Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma

9-ING-41 is a small molecule potent selective GSK-3β inhibitor with antitumor activity. This study investigates 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC). Patients with advanced SGC (including all histologic subtypes and adenoid cystic carcinoma [ACC]) will receive 9-ING-41 intravenously (IV) along with carboplatin IV at standard dosing together on Day 1, and 9-ING-41 alone on Day 4 of a 21-day cycle. Participants will be enrolled to two histologic cohorts: Cohort 1 will be comprised of those with ACC, and Cohort 2 will include patients with non-ACC SGC (or all other salivary gland cancer histologies). Treatment will continue until progression of disease, death, or discontinuation of therapy for any reason.

Start Date18 Dec 2030

Sponsor / Collaborator

Actuate Therapeutics, Inc.

NCT07065630

/ Not yet recruitingPhase 2IIT

A Phase II Study of Volrustomig, Paclitaxel, and Carboplatin Followed by Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer

The purpose of this study is to assess the objective response rate following neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin in previously untreated human papillomavirus (HPV)-negative locally advanced head and neck squamous cell carcinoma
.

Start Date17 Jan 2026

Sponsor / Collaborator

The University of Chicago

NCT05403723

/ SuspendedPhase 1IIT

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]

100 Clinical Results associated with Carboplatin

100 Translational Medicine associated with Carboplatin

100 Patents (Medical) associated with Carboplatin

25,559

Literatures (Medical) associated with Carboplatin

31 Dec 2025·NMC case report journal

A Primary Spinal Intramedullary Mixed Germ Cell Tumor: A Case Report and Literature Review

Article

Author: SHIMAUCHI-OHTAKI, Hiroya ; HORIGUCHI, Keishi ; HIRATO, Junko ; NAKATA, Satoshi ; HONDA, Fumiaki ; YOKOO, Hideaki ; GOTO, Yuta ; OYA, Soichi ; TOMOMASA, Ran ; NAKAMURA, Shunsuke

Central nervous system germ cell tumors are rare and account for 2% to 3% of all central nervous system tumors in Japan. Here, we report an extremely rare case of a primary spinal intramedullary mixed germ cell tumor. A 33-year-old man presented with a chief report of dysuria and numbness in the right lower extremity. Magnetic resonance imaging revealed a mass lesion on the left side of the intramedullary spinal cord at the Th10-11 vertebral body level with hyperintensity on T2-weighted images, isointensity on T1-weighted images, and uniform contrast in gadolinium. Cerebrospinal fluid examination revealed a few atypical cells. Although tumor removal using the posterior median sulcus approach was attempted, only a biopsy was performed because intraoperative rapid pathology suggested a possible diagnosis of germinoma. Permanent pathology revealed a mixed germ cell tumor (mainly comprising a germinoma with a yolk sac tumor). Postoperatively, cerebrospinal irradiation and 8 courses of the carboplatin and etoposide regimen were administered. No recurrence or new lesions were observed on magnetic resonance imaging at 94 months postoperatively. Our extensive literature search found only 4 cases of a mixed germ cell tumor of primary intramedullary origin in the spinal cord. Most spinal germ cell tumors described in the literature are either germinomas or mature teratomas; however, mixed germ cell tumors can also occur, albeit infrequently. Although additional cases need to be accumulated, our case suggests that yolk sac elements in spinal mixed germ cell tumors might not be directly associated with poor life expectancy.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

Author: Bernauer, Mark ; Roth, Joshua A. ; Dorman, Stephanie ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

01 Dec 2025·CHILDS NERVOUS SYSTEM

Holocord intramedullary pilocytic astrocytoma mimicking holocord spinal abscess: a case report and literature review

Review

Author: Erguven, Merve ; Sabanci, Pulat Akin ; Dolen, Duygu ; Gulsever, Cafer Ikbal ; Unverengil, Gokcen

PURPOSE:

This report aims to present a case of a child with holocord pilocytic astrocytoma and review the existing literature to provide insights into current management strategies.

CASE PRESENTATION:

An 11-month-old patient presented with progressive quadriplegia and was initially diagnosed with a spinal abscess. MRI revealed a heterogeneously enhancing cystic intramedullary lesion extending from the cervicomedullary region to the conus medullaris. The patient underwent an emergent T10-L1 total laminectomy and midline myelotomy for presumed abscess drainage. Intraoperative findings, however, were inconsistent with an abscess, suggesting a neoplastic process. Postoperative MRI indicated persistent spinal cord compression and histopathological examination showed no leukocytes or microorganisms. A second surgery the following day extended the laminectomy to T3, achieving gross total resection. Pathology confirmed a grade I pilocytic astrocytoma. Given the patient's age, chemotherapy with vincristine and carboplatin was initiated, as radiotherapy was unsuitable. Early physical therapy was commenced, resulting in significant neurological improvement to 4/5 muscle strength in all extremities according to the Medical Research Council (MRC) scale in the first year. Chemotherapy was discontinued due to systemic complications. At the 1-year follow-up, MRI demonstrated no tumor recurrence.

CONCLUSION:

The management of holocord pilocytic astrocytomas presents significant challenges, particularly in pediatric patients. While surgical resection remains the cornerstone of treatment, the role of chemotherapy requires further investigation. This case underscores the necessity of a multidisciplinary approach and highlights the potential for favorable outcomes with appropriate intervention.

1,047

News (Medical) associated with Carboplatin

12 Aug 2025

·pipelinereview.com

KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free and Overall Survival and Pathologic Complete Response Rate for Certain Patients with Muscle-Invasive Bladder Cancer When Given Before and After Surgery

First and only systemic therapy to improve survival when used before and after surgery for patients with MIBC who are ineligible for cisplatin-based chemotherapy First ever positive Phase 3 study in this cisplatin-ineligible patient population, representing significant advancement in MIBC RAHWAY, NJ, USA I August 12, 2025 I Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. In this study, KEYTRUDA ® (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv), given before and after surgery (radical cystectomy), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), the study’s primary endpoint, as well as overall survival (OS) and pathologic complete response (pCR) rate, key secondary endpoints, compared to surgery (radical cystectomy) alone. “Patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy have not seen any treatment advance beyond surgery and face high rates of disease recurrence and a poor prognosis, even after having their bladder removed,” said Dr. Christof Vulsteke, MD, PhD, head of Integrated Cancer Center Ghent (IKG) and Clinical Trial Unit Oncology Ghent and KEYNOTE-905 principal investigator. “The KEYNOTE-905 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival over standard-of-care surgery in this population, demonstrating the potential of this combination to address a critical unmet need.” The trial, evaluating Merck’s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), was conducted in collaboration with Pfizer (previously Seagen) and Astellas and builds on the clinical success of this combination in locally advanced or metastatic urothelial cancer. The trial is continuing to evaluate the secondary EFS, OS, and pCR rate endpoints for neoadjuvant and adjuvant KEYTRUDA versus surgery alone as they continue to mature. “There is a real and pressing need for more effective options for patients with bladder cancer who are ineligible for cisplatin-based treatment,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “The compelling survival results observed in this study reinforce the potential of combining KEYTRUDA with an antibody-drug conjugate to help address a significant unmet need in this vulnerable population.” The safety profile of KEYTRUDA plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination. The companies plan to share these results with regulatory authorities worldwide and will present the data at an upcoming medical meeting. KEYTRUDA plus Padcev is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA as monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC). Five additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic. Three of these studies are in MIBC including KEYNOTE-866 ( NCT03924856 ), KEYNOTE-992 ( NCT04241185 ) and KEYNOTE-B15 ( NCT04700124 ), which is also known as EV-304 and is being conducted in collaboration with Pfizer and Astellas. KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in the Phase 3 KEYNOTE-676 ( NCT03711032 ) trial, and as adjuvant treatment in patients with localized muscle-invasive urothelial carcinoma and locally advanced urothelial carcinoma KEYNOTE-123 ( NCT03244384 ). About KEYNOTE-905/EV-303 KEYNOTE-905, also known as EV-303, is an open-label, randomized, multi-arm, controlled, Phase 3 trial (ClinicalTrials.gov, NCT03924895 ) evaluating perioperative KEYTRUDA, with or without Padcev, versus surgery alone in patients with MIBC who are either not eligible for or declined cisplatin-based chemotherapy. The trial enrolled 595 patients who were randomized to receive either: The primary objective of this trial was to compare EFS between arm C and arm B, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) surgery or failure to undergo RC surgery in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence as assessed by imaging and/or biopsy or death due to any cause. The key secondary objectives were to compare OS and difference in pCR rate between arm C and arm B, as well as EFS, OS and the difference in pCR rate between arm A and arm B. The study remains ongoing to test hypotheses between arm A and arm B. About bladder cancer Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 patients each year globally. Muscle-invasive bladder cancer represents approximately 30% of all bladder cancer cases. The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival. However, up to half of patients with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery alone. About Merck’s early-stage cancer clinical program Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with more than 25 ongoing registrational studies across multiple types of cancer. About KEYTRUDA ® (pembrolizumab) injection, 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. 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. 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. 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. 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 is indicated for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent 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 (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. 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 whose tumors express PD-L1 (CPS ≥ 1) as determined by an FDA approved test. 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 locally advanced cervical cancer involving the lower third of the vagina, with or without extension to pelvic sidewall, or hydronephrosis/non-functioning kidney, or spread to adjacent pelvic organs (FIGO 2014 Stage III-IVA). 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. 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 . About the Merck, Pfizer and Astellas collaboration Merck previously entered a clinical collaboration agreement with Seagen and Astellas to evaluate the combination of Merck’s KEYTRUDA ® (pembrolizumab) and Seagen’s and Astellas’ Padcev ® (enfortumab vedotin-ejfv) in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. Padcev ® and the Padcev device are trademarks jointly owned by Agensys, Inc., and Seagen Inc. Pfizer Inc. completed its acquisition of Seagen on December 14, 2023. SOURCE: Merck

Clinical ResultPhase 3Drug ApprovalAccelerated Approval

11 Aug 2025

·www.globenewswire.com

Junshi Biosciences Announces the Acceptance of the sNDA for Toripalimab as the 1st-line Treatment of HER2-expressing Urothelial Carcinoma

Aug. 08, 2025 -- 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 supplemental new drug application (“sNDA”) for toripalimab (trade name: TUOYI®) in combination with disitamab vedotin, an antibody-drug conjugate (“ADC”) developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is defined as a HER2 immunohistochemistry test result of 1+, 2+, or 3+) locally advanced or metastatic urothelial carcinoma (“UC”), has been accepted by the National Medical Products Administration (“NMPA”). This is toripalimab’s 13th application for marketing submitted in the Chinese mainland. UC is one of the ten most prevalent malignant tumors in the world, and in China, its incidence and mortality rates continue rising annually. According to the latest data from the National Cancer Center, in 2022, the number of new cases of UC in China reached 92,900, and the number of deaths reached over 40,000. UC is a serious threat to the life and health of patients, and there are huge unmet clinical needs. In 2021, toripalimab was approved for the second-line and above treatment of advanced UC, becoming the first immunotherapy drug approved for non-selective, population-based indications of advanced UC in China. Over the past 5 years, the emergence of PD-(L)1 monoclonal antibodies and novel ADCs has been continuously reshaping the treatment landscape for advanced UC. Compared with conventional chemotherapy, novel therapies have demonstrated significant improvements in terms of survival benefit and tolerability, leading to more diverse and precise treatment options for patients. The sNDA is based on results from the RC48-C016 study (NCT05302284), a multi-center, randomized, open-label and controlled phase 3 clinical trial, which evaluated the efficacy and safety of toripalimab in combination with disitamab vedotin versus gemcitabine in combination with cisplatin/carboplatin in systemic-treatment-naive patients with HER2 (human epidermal growth factor receptor 2)-expressing locally advanced or metastatic UC. The study was conducted in 74 clinical centers across China with Professor Jun GUO from Beijing Cancer Hospital and Professor Aiping ZHOU from the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigators. In May 2025, the primary endpoints of progression-free survival (“PFS”, based on independent radiographic review) and overall survival (“OS”) of the RC48-C016 study met the pre-defined efficacy boundary. The results showed that in HER2-expressing, locally advanced or metastatic UC, toripalimab in combination with disitamab vedotin as a first-line treatment significantly improved PFS and OS compared to gemcitabine in combination with cisplatin/carboplatin. Toripalimab has a good safety profile that is consistent with previous studies, with no new safety signals identified. Further details will be presented at major international academic conferences. 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 twelve 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; first-line treatment for unresectable or metastatic melanoma. 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, United Arab Emirates, Kuwait and other countries and regions. In addition, toripalimab BLAs are under review in many countries or regions around the globe. 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 40 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 (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). The content above comes from the network. if any infringement, please contact us to modify.

Drug ApprovalImmunotherapyClinical ResultCSCO

08 Aug 2025

·pmlive.com

MSD receives NICE recommendation for Keytruda in advanced endometrial cancer

MSD – known as Merck & Co in the US and Canada – has announced that its anti-PD-1 therapy Keytruda (pembrolizumab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat endometrial cancer. The health technology assessment agency has issued final draft guidance recommending that the drug be used on the NHS in England and Wales, in combination with carboplatin and paclitaxel chemotherapy, for adults with previously untreated primary advanced or recurrent endometrial cancer. This includes both patients with mismatch repair proficient (pMMR) tumours and mismatch repair deficient (dMMR) tumours. More than 9,700 new cases of endometrial cancer are diagnosed every year in the UK. The disease is the most common type of womb cancer and, while survival is generally good when diagnosed early, five-year survival rates can be 50% or less when diagnosed at stage 3 or 4. Administered as an intravenous infusion, Keytruda works by increasing the ability of the body’s immune system to help detect and fight tumour cells. It will be available immediately for this patient population through the Cancer Drugs Fund. NICE’s recommendation comes shortly after the Scottish Medicines Consortium accepted Keytruda for primary advanced or recurrent endometrial carcinoma within NHS Scotland and was supported by positive results from the late-stage KEYNOTE-868 trial, in which the Keytruda regimen resulted in longer progression-free survival (PFS) compared to chemotherapy alone. Among patients with dMMR tumours, media PFS in the Keytruda regimen arm was not reached at a median follow-up of 14.4 months, compared to 8.3 months in the chemotherapy only cohort. For those with pMMR tumours, median PFS was 13.1 months in the Keytruda plus chemotherapy group at a median follow-up of ten months, versus 8.7 months in the chemotherapy arm. Benson Fayehun, head of oncology at MSD in the UK, said: “With over 9,700 cases of endometrial cancer being diagnosed across the UK annually, the decision is a significant milestone for endometrial cancer patients. In particular, for those with pMMR tumours who have previously been a particularly underserved population.” Also welcoming the recommendation, Eleanor Jones, chair of trustees at Peaches Womb Cancer Trust, said: “This additional treatment for primary advanced or recurrent pMMR and dMMR endometrial cancer will provide much needed options for patients currently facing the reality of limited cancer treatments.”

Clinical ResultPhase 3

100 Deals associated with Carboplatin

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KEGG	Wiki	ATC	Drug Bank
D01363	Carboplatin	L01XA02	DB00958

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent ovarian cancer	United States	Avyxa Pharma	08 Aug 2025
Endometrial Carcinoma	Japan	Clinigen KK	24 Jun 2024
Uterine Neoplasms	Japan	CHEPLAPHARM Arzneimittel GmbH	24 Jun 2024
Breast Cancer	Japan	Bristol-Myers Squibb KK	25 Nov 2011
Breast Cancer	Japan	CHEPLAPHARM Arzneimittel GmbH	25 Nov 2011
Breast Cancer	Japan	Clinigen KK	25 Nov 2011
Childhood Germ Cell Tumor	Japan	CHEPLAPHARM Arzneimittel GmbH	15 Sep 2005
Ewing Sarcoma	Japan	Clinigen KK	15 Sep 2005
Ewing Sarcoma	Japan	Bristol-Myers Squibb KK	15 Sep 2005
Hepatoblastoma	Japan	Clinigen KK	15 Sep 2005
Hepatoblastoma	Japan	Bristol-Myers Squibb KK	15 Sep 2005
Hepatoblastoma	Japan	CHEPLAPHARM Arzneimittel GmbH	15 Sep 2005
Neuroblastoma	Japan	CHEPLAPHARM Arzneimittel GmbH	15 Sep 2005
Neuroblastoma	Japan	Clinigen KK	15 Sep 2005
Neuroblastoma	Japan	Bristol-Myers Squibb KK	15 Sep 2005
Recurrent Ewing Sarcoma	Japan	CHEPLAPHARM Arzneimittel GmbH	15 Sep 2005
Refractory Ewing Sarcoma	Japan	CHEPLAPHARM Arzneimittel GmbH	15 Sep 2005
Retinoblastoma	Japan	Clinigen KK	15 Sep 2005
Retinoblastoma	Japan	Bristol-Myers Squibb KK	15 Sep 2005
Retinoblastoma	Japan	CHEPLAPHARM Arzneimittel GmbH	15 Sep 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Glioblastoma Multiforme	Phase 3	United States	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	Austria	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	Belgium	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	Denmark	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	France	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	Germany	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	Italy	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	Netherlands	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	Spain	CarThera SAS	29 Jan 2024
Glioblastoma Multiforme	Phase 3	Switzerland	CarThera SAS	29 Jan 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03811002 (NRG-LU005, CTgov)	Phase 3	Small cell lung cancer limited stage	544	Intensity-Modulated Radiation Therapy+Etoposide+Carboplatin+cisplatin (Arm I (Chemotherapy, Radiation Therapy))	rapgxxtubv(rgrdcecqhh) = hlmgbgeitw mxhcinfjxs (xgdjpxrblh, xtlpawzpgq - dajqqdhvpl) View more	-	12 Jun 2025
				Intensity-Modulated Radiation Therapy+Etoposide+Carboplatin+cisplatin+Atezolizumab (Arm II (Chemotherapy, Radiation Therapy, Atezolizumab))	rapgxxtubv(rgrdcecqhh) = egpjejmcwo mxhcinfjxs (xgdjpxrblh, tvxkaxtkyu - fyvwhjztxo) View more
NCT03783949 (EUDARIO, CTgov)	Phase 2	Primary peritoneal carcinoma \| Platinum-Sensitive Ovarian Carcinoma \| Fallopian Tube Carcinoma	122	Carboplatin+Gemcitabine+Paclitaxel+niraparib	rmyvxnlgmj(ubhryffagw) = aeraqavrbh afoumdajwz (cmeappqfsg, rkrwfkdupj - ioanvbgaqh) View more	-	11 Jun 2025
JPRN-jRCTs051190095 (Phase 2 study, ASCO2025)	Phase 2	Advanced Lung Non-Squamous Non-Small Cell Carcinoma Maintenance PD-L1	20	Carboplatin (CBDCA) + Pemetrexed (PEM) + Pembrolizumab (Pembro)	vdzbezjeyr(bwzydtlyft) = aueavgysxw uydnxsvuag (fidhpagsvb, 39.4 - 78.3) View more	Positive	30 May 2025
NCT03242915 (CTgov)	Phase 2	Non-Small Cell Lung Cancer \| EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	33	Carboplatin+Pemetrexed+Pembrolizumab (EGFR+ NSCLC)	nbjsnsfamv = ciyxuydqxv hwyckwaxid (bnnztfqzkq, rgnriasmhq - ipysswbrcx) View more	-	30 May 2025
				Carboplatin+Pemetrexed+Pembrolizumab (ALK+ NSCLC)	nbjsnsfamv = hlpwmwbpxy hwyckwaxid (bnnztfqzkq, dhoreainzi - apmsreppfb) View more
NCT04391049 (NRG-GI007, CTgov)	Phase 1	Adenocarcinoma of Esophagus \| Locally Advanced Malignant Neoplasm \| Esophageal Squamous Cell Carcinoma ... View more	16	Radiation Therapy+OBP-301+Carboplatin+Paclitaxel+Telomerase-specific Type 5 Adenovirus	dbjqxbtgau = rxhbuixvoe xwvjrhaedn (oollzqgxxi, twoxyeexqz - fxllufqtjr) View more	-	29 May 2025
NCT03416153 (CTgov)	Phase 2	Squamous Cell Carcinoma of the Oropharynx \| Oropharyngeal Neoplasms	91	Radiation Therapy+Carboplatin+Paclitaxel (Standard Treatment)	aamyykkbnd = ytwtbvbrqt hyxbgsbjhw (gwvalfgmsp, nsuxklvhxj - yuprtwdfbj) View more	-	22 May 2025
				Radiation Therapy+Carboplatin+Paclitaxel (De-escalation Treatment)	aamyykkbnd = mimossvvxv hyxbgsbjhw (gwvalfgmsp, dlzhiucnvu - uvaovdlsbx) View more
NCT03944915 (DEPEND, CTgov)	Phase 2	Human Papillomavirus Infection \| Human Papillomavirus-Related Squamous Cell Carcinoma \| Locally Advanced Head and Neck Squamous Cell Carcinoma	35	Nivolumab+Carboplatin+Paclitaxel (Standard Chemotherapy)	xejrateoec = ytlkzyjkon yxuuwzreic (kabgpvfjsh, swewzabqmf - oynapksleh) View more	-	11 May 2025
				Radiation+Filgrastim Injection+Paclitaxel+Hydroxyurea Pill+cisplatin+5-fluorouracil (De-escalated Chemotherapy)	xejrateoec = ggucjpjuad yxuuwzreic (kabgpvfjsh, yazzufjqwc - stnxfunwft) View more
NCT04967417 (PHOEBS, CTgov)	Phase 2	Non-Small Cell Lung Cancer \| metastatic non-small cell lung cancer \| Brain metastases	13	Carboplatin+Pembrolizumab+Pemetrexed (Non-squamous Cell Carcinoma)	gcewqmkolk(vxakldomsw) = dccfebgpdw ukoimvjyrz (xoekecpdab, wzmmeoswre - ublnjovfen) View more	-	09 May 2025
				Carboplatin+Paclitaxel+Pembrolizumab (Squamous Cell Carcinoma)	gcewqmkolk(vxakldomsw) = nsloeukdon ukoimvjyrz (xoekecpdab, yjvkkdcoom - fspblvfuzg) View more
NCT03107182 (OPTIMA II \| OPTIMA-II, CTgov)	Phase 2	Squamous Cell Carcinoma of Head and Neck \| HPV positive oropharyngeal squamous cell carcinoma \| Human Papillomavirus-Related Squamous Cell Carcinoma ... View more	72	Adjuvant RT+Nivolumab (Single Modality De-escalation Arm (SDA))	xqfcuoqtmk = ewublkkyix rxbtrlfats (ptljktfmua, fobcwlpiwl - qrhygqnpte) View more	-	06 May 2025
				Chemoradiotherapy+Nivolumab+Dexamethasone+Paclitaxel+hydroxyurea+cisplatin+Famotidine+Diphenhydramine+5-FU (Intermediate De-escalation Arm (IDA))	xqfcuoqtmk = afhloxjcat rxbtrlfats (ptljktfmua, ldavyjzuat - nifypgmbaf) View more
NCT04162015 (not provided, AACR2025)	Phase 1	Malignant Pleural Mesothelioma Neoadjuvant	22	Nivolumab with platinum and pemetrexed	cibtrpnqwc(kbnoiptlow) = ckcbxqnaoz purwbcphjt (jkzhuyybak ) View more	Positive	29 Apr 2025

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