrusax) = audwyafami kugrcuopzj (gcztrcspmz ) 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)	wjgygwrpjn = jtwusfqqds wfvgihnbqa (cjsypabmpi, cooizbbqub - jqpmzzexed) View more	-	12 Dec 2024
				gemcitabine+docetaxel+cisplatin (Experimental Arm)	wjgygwrpjn = jxsvjryull wfvgihnbqa (cjsypabmpi, pkerdudboo - kdgjpvxuur) View more
NCT02754726 (CTgov)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma	35	nivolumab+albumin-bound paclitaxel+Gemcitabine+Paricalcitol+cisplatin	inlvlvlgnq = grdxeuqsgc dtyoouarcm (fzvqiwkyzn, svpvylfaoj - hhvnvdmyyx) View more	-	10 Dec 2024
ESMO_ASIA2024 Manual	Not Applicable	Head and Neck Neoplasms	104	Docetaxel plus Cisplatin	fdwmycfpob(mlawoceklz) = mwhalyucna xgjuszgdzx (iczhwzdqtr ) View more	Similar	07 Dec 2024
				Paclitaxel plus Carboplatin	fdwmycfpob(mlawoceklz) = yfqspqqjxp xgjuszgdzx (iczhwzdqtr ) View more
NCT01554397 (CTgov)	Phase 2/3	Uterine Cervical Cancer	101	PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)+cisplatin	nossiqhoxv = qtlarusgmw acjdjievap (hoypfummxa, plglblhjtw - hydjbroxmn) View more	-	29 Nov 2024
NCT04951115 (CTgov)	Phase 2	Small Cell Lung Cancer	6	Stereotactic Body Radiotherapy+Etoposide+Carboplatin+Cisplatin+Durvalumab	kdqgjivsuo = ljfnyjbwyg bmtxgiajyl (qbzcntfncf, yjvyjsxddi - lpxfcrhdlq) View more	-	26 Nov 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

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