- |||||||||| 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.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
P2 data, Clinical Trial,Phase II, Journal: Neoadjuvant cemiplimab for resectable hepatocellular carcinoma: a single-arm, open-label, phase 2 trial. (Pubmed Central) - Mar 1, 2022 P2 This report is, to our knowledge, the largest clinical trial of a neoadjuvant anti-PD-1 monotherapy reported to date in hepatocellular carcinoma. The observed pathological responses to cemiplimab in this cohort support the design of larger trials to identify the optimal treatment duration and definitively establish the clinical benefit of preoperative PD-1 blockade in patients with hepatocellular carcinoma.
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Attitudes among dermatologists regarding non-melanoma skin cancer treatment options. (Pubmed Central) - Feb 25, 2022 However, for locally advanced and metastatic forms of basal and squamous cell carcinoma, Hedgehog Pathway Inhibitors and anti- Programmed cell death protein antibody treatment, respectively, were used in line with the newest evolution of therapies regarding this topic. Considering the importance of skin cancers and its progressive increase in incidence, it is crucial to improve the knowledge of different therapeutic approaches among dermatologists.
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Tumor Mutational Burden, IO biomarker: Immunotherapy for Non-melanoma Skin Cancer. (Pubmed Central) - Feb 22, 2022 Immunotherapy is emerging as the standard of care for several advanced NMSCs not amenable to surgery and radiation. Ongoing evaluation of the clinical trial landscape is needed to optimize enrollment and ensure continued innovation.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed, Enrollment change, Trial primary completion date: Cemiplimab-rwlc for Unresectable Locally Recurrent and/or Metastatic CSCC (clinicaltrials.gov) - Feb 21, 2022 P2, N=3, Active, not recruiting, Active, not recruiting --> Terminated Recruiting --> Active, not recruiting | N=27 --> 3 | Trial primary completion date: Jan 2022 --> Nov 2022
- |||||||||| Libtayo (cemiplimab) / Regeneron
Biomarker, Journal, PD(L)-1 Biomarker, IO biomarker: Survival with Cemiplimab in Recurrent Cervical Cancer. (Pubmed Central) - Feb 19, 2022 P3 Survival was significantly longer with cemiplimab than with single-agent chemotherapy among patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. (Funded by Regeneron Pharmaceuticals and Sanofi; EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 ClinicalTrials.gov number, NCT03257267.).
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Update on Management Recommendations for Advanced Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Feb 16, 2022 The anti-PD-1 agent cemiplimab is currently the only FDA/EMA-approved first-line therapy for patients with locally advanced or metastatic cSCC who are not candidates for curative surgery or RT. Given the likelihood of recurrence and the increased risk of developing multiple cSCC, close follow-up should be performed during the first years of treatment and continued long-term surveillance is warranted.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Journal, Checkpoint inhibition: Immune checkpoint inhibitors for advanced or metastatic basal cell carcinoma: how much evidence do we need? (Pubmed Central) - Feb 15, 2022 Immune checkpoint inhibitors have been assessed in melanoma and other cutaneous tumors, and very recently an anti-PD1 was approved for advanced BCC. In this paper, available data are reviewed on experimental and preclinical studies evaluating immunotherapy in BCC, as well as on the clinical evidence supporting the efficacy and safety of immune checkpoint inhibitors for advanced or metastatic BCC based on case reports, case series and clinical trials.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), balstilimab (AGEN2034) / Agenus, Recepta
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Current and emerging immunotherapies for recurrent cervical cancer. (Pubmed Central) - Feb 11, 2022 This review discusses the KEYNOTE-158 and KEYNOTE-826 trials of pembrolizumab, along with the EMPOWER CERVICAL 1 (R2810-ONC-1676/GOG 3016/ENGOT cx9) trial of cemiplimab and a phase 3 trial of balstilimab in cervical cancer. It also discusses the rationale for the use of immunotherapy in the cervical cancer setting, the mechanisms of action of available and currently studied immunotherapies, biomarkers for predicting and assessing response to treatment, and mechanisms of secondary tumoral escape or resistance to immunotherapy.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
IMMUNE RESPONSES FOLLOWING ANTI-PD-1 MONOCLONAL ANTIBODY INFUSION IN PERSONS WITH HIV ([VIRTUAL]) - Feb 7, 2022 - Abstract #CROI2022CROI_833; We evaluated multiple immunologic parameters following infusion of cemiplimab, an anti-PD1 monoclonal antibody, in ART-suppressed persons with HIV (PWH) in ACTG A5370...The benefits of this therapeutic strategy for HIV remission should be weighed against the potential for irAE. ?
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: A Vaccine (VSV-hIFN?-NIS) with or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma (clinicaltrials.gov) - Feb 7, 2022 P1, N=65, Recruiting, ? Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022
- |||||||||| ASP8374 / Astellas
Enrollment open: ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - Feb 6, 2022 P1, N=24, Recruiting, Trial completion date: Dec 2021 --> Dec 2023 | Trial primary completion date: Dec 2021 --> Dec 2022 Not yet recruiting --> Recruiting
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Immunotherapy Response in Cutaneous Squamous Cell Carcinoma Patients With Cranial Nerve Involvement (JW Marriott Phoenix Desert Ridge Resort and Spa - Grand Canyon 6-8) - Feb 6, 2022 - Abstract #MHNCS2022MHNCS_223; All patients treated with IO alone demonstrated a clinical response, indicating IO can be an effective monotherapy. Given the challenges of RT with extensive perineural invasion, RT can be reserved in the event of local failure after IO.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Cemiplimab (PD-1 inhibitor) Induced Rash and Mucositis () - Feb 4, 2022 - Abstract #AAAAI2022AAAAI_1483; Although similar mucocutaneous symptoms have been reported in the literature with other immune-checkpoint inhibitors, this is the first reported case of cemiplimab-induced rash and mucositis. This case illustrates the importance of timely recognition of potential mucocutaneous symptoms associated with immune checkpoint inhibitors such as cemiplimab, in order to avoid delays in diagnosis and initiate appropriate treatment.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Trial initiation date: CEMangio: Cemiplimab for Secondary Angiosarcomas (clinicaltrials.gov) - Feb 3, 2022 P2, N=18, Recruiting, The oculofacial plastic surgeon plays a pivotal role - in diagnosis, coordination of interdisciplinary management, thoughtful surgical reconstruction, and postoperative surveillance. Not yet recruiting --> Recruiting | Initiation date: Oct 2021 --> Jan 2022
- |||||||||| Review, Journal: Investigative Landscape in Advanced Non-Melanoma Skin Cancers. (Pubmed Central) - Feb 1, 2022
Current clinical trials are continuing to evaluate the use of immune checkpoint inhibitors and hedgehog pathway inhibitors. There is further need for ongoing research and development of new therapies in both malignancies.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
Enrollment open, Trial completion date, Trial primary completion date, IO biomarker: LAG3 PET Imaging in Advanced Solid Tumors (clinicaltrials.gov) - Feb 1, 2022 P1/2, N=38, Recruiting, There is further need for ongoing research and development of new therapies in both malignancies. Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Sep 2024 | Trial primary completion date: Jan 2024 --> Sep 2024
- |||||||||| ASP8374 / Astellas
Enrollment change: ASP8374 + Cemiplimab in Recurrent Glioma (clinicaltrials.gov) - Feb 1, 2022 P1, N=24, Not yet recruiting, Not yet recruiting --> Recruiting | Trial completion date: Jan 2024 --> Sep 2024 | Trial primary completion date: Jan 2024 --> Sep 2024 N=65 --> 24
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, PK/PD data, Journal: Population pharmacokinetic characteristics of cemiplimab in patients with advanced malignancies. (Pubmed Central) - Jan 29, 2022 P1, P2 Similarity in observed cemiplimab exposure at the fixed 350 mg Q3W and the weight-based 3 mg/kg Q2W dose regimens confirmed this fixed dose selection. A robust PopPK model was developed to describe cemiplimab concentrations and supported use of the fixed 350 mg Q3W IV dose regimen.
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