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

122,991

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 ; 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.

1,092

News (Medical) associated with Cisplatin

27 Mar 2025

·pipelinereview.com

Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) KEYTRUDA® (pembrolizumab) in Pivotal 3475A-D77 Trial

Subcutaneous pembrolizumab administered every six weeks with a median injection time of two minutes, in combination with chemotherapy, shows consistent results across reported efficacy and safety endpoints compared to IV KEYTRUDA in combination with chemotherapy A time and motion descriptive analysis shows nearly 50% reductions in patient chair and treatment room time, and in total active healthcare professional time related to treatment tasks, for subcutaneous pembrolizumab compared to IV KEYTRUDA Applications for subcutaneous pembrolizumab are under review in the U.S. and Europe RAHWAY, NJ, USA I March 27, 2025 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous administration of pembrolizumab, together with berahyaluronidase alfa (MK-3475A; from now on referred to as “subcutaneous pembrolizumab”). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. These results are being presented today at the European Lung Cancer Congress (ELCC) 2025 (Abstract #8MO) and published simultaneously in Annals of Oncology. The study met its primary endpoints, demonstrating noninferior pharmacokinetics (PK) for subcutaneous pembrolizumab administered with chemotherapy with a median injection time of two minutes, versus intravenous (IV) KEYTRUDA ® (pembrolizumab) administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). The secondary endpoints of objective response rate (ORR), progression-free survival (PFS) and duration of response (DOR) and safety were consistent for subcutaneous pembrolizumab with chemotherapy compared to IV KEYTRUDA with chemotherapy. Median overall survival (OS) was not reached in either arm. Based on these data, the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) seeking approval of subcutaneous pembrolizumab across all previously approved solid tumor indications for KEYTRUDA. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Sept. 23, 2025. Additionally, the European Medicines Agency (EMA) has validated an extension application to introduce a new pharmaceutical form and new route of administration for KEYTRUDA. In addition, results of a prospective, observational time and motion descriptive analysis conducted alongside study 3475A-D77 show that, compared to IV KEYTRUDA, subcutaneous pembrolizumab reduced time for patients spent in-chair and in the treatment room by 49.7% and 47.4%, respectively, and reduced the total active time spent by healthcare professionals (HCPs) on treatment preparation, administration process and patient monitoring by 45.7%. These results are being presented as a poster at ELCC (Poster #33P). Pharmacokinetic, efficacy, safety and time and motion results are described further below. “These study findings demonstrate subcutaneous pembrolizumab reduces time demands for both the patient and the healthcare provider, all while providing a consistent efficacy and safety profile with IV pembrolizumab,” said Dr. Enriqueta Felip, head of Thoracic Tumors Group, Vall d’Hebron Institute of Oncology. “As a physician, I am thrilled to see these data for subcutaneous pembrolizumab, which, if approved, have the potential to give patients valuable time back in their treatment day with results that are consistent with IV pembrolizumab.” In the 3475A-D77 trial, subcutaneous pembrolizumab, administered every six weeks with a median injection time of two minutes (4.8 mL) along with chemotherapy, demonstrated noninferiority of area under the curve (AUC) exposure of pembrolizumab during the first dosing cycle (geometric mean ratio of 1.14 [96% CI, 1.06-1.22]; p<0.0001) and model-based trough concentration (Ctrough) of pembrolizumab measured at steady state (geometric mean ratio of 1.67 [94% CI, 1.52-1.84]; p<0.0001), compared to IV KEYTRUDA administered every six weeks with chemotherapy. “KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved, we are excited about the potential of subcutaneous pembrolizumab to become a new meaningful treatment option that may increase access and save time needed for administration compared to IV KEYTRUDA. We look forward to working with global regulatory authorities to bring the first subcutaneous checkpoint inhibitor that can be administered in approximately two minutes to patients and providers.” In the prospective, observational time and motion study, patient time in chair during treatment with pembrolizumab was reduced by 49.7% (weighted means [WM]: 59.0 versus 117.2 minutes) for subcutaneous pembrolizumab with chemotherapy compared to IV KEYTRUDA with chemotherapy. Patients receiving subcutaneous pembrolizumab versus IV KEYTRUDA spent 47.4% less time in the treatment room (WM: 66.7 versus 126.9 minutes). Time associated with chemotherapy administration was removed from chair and treatment room duration. Results also show that subcutaneous pembrolizumab with chemotherapy reduced total active HCP time by 45.7% (WM: 14.0 versus 25.8 minutes;), including 44.6% less time on subcutaneous pembrolizumab preparation (WM: 5.1 versus 9.2 minutes) and 46.7% less time on subcutaneous pembrolizumab administration process and patient monitoring (WM: 8.9 versus 16.7 minutes) compared to IV KEYTRUDA with chemotherapy. The differences as measured by a linear mixed model were statistically significant (p<0.0001) for active HCP and patient time endpoints. In addition to the 3475A-D77 trial, Merck’s subcutaneous pembrolizumab clinical development program includes the 3475A-F84 Phase 3 trial evaluating subcutaneous pembrolizumab administered alone compared to IV KEYTRUDA alone for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), as well as the 3475A-F65 Phase 2 trial evaluating subcutaneous pembrolizumab administered alone in relapsed or refractory classical Hodgkin lymphoma and relapsed or refractory primary mediastinal large B-cell lymphoma. Merck is also conducting a patient preference Phase 2 study, 3475A-F11, evaluating participant-reported preference for subcutaneous pembrolizumab compared to IV KEYTRUDA. Study design and additional data from 3475A-D77 Study 3475A-D77 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT05722015 ) evaluating the subcutaneous administration of pembrolizumab together with berahyaluronidase alfa administered every six weeks with chemotherapy compared to IV KEYTRUDA administered every six weeks in combination with chemotherapy for the first-line treatment of adult patients with metastatic NSCLC, regardless of PD-L1 TPS expression. The study is designed to assess the dual primary PK endpoints of the AUC of pembrolizumab exposure during the first dosing cycle and the Ctrough of pembrolizumab measured at steady state. Secondary endpoints include additional PK parameters as well as efficacy (ORR, DOR, PFS and OS) and safety. The trial enrolled 377 patients who were randomized (2:1) to receive either subcutaneous pembrolizumab administered with chemotherapy or IV KEYTRUDA in combination with chemotherapy. Secondary efficacy endpoints of the study, which were descriptive, showed: Among patients who received subcutaneous pembrolizumab with chemotherapy (n=251), Grade ≥3 adverse events (AEs) occurred in 47% of patients versus 47.6% of patients who received IV KEYTRUDA with chemotherapy (n=126). The incidence of local injection site reactions for subcutaneous pembrolizumab with chemotherapy was 2.4%, all of which were low grade. Treatment-related adverse events (TRAEs) led to discontinuation of subcutaneous pembrolizumab in 8.4% of patients in the subcutaneous pembrolizumab with chemotherapy arm and in 8.7% of patients in the IV KEYTRUDA with chemotherapy arm. Additionally, TRAEs led to discontinuation of chemotherapy in 15.1% of patients in the subcutaneous pembrolizumab with chemotherapy arm and 11.9% of patients in the IV KEYTRUDA with chemotherapy arm. Treatment-related deaths occurred in 3.6% of patients who received subcutaneous pembrolizumab with chemotherapy and 2.4% of patients who received IV KEYTRUDA with chemotherapy. Study design from time and motion study The global observational time and motion study enrolled 17 sites across eight countries in Europe (4), South America (3) and Asia (1) from the 3475A-D77 trial. Primary endpoints were patient time in chair during treatment, patient time in treatment room and total active HCP time for tasks related to subcutaneous pembrolizumab preparation, administration process and patient monitoring. Time was measured by trained observers using a stopwatch, and time associated with chemotherapy administration was removed from patient in-chair and treatment room duration. Descriptive statistics were calculated including WM to account for unequal sample sizes across countries in each group. Statistical differences between subcutaneous and IV arms were explored via a linear mixed model. About KEYTRUDA ® (pembrolizumab) injection for intravenous use, 100 mg KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD- L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers. Selected KEYTRUDA ® (pembrolizumab) Indications in the U.S. Non-Small Cell Lung Cancer KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC. KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [Tumor Proportion Score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is: KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. KEYTRUDA is indicated for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with Stage IB (T2a ≥4 cm), II, or IIIA NSCLC. Melanoma KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma. KEYTRUDA is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection. Malignant Pleural Mesothelioma KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). Head and Neck Squamous Cell Cancer KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. Classical Hodgkin Lymphoma KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy. Primary Mediastinal Large B-Cell Lymphoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy. Urothelial Cancer KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer. KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma: KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Microsatellite Instability-High or Mismatch Repair Deficient Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-approved test. Gastric Cancer KEYTRUDA, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Esophageal Cancer KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation either: Cervical Cancer KEYTRUDA, in combination with chemoradiotherapy (CRT), is indicated for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer. KEYTRUDA, in combination with chemotherapy, with or without bevacizumab, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. Hepatocellular Carcinoma KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) secondary to hepatitis B who have received prior systemic therapy other than a PD-1/PD-L1-containing regimen. Biliary Tract Cancer KEYTRUDA, in combination with gemcitabine and cisplatin, is indicated for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). Merkel Cell Carcinoma KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). Renal Cell Carcinoma KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). KEYTRUDA is indicated for the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Endometrial Carcinoma KEYTRUDA, in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma. KEYTRUDA, as a single agent, is indicated for the treatment of adult patients with advanced endometrial carcinoma that is MSI-H or dMMR, as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation. Tumor Mutational Burden-High Cancer KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established. Cutaneous Squamous Cell Carcinoma KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation. Triple-Negative Breast Cancer KEYTRUDA is indicated for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved test. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www-merck-com.libproxy1.nus.edu.sg/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . SOURCE: Merck

Clinical ResultPhase 3Phase 2

27 Mar 2025

·www.globenewswire.com

Junshi Biosciences Announces Toripalimab’s Approval in Singapore

SHANGHAI, March 26, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the New Drug Application (the “NDA”) for toripalimab (Singapore trade name: LOQTORZI®) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (“NPC”) has been approved by the Singapore Health Sciences Authority (the HSA). Toripalimab has become the first and only approved immuno-oncology treatment for NPC in Singapore. NPC is a malignant tumor that occurs in the epithelium mucosae of the nasopharynx and is one of the most common types of head and neck cancers. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Toripalimab is the only preferred regimen recommended for the comprehensive treatment of recurrent or metastatic NPC in the National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025) for head and neck cancers. The approval is primarily based on the results from JUPITER-02 (NCT03581786), the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size. JUPITER-02 is also the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) demonstrating a significant overall survival (“OS”) benefit for first-line immunotherapy combined with chemotherapy compared to chemotherapy alone in NPC. JUPITER-02’s results were presented in an oral report during a Plenary Session at the 2021 American Society of Clinical Oncology (ASCO) annual meeting (#LBA2). These results were subsequently featured on the cover of Nature Medicine and published in full in the Journal of the American Medical Association (JAMA). The results of the study showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (“PFS”) in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined therapy achieved a higher objective response rate (“ORR”) and longer duration of response (“DoR”), with a complete response (CR) rate of 26.7%, and no new safety signal was identified. Long-term survival follow-up data was presented at ASCO 2024, with a 5-year survival rate of 52%. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “Toripalimab’s approval in Singapore represents our formal entry into the Southeast Asian market. Southeast Asia is a region with a high incidence of NPC, and we are proud to introduce this groundbreaking therapy to address unmet medical needs and transform the local treatment landscape. As of now, toripalimab has received marketing authorization in over 35 countries and regions across four continents. We remain committed to our ‘In China, For Global’ strategy, advancing innovative medicines from China to improve healthcare for patients across the globe.” The NDA was submitted under Project Orbis. Project Orbis, initiated and advocated by the Oncology Center of Excellence (OCE) of the U.S. Food and Drug Administration (the “FDA”), provides a collaborative mechanism and framework among the FDA and regulatory authorities in other countries and regions, allowing different regulatory authorities to jointly review the applications for registration of oncology drugs. Toripalimab was the first domestic oncology drug to be included in Project Orbis. Previously, the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the “TGA”) approved two New Chemical Entity applications for toripalimab in NPC under Project Orbis. About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are eleven approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy;recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients. The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries or regions around the global. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact Information IR Team: Junshi Biosciences info@junshipharma.com + 86 021-6105 8800 PR Team: Junshi Biosciences Zhi Li zhi_li@junshipharma.com + 86 021-6105 8800

Drug ApprovalPhase 3ImmunotherapyClinical ResultASCO

26 Mar 2025

·www.prnewswire.com

ANNOUNCEMENT OF ANNUAL RESULTS FOR 2024

Notable Progress in R&D and Commercialization Gross Profit Surging 68% CHENGDU, China, March 26, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Pharmaceutical Co., Ltd. (" Kelun-Biotech" or the " Company", Stock Code: 6990.HK) announced its audited consolidated results for the year ended December 31, 2024 (the " Reporting Period"). In 2024, the pharmaceutical and healthcare sector experienced significant turbulence amid multiple internal and external shocks. China's biopharmaceutical industry continued to advance through transformation and breakthroughs, with factors such as pharmaceutical innovation, overseas expansion of innovative drugs, a "wave of M&A" in capital market, and the deepening of anti-corruption campaigns in healthcare collectively driving the industry toward steady recovery and innovative development. Adhering to its innovation-driven development strategy, the Company has consistently expanded into new targets, technologies, payloads, and therapeutic areas while continuously unlocking the clinical value of its core programs. From rapid advancement of key projects and sustained exploration of novel technologies to the steady establishment of a commercialization framework and the approval of three innovative drugs for market launch, the Company has achieved new breakthroughs in its "Pin(品)"-shaped strategic operational framework, with business progress yielding highly encouraging results. As of the latest update, the Company is actively developing over 30 drug candidates, including its core product sac-TMT (approved for marketing in China) as well as key products Tagitanlimab and Cetuximab N01. The Company has 11 ADC and novel DC assets at clinical stage or above, Through focused recognition of projects with competitive advantages and market value, along with strategic allocation of existing R&D resources to these prioritized programs, the Company's pipeline mainly consists of oncology drug candidates as well as drug candidates for non-oncology diseases and conditions such as autoimmune, metabolism and other disease areas. Core ADC Programs Advance Rapidly with Enhanced Value Across Innovative Pipeline Sac-TMT (sacituzumab tirumotecan, TROP2 ADC) (also known as SKB264/MK-2870) TNBC. In March 2024, sac-TMT was granted Breakthrough Therapy Designation by the NMPA for the first-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC. The Company has initiated a Phase 3 registrational study of sac-TMT monotherapy versus investigator-choice chemotherapy for 1L advanced TNBC. The results from the Phase 3 study of sac-TMT in patients with previously treated locally recurrent or metastatic TNBC were presented at the ASCO Annual Meeting in May 2024. Sac-TMT demonstrated a significant statistically and clinically meaningful improvement in PFS (HR: 0.32, representing a 68% reduction in disease progression risk) and OS (HR: 0.53, representing a 47% reduction in mortality risk). In November 2024, the Company received marking authorization in China from the NMPA for sac-TMT in 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). Sac-TMT is the first domestically developed ADC with global intellectual property rights to receive complete marketing authorization in China. HR+/HER2- BC. A Phase 3 registrational study for 2L+ HR+/HER2- locally advanced or metastatic BC is in progress. EGFR-mutant NSCLC. In October 2024, the NDA 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 NMPA and was included in the priority review and approval process. In March 2025, the Company received marketing authorization in China from the NMPA for sac-TMT for the treatment of adult patients with EGFR mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Compared with docetaxel, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in ORR, PFS and OS. In addition, a Phase 3 registrational study of sac-TMT combined with osimertinib as first-line treatment of locally advanced or metastatic non-squamous EGFR-mutant NSCLC is in progress. EGFR-wild type NSCLC. Two Phase 3 registrational studies of sac-TMT, namely sac-TMT in combination with pembrolizumab (KEYTRUDA®) versus pembrolizumab for first-line treatment of patients with PD-L1 positive locally advanced or metastatic NSCLC, and sac-TMT in combination with pembrolizumab versus chemotherapy combined with pembrolizumab as first-line treatment for patients with PD-L1 negative locally advanced or metastatic non-squamous NSCLC are in progress. T rastuzumab Botidotin (HER2 ADC, also known as A166) ( 舒泰萊 ®) In January 2025, an NDA for the treatment of adult patients with HER2+ unresectable or metastatic BC who have received at least one prior anti-HER2 therapy was accepted by the CDE of the NMPA. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1. Trastuzumab botidotin has met the primary endpoints of its pivotal Phase 2 trial for 3L+ advanced HER2+ BC based on results from the primary analysis, which the Company used to submit an NDA to the NMPA. The Company has also initiated an open, multicenter Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor ADC. Other ADCs and Novel Conjugate Drugs SKB315 (CLDN18.2 ADC). SKB315 is configured with a proprietary, in-house developed humanized CLDN18.2 mAb and a differentiated payload-linker design. The early-stage clinical data of SKB315 demonstrates promising efficacy and acceptable safety profile in GC with mid and high CLDN18.2 expression. The Company is conducting a Phase 1b clinical trial of SKB315. SKB410/MK-3120 (Nectin-4 ADC). SKB410 is a novel Nectin-4 ADC targeting advanced solid tumors and utilizing a differentiated payload-linker strategy. SKB410 has shown promising Phase 1 clinical data. MSD, as the sponsor, has launched the global Phase 1/2 clinical trial of SKB410. SKB571/MK-2750. SKB571 is a novel bsADC that primarily targets various solid tumors such as LC and CRC etc. being developed in collaboration with MSD. The Phase 1 clinical trial in China is ongoing. SKB518, SKB535/MK-6204 and SKB445. SKB518, SKB535 and SKB445 are novel ADC drugs with potential FIC targets. The Phase 1 clinical trials for each of them are ongoing in China. The Company has entered into a license and collaboration agreement with MSD to develop SKB535. It was announced on the official website of the NMPA that SKB535 is the first pilot project approved by the NMPA through the optimized clinical trial review scheme for innovative drugs, and the review and approval time is 21 days. SKB500 and SKB501. SKB500 and SKB501 are novel ADC drugs with verified targets but differentiated payload-linker strategies. In November and December 2024, the Company received a clinical trial notice approving the IND application of SKB501 and SKB500, respectively, for advanced solid tumors from the NMPA. SKB107. SKB107 is an RDC drug jointly developed by us and the Affiliated Hospital of Southwest Medical University (西南醫科大學附屬醫院) targeting tumor bone metastasis. In January 2025, an IND application for SKB107 was accepted by the NMPA. Three I nnovative D rugs A pproved for M arket L aunch, M arking a S uccessful C ommercialization M ilestone for the P roduct P ipeline Currently, the Company has received marketing authorization for sac-TMT, tagitanlimab (科泰萊®) and Cetuximab N01 (達泰萊®) and has commenced their commercialization. The Company expects to launch trastuzumab botidotin (舒泰萊®) in the China market and file an NDA for A400 in 2025. Sacituzumab tirumotecan sac-TMT is a China's first domestically developed original TROP2 ADC targeting drug and the first domestically developed ADC to receive complete marketing authorization in China. It provides a novel and superior treatment pathway for Chinese patients with advanced triple-negative breast cancer (TNBC). Tagitanlimab (PD-L1 mAb, also known as A167) (科泰萊®) is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. In December 2024, the Company received marketing authorization of tagitanlimab in China from NMPA for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. In January 2025, the Company received marketing authorization of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic NPC in China from NMPA. Cetuximab N01 (EGFR mAb, also known as A140) (達泰萊®). In February 2025, the Company received marketing authorization in China from the NMPA for Cetuximab N01 Injection used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of RAS wild-type mCRC. As demonstrated by a large-scale domestic Phase 3 clinical study conducting a head-to-head comparison of Cetuximab N01 Injection with Cetuximab Solution for Injection (Erbitux®), the Cetuximab N01 combination chemotherapy was clinical equivalent in ORR (Cetuximab N01 vs. Cetuximab Solution for Injection (Erbitux®): 71.0% vs. 77.5%; ORR ratio is 0.93 [95% CI: 0.87, 0.99]), and Cetuximab N01 did not demonstrate any clinically meaningful or statistically significant differences in DoR and PFS compared with Cetuximab Solution for Injection (Erbitux®) (median PFS: 10.9 months vs 10.8 months, HR: 1.03 [95% CI: 0.83, 1.28]; median DoR: 10.2 months vs. 9.5 months). As for safety, this study has sufficiently proven that the Cetuximab N01 combination chemotherapy is comparable in safety, tolerance and immunogenicity compared with Cetuximab Solution for Injection (Erbitux®) combination chemotherapy. The Company has set up a fully-fledged commercialization team to prepare and implement the marketing and commercialization of its strategic products and established a departmental structure within the Company, consisting of various departments such as Marketing, Commercial and Marketing Access, Medical Affairs, Sales, and Strategic Planning and Commercial Excellence. The Company will continue to refine our commercialization strategies for each late-stage drug candidate, first prioritizing therapeutic areas with medical needs in China, such as BC, NSCLC and GI cancers, while offering synergistic treatment options enabled by our diverse pipeline to optimize patient outcome. Globally, the Company will continue to pursue a flexible strategy to capture the commercial value in major international market, through forging synergistic license and collaboration opportunities worldwide. Steady Advancement in International Collaboration and Capital Management, with Continuous Refinement of ESG Governance Structure In 2024, the Company upheld its international development strategy and, in collaboration with MSD, promoted multi-dimensional, multi-level, and various forms of interaction and exchange to deepen their strategic partnership. MSD exercised its exclusive option for the SKB571, and several other collaborative pipelines received milestone payments from partners, marking a solid step forward in the cooperation. The Company has entered into license and collaboration agreements with MSD to develop multiple ADC assets for cancer treatment. The Company has granted MSD an exclusive, royalty-bearing and sub-licensable license to develop, use, manufacture and commercialize sac-TMT outside Greater China. The Company retains the right to develop and commercialize sac-TMT within Greater China. As of 4 March 2024, MSD has initiated 12 ongoing Phase3 global clinical studies of sac-TMT as amonotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. The Company is also collaborating with MSD on several global Phase 2 basket studies for sac-TMT as monotherapy or in combination with other agents for multiple solid tumors and those studies are ongoing. In addition to sac-TMT, the Company is also collaborating with MSD on certain ADC assets including SKB410/MK-3120, SKB571/MK-2750, SKB535/MK-6204, etc. to continuously explore favorable ADC pipeline portfolios. In the third quarter of 2024, the Company was informed by MSD regarding an exclusive option to exercise SKB571/MK-2750. MSD has paid US$37.5 million to the Company in connection with the option to exercise, and the Company is eligible to receive further milestone payments conditional upon the achievement of specified development and sales milestones and tiered royalties on net sales of SKB571/MK-2750 if commercialized. Regarding the collaboration with Ellipses Pharma, in March 2024, it was announced that A400/EP0031 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, A400 was cleared by the FDA to progress into Phase 2 clinical development. As of December 31, 2024, a total of 33 clinical sites in the United States, Europe and UAE were set up for A400/EP0031. Regarding the collaboration with Windward Bio, in January 2025, the Company and Harbour BioMed had entered into an exclusive license agreement with Windward Bio, under which the Company and Harbour BioMed granted Windward Bio an exclusive license for the research, development, manufacturing and commercialization of SKB378/WIN378 globally (excluding Greater China and several Southeast and West Asian countries). The Company has received upfront and milestone payments totaling US$147.5 million from partners with regard to multiple collaborated pipelines in 2024 and up to now. During the Reporting Period, the Company maintained a steady and disciplined approach to capital operations. It successfully completed a Hong Kong placement and domestic share issuance, raising US$150 million, providing strong and sustained momentum for its growth. Additionally, the Company continued to improve its ESG governance structure, issuing its first ESG report to reaffirm its commitment to environmental protection, social responsibility, and corporate governance, demonstrating its dedication as a publicly listed enterprise. In 2024, the Company was awarded "Excellence in ESG Governance Performance Award" by Ming Pao, and the Emerging Innovation Power Award from the China National Pharmaceutical Industry Information Center. Outlook In 2025, the Company will continue to deepen its R&D innovation reforms. By focusing on its core strengths, the Company aims to enhance efficiency, strengthen external collaborations, benchmark against the highest industry standards, and improve its scientific decision-making capabilities—thus maintaining and expanding its leading position in pioneering projects and key technology areas such as ADCs. Simultaneously, the Company will cultivate a product market-oriented mindset and, in response to unmet clinical needs, develop innovative drugs with differentiated advantages and international potential. Leveraging big data and artificial intelligence, the Company will further bolster its research capabilities in biology and translational medicine to improve the efficacy and success rate of innovative drug development. In addition, it will intensify international collaboration in innovative drugs, accelerate the cultivation of new competitive advantages, and integrate more deeply into the global innovative drug network to realize greater value for its innovations across broader market. About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (referred to as "Kelun-Biotech" Stock Code: 6990.HK) is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., specializing in the R&D, production, commercialization, and international collaboration of innovative biotechnology and small-molecule drugs. The Company focuses on addressing unmet clinical needs both globally and in China, with a strategic emphasis on major disease areas such as oncology, autoimmune disorders, inflammation, and metabolic diseases. It is dedicated to building an international platform for drug R&D and industrialization, with the aim of becoming a global leader in the innovative drug sector. Currently, Kelun-Biotech has over 30 key innovative drug projects, including 3 projects that have received market approval, 1 project at the NDA stage, and more than 10 projects in clinical trials. The Company has also successfully established its internationally renowned proprietary ADC development platform, OptiDCTM, with 1 ADC project approved for market launch, 1 ADC project at the NDA stage, and several ADC or novel ADC projects in clinical or preclinical development. For more information, please visit the official website: . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 3Phase 2Clinical ResultDrug Approval

100 Deals associated with Cisplatin

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KEGG	Wiki	ATC	Drug Bank
D00275	Cisplatin	L01XA01	DB00515

R&D Status

Approved

10 top approved records.

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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.

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


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))	bmamayeuev = lwkinhzaie cuxrzxxyjw (stoeaxvuxy, vftxhrrwsh - ihtkrfgnez) View more	-	25 Mar 2025
				Intensity-Modulated Radiation Therapy+Carboplatin+Pemetrexed+cisplatin+Pemetrexed Disodium (Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS))	bmamayeuev = etgwzqbujz cuxrzxxyjw (stoeaxvuxy, vypkybmwqe - wzsfqqonbo) View more
NCT02662062 (ANZUP 1502 \| PCR-MIB, CTgov)	Phase 2	Non-Muscle Invasive Bladder Neoplasms	28	Radiotherapy+cisplatin+pembrolizumab	xvzutlxdvp = vdkzflqqdy uennsfaxmr (yrjxcbpbwt, lwehkfpzbr - vmtjnxobwu) View more	-	25 Mar 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)	xtyfijvdbp = hybtuxwmqq nauirnotxd (lvuptpfevq, bzlwjvwyti - fnyfydltai)	-	18 Mar 2025
				Cisplatin+Pembrolizumab (Cohort I: Cisplatin Eligible - Pembrolizumab 200 mg)	jxowtjrfvu = pyokoqfiah cwigdrhwnp (dhahehhnwn, muvjbwjygr - rxsxrrliut) View more
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	hbsedhbpmn(ngnlutydiq) = pyoiipawnw pdofehwdte (gtyowaensy ) View more	Positive	23 Jan 2025
				S-1/cisplatin + Trastuzumab	hbsedhbpmn(ngnlutydiq) = qwvmlrlvno pdofehwdte (gtyowaensy ) View more
ASCO_GI2025 Manual	Not Applicable	Locally Advanced Esophageal Squamous Cell Carcinoma	23	docetaxel (DTX), cisplatin (CDDP), and 5-fluorouracil (5-FU) (DCF) therapy + nivolumab	jyrnkxkukv(tiwijeeylu) = yjzxaazlpz uuyvdgrrqy (bejftarqjr ) View more	Positive	23 Jan 2025
NCT00478699 (GECP-SCAT \| SCAT Ph III Trial \| SCAT Trial, CTgov)	Phase 3	Non-small cell lung cancer stage IIIA	500	Docetaxel+Cisplatin (Control Arm)	spdyhsspai = lkniisxgxs gmzvpwykqn (gvvmsyuzdy, gqzobpipcl - wyyswxxuxf) View more	-	12 Dec 2024
				gemcitabine+docetaxel+cisplatin (Experimental Arm)	spdyhsspai = shaxebewbb gmzvpwykqn (gvvmsyuzdy, qsnfmypyro - vaanpsesel) View more
NCT02754726 (CTgov)	Phase 2	Metastatic Pancreatic Ductal Adenocarcinoma	35	nivolumab+albumin-bound paclitaxel+Gemcitabine+Paricalcitol+cisplatin	viopwxsnmf = olmxcoeomh dgazepiofk (juqaucoomo, kbsgoirfqx - pldbrvtdok) View more	-	10 Dec 2024
ESMO_ASIA2024 Manual	Not Applicable	Head and Neck Neoplasms	104	Docetaxel plus Cisplatin	qykjdphasw(ajaieafgrb) = injvpnvgmw fslbykabcc (xupzhzxhqx ) View more	Similar	07 Dec 2024
				Paclitaxel plus Carboplatin	qykjdphasw(ajaieafgrb) = csendqcypu fslbykabcc (xupzhzxhqx ) View more
NCT01554397 (CTgov)	Phase 2/3	Uterine Cervical Cancer	101	PET-guided Bone Marrow-Sparing Intensity Modulated Radiation Therapy (IMRT)+cisplatin	czpcmphkch = ljenghxahq aektgzqayr (tuxogdtjxc, dzfeocmhgz - vfatknmjuk) View more	-	29 Nov 2024
NCT04951115 (CTgov)	Phase 2	Small Cell Lung Cancer	6	Stereotactic Body Radiotherapy+Etoposide+Carboplatin+Cisplatin+Durvalumab	zfcdsgycpi = lsajmvawye ktahrfaaxt (nwefzjzdhy, usxzauwlqg - ygqrcpbbqa) View more	-	26 Nov 2024

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