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1 Disease |  |
67 Trials |
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67 Trials |  |
1555 News |  |
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- ||||| Libtayo (cemiplimab-rwlc) / Regeneron, dalmitamig (REGN7075) / Regeneron
New P1/2 trial: COMBINE-EGFR-1: A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers (clinicaltrials.gov) - Nov 11, 2020
P1/2, N=312, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- || Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open: Plerixafor and Cemiplimab in Metastatic Pancreatic Cancer (clinicaltrials.gov) - Nov 8, 2020
P2, N=21, Recruiting, Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Not yet recruiting --> Recruiting
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] LIBTAYO (cemiplimab), a new horizon for patients with nonmelanoma skin cancers (PLATFORM 2) - Nov 2, 2020 - Abstract #RNCO2020RNCO_212;
- ||| Akalux (cetuximab sarotalocan) / Rakuten Medical
Enrollment open, Enrollment change: An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination with Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors (clinicaltrials.gov) - Oct 28, 2020
P1b/2, N=74, Recruiting, Sponsor: Rakuten Medical, Inc.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | N=54 --> 74
- | Bavencio (avelumab) / EMD Serono, Pfizer, Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Immunologic Characteristics of Nonmelanoma Skin Cancers: Implications for Immunotherapy. (Pubmed Central) - Oct 27, 2020
Specifically, pembrolizumab and avelumab are U.S. Food and Drug Administration-approved for treatment of metastatic MCC and cemiplimab for metastatic CSCC. Several ongoing trials are investigating novel immunotherapies (monotherapies as well as combination) for treatment of NMSCs.
- Libtayo (cemiplimab) / Sanofi, Regeneron, INO-9012 / Inovio, INO-5401 / Inovio
[VIRTUAL] INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma () - Oct 24, 2020 - Abstract #SNO2020SNO_268;
P1/2
Overall survival is encouraging. Clinical trial information: NCT03491683.
- Ad-RTS-hIL-12 / Ziopharm, Precigen, Libtayo (cemiplimab) / Sanofi, Regeneron, veledimex (INXN-1001) / Ziopharm
[VIRTUAL] Phase 2 Trial of Controlled IL-12 in Combination with PD-1 Inhibitor in Adult Subjects with Recurrent Glioblastoma (rGBM) () - Oct 24, 2020 - Abstract #SNO2020SNO_20;
P2
Ad-RTS-hIL-12 (Ad) is a gene therapy candidate for intratumoral (IT) delivery that conditionally expresses IL-12 (IL-12) under the transcriptional control of orally administered veledimex (V) acting via the RheoSwitch Therapeutic Systemâ gene switch...This phase 2 trial (NCT04006119) in adults with rGBM is evaluating safety and efficacy (overall survival) of Ad + V with pre/post-operative cemiplimab-rwlc (cemi) 350 mg IV, Days -7, 15, then Q3W; Ad single IT injection (2 x 1011 viral particles, day of resection (Day 0) /craniotomy); and V (20 mg PO, Days 0-14)...V crossed the blood-brain barrier to produce functional IL-12. Controlled IL-12 therapy and cemi is a rational combination with initial data consistent with immune-mediated anti-tumor effects with a favorable safety profile.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Combination of Controlled Interleukin-12 Gene Therapy with Immune Checkpoint Blockade in Recurrent Glioblastoma: Updated Results of a Multi-Institutional, Open Label Phase 1 Trial () - Oct 24, 2020 - Abstract #SNO2020SNO_15;
P1
A published clinical trial of veledimex (V)-regulatable interleukin-12 (IL-12) gene therapy (“Controlled IL-12”) under the control of a transcriptional switch (RheoSwitch Therapeutic Systemâ, RTSâ) as monotherapy in recurrent glioblastoma (rGBM) showed sustained infiltration of activated T cells within the tumor months after treatment (Sci Transl Med...These T cells demonstrated up-regulation of immune checkpoint signaling, providing a rationale for combination therapy with the PD-1 inhibitor, nivolumab (nivo)...Baseline and post-treatment histochemical staining and multiplex immunofluorescence analyses for a subgroup of subjects will be discussed. The safety of this combination immunotherapy has been established, leading to a currently accruing phase 2 clinical trial of loco-regional Controlled IL-12 gene therapy in combination with the PD-1 inhibitor cemiplimab-rwlc (NCT 04006119).
- Libtayo (cemiplimab) / Sanofi, Regeneron, Pexa-Vec (pexastimogene devacirepvec) / SillaJen, Transgene
[VIRTURL] Correlation of virus-specific CD8+ T cells to clinical response following treatment with Pexa-Vec and Cemiplimab in patients with advanced renal cell carcinoma () - Oct 24, 2020 - Abstract #SITC2020SITC_1870;
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Successful Clinical Application of Intratumoral Injection of Influenza Vaccine to Sensitize Metastatic Cutaneous Squamous Cell Carcinoma to Cemiplimab and Radiotherapy () - Oct 23, 2020 - Abstract #ASDS2020ASDS_263;
The influenza vaccine is priced at less than US $100, while the cost for a course of TVEC is approximately US $65,000. Formal studies are needed evaluating the clinical efficacy of intratumoral injection of Flubok Quadrivalent recombinant influenza vaccine in CSCCs as well as other tumors.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Persistent Development of in Situ and Early Invasive Cutaneous Squamous Cell Carcinomas (cSCC) in Patients on Successful PD1 Inhibitor Therapy for Locally Advanced cScc () - Oct 23, 2020 - Abstract #ASDS2020ASDS_247;
In September of 2018, the anti-programmed cell death protein 1 (PD-1) antibody, cemiplimab, received an indication for advanced cSCC...T cell recruitment in the subcutaneous tissue is superior to that in the epidermis and upper to mid dermis. This effect could be attributed to local immunosuppressive factors in the more superficial compartments of the skin that are not present in subcutaneous tissue.
- || Sarclisa (isatuximab-irfc) / Sanofi
Enrollment closed, Trial completion date, Trial primary completion date: A Study of Isatuximab-based Therapy in Participants With Lymphoma (clinicaltrials.gov) - Oct 20, 2020
P1/2, N=130, Active, not recruiting, Sponsor: Sanofi
This effect could be attributed to local immunosuppressive factors in the more superficial compartments of the skin that are not present in subcutaneous tissue. Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Nov 2023 | Trial primary completion date: May 2023 --> Nov 2023
- ||| REGN6569 / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open: Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - Oct 19, 2020
P1, N=75, Recruiting, Sponsor: Regeneron Pharmaceuticals
Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Nov 2023 | Trial primary completion date: May 2023 --> Nov 2023 Not yet recruiting --> Recruiting
- ||||| ubamatamab (REGN4018) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron, REGN5668 / Regeneron
New P1/2 trial: R5668-ONC-1938: A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018 (clinicaltrials.gov) - Oct 19, 2020
P1/2, N=290, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Characterizing severe acute kidney injury in patients treated with immune checkpoint inhibitors () - Oct 14, 2020 - Abstract #SITC2020SITC_1664;
A further 8.7% of patients experienced other irAEs with AKI, suggesting that the true prevalence of immune-related nephritis is likely underdiagnosed. Notably, 84.8% of patients who develop AKI after ICI therapy have a non-ICI-related etiology, and no patient in our cohort of 46 patients underwent renal biopsy, highlighting the need for blood-based biomarker development for immune-related nephritis.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Interim analysis of Phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma (mBCC) who progressed on or are intolerant to hedgehog inhibitors (HHIs) () - Oct 14, 2020 - Abstract #SITC2020SITC_1458;
P2
The study was conducted in accordance with the principles of the Declaration of Helsinki and with Good Clinical Practice guidelines as defined by the International Conference on Harmonization. All patients provided written informed consent before enrollment.
- Keytruda (pembrolizumab) / Merck (MSD), cavrotolimod (AST-008) / Exicure
[VIRTUAL] Safety and preliminary efficacy of intratumoral cavrotolimod (AST-008), a spherical nucleic acid TLR9 agonist, in combination with pembrolizumab in patients with advanced solid tumors () - Oct 14, 2020 - Abstract #SITC2020SITC_1454;
P1b/2
Conclusions IT administration of cavrotolimod appears to be safe and well tolerated in combination with pembrolizumab. Durable responses have occurred in patients previously experiencing progressive disease on PD-1 blockade.
- SAR441000 / Sanofi, BioNTech, Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] A first-in-human study of intratumoral SAR441000, an mRNA mixture encoding IL-12sc, interferon alpha2b, GM-CSF and IL-15sushi as monotherapy and in combination with cemiplimab in advanced solid tumors () - Oct 14, 2020 - Abstract #SITC2020SITC_1422;
These data support further clinical evaluation of SAR441000. Ethics Approval The study was approved by each participating Institution’s Ethics or Institutional Review Board(s).
- Libtayo (cemiplimab) / Sanofi, Regeneron, Pexa-Vec (pexastimogene devacirepvec) / SillaJen, Transgene
[VIRTUAL] Correlation of virus-specific CD8+ T cells to clinical response following treatment with Pexa-Vec and Cemiplimab in patients with advanced renal cell carcinoma () - Oct 14, 2020 - Abstract #SITC2020SITC_1298;
P1b
In addition, 10-day expansion of low levels of OV-specific circulating T cells can amplify signals in ELISPOT analysis and might enable systemic tracking of patient responses in blood samples collected at early time points. The observed CD8+ T cell response to oncolytic vaccinia virus in patients supports the rationale for combination treatment with Pexa-Vec and immune checkpoint inhibitors.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Characterizing severe acute kidney injury in patients treated with immune checkpoint inhibitors () - Oct 14, 2020 - Abstract #SITC2020SITC_929;
A further 8.7% of patients experienced other irAEs with AKI, suggesting that the true prevalence of immune-related nephritis is likely underdiagnosed. Notably, 84.8% of patients who develop AKI after ICI therapy have a non-ICI-related etiology, and no patient in our cohort of 46 patients underwent renal biopsy, highlighting the need for blood-based biomarker development for immune-related nephritis.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Interim analysis of Phase 2 results for cemiplimab in patients with metastatic basal cell carcinoma (mBCC) who progressed on or are intolerant to hedgehog inhibitors (HHIs) () - Oct 14, 2020 - Abstract #SITC2020SITC_723;
P2
The study was conducted in accordance with the principles of the Declaration of Helsinki and with Good Clinical Practice guidelines as defined by the International Conference on Harmonization. All patients provided written informed consent before enrollment.
- Keytruda (pembrolizumab) / Merck (MSD), cavrotolimod (AST-008) / Exicure
[VIRTUAL] Safety and preliminary efficacy of intratumoral cavrotolimod (AST-008), a spherical nucleic acid TLR9 agonist, in combination with pembrolizumab in patients with advanced solid tumors () - Oct 14, 2020 - Abstract #SITC2020SITC_719;
P1b/2
Conclusions IT administration of cavrotolimod appears to be safe and well tolerated in combination with pembrolizumab. Durable responses have occurred in patients previously experiencing progressive disease on PD-1 blockade.
- SAR441000 / Sanofi, BioNTech, Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] A first-in-human study of intratumoral SAR441000, an mRNA mixture encoding IL-12sc, interferon alpha2b, GM-CSF and IL-15sushi as monotherapy and in combination with cemiplimab in advanced solid tumors () - Oct 14, 2020 - Abstract #SITC2020SITC_687;
These data support further clinical evaluation of SAR441000. Ethics Approval The study was approved by each participating Institution’s Ethics or Institutional Review Board(s).
- Libtayo (cemiplimab) / Sanofi, Regeneron, Pexa-Vec (pexastimogene devacirepvec) / SillaJen, Transgene
[VIRTUAL] Correlation of virus-specific CD8+ T cells to clinical response following treatment with Pexa-Vec and Cemiplimab in patients with advanced renal cell carcinoma () - Oct 14, 2020 - Abstract #SITC2020SITC_563;
P1b
In addition, 10-day expansion of low levels of OV-specific circulating T cells can amplify signals in ELISPOT analysis and might enable systemic tracking of patient responses in blood samples collected at early time points. The observed CD8+ T cell response to oncolytic vaccinia virus in patients supports the rationale for combination treatment with Pexa-Vec and immune checkpoint inhibitors.
- | Biomarker, Phase classification, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Oct 14, 2020
P1, N=4000, Recruiting, Sponsor: QuantumLeap Healthcare Collaborative
The observed CD8+ T cell response to oncolytic vaccinia virus in patients supports the rationale for combination treatment with Pexa-Vec and immune checkpoint inhibitors. Phase classification: P2 --> P1
- Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] PREDICTORS OF IMMUNOTHERAPY (IO) RESPONSE AND SUBSEQUENT TYROSINE KINASE INHIBITOR (TKI) RESPONSE IN HEPATOCELLULAR CARCINOMA (HCC). () - Oct 11, 2020 - Abstract #AASLD2020AASLD_1164;
Disease control from tumor shrinkage or stable disease, development of immune mediated toxicity, and subsequent TKI use after IO are independent predictors for prolonged OS and PFS in HCC pts receiving IO therapy. Abnormal TSH during IO treatment tended toward improved mOS.
- | Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 2. Treatment. (Pubmed Central) - Oct 9, 2020
Second-line systemic treatments for advanced cSCC include epidermal growth factor receptor inhibitors (cetuximab) combined with chemotherapy or radiation therapy...Patients should be engaged with informed decisions on management and be provided with best supportive care to optimise symptom management and improve quality of life. Frequency of follow-up visits and investigations for subsequent new cSCC depend on underlying risk characteristics.
- ||| Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal, Adverse events, Checkpoint inhibition: Management of the Adverse Effects of Immune Checkpoint Inhibitors. (Pubmed Central) - Oct 8, 2020
The identification and treatment of irAEs in the early stages may allow patients to resume therapy with ICPI. This review is an instrument to support healthcare professionals involved in the treatment and monitoring of patients who are administered ICPI, contributing to the timely identification and management of irAEs.
- ||||| Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment closed, PD(L)-1 Biomarker: EMPOWER-Lung 3: Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer (clinicaltrials.gov) - Oct 7, 2020
P3, N=790, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
This review is an instrument to support healthcare professionals involved in the treatment and monitoring of patients who are administered ICPI, contributing to the timely identification and management of irAEs. Recruiting --> Active, not recruiting
- || Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, Journal: CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. (Pubmed Central) - Oct 7, 2020
P=N/A
CemiplimAb-rwlc Survivorship and Epidemiology (CASE) is a prospective Phase IV, noninterventional, survivorship and epidemiology study that will enroll patients with advanced CSCC who have recently initiated or who plan to receive cemiplimab in a real-world setting. Trial registration number: NCT03836105.
- Libtayo (cemiplimab-rwlc) / Regeneron, Aphexda (motixafortide) / BioLineRx, Ayrmid
Enrollment open, Checkpoint inhibition: Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma (clinicaltrials.gov) - Oct 4, 2020
P2, N=10, Recruiting, Sponsor: Gulam Manji
Trial registration number: NCT03836105. Not yet recruiting --> Recruiting
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Cemiplimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma in Italy- A Budget Impact Analysis () - Oct 3, 2020 - Abstract #ISPOREU2020ISPOR-EU_343;
Not yet recruiting --> Recruiting Cemiplimab in Italy can improve outcomes for aCSCC patients with limited economic impact for the SSN.
- | Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / Ono Pharma, BMS
Journal, PARP Biomarker, PD(L)-1 Biomarker, IO Biomarker: Novel Therapeutics for Recurrent Cervical Cancer: Moving Towards Personalized Therapy. (Pubmed Central) - Oct 3, 2020
Additional checkpoint inhibitors including nivolumab, durvalumab, atezolizumab, and camrelizumab are in different stages of clinical development for the disease. Finally, an additional targeted approach being pursued involves PARP inhibitors (rucaparib and olaparib are both in Phase II) based on earlier study results.
- ||| Libtayo (cemiplimab) / Sanofi, Regeneron
Nuevos datos de @SanofiES sobre cemiplimab en #carcinoma basocelular #ESMO2020 - https://t.co/iuYcQ0VQ09 (Twitter) - Oct 2, 2020
- | Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Checkpoint inhibition, Tumor mutational burden: A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer (clinicaltrials.gov) - Oct 1, 2020
P2, N=34, Recruiting, Sponsor: University of Southern California
Finally, an additional targeted approach being pursued involves PARP inhibitors (rucaparib and olaparib are both in Phase II) based on earlier study results. Not yet recruiting --> Recruiting
- || cavrotolimod (AST-008) / Exicure, Bluejay Therap
Trial completion date, Trial primary completion date, PD(L)-1 Biomarker, IO biomarker: Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors (clinicaltrials.gov) - Sep 29, 2020
P1b/2, N=130, Recruiting, Sponsor: Exicure, Inc.
Not yet recruiting --> Recruiting Trial completion date: Sep 2021 --> Jun 2023 | Trial primary completion date: Jun 2021 --> Dec 2021
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
#ESMO20 | Sono stati presentati i dati dello Studio EMPOWER-Lung 1 su cemiplimab in monoterapia in prima linea per i pazienti con NSCLC avanzato con PD-L1 ≥50%. Ce li illustra e commenta @marinagarassino. https://t.co/E6LRuDGNrI (Twitter) - Sep 28, 2020
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] EMPOWER-Lung 1-Phase III first-line (1L) cemiplimab monotherapy vs platinum-doublet chemotherapy (chemo) in advanced non-small cell lung cancer (NSCLC) with programmed cell death-ligand 1 (PD-L1) ≥50% (Channel 3) - Sep 24, 2020 - Abstract #ESMOAsia2020ESMO_Asia_224;
P3
and Sanofi. Clinical trial identification: NCT03088540.
- ||||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
Clinical: Following the presentation of Keynote024, as well as EMPOWER-Lung 1 (cemiplimab) and the PIONeeR study (pembrolizumab or atezolizumab), @DrRoyHerbstYale's discussion concluded that immunotherapy could be curative for patients with #NSCLC, but personalisation is key. #ESMO20 (Twitter) - Sep 21, 2020
- ||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Licensing / partnership: Yes, 3 takeaways from @DrRoyHerbstYale discussion of KN-24 5 yr OS, EMPOWER (cemiplimab) @barlesi PIONEER study & at @myESMO #ESMO20 - personalise immunotherapy, targeted immunotherapy & public-private partnerships. Goal: attempting to ‘cure’ metastatic #lungcancer #NSCLC ! #LCSM (Twitter) - Sep 21, 2020
- ||||| Libtayo (cemiplimab) / Sanofi, Regeneron
#ESMO20 EMPOWER trial Cemiplimab vs CT in PDL1+ >50% #lcsm is positive despite some IHC testing issues in initial 235pts, OS HR 0.68 in ITT and 0.57 in PDL1≥50%+, ORR 36.5% ITT and 39.2% PDL1≥50%+ vs 20% in CT arm (Twitter) - Sep 21, 2020
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Clinical: #cemiplimab very similar results to #pembrolizumab. But one question: when the trial started pembro was already a first line. Why the comparator is chemo? @OncoAlert @myESMO (Twitter) - Sep 21, 2020
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] SERIO – Side Effect Registry Immuno‐Oncology () - Sep 20, 2020 - Abstract #ADO2020ADO_422;
The findings will enable an optimized handling of side effects and better patient education regarding the course of adverse events. It also enables a better understanding of the pathogenesis and prediction of rare immune-mediated side effects.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Concomitant chronic lymphocytic leukemia appears to be associated with a poorer response in patients with advanced cutaneous squamous cell carcinoma to immunotherapy with PD-1 antibodies (ePoster Terminal 3) - Sep 20, 2020 - Abstract #ADO2020ADO_347;
Background: The treatment options for advanced or metastatic cutaneous squamous cell carcinoma were limited until the approval of cemiplimab...An 89-year-old immunocompetent patient with a locoregionally metastatic cSCC on the scalp was treated with nivolumab...A 79-year-old patient who also suffered from stable CLL was treated with pembrolizumab for lymph node metastases from a cSCC on the right cheek...A possible cause could be the immunosuppression or dysfunctionality of the cellular immune system in the context of CLL. This hypothesis should be examined further in larger collectives.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Sustained response of a lymphogenically metastatic cutaneous squamous cell carcinoma infiltrating into the orbit and the paranasal sinuses under immunotherapy with the PD-1 antibody cemiplimab (ePoster Terminal 3) - Sep 20, 2020 - Abstract #ADO2020ADO_342;
At the same time, if there was an urgent need for therapy, we initiated radio‐ / chemotherapy with cisplatin 40 mg / m2, which led to an initial stabilization of the findings...Using the newly approved PD-1 antibody cemiplimab saved the patient from having to undergo radical surgery including removal of the eyeball. The therapy significantly expands the range of treatment options for infiltrative growing squamous cell carcinomas with the chance of long-lasting remission and can close a gap in the treatment of pronounced and metastatic findings.
- Opdivo (nivolumab) / Ono Pharma, BMS
[VIRTUAL] Single-center experience in immune checkpoint inhibitor therapy in advanced squamous cell carcinoma (ePoster Terminal 3) - Sep 20, 2020 - Abstract #ADO2020ADO_339;
The good response rates of the approval studies were confirmed in our patient collective. The good tolerance in our patient group should be emphasized.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] CemiSkin - An observational study for patients with advanced cutaneous squamous cell carcinoma (CSCC) treated with cemiplimab or other approaches (ePoster Terminal 3) - Sep 20, 2020 - Abstract #ADO2020ADO_338;
Documentation start in both cohorts is expected in 2020. Supported by Sanofi‐Aventis Deutschland GmbH.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
[VIRTUAL] Myasthenia gravis-like myopathy in a case of metastatic cutaneous squamous cell carcinoma under anti-PD-1 therapy. (ePoster Terminal 3) - Sep 20, 2020 - Abstract #ADO2020ADO_337;
Cemiplimab was paused and systemic steroids with prednisolone 0.5 mg/kg PO Q1D were started...Based on the severe adverse reaction Cemiplimab was switched to epidermal growth factor receptor (EGFR) antibody Cetuximab...The patho‐mechanism of anti‐PD‐1 associated myasthenia gravis‐like myopathy as a rare irAE have not been elucidated in detail so far. Further investigations are needed in order to ameliorate the clinical management of this rare irAE.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] A Phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation in patients with high-risk cutaneous squamous cell carcinoma (CSCC) (ePoster Terminal 3) - Sep 20, 2020 - Abstract #ADO2020ADO_335;
In optional Part 2 (unblinded), patients in the placebo arm who experience disease recurrence or patients in the cemiplimab arm who experience disease recurrence ≥3 months after completion of 48‐week treatment in Part 1 will be eligible to receive open‐label 350 mg Q3W cemiplimab for up to 96 weeks. Key objectives are to compare disease‐free survival (primary) as well as overall survival, freedom from locoregional relapse, and distant relapse (secondary) of adjuvant cemiplimab versus placebo in patients with high‐risk CSCC.
- Libtayo (cemiplimab) / Sanofi, Regeneron
[VIRTUAL] Successful care of very old patients with cemiplimab in daily practice (Stream 4) - Sep 20, 2020 - Abstract #ADO2020ADO_281;
We would like to highlight one case of an 84-year-old patient with concomitant B-CLL who was able to experience a complete remission of a squamous cell carcinoma of the forehead and an extensive parotid metastasis after 6 cycles of cemiplimab. Therapy was terminated after 6 cycles, and the remission lasted 3 months after the end of therapy.