- |||||||||| Adcetris (brentuximab vedotin) / Takeda, Pfizer, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Clinical, Journal, Checkpoint inhibition: Distinct autoantibody profiles across checkpoint inhibitor types and toxicities. (Pubmed Central) - May 13, 2024
P1/2
We conclude that dynamic autoantibody profiles may differ according to ICI category and irAE type. These findings may have relevance to clinical monitoring and irAE treatment.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / BMS, Padcev (enfortumab vedotin-ejfv) / Astellas, Pfizer
Review, Journal, Metastases: How Immunotherapy Has Redefined the Treatment Paradigm of Metastatic or Locally Advanced Muscle-Invasive Urothelial Bladder Carcinoma. (Pubmed Central) - May 11, 2024
In this review, we discuss the role of ICIs, alone or in combination, in bladder cancer management in the metastatic and adjuvant settings in 2024, considering the latest published trials. The potential role of ICIs as neoadjuvants is also discussed.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Adcetris (brentuximab vedotin) / Takeda, Pfizer, Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: Paradigm Shifts in Hodgkin Lymphoma Treatment: From Frontline Therapies to Relapsed Disease. (Pubmed Central) - May 10, 2024
The novel agents are also useful in the treatment of older patients who have poor outcomes with traditional therapy. This manuscript will review current strategies for approaching the management of previously untreated, RR, and challenging populations with cHL, including how to incorporate the novel agents.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Tecentriq (atezolizumab) / Roche
Journal, PD(L)-1 Biomarker, IO biomarker: Top advances of the year: Perioperative therapy for lung cancer. (Pubmed Central) - May 8, 2024
P3
Perioperative pembrolizumab became the first ICI to attain US Food and Drug Administration approval in this setting through the KEYNOTE-671 trial (ClinicalTrials.gov identifier NCT03425643), which also demonstrated a definitive overall survival benefit in the entire study population. However, questions remain regarding patient selection for either approach and how we can optimize biomarkers to determine who needs adjuvant therapy after surgery.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Herceptin (trastuzumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: Research advances in the molecular classification of gastric cancer. (Pubmed Central) - May 8, 2024
Here, we discuss the intrinsic characteristics of GC from a molecular perspective and provide a comprehensive review of classification and treatment advances in the disease. Finally, we suggest several strategies based on the intrinsic molecular characteristics of GC to aid in overcoming clinical challenges in the development of precision medicine and improve patient prognosis.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Clinical, P3 data, Clinical Trial,Phase III, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Nivolumab plus chemotherapy or ipilimumab versus chemotherapy in patients with advanced esophageal squamous cell carcinoma (CheckMate 648): 29-month follow-up from a randomized, open-label, phase III trial. (Pubmed Central) - May 8, 2024
P3
Initiation date: Jun 2024 --> Jan 2025 Nivolumab plus chemotherapy and nivolumab plus ipilimumab continued to demonstrate clinically meaningful OS benefit versus chemotherapy with no new safety signals identified with longer follow-up, further supporting use as first-line standard treatment options for patients with advanced ESCC.
- |||||||||| sitravatinib (MGCD516) / BeiGene
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study (clinicaltrials.gov) - May 8, 2024
P2/3, N=55, Active, not recruiting,
In this study of patients with advanced MSS CRC, combination ONC201/nivolumab was well-tolerated; objective responses to ONC201/nivolumab were not observed. Enrolling by invitation --> Active, not recruiting | N=200 --> 55 | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD)
Journal: A Cautionary Note on Pembrolizumab use in Patients with Ascending Aortic Aneurysms. (Pubmed Central) - May 8, 2024
However, they are a relatively new group of medications, and the side effect profile of each is yet to be fully recognised. Aortitis has occurred with several different immune checkpoint inhibitors.Patients with known aortic aneurysms should undergo careful surveillance when commencing immune checkpoint inhibitors.All interventional therapeutic options should be considered early in these patients on the development of aneurysmal expansion.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal: Haemophagocytic Lymphohistiocytosis Following the anti-PD-1 Nivolumab in a Patient with Gastric Cancer and Ankylosing Spondylitis. (Pubmed Central) - May 8, 2024
Aortitis has occurred with several different immune checkpoint inhibitors.Patients with known aortic aneurysms should undergo careful surveillance when commencing immune checkpoint inhibitors.All interventional therapeutic options should be considered early in these patients on the development of aneurysmal expansion. Haemophagocytic lymphohistiocytosis (HLH) post seventh cycle of trastuzumab (anti-HER2) and nivolumab (anti-PD-1) was controlled with glucocorticoid.Breach of tolerance was due to immunotherapy-induced HLH in a patient with pre-existing autoimmune condition (HLA B27- positive ankylosing spondylitis).There was a complete disappearance of liver metastases 8 months post-HLH.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Cabometyx (cabozantinib tablet) / Exelixis, Ipsen
CYTO-KIK TRIAL (CYTO REDUCTIVE SURGERY IN KIDNEYCANCER PLUS IMMUNOTHERAPY (NIVOLUMAB) ANDTARGETED KINASE INHIBITION (CABOZANTINIB) () - May 8, 2024 - Abstract #AUA2024AUA_4246;
P2
In trials withcombination immune checkpoint inhibitors such as nivolumab plusipilimumab and pembrolizumab plus axitinib complete responses werenoted in nearly 10% of subjects...Aspirin (up to 325 mg/day), low- dose warfarin ( 1 mg/day), prophylactic and therapeuticlow molecular weight heparin (LMWH) are permitted...Primary Correlative Objective: To determine biomarkers of responseto nivolumab and cabozantinib through analysis of RNA-seq data obtained from pre-treatment RCC samples. Biomarkers will be ascertainedthrough analysis of the pre-treatment tumor microenvironment (TME)using next-gen Cibersort and Master Regulator analysis; to determinethe mechanism of action in responding patients and mechanism ofresistance in non-responders through comparison of pre-treatment biopsies and post-treatment nephrectomy specimens thought RNA-seqbased analysis of the TME using next-gen CiberSort and VIPER.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Combination therapy, Real-world evidence, Real-world, Metastases: Real-world outcomes of nivolumab plus ipilimumab combination therapy for advanced renal cell carcinoma in Japanese patients: data with a minimum of 3 (Pubmed Central) - May 7, 2024
The 3-year follow-up data showed that nivolumab plus ipilimumab combination therapy exhibited a feasible effectiveness in real-world Japanese patients with advanced renal cell carcinoma. Accordingly, the high risk of adverse event development, which often requires treatment withdrawal and corticosteroid administration, should be considered.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Clinical data, Clinical Trial,Phase III, Journal, Real-world evidence, Real-world: Clinical outcomes of adjuvant nivolumab in resected stage III melanoma: comparison of CheckMate 238 trial and real-world data. (Pubmed Central) - May 7, 2024
Accordingly, the high risk of adverse event development, which often requires treatment withdrawal and corticosteroid administration, should be considered. In this comparative analysis, OS in the CheckMate 238 trial was similar to rwOS in the Flatiron Health database after adjustments in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab, validating the trial results.
- |||||||||| Journal, Metastases: Advanced melanoma with low-burden and low-risk disease: a clinical case. (Pubmed Central) - May 6, 2024
Patients with low tumor burden and low-risk disease (i.e., with normal LDH levels), having higher survival rates and probability of good outcome to systemic therapy, represent a challenge for the clinician, deserving the attempt to reach long-term complete responses. The following case report is quite representative of the above-mentioned clinical situation.
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, Opdivo (nivolumab) / Ono Pharma, BMS
Journal: Maxillary Sinus NUT Carcinoma: A Case Report. (Pubmed Central) - May 6, 2024
Effective treatments for NUT carcinoma have not yet been established. However, early testing to establish the diagnosis may provide useful insights to guide clinical decisions to improve patient outcomes.
- |||||||||| Review, Journal, Metastases: The evolving treatment landscape of metastatic urothelial cancer. (Pubmed Central) - May 4, 2024
Maintenance therapy with avelumab revealed improved overall (OS) and progression-free survival (PFS) compared with best supportive care alone in patients with platinum-responsive mUC...In the former, the combination of enfortumab vedotin and pembrolizumab showed significant improvements in OS, PFS and overall response rate compared with chemotherapy alone; the combination of nivolumab with gemcitabine-cisplatin chemotherapy demonstrated a significant extension in median OS, PFS and overall response rate compared with chemotherapy alone. In
- |||||||||| BMS-986218 / BMS, Opdivo (nivolumab) / Ono Pharma, BMS
Enrollment change, Trial termination, Combination therapy, Metastases: First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - May 3, 2024
P1/2, N=512, Terminated,
Such information is crucial for understanding potential interactions that may impact both immunological and clinical effects. N=390 --> 512 | Active, not recruiting --> Terminated; Business Objectives have changed.
- |||||||||| zamaporvint (RXC004) / Redx
Trial completion, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy, Metastases: PORCUPINE: A Study to Assess Efficacy of RXC004 +/- Nivolumab in Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer After Progression on Standard of Care (SOC) (clinicaltrials.gov) - May 3, 2024
P2, N=25, Completed,
N=390 --> 512 | Active, not recruiting --> Terminated; Business Objectives have changed. Recruiting --> Completed | N=50 --> 25 | Trial completion date: Dec 2023 --> Apr 2024 | Trial primary completion date: Aug 2023 --> Apr 2024
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Tumor cell: Immunotherapy drives mesenchymal tumour cell state shift and TME immune response in glioblastoma patients. (Pubmed Central) - May 2, 2024
We find a resistance mechanism signature in a quarter of glioblastoma patients associated with a tumour-cell transition to a more aggressive mesenchymal-like state, increase in TAMs and proliferative and exhausted T cells in response to immunotherapy. These patients may instead benefit from neuro-oncology therapies targeting mesenchymal tumour cells.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition, Cytokine release syndrome: Severe Cytokine Release Syndrome and Immune Effector Cell-associated Neurotoxicity Syndrome in a Man Receiving Immune Checkpoint Inhibitors for Lung Cancer: A Case Report. (Pubmed Central) - May 1, 2024
Organ damage was gradually controlled with immunosuppressive drugs, including steroids, and the patient was discharged. Successful treatment is rare in patients with CRS, including ICANS, during immune checkpoint inhibitor treatment for solid tumors.
- |||||||||| Review, Journal: Advances in Radionuclide Therapies for Patients with Neuro-endocrine Tumors. (Pubmed Central) - May 1, 2024
There is great demand to enhance the efficacy of PRRT through combination with other anticancer treatments. While research in this area is currently limited, the field is rapidly evolving with numerous ongoing clinical trials aiming to address this need and explore novel therapeutic combinations.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / Ono Pharma, BMS, Yervoy (ipilimumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition, Metastases: Unanticipated pathological clearance in two cases of clinical T4b dMMR/MSI-h advanced colorectal cancer: the potential of immune checkpoint inhibitors despite positive positron-emission tomography results. (Pubmed Central) - May 1, 2024
However, it remains unknown whether ICI therapy can replace surgery or diminish the optimal extent of resection, or whether adjuvant chemotherapy is needed after surgery in the case of achieving pCR after ICI therapy. Overall, this case report suggests that ICI before colorectal surgery can be effective and potentially a 'watch-and-wait" strategy could be used for cases in which ICI is effective.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion date, Trial primary completion date, Combination therapy: Nivolumab and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma (clinicaltrials.gov) - May 1, 2024
P1/2, N=36, Active, not recruiting,
Nivolumab combination chemotherapy shows promise as a clinically beneficial treatment approach for gastric remnant cancer with liver metastasis, particularly when pCR can be achieved following conversion surgery. Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Trial completion, Trial completion date, Trial primary completion date: HCRN GU 16-257: Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing (clinicaltrials.gov) - Apr 30, 2024
P2, N=76, Completed,
Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024 Active, not recruiting --> Completed | Trial completion date: Aug 2024 --> Mar 2024 | Trial primary completion date: Mar 2021 --> Feb 2024
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, HEOR, Real-world evidence, Real-world: Real-world data on efficacy/safety and economic impact of nivolumab administered every 2 and 4 (Pubmed Central) - Apr 29, 2024
Introduction: The Meet-URO 18 study is a multicentric study of patients with metastatic renal cell carcinoma receiving nivolumab in the second-line and beyond, categorized as responders (progression-free survival ? Collectively, our findings suggest that nivolumab 480
- |||||||||| Review, Journal: Combination immune checkpoint and targeted protein kinase inhibitors for the treatment of renal cell carcinomas. (Pubmed Central) - Apr 28, 2024
Other combination therapies include pembrolizumab (targeting programed cell death protein 1) and axitinib (a VEGFR and PDGFR blocker) or lenvatinib (a multikinase inhibitor). Since the KEYNOTE-426 clinical trial, the use of immune checkpoint inhibitors in combination with protein-tyrosine kinase inhibitors is now the standard of care for most patients with metastatic renal cell carcinomas and monotherapies are used only in those individuals who cannot receive or tolerate immune checkpoint inhibitors.
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