- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
Retrospective data, Review, Journal, Monotherapy, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: PD-(L)1 Inhibitors as Monotherapy for the First-Line Treatment of Non-Small-Cell Lung Cancer Patients with High PD-L1 Expression: A Network Meta-Analysis. (Pubmed Central) - Apr 7, 2021 In conclusion, PD-(L)1 inhibitor monotherapy improves efficacy outcomes in the first line setting of advanced NSCLC patients with high PD-L1 expression. Evaluations with longer follow up are still needed to determine the superiority of any specific drug.
- |||||||||| Jemperli (dostarlimab) / GSK, Opdivo (nivolumab) / Ono Pharma, BMS
Journal: Dostarlimab for the treatment of endometrium cancer and other solid tumors. (Pubmed Central) - Mar 24, 2021 The preliminary results, particularly in endometrial cancer, show a high affinity against PD-1 with encouraging clinical activity. Here we summarize the development of this compound as well as the current preclinical and clinical data and potential future development.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Clinical data, Review, Journal, PD(L)-1 Biomarker, IO biomarker: Clinical outcomes and influencing factors of PD-1/PD-L1 in hepatocellular carcinoma. (Pubmed Central) - Mar 19, 2021 Thus, tumor immunotherapy using PD-1/PD-L1 blockers exhibits promising outcomes for the treatment of HCC, and more novel PD-1/PD-L1 inhibitors are being developed to fight against this disease. The present review discusses the clinical results and influencing factors of PD-1/PD-L1 inhibitors in HCC to provide insight into the development and optimization of PD-1/PD-L1 inhibitors in the treatment of HCC.
- |||||||||| Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Combination therapy, Metastases: Anti-PD1-antibody and Pulsed HHI for Advanced BCC (clinicaltrials.gov) - Mar 18, 2021 P2, N=20, Recruiting, The present review discusses the clinical results and influencing factors of PD-1/PD-L1 inhibitors in HCC to provide insight into the development and optimization of PD-1/PD-L1 inhibitors in the treatment of HCC. Not yet recruiting --> Recruiting
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Review, Journal: Multidisciplinary Management of Locally Advanced and Metastatic Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Mar 12, 2021 A new systemic therapy, cemiplimab, has been approved for the treatment of locally advanced and metastatic cSCC. In the present review, we provide recommendations for patient classification and staging based on current guidelines, direction for determining patient eligibility for surgery and RT, and an overview of the available systemic treatment options for advanced cSCC and of the benefits of a multidisciplinary approach to patient management.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Sarclisa (isatuximab-irfc) / Sanofi
[VIRTUAL] Targeting CD38 and PD-1 with isatuximab (Isa) plus cemiplimab (Cemi) in patients (pts) with advanced malignancies: Results from a Phase 1/2 open-label, multicenter study () - Mar 11, 2021 - Abstract #AACR2021AACR_3406; P1/2 In the present review, we provide recommendations for patient classification and staging based on current guidelines, direction for determining patient eligibility for surgery and RT, and an overview of the available systemic treatment options for advanced cSCC and of the benefits of a multidisciplinary approach to patient management. The present study suggests that CD38 and PD-1 modulation by Isa+Cemi has a manageable safety profile, reduces CD38+ immune cells in the TME, and activates peripheral T cells; however, this was not associated with significant antitumor activity in these small cohorts of mCRPC and NSCLC pts.
- |||||||||| nezastomig (REGN5678) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date, Combination therapy, IO biomarker, Metastases: A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors (clinicaltrials.gov) - Mar 10, 2021 P1/2, N=129, Recruiting, Pathological response data support larger trials to identify optimal clinical endpoints that correlate with improvement in survival, and to establish the utility and safety of perioperative PD-1 blockade. Trial completion date: Sep 2025 --> Jun 2024 | Trial primary completion date: Sep 2025 --> Jun 2024
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal, Checkpoint inhibition, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Immune Checkpoint Blockade in Advanced Cutaneous Squamous Cell Carcinoma: What Do We Currently Know in 2020? (Pubmed Central) - Mar 5, 2021 In this review, we focus on the differences between cSCC and cutaneous melanoma (CM) and their implications on therapy, summarize the current evidence on ICB for the treatment of advanced cSCC and discuss the chances and pitfalls of this therapy option for this cancer entity. Furthermore, we focus on special subgroups of interest such as organ transplant recipients, patients with hematologic malignancies, XP and field cancerization.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Biomarker, Review, Journal, Tumor microenvironment: The Tumor Microenvironment in SCC: Mechanisms and Therapeutic Opportunities. (Pubmed Central) - Feb 27, 2021 This review will highlight the mechanisms by which the immune checkpoint molecules regulate the tumor microenvironment (TME), as well as the ongoing clinical trials that are employing single or combinatory therapeutic approaches for SCC immunotherapy. We also discuss the regulation of additional pathways that might promote superior therapeutic efficacy, and consequently provide increased survival for those patients that do not benefit from the current checkpoint inhibitor therapies.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, SAR439459 / Sanofi
Enrollment open, IO biomarker, Metastases: SAR439459 and Cemiplimab for the Treatment of Advanced or Unresectable Solid Tumors, Strategic Alliance, TACTIC TRIAL (clinicaltrials.gov) - Feb 25, 2021 P1b, N=40, Recruiting, Pruritus was found in 25/181 patients in this series; only in 6/25 patients no potential cause other than ICI could be found, and pruritus was not associated with differences in survival. Not yet recruiting --> Recruiting
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Cutaneous Squamous Cell Carcinoma: From Pathophysiology to Novel Therapeutic Approaches. (Pubmed Central) - Feb 13, 2021 Extensive studies of cSCC pathogenic mechanisms identified several pharmaceutical targets and allowed the development of new systemic therapies, including immunotherapy with immune checkpoint inhibitors, such as Cemiplimab, and epidermal growth factor receptor inhibitors for metastatic and locally advanced cSCC. Furthermore, the implementation of prevention measures has been useful in patient management.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: Immune Checkpoint Inhibitor-Related Pulmonary Toxicity: Focus on Nivolumab. (Pubmed Central) - Feb 11, 2021 Ipilimumab targets cytotoxic T lymphocyte-associated antigen 4...These complications include dyspnea, pneumonitis, pleural effusion, pulmonary sarcoidosis, pulmonary tuberculosis, acute fibrinous organizing pneumonia, organizing pneumonia, eosinophilic pneumonia, adult respiratory distress syndrome, and lung cavitation. Clinicians must be aware of these toxicities and mindful when prescribing these medications in patients with known lung dysfunction due to chronic lung diseases or lung cancer.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal, Checkpoint inhibition: Identifying and treating candidates for checkpoint inhibitor therapies in multiple myeloma and lymphoma. (Pubmed Central) - Feb 4, 2021 The authors reviewed articles on the topic on PubMed and relevant clinical trials on clinicaltrials.gov before October 2019.Expert opinion: So far, nivolumab and pembrolizumab have been approved for treating patients with relapsed/refractory classical Hodgkin lymphoma and primary mediastinal B cell lymphoma...Although the combination of PD-1/PD-L1 inhibitors with immunomodulatory agents initially seemed promising, unexpected immune related toxicities have stopped any further development. Novel strategies and more potent combinations in myeloma and lymphoma are further discussed in the manuscript.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Double the Battle: Two Cases of Irreversible Endocrinopathies in Patients Already Fighting Metastatic Cancer. (On-Demand) - Feb 2, 2021 - Abstract #ENDO2021ENDO_2178; ICIs are categorized as target programmed death-1 receptor inhibitors (PD-1) nivolumab, pembrolizumab, cemiplimab, programmed death-ligand 1 inhibitors (PDL1) atezolizumab, avelumab, durvalumab and cytotoxic T-lymphocyte associated protein-4 (CTLA-4) iplimumab...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
- |||||||||| Hiltonol (poly-ICLC) / Oncovir
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1 (clinicaltrials.gov) - Feb 1, 2021 P1/2, N=7, Terminated, The administrative responsibilities have been met with extraordinary challenges. Current funding does not match the incurring costs.
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