- |||||||||| Sarclisa (isatuximab-irfc) / Sanofi
Trial completion date: A Study of Isatuximab-based Therapy in Participants With Lymphoma (clinicaltrials.gov) - Sep 28, 2021 P1/2, N=130, Active, not recruiting, Cemiplimab may offer improvements in survival for advanced cutaneous squamous cell carcinoma patients compared with existing systemic therapies. Trial completion date: May 2022 --> Oct 2022
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Emerging Cardiovascular Side Effects of Selective and Non-Selective Immunotherapies in Cancer Patients: 2021 Results from the Global WHO Database (ePosters) - Sep 24, 2021 - Abstract #AHA2021AHA_319; Based on the records obtained to-date, a total of 6,000 cardiovascular ADRs caused by ICIs (Ipilimumab, Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Avelumab and Durvalumab), and 500 ADRs by ACTs (Kymriah, Yescarta, Tecartus, Brevanzi and Abecma) have been reported. Using a large-scale global WHO data platform, we have identified unique tendencies for cardiovascular ADRs resulting from non-selective (ICIs) and highly-selective (ACTs) immunotherapies for cancer: the former is associated with serious autoimmune effects, and the latter is associated with acute cytokine-release-related ADRs.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, Sarclisa (isatuximab-irfc) / Sanofi
Enrollment open: ICING: Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy (clinicaltrials.gov) - Sep 23, 2021 P2, N=37, Recruiting, Using a large-scale global WHO data platform, we have identified unique tendencies for cardiovascular ADRs resulting from non-selective (ICIs) and highly-selective (ACTs) immunotherapies for cancer: the former is associated with serious autoimmune effects, and the latter is associated with acute cytokine-release-related ADRs. Not yet recruiting --> Recruiting
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono
Successive treatment with radiation and immunotherapy results in tumor remission in a patient with advanced CSCC (Stream 5) - Sep 20, 2021 - Abstract #ADO2021ADO_211; Results : Already one month after starting PD-1 therapy with Cemiplimab, an incipient improvement in the findings and a significant improvement in the general condition could be determined...Conclusion : The successive combination of radiation therapy and PD-1 therapy can represent a valuable treatment option for advanced CSCC. The case underlines the relevance of the close interdisciplinary collaboration between dermatology, radiation oncology and internal oncology in order to achieve a successful therapy.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Development of a thoracic sarcoid response associated with a complete response to anti-PD-1 therapy in a patient with advanced cutaneous squamous cell carcinoma (Stream 5) - Sep 20, 2021 - Abstract #ADO2021ADO_210; On the basis of a medical hardship application, treatment with pembrolizumab was initiated...At this point, the patient was switched to cemiplimab, which, in the meantime, had become available in Germany...In conclusion, we describe, for the first time, the case of a patient with advanced cSCC who developed disseminated thoracic SRs which were associated with dramatic regression of tumor masses. Thus, as with other irAEs, development of SRs might be indicative of an anti-tumor response to anti-PD-1 therapy.
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Cemiplimab is a new option in BCC. (Pubmed Central) - Sep 15, 2021 Last but not least, the patient must be informed that his underlying neurological disease can rapidly worsen and that a lethal course is also possible. No abstract available
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Review, Journal: Immunotherapy for the Treatment of Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - Sep 14, 2021 Subsequently, the anti-PD-1 pembrolizumab received the approval for the treatment of advanced CSCC by the FDA only. In this review, we will focus on the definition of advanced CSCC and on the current and future therapeutic options, with a particular regard for immunotherapy.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial initiation date, Trial primary completion date: Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov) - Sep 13, 2021 P2, N=44, Not yet recruiting, In this review, we will focus on the definition of advanced CSCC and on the current and future therapeutic options, with a particular regard for immunotherapy. Trial completion date: Jun 2024 --> Jun 2025 | Initiation date: Aug 2021 --> Nov 2021 | Trial primary completion date: Jun 2024 --> Jun 2025
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS
Journal: Incidence and Risk of Colitis With Programmed Death 1 Versus Programmed Death Ligand 1 Inhibitors for the Treatment of Cancer. (Pubmed Central) - Sep 4, 2021 We also conducted subgroup meta-analyses of non-small cell lung cancer (NSCLC) or urothelial carcinoma (UC) trials, and a network meta-analysis of randomized trials comparing PD-1 or PD-L1 inhibitors with docetaxel for NSCLC...The reporting odds ratio of colitis with PD-1 versus PD-L1 inhibitors was 1.80 (95% CI; 1.53-2.14). In this meta-analysis of clinical trials exploring PD-1 and PD-L1 inhibitors in solid tumors, PD-1 inhibitors were associated with a higher risk of colitis.
- |||||||||| Biomarker, Trial completion date, Trial primary completion date: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Aug 27, 2021
P2, N=4000, Recruiting, In this meta-analysis of clinical trials exploring PD-1 and PD-L1 inhibitors in solid tumors, PD-1 inhibitors were associated with a higher risk of colitis. Trial completion date: Dec 2026 --> Dec 2031 | Trial primary completion date: Dec 2025 --> Dec 2030
- |||||||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, Journal: Drug-Associated Eosinophilic Fasciitis: A Case of Eosinophilic Fasciitis Secondary to Cemiplimab Therapy. (Pubmed Central) - Aug 25, 2021 The patient continued cemiplimab therapy for approximately 1 year and was subsequently transitioned to carboplatin and radiation therapy...Cemiplimab was held and the patient was treated with hydroxychloroquine, prednisone, and sulfasalazine...CONCLUSIONS Eosinophilic fasciitis is a rare but important adverse effect of immune checkpoint inhibitors. Individuals receiving immunotherapy should be monitored closely for symptoms of eosinophilic fasciitis, as prompt treatment is essential to prevent long-term complications.
- |||||||||| Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab) / Sanofi, Regeneron, Erivedge (vismodegib) / Roche
Journal, PD(L)-1 Biomarker, IO biomarker: Known and new facts on basal cell carcinoma. (Pubmed Central) - Aug 20, 2021 The hedgehog inhibitors vismodegib and sonidegib are currently approved for systemic therapy of BCC in Europe. Approval for the PD1 inhibitor cemiplimab as second-line therapy is expected in the near future.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion date, Trial primary completion date: CONTRAC: Cemiplimab in AlloSCT/SOT Recipients With CSCC (clinicaltrials.gov) - Aug 18, 2021 P1, N=12, Recruiting, Trial primary completion date: Oct 2023 --> Jun 2022 Trial completion date: Jul 2022 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2022
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