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- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
Regeneron acquires cemiplimab from Sanofi for ~ $1 billion in time for #ASCO22. #LCSM https://t.co/oH2RLTIzdf (Twitter) - Jun 3, 2022
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Just landed at O'Hare to discover $SNY has given up on Libtayo on the eve of #ASCO22. Hm! $REGN (Twitter) - Jun 2, 2022
- |||| Yervoy (ipilimumab) / BMS
New P2 trial: RAD-IO: Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC (clinicaltrials.gov) - Jun 2, 2022
P2, N=54, Not yet recruiting, Sponsor: The Netherlands Cancer Institute
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron, rocakinogene sifuplasmid (INO-9012) / Inovio, INO-5401 / Inovio
Combination therapy: First- @delaFuenteNOnc is a co-author in the oral presentation “Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma”. https://t.co/ckR8MRLpzZ (Twitter) - Jun 1, 2022
- || Retrospective data, Review: Comparative Efficacy and Safety of Anti-PD-1/PD-L1 for the Treatment of Non-Small Cell Lung Cancer: A Network Meta-Analysis of 13 Randomized Controlled Studies. (Pubmed Central) - May 29, 2022
Based on available evidence, cemiplimab may have the most favorable risk-benefit ratio for NSCLC patients compared with other common therapeutic management. However, future research with a large-scale, high-quality, and mature follow-up is needed to further determine which agents should be preferentially selected for NSCLC patients due to the limitations of our NMA and variations of eligible studies in treatment line and PD-L1 status.
- || Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD), Tecentriq (atezolizumab) / Roche
Retrospective data, Review, Journal: First-line treatment options for advanced non-small cell lung cancer patients with PD-L1 ≥ 50%: a systematic review and network meta-analysis. (Pubmed Central) - May 26, 2022
The study suggested that chemotherapy plus ICIs might improve PFS and ORR than single-agent ICIs for advanced NSCLC patients with PD-L1 ≥ 50%. However, it did not lead to OS benefit.
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: PD-1 Blockade With Concurrent Radiotherapy for Locally Advanced Inoperable Cutaneous Squamous Cell Carcinoma. (Pubmed Central) - May 26, 2022
The Cem-RT combination was safe and well tolerated with significant tumor response suggesting Cem-RT may be a viable therapeutic option for LA-cSCC. Our hypothesis generating data support the rationale for future prospective studies.
- RHEUMATOLOGICAL IMMUNE-MEDIATED ADVERSE EVENTS OF IMMUNE CHECKPOINT INHIBITORS BASED ON THE FDA ADVERSE EVENTS REPORTING SYSTEM () - May 24, 2022 - Abstract #EULAR2022EULAR_4370;
The most frequent complaints were unspecific, such as arthralgia, myalgia, or muscle weakness. Arthritis, myositis, Sjogren’s syndrome, and sarcoidosis were also relatively frequent.
- || Review, Journal: Advanced basal cell carcinoma: What dermatologists need to know about treatment. (Pubmed Central) - May 24, 2022
In patients who progress on hedgehog inhibitors or cannot tolerate hedgehog inhibitors, the programmed cell death protein 1 inhibitor cemiplimab can be used to treat locally advanced or metastatic disease. Complex cases of locally advanced or metastatic BCC may be best discussed through a multidisciplinary approach in order to determine the optimal treatment approach for the individual patient.
- ||||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, IO biomarker: CSCC has a high tumor mutational burden. this is classically associated with high response to #immunotherapy. It was logical that these patients would respond to #cemiplimab. #Immunotherapy associated with low % toxicity, high duration of response. (Twitter) - May 20, 2022
- ||| Libtayo (cemiplimab) / Sanofi, Regeneron
Also consider #Immunotherapy with #PD1 inhibitors #cemiplimab is approved in the setting of HHI intolerance. (Twitter) - May 20, 2022
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical: the approval of cemiplimab is in patients not amenable to local measures (radiation or surgery) and not a candidate for hedgehog inhibitors. This patient may be considered based on factors. #PD1 #immunotherapy (Twitter) - May 20, 2022
- ||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical: Are there specific patients for whom you would use cemiplimab as first-line therapy? @OmidHamidMD of @angelesclinic and experts of #SKsm #TargetedChat (Twitter) - May 20, 2022
- ||| Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical: Would you give cemiplimab as frontline therapy for this patient? Why? @OmidHamidMD of @angelesclinic #TargetedChat (Twitter) - May 20, 2022
- || Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical: Would you give cemiplimab as frontline therapy for this patient? (Twitter) - May 19, 2022
- || Libtayo (cemiplimab-rwlc) / Regeneron
New P1 trial: Study of Cemiplimab - TP Induction Chemotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (clinicaltrials.gov) - May 16, 2022
P1, N=24, Not yet recruiting, Sponsor: Krzysztof Misiukiewicz
- | Sarclisa (isatuximab-irfc) / Sanofi
Enrollment change, Trial termination: Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies (clinicaltrials.gov) - May 16, 2022
P1/2, N=44, Terminated, Sponsor: Sanofi
Complex cases of locally advanced or metastatic BCC may be best discussed through a multidisciplinary approach in order to determine the optimal treatment approach for the individual patient. N=134 --> 44 | Completed --> Terminated; The study was stopped after interim analysis indicated that overall result was not sufficient to satisfy per-protocol criteria to move forward in metastatic, castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer (NSCLC) cohorts.
- |||| Libtayo (cemiplimab) / Sanofi, Regeneron
Heterogeneity: Dr. @caliraf gives a nice discussion on cemiplimab and EMPOWER-Lung 3 at the hybrid #RomeLung22. These are encouraging data, though the heterogeneity of histologic subtype dilutes the power to interpret each subtype individually. Another entry in a crowded field. (Twitter) - May 16, 2022
- || Libtayo (cemiplimab) / Sanofi, Regeneron
Clinical, Journal: Maintenance of clinical response after short treatment with cemiplimab for advanced squamous cell carcinoma. (Pubmed Central) - May 15, 2022
N=134 --> 44 | Completed --> Terminated; The study was stopped after interim analysis indicated that overall result was not sufficient to satisfy per-protocol criteria to move forward in metastatic, castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer (NSCLC) cohorts. No abstract available
- | Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Impressive response to four cycles cemiplimab of a sonidegib-resistant giant basosquamous carcinoma of the midface. (Pubmed Central) - May 15, 2022
No abstract available No abstract available
- || Libtayo (cemiplimab) / Sanofi, Regeneron, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker: High-risk cutaneous squamous cell carcinoma (CSCC): Challenges and emerging therapies. (Pubmed Central) - May 14, 2022
The response rate varies based on the patient, although there is still a lack of proof. This article discusses the misconception that CSCC is a tumor with a favorable prognosis, as well as the difficulties in treating high-risk CSCC.
- | Journal, Checkpoint inhibition: Immune-related dissociated response as a specific atypical response pattern in solid tumors with immune checkpoint blockade. (Pubmed Central) - May 14, 2022
Although DR is also associated with treatment efficacy and a favorable prognosis, it is different from pseudoprogression, which has concordant progressive lesions and can be regularly captured by immune RECIST. This review article aims to comprehensively determine the frequency, definition, radiological evaluation, probable molecular mechanisms, prognosis, and clinical management of immune-related DR and help clinicians and radiologists objectively and correctly interpret this specific atypical response and better understand and manage cancer patients with immunotherapy and guarantee their best clinical benefit.
- | Jakafi (ruxolitinib) / Novartis, Incyte, Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Cemiplimab and ruxolitinib in concomitant cutaneous squamous cell carcinoma and myelofibrosis. (Pubmed Central) - May 7, 2022
This review article aims to comprehensively determine the frequency, definition, radiological evaluation, probable molecular mechanisms, prognosis, and clinical management of immune-related DR and help clinicians and radiologists objectively and correctly interpret this specific atypical response and better understand and manage cancer patients with immunotherapy and guarantee their best clinical benefit. No abstract available
- || Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Retrospective data, Review, Journal, Checkpoint inhibition: Immune Checkpoint Inhibitors for Advanced Cutaneous Squamous Cell Carcinoma: A Systematic Review with Meta-Analysis. (Pubmed Central) - May 6, 2022
ICIs demonstrate promising results for LA, LR, and R/M CSCC not amenable to surgery. Endpoints assessing survival and durability of response have not been reached, warranting additional trials exploring neoadjuvant or adjuvant therapy in combination with local treatment.
- | Libtayo (cemiplimab) / Sanofi, Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Journal, CAR T-Cell Therapy, PD(L)-1 Biomarker, IO biomarker: Pressure increases PD-L1 expression in A549 lung adenocarcinoma cells and causes resistance to anti-ROR1 CAR T cell-mediated cytotoxicity. (Pubmed Central) - May 6, 2022
In xenograft mice, pressure preconditioning increases tumorigenesis of A549 cells, which can be blocked by a combined therapy using Pembrolizumab and αROR1-CAR T cells. Together, our studies suggest that elevated pressure in the tumor microenvironment could blunt the T cell therapy by upregulating PD-L1 expression, which could be overcome by combining CAR T therapy with immune checkpoint inhibitors.
- Treatment of immune checkpoint inhibitor-induced inflammatory arthritis and polymyalgia rheumatica (Poster View 10) - May 6, 2022 - Abstract #EULAR2022EULAR_1858;
csDMARDs are effective in a significant proportion of patients. Tocilizumab is highly effective and well tolerated in ICI-induced arthritis.
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Infrequent liver injury from cemiplimab in patients with advanced cutaneous squamous cell carcinoma. (Pubmed Central) - May 6, 2022
Liver injury arising during cemiplimab therapy is mild and infrequent in cSCC patients. Due to its favorable safety profile, cemiplimab should be considered in patients with cSCC and pre-existing liver disease.
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: PD-1 N58-Glycosylation-Dependent Binding of Monoclonal Antibody Cemiplimab for Immune Checkpoint Therapy. (Pubmed Central) - May 6, 2022
These results indicate that both the binding and blocking efficacy of cemiplimab require the N58 glycosylation of PD-1. Taken together, these findings expand our understanding of the significance of PD-1 glycosylation in the interaction with cemiplimab.
- |||||| Libtayo (cemiplimab-rwlc) / Regeneron
New trial: CEMI-LUNG: An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (clinicaltrials.gov) - May 4, 2022
P=N/A, N=300, Not yet recruiting, Sponsor: Sanofi
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Cemiplimab in cutaneous squamous cell carcinomas (SCC): an overview and a clinical case. (Pubmed Central) - May 4, 2022
Taken together, these findings expand our understanding of the significance of PD-1 glycosylation in the interaction with cemiplimab. Immunotherapy is a new therapeutic option in cSCC.
- || BNT111 / BioNTech
Trial completion date, Trial primary completion date: BNT111-01: Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma (clinicaltrials.gov) - May 3, 2022
P2, N=180, Recruiting, Sponsor: BioNTech SE
Immunotherapy is a new therapeutic option in cSCC. Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: May 2022 --> Oct 2024
- | New P1 trial, Checkpoint inhibition, IO biomarker: Exercise to Boost Response to Checkpoint Blockade Immunotherapy (clinicaltrials.gov) - May 2, 2022
P1, N=32, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
- | CP-506 / Convert Pharma
Trial completion date, Trial initiation date, Trial primary completion date, Monotherapy: Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI (clinicaltrials.gov) - May 2, 2022
P1/2, N=126, Not yet recruiting, Sponsor: Maastricht University
Trial completion date: Dec 2023 --> Jun 2025 | Trial primary completion date: May 2022 --> Oct 2024 Trial completion date: Oct 2024 --> Oct 2025 | Initiation date: Oct 2021 --> Jun 2022 | Trial primary completion date: Sep 2024 --> Sep 2025
- || cisplatin / Generic mfg.
Review, Journal, Combination therapy, PD(L)-1 Biomarker, IO biomarker: Application of Approved Cisplatin Derivatives in Combination Therapy against Different Cancer Diseases. (Pubmed Central) - Apr 30, 2022
An important approach for overcoming the drug resistance and reduction of toxicity of Cisplatin derivatives is the application of nanocarriers (polymers and liposomes), which provide improved targeted delivery, increased intracellular penetration, selective accumulation in tumor tissue, and enhanced therapeutic efficacy. The advantages of combination therapy are maximum removal of tumor cells in different phases; prevention of resistance; inhibition of the adaptation of tumor cells and their mutations; and reduction of toxicity.
- First-Line Choice in PD-L1 Positive Patients (Hall C1) - Apr 30, 2022 - Abstract #IASLCWCLC2022IASLC_WCLC_324;
Approved drugs for 1st line treatment: pembrolizumab, atezolizumab and cemiplimab, and nivolumab+ipilimumab. A summary of best treatment choices for NSCLC patients is given including factors that influence the clinical decision making.
- |||||||||| Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
New P3 trial: R3767-ONC-2011: Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma (clinicaltrials.gov) - Apr 28, 2022
P3, N=1100, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- | Libtayo (cemiplimab) / Sanofi, Regeneron
Journal: Benefit with cemiplimab in cervical cancer. (Pubmed Central) - Apr 28, 2022
A summary of best treatment choices for NSCLC patients is given including factors that influence the clinical decision making. No abstract available
- || Voyager-V1 / Vyriad
Trial completion date, Trial primary completion date: Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients (clinicaltrials.gov) - Apr 28, 2022
P2, N=152, Recruiting, Sponsor: Vyriad, Inc.
No abstract available Trial completion date: Mar 2023 --> Mar 2025 | Trial primary completion date: Mar 2022 --> Mar 2024
- Comparative efficacy and safety of immunotherapy for advanced NSCLC: A systematic review and network meta-analysis. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_6306;
In our study, we provide relative comprehensive results for latest researches of first-line ICIs. Overall, Care-Chemo, Pem-Chemo, Sint-Chemo, are prior to be recommended according to our study.
- Libtayo (cemiplimab) / Regeneron, rocakinogene sifuplasmid (INO-9012) / Inovio, INO-5401 / Inovio
Intramuscular (IM) INO-5401 + INO-9012 with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4445;
P1/2
Pre-treatment gene expression signatures in MGMT-unmethylated patients were statistically associated with OS18. Overall, INO-5401 elicits antigen-specific T cells that can infiltrate GBM tumors.
- Libtayo (cemiplimab) / Regeneron, REGN4336 / Regeneron
A phase 1/2 study of REGN4336, a PSMAxCD3 bispecific antibody, alone and in combination with cemiplimab in patients with metastatic castration-resistant prostate cancer. (Available On Demand; 282a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3713;
P1/2, P3
At selected sites, PSMA positron emission tomography/computed tomography scans will be performed at predefined timepoints on study. This study is currently open to enrollment.
- Libtayo (cemiplimab) / Regeneron
A phase II trial of cemiplimab alone or in combination with standard of care chemotherapy in locally advanced or metastatic penile carcinoma (EPIC Trial). (Available On Demand; 276b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3702;
Eligibility includes patients with la/mPC who are candidates for immunotherapy +/- SOC chemotherapy (local UK centre choice of cisplatin/5FU or TPF or TIP regimes)...To date, 4 patients have been recruited from 2 centres with the aim to open all UK centres to recruitment by June 2022. The EPIC trial is NCRN badged.
- Libtayo (cemiplimab) / Regeneron
Cemiplimab in advanced cutaneous squamous cell carcinoma: A real-world experience of outcomes and safety. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3552;
To the best of our knowledge, this is the first real-world outcomes study of advanced cSCC patients treated with cemiplimab in the United States. The overall efficacy, response rate, and safety profile were better in comparison to the results of the EMPOWER-CSCC-1 trial.
- Two checkpoint inhibitor combinations in patients with cutaneous melanoma: A systematic review of clinical trials. () - Apr 28, 2022 - Abstract #ASCO2022ASCO_3543;
In early phase trials, combinations of ipi, nivo, pemb, lag525, spa, fian, and cem were effective in advanced melanoma. Nivo, ipi, and rela were effective in patients with resectable melanoma.
- Voyager-V1 / Vyriad, Profectus, Libtayo (cemiplimab) / Regeneron, Yervoy (ipilimumab) / Ono Pharma, BMS
Optimization of Voyager V1 (VV1) oncolytic virus systemic delivery in combination with cemiplimab and ipilimumab in patients with melanoma and non–small cell lung cancer (NSCLC). (Available On Demand; 186a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3511;
P2
The study includes serial biopsies in ≥3/10 pts in Stage 1 of each of the IV melanoma cohorts (doublet and triplet therapy), all pts in Stage 2 of these IV melanoma cohorts, and all pts in both Stage 1 and Stage 2 of the IV/IT melanoma cohort, to permit a thorough investigation of the impact of the 3 immunotherapies under investigation. The study is currently ongoing in the USA.
- Libtayo (cemiplimab) / Regeneron, vusolimogene oderparepvec (RP1) / Replimune
A randomized, controlled, open-label, phase 2 study of cemiplimab ± RP1 in patients with advanced cutaneous squamous cell carcinoma (CERPASS). (Available On Demand; 184a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3509;
P2
Preliminary results from IGNYTE, a phase I/II clinical study of RP1 in combination with nivolumab showed a high rate of deep and durable responses in patients (pts) with CSCC...Exploratory endpoints include quality of life, and immune biomarker analyses. This trial is currently enrolling pts.
- Libtayo (cemiplimab) / Regeneron
C-POST protocol update: A phase 3, randomized, double-blind study of adjuvant cemiplimab versus placebo post-surgery and radiation therapy (RT) in patients (pts) with high-risk cutaneous squamous cell carcinoma (CSCC). (Available On Demand; 183b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3508;
P3
Key primary objective is to compare disease-free survival; secondary objectives include evaluating overall survival, freedom from locoregional relapse, and distant relapse with adjuvant cemiplimab versus placebo in patients with high-risk CSCC. This study is once again open for enrolment following interruptions owing to the COVID-19 pandemic.
- Opdivo (nivolumab) / Ono Pharma, BMS, vusolimogene oderparepvec (RP1) / Replimune
Updated results from the skin cancer cohorts from an ongoing phase 1/2 multicohort study of RP1, an enhanced potency oncolytic HSV, combined with nivolumab (IGNYTE). (Available On Demand; 146) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3469;
P2
The combination continued to be generally well tolerated with no new safety signals identified. Based on this data, enrollment into both a registration-directed cohort of pts who have anti-PD1 failed cutaneous mel (n = 125) and a cohort of pts with anti-PD1 failed NMSC (n = 30) is ongoing.
- Erbitux (cetuximab) / Eli Lilly, EMD Serono
Immunotherapy followed by cetuximab in locally advanced/metastatic (LA/M) cutaneous squamous cell carcinomas (cSCC): The I-TACKLE trial. (Available On Demand; 113) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3435;
P2
In LA/M cSCC, the addition of C to P reverts primary and acquired resistance, with manageable toxicities. The sequential approach deserves to be studied in future clinical trials.
- Libtayo (cemiplimab) / Regeneron
Long-term outcomes of a phase II trial of neoadjuvant immunotherapy for advanced, resectable cutaneous squamous cell carcinoma of the head and neck (CSCC-HN). (Available On Demand; 112) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3434;
P2
Consistent with other cancer types, pathologic response to neoadjuvant immunotherapy is durable in patients with advanced, resectable CSCC-HN. Adjuvant radiation therapy may be spared in patients who achieve a pCR and warrants further investigation.