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- ||| GemRIS (gemcitabine-releasing intravesical system) / J&J, cetrelimab (JNJ-63723283) / J&J
Enrollment closed, Combination therapy: SunRISe-1: A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Gu (clinicaltrials.gov) - Jul 17, 2024
P2, N=220, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting
- || Tecvayli (teclistamab-cqyv) / Genmab, J&J, Talvey (talquetamab-tgvs) / J&J
New P2 trial: TALTEC: Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients (clinicaltrials.gov) - Jul 17, 2024
P2, N=50, Recruiting, Sponsor: North Estonia Medical Centre
- |||| Carvykti (ciltacabtagene autoleucel) / J&J
Enrollment open, Enrollment change, CAR T-Cell Therapy: CARTITUDE-2: A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (clinicaltrials.gov) - Jul 16, 2024
P2, N=237, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting | N=169 --> 237
- | Orencia (abatacept) / BMS
Trial completion, Trial completion date: Abatacept as GVHD Prophylaxis Phase 2 (clinicaltrials.gov) - Jul 16, 2024
P2, N=186, Completed, Sponsor: Boston Children's Hospital
Active, not recruiting --> Recruiting | N=169 --> 237 Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Mar 2024
- | Rituxan (rituximab) / Roche
Journal: Shrinking lung syndrome mimicking diaphragmatic palsy in systemic lupus erythematosus. (Pubmed Central) - Jul 16, 2024
Further investigation suggested an overlap myositis with shrinking lung syndrome from systemic lupus erythematosus. She improved following immunosuppression with pulse corticosteroids and rituximab, and at 3?months no longer needed bilevel positive airway pressure support.
- | Rituxan (rituximab) / Roche
Journal: Variation in approaches to acute ANCA-associated vasculitis in Australia and New Zealand: rituximab, plasma exchange and glucocorticoids. (Pubmed Central) - Jul 16, 2024
There is substantial variation in approaches to the acute management of AAV in Australia and New Zealand, including differences in resource availability. This variation in care demonstrates the need to implement current practice guidelines and institute contemporary monitoring of AAV management, to achieve best patient outcomes.
- || VRC07-523LS / National Institute of Allergy and Infectious Diseases, IAVI, TaiMed Biologics
Clinical, P1 data, PK/PD data, Journal: Safety and pharmacokinetics of VRC07-523LS administered via different routes and doses (HVTN 127/HPTN 087): A Phase I randomized clinical trial. (Pubmed Central) - Jul 16, 2024
P1
This variation in care demonstrates the need to implement current practice guidelines and institute contemporary monitoring of AAV management, to achieve best patient outcomes. VRC07-523LS was safe and well tolerated across a range of doses and routes and is a promising long-acting bnAb for inclusion in HIV-1 prevention regimens.
- | Ocrevus (ocrelizumab) / Roche
Observational data, Journal: Longitudinal study of immunity to SARS-CoV2 in ocrelizumab-treated MS patients up to 2?years after COVID-19 vaccination. (Pubmed Central) - Jul 16, 2024
VRC07-523LS was safe and well tolerated across a range of doses and routes and is a promising long-acting bnAb for inclusion in HIV-1 prevention regimens. Humoral and cellular benefits of COVID-19 vaccination in B-cell-depleted MS patients were sustained for up to 2?years when booster doses were administered.
- | Darzalex (daratumumab) / J&J
Journal, IO biomarker: Anti-CD38 monoclonal antibody impairs CD34+ mobilization and affects clonogenic potential in multiple myeloma patients. (Pubmed Central) - Jul 16, 2024
Interestingly, the observation that daratumumab might negatively impact BFU-E colony formation, independent of CD34+ cell count, offers novel biological perspectives. Appropriate strategies should be adopted by the Apheresis teams to mitigate these potential negative effects.
- | Ibrance (palbociclib) / Pfizer
Journal: Palbociclib in Patients With Soft Tissue Sarcoma With CDK4 Amplifications: Results From the Targeted Agent and Profiling Utilization Registry Study. (Pubmed Central) - Jul 16, 2024
Appropriate strategies should be adopted by the Apheresis teams to mitigate these potential negative effects. Palbociclib met prespecified criteria to declare a signal of antitumor activity in patients with sarcoma and CDK4 amplification.
- | Tecentriq (atezolizumab) / Roche
Journal, Checkpoint inhibition: Opsoclonus-Ataxia Syndrome in a Patient With Small-Cell Lung Cancer Treated With Immune Checkpoint Inhibitors. (Pubmed Central) - Jul 16, 2024
The clinical pattern and reversibility bring the present case close to a few patients with paraneoplastic OMAS described before the ICI era. More research is needed to clarify the pathogenesis and outcomes of OMAS in the context of ICI.
- | Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
Journal, Real-world evidence, Real-world: Atezolizumab and bevacizumab with anticoagulant or antiplatelet therapy in hepatocellular carcinoma patients: Real-world data for informed clinical decision-making. (Pubmed Central) - Jul 16, 2024
More research is needed to clarify the pathogenesis and outcomes of OMAS in the context of ICI. No abstract available
- | alvocidib (DSP-2033) / Sumitomo Pharma
Journal: Uncovering potential CDK9 inhibitors from natural compound databases through docking-based virtual screening and MD simulations. (Pubmed Central) - Jul 16, 2024
The first-generation CDK inhibitor Flavopiridol was used as a reference to compare with our novel hit compound as a CDK9 antagonist...They also showed reasonable figures in the predicted absorption, distribution, metabolism, excretion, and toxicity (ADMET) calculations as well as in computational cytotoxicity predictions. Therefore, we anticipate that the proposed scaffolds could contribute to developing potential and selective CDK9 inhibitors subjected to further validations.
- | Adcetris (brentuximab vedotin) / Takeda, Pfizer
Journal, IO biomarker: Nodal T follicular helper cell lymphoma with aberrant CD20 expression and monoclonal TCR, IG rearrangements secondary to Classical Hodgkin Lymphoma: a case report. (Pubmed Central) - Jul 16, 2024
He received six cycles of the Adriamycin, Bleomycin, Vinblastine, Dacarbazine (ABVD) regimen, achieving complete clinical remission. The patient underwent two cycles of chemotherapy with brentuximab vedotin and the Gemcitabine-Oxaliplatin (G-mox) regimen, resulting in a reduction of the skin lesions to 2
- | Promacta (eltrombopag) / Novartis
Journal: Bioequivalence and Food Effect Assessment of Eltrombopag Olamine Tablets in Healthy Chinese Subjects: An Open, Randomized, Single-Dose, and Two-Period Crossover Study. (Pubmed Central) - Jul 16, 2024
In conclusion, eltrombopag is well tolerated and exhibits a favorable safety profile in the Chinese population. The achievement of bioequivalence under fasting and fed conditions supports the demonstration of biosimilarity between the test and reference formulations.
- | Polivy (polatuzumab vedotin-piiq) / Roche, Monjuvi (tafasitamab-cxix) / Incyte
Journal, Real-world evidence, Real-world: Real-world outcomes with novel therapies in relapsed/refractory diffuse large B-cell lymphoma. (Pubmed Central) - Jul 16, 2024
Outcomes were particularly poor for patients with relapse following CAR T, indicating that polatuzumab- and tafasitamab-based regimens in 2?L?+?R/R DLBCL have suboptimal outcomes in the real world. Additional treatment options are needed.
- | Rituxan (rituximab) / Roche
Journal: Can we effectively manage chronic kidney disease with a precision-based pharmacotherapy plan? Where are we? (Pubmed Central) - Jul 16, 2024
The understanding of MN pathogenesis as an autoimmune disease and the discovery of several autoantibodies allows a better characterization of patients. High-sensible techniques for lymphocyte counting open the possibility of more personalized use of anti CD20 therapies.
- | Tevimbra (tislelizumab-jsgr) / BeiGene
Journal, HEOR, PD(L)-1 Biomarker, IO biomarker, Cost-effectiveness, Cost effectiveness, Metastases: Cost-effectiveness of tislelizumab plus chemotherapy vs chemotherapy as first-line treatment of PD-L1 positive advanced gastric or gastroesophageal junction adenocarcinoma from a Chinese perspective. (Pubmed Central) - Jul 16, 2024
P3
However, TIS+Chemo might be cost-effective in provinces with higher WTP threshold. RATIONALE 305, www.clinicaltrials.gov, identifier is NCT03777657.
- ||| Ibrance (palbociclib) / Pfizer, Kisqali (ribociclib) / Novartis, Verzenio (abemaciclib) / Eli Lilly
Journal, Adverse events: Infection associated with CDK4/6 inhibitors: a pharmacovigilance analysis of the FDA adverse event reporting system database. (Pubmed Central) - Jul 16, 2024
Infection-related AEs were highly associated with three CDK4/6 inhibitors, especially palbociclib and ribociclib, based on the real-world data from the FAERS database. However, further causality assessment is required.
- | cisplatin / Generic mfg.
Journal: Pharmacological inhibition of CDK4/6 impairs diffuse pleural mesothelioma 3D spheroid growth and reduces viability of cisplatin-resistant cells. (Pubmed Central) - Jul 16, 2024
Abemaciclib also synergized with cisplatin and reduced the viability of DPM cells with acquired resistance to cisplatin. Overall, our results suggest that CDK4/6 inhibitors alone or in combination with standard of care should be further explored for DPM therapy.
- | Opdivo (nivolumab) / BMS
Journal, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker, Metastases: Refractory Hypercalcemia Secondary to Metastatic Parathyroid Carcinoma Treated With Immunotherapy. (Pubmed Central) - Jul 16, 2024
The patient has tolerated ongoing treatment with 3 weekly cycles of nivolumab. She remains in biochemical remission as of June 2024, which is now 12 months after commencement of nivolumab.
- | Darzalex (daratumumab) / J&J
Journal: Daratumumab for De-sensitization of Donor Specific Antibodies: Is it a Quicker and Easier way? (Pubmed Central) - Jul 16, 2024
However, it has been utilized widely in solid organ transplantation for this purpose. Our experience with daratumumab regarding effective reduction of DSA followed by successful engraftment might encourage its use in de-sensitization protocols without much delay in transplantation.
- | Avastin (bevacizumab) / Roche, Tecentriq (atezolizumab) / Roche
Journal: Safety/efficacy of atezolizumab + bevacizumab during anti-platelet/anticoagulation therapy in unresectable hepatocellular carcinoma. (Pubmed Central) - Jul 16, 2024
Our experience with daratumumab regarding effective reduction of DSA followed by successful engraftment might encourage its use in de-sensitization protocols without much delay in transplantation. Atezolizumab + bevacizumab therapy shows similar safety and efficacy in patients receiving and those not receiving anti-platelet agents or anticoagulants; therefore, it can be considered for patients with hepatocellular carcinoma receiving anti-platelet agents or anticoagulants.
- Orencia (abatacept) / BMS
Observational data, Journal, Real-world evidence, Real-world: Abatacept retention and clinical effectiveness in patients with rheumatoid arthritis in a real-world setting in Taiwan. (Pubmed Central) - Jul 16, 2024
Atezolizumab + bevacizumab therapy shows similar safety and efficacy in patients receiving and those not receiving anti-platelet agents or anticoagulants; therefore, it can be considered for patients with hepatocellular carcinoma receiving anti-platelet agents or anticoagulants. The 24-month retention rate of abatacept was 59.9%; abatacept was associated with improved clinical outcomes and was well-tolerated in the real-world setting in Taiwan.
- | Rituxan (rituximab) / Roche
Journal: Symptomatic Follicular Lymphoma: Complete Remission After Chemoimmunotherapy with Bendamustine-Rituximab. (Pubmed Central) - Jul 16, 2024
The patient tolerated the treatment well and completed six cycles of chemoimmunotherapy, and the follow-up FDG PET/CT showed complete remission of the disease.The patient achieved complete remission after series of chemoimmunotherapy with Bendamustine-Rituximab. Future assessment is still required for this patient to ensure the remission status of the lymphoma.
- Bavencio (avelumab) / EMD Serono
Phase classification: AVAIL-T: Avelumab in Relapsed and Refractory Peripheral T-cell Lymphoma (clinicaltrials.gov) - Jul 16, 2024
P2, N=35, Completed, Sponsor: University of Birmingham
Future assessment is still required for this patient to ensure the remission status of the lymphoma. Phase classification: P2a --> P2
- | Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment open, Metastases: A Study to Test the Benefit of Vitamin B5 in Patients With Melanoma (clinicaltrials.gov) - Jul 16, 2024
P1, N=12, Recruiting, Sponsor: University Health Network, Toronto
Phase classification: P2a --> P2 Not yet recruiting --> Recruiting
- ||| TEV-'278 / Teva
Enrollment open, Combination therapy, Monotherapy, Metastases: An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - Jul 16, 2024
P1, N=240, Recruiting, Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Tyvyt (sintilimab) / Eli Lilly, Aqupla (nedaplatin) / Simcere
New trial: A single-arm, Phase II exploratory clinical study of Sintilimab in combination with albumin-paclitaxel and nedaplatin for neoadjuvant treatment of esophageal cancer (EUDRACT) - Jul 16, 2024
P=N/A, N=132, Recruiting, Sponsor: Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences; Shandong Cancer Hospital and Insti
- | Tyvyt (sintilimab) / Eli Lilly
New P2 trial: An open, single-arm clinical study to explore the safety and efficacy of sintilimab in combination with albumin-paclitaxel/cisplatin for neoadjuvant treatment of esophageal cancer (EUDRACT) - Jul 16, 2024
P2, N=46, Recruiting, Sponsor: Friendship Hospital Affiliated to Capital Medical University; Friendship Hospital Affiliated to Capital Medical University
- | AiRuiKa (camrelizumab) / HLB Bio Group
Enrollment open: A phase II study for Albumin Bound Paclitaxel plus Camrelizumab (SHR1210) as therapy in patients with unresectable locally advanced or metastatic urothelial carcinoma (EUDRACT) - Jul 16, 2024
P2, N=60, Recruiting, Sponsor: Sun Yat-Sen University Cancer Center; Sun Yat-Sen University Cancer Center
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Keytruda (pembrolizumab) / Merck (MSD)
Enrollment open: A prospective clinical study evaluating pembrolizumab combined with chemotherapy (cisplatin or carboplatin + nab-paclitaxel) in first-line treatment of patients with recurrent and metastatic squamous cell carcinoma of the nasal cavity and paranasal sinuses (EUDRACT) - Jul 16, 2024
P2, N=20, Recruiting, Sponsor: Cancer Hospital Chinese Academy of Medical Science; Cancer Hospital Chinese Academy of Medical Science
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | AiTan (rivoceranib) / HLB Bio Group, Teysuno (gimeracil/oteracil/tegafur) / Nordic Group, Otsuka, AiRuiKa (camrelizumab) / HLB Bio Group
Enrollment open: A single-arm exploratory and prospective clinical trial of S-1 combined with camrelizumab and apatinib in the second-line treatment of patients with biliary tract tumors (EUDRACT) - Jul 16, 2024
P2, N=53, Recruiting, Sponsor: West China Hospital, Sichuan University; West China Hospital, Sichuan University
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | Tevimbra (tislelizumab-jsgr) / BeiGene
Enrollment open, Enrollment change: A prospective clinical study evaluating the efficacy and safety of tislelizumab combined with nab-paclitaxel and cisplatin induction chemotherapy in the treatment of newly treated locally advanced hypopharyngeal carcinoma (EUDRACT) - Jul 16, 2024
P2, N=40, Recruiting, Sponsor: Cancer Hospital Chinese Academy of Medical Science; Cancer Hospital Chinese Academy of Medical Science
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | N=20 --> 40
- | AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma
Trial completion, Metastases: SHR6390 in Treating Patients with Recurrent and/or Metastatic Mucosal Melanoma of Head and Neck Harboring CDK4 Amplification (EUDRACT) - Jul 16, 2024
P=N/A, N=17, Completed, Sponsor: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine; Shanghai Ninth People's Hospital, Shanghai Jiaotong University Scho
Not yet recruiting --> Recruiting | N=20 --> 40 Recruiting --> Completed
- | AiRuiKa (camrelizumab) / HLB Bio Group
Trial completion, Phase classification: A Trial Of Neoadjuvant Chemotherapy With Or Without Camrelizumab In Patients With Resectable Esophageal Squamous Cell Carcinoma (EUDRACT) - Jul 16, 2024
P3, N=390, Completed, Sponsor: Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences
Recruiting --> Completed Not yet recruiting --> Completed | Phase classification: P4 --> P3
- | Brukinsa (zanubrutinib) / BeiGene, Gazyva (obinutuzumab) / Roche, Biogen
New P2 trial: ZGR: Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma (clinicaltrials.gov) - Jul 16, 2024
P2, N=39, Not yet recruiting, Sponsor: Institute of Hematology & Blood Diseases Hospital, China
- ||| YH008 / Biocytogen
Enrollment open, Trial initiation date, Metastases: A Study of NWY001 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - Jul 16, 2024
P1, N=196, Recruiting, Sponsor: Chipscreen Biosciences, Ltd.
Not yet recruiting --> Completed | Phase classification: P4 --> P3 Not yet recruiting --> Recruiting | Initiation date: Oct 2023 --> Jan 2024
- Mekinist (trametinib) / Novartis, BeiGene, Keytruda (pembrolizumab) / Merck (MSD), Tafinlar (dabrafenib) / Novartis, BeiGene
Concurrent BRAF targeted therapy (TT) with dabrafenib and trametinib and anti-PD-1 agent pembrolizumab (PD1) increased B cell signalling and inflammatory pathways more effectively than when given sequentially or with anti-PD-1 alone (Valencia Auditorium - Hall 5) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1864;
- Keytruda (pembrolizumab) / Merck (MSD), sotigalimab (PYX-107) / Pyxis Oncology
Clinical and biomarker analyses of intratumoral CD40 agonist sotigalimab in combination with pembrolizumab in metastatic melanoma: a phase 1/2 trial (Valencia Auditorium - Hall 5) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1863;
- BNT113 / BioNTech
HARE-40: A phase I/II trial of therapeutic HPV vaccine (BNT113) in patients with HPV16 driven carcinoma (Granada Auditorium - Hall 6) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1855;
- Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Nivolumab and Ipilimumab combination treatment in advanced dMMR/MSI-H noncolorectal cancers: Results from the phase II MoST-CIRCUIT study (Granada Auditorium - Hall 6) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1853;
- Keytruda (pembrolizumab) / Merck (MSD), ATG-037 / Antengene
A First-In-Human Phase I/Ib study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Advanced Solid Tumors (Granada Auditorium - Hall 6) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1852;
- dazostinag (TAK-676) / Takeda, Keytruda (pembrolizumab) / Merck (MSD)
Dazostinag (TAK-676) alone and in combination with pembrolizumab (pembro) in patients (pts) with advanced/metastatic solid tumors: data from phase 1 dose escalation (Granada Auditorium - Hall 6) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1851;
- Yinuokai (orelabrutinib) / InnoCare, Biogen, Gazyva (obinutuzumab) / Roche, Biogen
A prospective study of orelabrutinib plus obinutuzumab (O2) in treatment-na (Oviedo Auditorium - Hall 3) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1831;
- Tevimbra (tislelizumab-jsgr) / BeiGene, timdarpacept (IMM01) / ImmuneOnco Biopharma
Efficacy and safety results from the phase 2 study of Timdarpacept in combination with tislelizumab, in prior anti-PD-1 failed classical Hodgkin lymphoma (Oviedo Auditorium - Hall 3) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1824;
- sacituzumab tirumotecan (MK-2870) / Merck (MSD), Keytruda (pembrolizumab) / Merck (MSD)
Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT) Plus Pembrolizumab in Patients with Recurrent or Metastatic Cervical Cancer (Santander Auditorium - Hall 5) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1815;
- Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, Focus V (anlotinib) / Advenchen, Sino Biopharm
A Clinical Study of the Safety and Efficacy of Toripalimab in Combination with Anilotinib for the Treatment of Recurrent Glioblastoma (GBM) (Salamanca Auditorium - Hall 5) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1805;
- Kymriah (tisagenlecleucel-T) / Novartis
Real-world efficacy and safety of Tisagenlecleucel (CTL019) for relapse or refractory follicular lymphoma patients included in the Early Access Program through the French DESCAR-T registry (Toledo Auditorium - Hall 3) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1785;
- timdarpacept (IMM01) / ImmuneOnco Biopharma
Efficacy and Safety of a Phase 2 Study: Timdarpacept (IMM01) Combined with Azacitidine (AZA) As the First-Line Treatment in Adults with Chronic Myelomonocytic Leukemia (CMML) (Toledo Auditorium - Hall 3) - Jul 16, 2024 - Abstract #ESMO2024ESMO_1779;