- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Diabetic ketoacidosis as a hallmark of autoimmune diabetes occurring after two cycles of cemiplimab. (Pubmed Central) - Apr 27, 2022
The mechanism by which cemiplimab caused insulin-dependent diabetes mellitus is most likely due to lack of endogenous insulin production in the setting of immune-mediated loss of pancreatic beta-cells. Patients may benefit from fasting blood glucose monitoring and early immune checkpoint inhibitor discontinuation where elevated serum glucose is detected.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Cemiplimab for locally advanced and metastatic basal cell carcinoma. (Pubmed Central) - Apr 27, 2022
Experts currently recommend cemiplimab as a first-line systemic alternative. As cemiplimab therapy is associated with a risk of organ graft rejection, advantages and disadvantages should be evaluated for every individual OTR patient with laBCC or mBCC, eligible for cemiplimab therapy.
- |||||||||| ISA101 / ISA Pharma
Trial primary completion date: OpcemISA: A Randomized Phase 2 Study of Cemiplimab (clinicaltrials.gov) - Apr 14, 2022
P2, N=194, Recruiting,
Cemiplimab is a cost-effective option in the first-line treatment of NSCLC in patients who are at least 50% PD-L1 positive from an American perspective. Trial primary completion date: Dec 2021 --> Jun 2022
- |||||||||| Review, Journal, Checkpoint inhibition, PD(L)-1 Biomarker, IO biomarker: First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data. (Pubmed Central) - Apr 9, 2022
Several ICIs (pembrolizumab, atezolizumab, nivolumab, and recently durvalumab) in combination with chemotherapy achieved overall survival gains among "all comers", compared with chemotherapy alone...Recently, nivolumab-ipilimumab and two chemotherapy cycles limited patient exposure to chemotherapy and obtained positive results compared with the latter alone...Little is known about immunotherapy and combination immunotherapy-chemotherapy efficacies in never-smokers or patients with tumors harboring an epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. In this review, we report our analysis of the main results available on first-line ICI use, as monotherapy or combined or in combination with chemotherapy, to treat metastatic NSCLCs in general and also for specific populations: the elderly, never-smokers, patients with brain metastases, and those with an EGFR mutation or ALK translocation.
- |||||||||| pegenzileukin (SAR444245) / Sanofi, Innovent Biologics
Trial completion date, Trial primary completion date, Metastases: A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201) (clinicaltrials.gov) - Apr 8, 2022
P1/2, N=80, Recruiting,
In this review, we report our analysis of the main results available on first-line ICI use, as monotherapy or combined or in combination with chemotherapy, to treat metastatic NSCLCs in general and also for specific populations: the elderly, never-smokers, patients with brain metastases, and those with an EGFR mutation or ALK translocation. Trial completion date: Jun 2023 --> Nov 2023 | Trial primary completion date: Jun 2023 --> Nov 2023
- |||||||||| cavrotolimod (AST-008) / Exicure
Trial completion date, Trial termination, Trial primary completion date, IO biomarker, Metastases: Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors (clinicaltrials.gov) - Apr 7, 2022
P1b/2, N=57, Terminated,
Trial completion date: Jun 2023 --> Nov 2023 | Trial primary completion date: Jun 2023 --> Nov 2023 Trial completion date: Dec 2023 --> Mar 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2022 --> Mar 2022; The study was canceled for administrative reasons.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma (clinicaltrials.gov) - Apr 6, 2022
P1, N=41, Recruiting,
Trial completion date: Dec 2023 --> Mar 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Jun 2022 --> Mar 2022; The study was canceled for administrative reasons. Completed --> Recruiting | N=17 --> 41 | Trial completion date: Jul 2021 --> Sep 2023 | Trial primary completion date: Jul 2021 --> Sep 2023
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov) - Apr 6, 2022
P2, N=44, Not yet recruiting,
Completed --> Recruiting | N=17 --> 41 | Trial completion date: Jul 2021 --> Sep 2023 | Trial primary completion date: Jul 2021 --> Sep 2023 Trial completion date: Apr 2025 --> Sep 2025 | Trial primary completion date: Apr 2025 --> Sep 2025
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: Immune checkpoint inhibitors in the treatment of cancer. (Pubmed Central) - Apr 5, 2022
Trial completion date: Apr 2025 --> Sep 2025 | Trial primary completion date: Apr 2025 --> Sep 2025 This review also highlighted the most common adverse effects caused by ICIs and which affect people in different ways.
- |||||||||| pertuzumab zuvotolimod (SBT6050) / ARS Pharma
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors (clinicaltrials.gov) - Apr 5, 2022
P1, N=58, Active, not recruiting,
Trial completion date: Mar 2023 --> Mar 2024 | Trial primary completion date: Mar 2022 --> Mar 2023 Recruiting --> Active, not recruiting | N=344 --> 58 | Trial completion date: Aug 2024 --> Dec 2022 | Trial primary completion date: Aug 2023 --> Dec 2022
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date, Metastases: PRIME-CUT: REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (clinicaltrials.gov) - Apr 4, 2022
P2, N=20, Recruiting,
Recruiting --> Active, not recruiting | N=344 --> 58 | Trial completion date: Aug 2024 --> Dec 2022 | Trial primary completion date: Aug 2023 --> Dec 2022 Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Sep 2020 --> Dec 2022
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Review, Journal: Cemiplimab in advanced cutaneous squamous cell carcinoma. (Pubmed Central) - Apr 2, 2022
To this end, I reviewed EMBASE, MEDLINE, PubMed, and clinical trial registries/databases by using the following keywords alone or in combination: "cemiplimab," "Libtayo," "cutaneous squamous cell carcinoma," "REGN2810," and "SER439684." Cemiplimab showed clinical efficacy and considerable safety and was associated with low rates of treatment discontinuation (7%) and death (3%). However, the current recommendation is primarily based on only phase II clinical testing due to the absence of an approved comparator agent.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Biomarker, Review, Journal: Combination strategies with PD-1/PD-L1 blockade: current advances and future directions. (Pubmed Central) - Apr 1, 2022
Moreover, we focused on the advances of α-PD-1/PD-L1-based immunomodulatory strategies in clinical studies. Given the heterogeneity across patients and cancer types, individualized combination selection could improve the effects of α-PD-1/PD-L1-based immunomodulatory strategies and relieve treatment resistance.
- |||||||||| Sarclisa (isatuximab-irfc) / Sanofi
Trial completion date, Trial primary completion date, Combination therapy: Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (clinicaltrials.gov) - Apr 1, 2022
P1/2, N=109, Active, not recruiting,
Given the heterogeneity across patients and cancer types, individualized combination selection could improve the effects of α-PD-1/PD-L1-based immunomodulatory strategies and relieve treatment resistance. Trial completion date: Jun 2022 --> Dec 2022 | Trial primary completion date: Jun 2022 --> Dec 2022
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Retrospective data, Journal, PD(L)-1 Biomarker, IO biomarker: Optimum immunotherapy method according to PD-L1 expression in advanced lung cancer: a network meta-analysis. (Pubmed Central) - Mar 26, 2022
As for patients with ≥50% PD-L1 expression, platinum-based chemotherapy plus pembrolizumab/atezolizumab and pembrolizumab/cemiplimab monotherapy were associated with better survival than chemotherapy. These results provide reference for selecting the optimum immunotherapy method based on the expression of PD-L1 in patients with advanced lung cancer.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date, Metastases: Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer (clinicaltrials.gov) - Mar 25, 2022
P2, N=21, Recruiting,
These results provide reference for selecting the optimum immunotherapy method based on the expression of PD-L1 in patients with advanced lung cancer. Trial completion date: Nov 2024 --> Sep 2023 | Trial primary completion date: Nov 2024 --> Sep 2023
- |||||||||| Avastin (bevacizumab) / Roche, balstilimab (AGEN2034) / Agenus, Recepta
Review, Journal: Balstilimab and other immunotherapy for recurrent and metastatic cervical cancer. (Pubmed Central) - Mar 23, 2022
P1/2
Recurrent and metastatic cervical cancer is generally treated by cisplatin, paclitaxel, and bevacizumab with limited benefit this constituting an unmet need...Recently, a PD-1 inhibitor, pembrolizumab was approved for such cancer...Balstilimab plus zalifrelimab combination (NCT03495882) produced improved clinical benefit over monotherapy as evidenced by higher relative response rates and longer response duration, as well as a manageable safety profile. Interesting development of this combination and other immunotherapies in R/M CC are discussed in this ensuing review.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
IMMUNE CHECKPOINT INHIBITOR-INDUCED OVERLAP SYNDROME: A CASE SERIES ([VIRTUAL]) - Mar 23, 2022 - Abstract #SCCM2022SCCM_1616;
The incidence of rare and potentially fatal IRAE toxicities is increasing with the growing use and indications of ICI therapy. ICU staff managing cancer patients should be aware of the IRAEs and their management.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Cutaneous Reactions to PD-1 Inhibitors () - Mar 21, 2022 - Abstract #AAD2022AAD_2758;
Twenty-four patients (32%) developed adverse cutaneous reactions after being treated with nivolumab (n=14), pembrolizumab (n=10), atezolizumab (n=3), and cemiplimab (n=3). Understanding the cutaneous reactions to PD-1 inhibitors will facilitate counseling patients of possible risk factors and the development of more effective management.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Journal, Checkpoint inhibition: Neuro-Ophthalmic Complications in Patients Treated With CTLA-4 and PD-1/PD-L1 Checkpoint Blockade. (Pubmed Central) - Mar 19, 2022
This study describes the variable neuro-ophthalmic adverse events associated with use of immune checkpoint inhibitors and contributes a more thorough understanding of their clinical presentations and treatment outcomes. We expect this will increase awareness of these drug complications and guide specialists in the care of these patients.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: New Emerging Treatment Options for Advanced Basal Cell Carcinoma and Squamous Cell Carcinoma. (Pubmed Central) - Mar 16, 2022
Studies evaluating pembrolizumab, ipilimumab and nivolumab as alternative treatments for advanced squamous cell carcinoma are still underway. Objective of this review is to analyze and discuss the novel therapies for advanced basal cell carcinoma and squamous cell carcinoma to obtain a sharper perspective of the available treatment options.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: Immune Checkpoint Inhibitors-Associated Cardiotoxicity. (Pubmed Central) - Mar 11, 2022
Ipilimumab and pembrolizumab use may increase the risk of cardiotoxicity compared to other agents. Avelumab also estimated a highly elevated risk (aHR: 1.92; 95% CI: 0.85-4.34; p = 0.117) compared to nivolumab and other PD-L1 agents, although the estimate did not reach statistical significance, warranting future studies.
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