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- Entyvio (vedolizumab) / Takeda
Recurrent Checkpoint Inhibitor Colitis Complicated by Treatment Induced Liver Injury Requiring Vedolizumab Therapy (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_2166;
Case Description/ A 37 year old woman with a past medical history of basal cell carcinoma syndrome on cemiplimab, and endocervical adenocarcinoma in situ status-post hysterectomy presented to the emergency department with 4 days of persistent nausea, vomiting, and frequent watery diarrhea...Repeat colonoscopy again showed severe pancolitis, and infliximab therapy was restarted...Alternative therapy may involve vedolizumab, ustekinumab, tofacitinib, or fecal microbiota transplantation...A-F respectively: Rectosigmoid junction (A), descending colon (B), splenic flexure (C), transverse colon (D), hepatic flexure (E), ascending colon (F). Histology exhibiting chronic active colitis with cryptitis and crypt abscesses along with glandular distortion (G, H).
- Prevalence and Treatment of Immune Checkpoint Inhibitor (ICI) Colitis in Patients with Gastrointestinal Malignancy: A Multi-Center Network Study (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_674;
Among patients with a history of GI malignancy, the prevalence of ICI colitis was 7.9% for patients on PD-1 inhibitors, 6.2% for patients on PD-L1 inhibitors, and 8.6% for patients on combination PD-1/CTLA-4 inhibitors. Patients with ICI colitis from PD-1 inhibitors vs. combination PD-1/CTLA-4 inhibitors similarly required biologics (Vedolizumab (1.7% vs.
- || Libtayo (cemiplimab-rwlc) / Regeneron
New P2 trial, Tumor mutational burden: The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer (clinicaltrials.gov) - Jul 27, 2023
P2, N=50, Not yet recruiting, Sponsor: M.D. Anderson Cancer Center
- Libtayo (cemiplimab-rwlc) / Regeneron, Pexa-Vec (pexastimogene devacirepvec) / SillaJen, Transgene
Pexa-vec (thymidine kinase-deactivated vaccinia virus plus GM-CSF) in combination with cemiplimab (REGN2810; ANTI-PD-1) for metastatic or unresectable renal cell carcinoma REN026: Results from a phase II study () - Jul 27, 2023 - Abstract #ESMO2023ESMO_3339;
P1b/2a
3 of 13.3% in Arm A, 0% in Arm B,0% in Arm C, and 3.6% in Arm D. No Grade 5 events occurred in any of the study arms. Table: 1885P Summary of efficacy results Conclusions The combination immunotherapy of IV PV and cemiplimab demonstrated an acceptable safety profile and encouraging efficacy of ORR and survival with durable responses in patients with metastatic or unresectable RCC, regardless of previous ICI treatment.
- BNT116 / BioNTech, Libtayo (cemiplimab-rwlc) / Regeneron
A phase II study of cemiplimab plus BNT116 versus cemiplimab alone in first-line treatment of patients with advanced non-small cell lung cancer with PD-L1 expression ?50% () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2994;
P2
Enrollment of up to 100 patients is planned. Enrolment is ongoing.
- Libtayo (cemiplimab-rwlc) / Regeneron
Cemiplimab plus chemotherapy versus chemotherapy in non-small cell lung cancer with PD-L1 ?1%: EMPOWER-Lung 3 results () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2986;
P3
The safety profile for cemiplimab + chemo in patients with PD-L1 ?1% was generally consistent with that in overall patients. Table: 1495P Conclusions Cemiplimab + chemo showed improved efficacy compared with chemo alone in PD-L1
- Libtayo (cemiplimab-rwlc) / Regeneron
A phase II, multi-center, open-label, dose-optimization study evaluating telomere targeting agent THIO sequenced with cemiplimab in patients with advanced NSCLC: Preliminary results () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2984;
P2
The first 2 patients enrolled were discontinued after 5 and 4 cycles respectively due to withdrawal of consent and delayed recovery of toxicities; they are alive and progression-free with no new treatment at 10- and 9-months follow-up. Conclusions The study continues patient enrollment at all 3 dose-levels.
- Libtayo (cemiplimab-rwlc) / Regeneron
Patient-reported outcomes (PROs) with cemiplimab plus chemotherapy (CEMI + CHEMO) for first-line treatment of advanced non-small cell lung cancer (aNSCLC): PD-L1 level subgroups in EMPOWER-Lung 3 () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2934;
P3
No analyses yielded statistically significant PRO results favouring PBO + CHEMO on any QLQ-C30 or QLQ-LC13 scale. Conclusions Across PD-L1 subgroups in patients with aNSCLC, CEMI + CHEMO resulted in significant overall improvement and delayed TTD in multiple patient-reported functioning and cancer-related and lung cancer
- Libtayo (cemiplimab-rwlc) / Regeneron
Cemiplimab for advanced non-small cell lung cancer: Squamous subgroup analysis for EMPOWER-Lung 1 and 3 () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2929;
P3
Conclusions Subgroup analysis with long-term follow up data from two large phase 3 studies demonstrate improved clinical benefit of cemiplimab as 1L monotherapy or in combination with platinum-doublet chemo over chemo alone in pts with squamous NSCLC. Table: 1438P
- Clinical benefit of combination chemo-immunotherapy in first-line treatment for patients over the age of 65 or 75 with metastatic NSCLC () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2919;
Conclusions For patients over the age of 65 with untreated NSCLC, the anti-PD-1/PD-L1 combination with CT, compared with CT alone, is associated with significantly improved OS and PFS. Due to the low number of patients it is difficult to conclude for those over 75.
- Libtayo (cemiplimab-rwlc) / Regeneron
Changes in peripheral and local tumor immunity after cemiplimab treatment early describe clinical outcomes in patients with cutaneous squamous cell carcinoma () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2668;
sera levels decreased after treatment only in responder patients, in line with its role as a determinant of resistance to PD1 targeting. Conclusions Our results provided new key elements to monitor response to therapy, determining putative markers to early define responsiveness to ICI in cSCC patients and suggest how to improve their clinical management.
- Libtayo (cemiplimab-rwlc) / Regeneron
Early discontinuation of cemiplimab in patients with advanced cutaneous squamous cell carcinoma () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2666;
Only one patient, after being treated for a haematological pathology, developed a new primary CSCC, while pre-existing lesions maintained complete clinical response. Conclusions Our findings suggest that early discontinuation of cemiplimab in patients with advanced CSCC upon achieving a tumour response does not appear to negatively impact on the duration of response.
- Libtayo (cemiplimab-rwlc) / Regeneron
Cemiplimab versus historical systemic treatments for locally advanced (la) or metastatic (m) cutaneous squamous cell carcinomas (CSCC): Results from the French study TOSCA () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2665;
P=N/A
Adverse drug reactions of all grades were documented in 27% (cemiplimab) and 33% (HST) of patients. Conclusions TOSCA is the first comparative study in CSCC and showed significantly longer outcomes in patients treated with cemiplimab versus HST, confirming its benefits in patients with la/mCSCCs.
- SNS-101 / Sensei Biotherap, Libtayo (cemiplimab-rwlc) / Regeneron
Phase I/II, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SNS-101 (anti-VISTA) as monotherapy and in combination with cemiplimab in patients (pts) with advanced solid tumors () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2611;
Tumor types for P2 will be determined based on data from P1 and emerging results from preclinical studies/scientific data. The IND cleared in April 2023 and the study is open for enrollment.
- Analysis of pulmonary adverse events associated with immune checkpoint inhibitors based on FAERS and VigiBase database () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2604;
We offer a groundbreaking revelation, identifying the occurrence of pirAEs which manifest early on, within the initial 60 days of treatment, and exhibit a high incidence and mortality rate. Among pirAEs, interstitial lung disease, dyspnea, and pneumonitis were most frequently reported with respiratory failure being a consistently fatal adverse event highlighting the necessity of heightened physician vigilance.
- The interchangeability of Immune checkpoint inhibitors () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2600;
We call for (publicly funded) randomized multi-cancer trials for a direct head-to-head comparison of ICIs. Such direct comparative evidence is needed to reach a competitive field.
- ubamatamab (REGN4018) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
Ubamatamab (MUC16xCD3 bispecific antibody) with cemiplimab (anti-PD-1 antibody) in recurrent ovarian cancer: Phase I dose-escalation study () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2316;
P1/2
Conclusions In pts with heavily pretreated OC, an acceptable safety profile and durable responses were observed with ubamatamab + cemiplimab. A randomised phase 2 expansion of ubamatamab +/- cemiplimab is ongoing.
- Libtayo (cemiplimab-rwlc) / Regeneron
A phase II study of neoadjuvant cemiplimab for stage II to IV cutaneous squamous cell carcinoma (CSCC): One-year follow-up (Le) - Jul 27, 2023 - Abstract #ESMO2023ESMO_641;
P2
A randomised phase 2 expansion of ubamatamab +/- cemiplimab is ongoing. Conclusions In pts with resectable stage II
- ||||| Libtayo (cemiplimab) / Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
Clinical, Metastases: Omid Hamid, MD, discussed the efficacy of fianlimab + cemiplimab for advanced #melanoma. #melsm | @angelesclinic @OmidHamidMD https://t.co/Yr62GXLuAW (Twitter) - Jul 25, 2023
- ||||| Libtayo (cemiplimab) / Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
Metastases: Fianlimab Plus Cemiplimab Produces Durable Responses in Advanced Melanoma @OmidHamidMD @angelesclinic @ASCO #ASCO23 #melsm https://t.co/zv00MUGAPO (Twitter) - Jul 25, 2023
- ||| Libtayo (cemiplimab) / Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
Metastases: Fianlimab Plus Cemiplimab Produces Durable Responses in Advanced Melanoma https://t.co/fJPuP1dkEh via @onclive (Twitter) - Jul 25, 2023
- Libtayo (cemiplimab) / Regeneron
Disease Progression on PROs in Patients With aNSCLC With PD-L1 ?50% Receiving Cemiplimab vs Chemotherapy: EMPOWER-Lung 1 (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2240;
P3
In patients with aNSCLC with PD-L1 50%, overall change from baseline and TTD in GHS/QoL significantly favoured patients without disease progression vs those with disease progression. These results suggest that an increase in PFS may lead to more favourable overall change from baseline and greater delay in TTD in GHS/QoL among patients with aNSCLC with PD-L1 50%.
- Libtayo (cemiplimab) / Regeneron
Cemiplimab-Based Treatment in Advanced NSCLC With Liver Metastases: Updated Analysis From EMPOWER-Lung 1 and EMPOWER-Lung 3 (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2231;
P3
These results suggest that an increase in PFS may lead to more favourable overall change from baseline and greater delay in TTD in GHS/QoL among patients with aNSCLC with PD-L1 50%. Long-term results continue to demonstrate clinical benefit with cemiplimab monotherapy and cemiplimab combination treatments over platinum-based chemotherapy among the patient subpopulation with liver metastases at baseline from advanced NSCLC.
- Libtayo (cemiplimab) / Regeneron
Pharmacokinetics of Cemiplimab in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2214;
P3
Moreover, immunogenicity against cemiplimab was low and did not affect cemiplimab pharmacokinetics.Pharmacokinetic parameters of cemiplimab in EMPOWER-Lung 1 and EMPOWER-Lung 3 (Part 1 and 2)Analysis populationNAfter first doseAt steady-statenCtrough,mean (SD), mg/LnCmax,mean (SD), mg/LnCtrough,mean (SD), mg/LnCmax,mean (SD), mg/LEMPOWER-Lung 1 Cemiplimab 350 mg Q3W monotherapyaOverall population27025722.1 (14.8)264120 (65.0)13661.7 (29.4)136181 (77.3)EMPOWER-Lung 3 Part 2 Cemiplimab 350 mg Q3W + chemotherapyb Overall population29527021.5 (18.4)28595.3 (48.6)17748.6 (25.0)236129 (46.9)Squamous cell histology13212120.3 (8.8)12693.5 (49.5)9444.8 (19.3)107134 (45.4)Non-squamous cell histology16314922.6 (23.5)15996.8 (48.1)8353.0 (29.8)129125 (47.9)PD-L1 <1%888021.9 (19.4)88101 (46.1)4848.3 (19.3)68123 (45.5)PD-L1 1-49%1099822.7 (21.2)10595.0 (55.7)6844.5 (23.9)88131 (50.9)PD-L1 50%989220.1 (14.0)9290.2 (41.8)6153.6 (29.3)80131 (43.5)EMPOWER-Lung 3 Part 1Cemiplimab 350 mg Q3W + chemotherapycOverall population1079425.4 (31.6)103124 (75.1)5668.1 (43.9)80159 (88.1)Squamous cell histology565329.0 (41.4)55122 (70.4)3370.1 (48.2)46173 (109)Non-squamous cell histology514120.7 (7.7)48127 (80.8)2365.2 (37.6)34140 (41.3)PD-L1 <1%524621.2 (11.3)52118 (77.6)2859.4 (25.6)39145 (88.4)PD-L1 1-24%433731.1 (48.4)40122 (70.6)2377.6 (60.5)32178 (93.7)PD-L1 25-50%121123.7 (9.5)11159 (75.9)572.8 (28.9)9157 (57.3)Cemiplimab 350 mg Q3W + chemotherapy + ipilimumab 50 mg Q6WdOverall population10910019.7 (7.9)102116 (78.1)4963.5 (35.4)87158 (80.6)Squamous cell histology575219.3 (7.0)52126 (101)2367.8 (40.9)45152 (62.3)Non-squamous cell histology524820.2 (8.7)50106 (40.3)2659.8 (30.1)42164 (96.9)PD-L1 <1%545120.2 (8.3)51125 (91.6)2560.2 (35.8)39166 (103)PD-L1 1-24%413718.7 (7.3)37111 (65.6)1867.3 (35.9)36145 (54.9)PD-L1 25-50%141221.0 (7.7)1499.5 (49.3)666.2 (37.5)12166 (61.5)aCmax and Ctrough values are reported for the PD-L1 50% population that received cemiplimab 350 mg Q3W and are based on a data cutoff date of 28 February 2020. The duration of each cemiplimab treatment cycle was three weeks (one Q3W dose).bCmax and Ctrough values are reported for patients that received cemiplimab 350 mg Q3W in combination with 4 cycles of platinum-doublet chemotherapy and are based on a data cutoff date of 14 June 2021.
- Libtayo (cemiplimab) / Regeneron
Predictive Utility of Patient-Reported Outcomes for Survival in 1st-Line Treated Patients with aNSCLC in EMPOWER-Lung 1 and 3 (405C) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1001;
P3
Patient reported physical functioning had better predictive performance for OS compared to physician defined ECOG-PS. These results suggest that baseline PROs such as physical functioning represent clinical utility in predicting patient survival in aNSCLC.
- || BNT111 / BioNTech
Trial completion date, Trial primary completion date: 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) - Jul 21, 2023
P2, N=180, Recruiting, Sponsor: BioNTech SE
These results suggest that baseline PROs such as physical functioning represent clinical utility in predicting patient survival in aNSCLC. Trial completion date: Jun 2025 --> Jul 2026 | Trial primary completion date: Oct 2024 --> Nov 2025
- | Ibrance (palbociclib) / Pfizer, Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment open, Trial initiation date, IO biomarker, Metastases: Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma (clinicaltrials.gov) - Jul 21, 2023
P2, N=72, Recruiting, Sponsor: Alliance for Clinical Trials in Oncology
Trial completion date: Jun 2025 --> Jul 2026 | Trial primary completion date: Oct 2024 --> Nov 2025 Not yet recruiting --> Recruiting | Initiation date: Jan 2023 --> May 2023
- | Libtayo (cemiplimab) / Regeneron, Erivedge (vismodegib) / Roche
Journal: Complete response of a large basosquamous carcinoma following treatment with cemiplimab and vismodegib. (Pubmed Central) - Jul 19, 2023
After 21 cycles of cemiplimab, the left shoulder ulcerated lesion was completely re-epithelialised. He remains in complete remission after 31 cycles of cemiplimab in addition to vismodegib.
- | Libtayo (cemiplimab) / Regeneron
Journal, Metastases: Neoadjuvant cemiplimab induces durable complete response in locally advanced cutaneous squamous cell carcinoma. (Pubmed Central) - Jul 17, 2023
He remains in complete remission after 31 cycles of cemiplimab in addition to vismodegib. No abstract available
- || Libtayo (cemiplimab) / Regeneron
Review, Journal, PD(L)-1 Biomarker, IO biomarker: Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. (Pubmed Central) - Jul 17, 2023
In metastatic non-small cell lung cancer (NSCLC), tumors that do not harbor driver mutations in EGFR or gene fusions in ALK and ROS, PD-1 and PD-L1 inhibitors have become a cornerstone in first line treatment, either as monotherapy or in combination with chemotherapy. This paper reviews cemiplimab-rwlc, the third PD-1/L1 inhibitor to be approved in the setting for first line treatment in NSCLC, as monotherapy or in combination therapy with chemotherapy, to provide a perspective on the subtle differences in patient population for the cemiplimab studies and consideration of its primary and subgroup results in the context of first line therapies for NSCLC.
- ||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion, Trial completion date, Trial primary completion date, HEOR, Real-world evidence, Real-world, Metastases: REACT-CEMI: Real World Study on the Use of Cemiplimab in Adult Patients in UK (clinicaltrials.gov) - Jul 14, 2023
P=N/A, N=110, Completed, Sponsor: Sanofi
This paper reviews cemiplimab-rwlc, the third PD-1/L1 inhibitor to be approved in the setting for first line treatment in NSCLC, as monotherapy or in combination therapy with chemotherapy, to provide a perspective on the subtle differences in patient population for the cemiplimab studies and consideration of its primary and subgroup results in the context of first line therapies for NSCLC. Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Nov 2022 | Trial primary completion date: Jun 2023 --> Nov 2022
- ||||||| Libtayo (cemiplimab-rwlc) / Regeneron
Trial completion, Metastases: EMPOWER-Cervical 1: Study of Cemiplimab in Adults With Cervical Cancer (clinicaltrials.gov) - Jul 12, 2023
P3, N=608, Completed, Sponsor: Regeneron Pharmaceuticals
Active, not recruiting --> Completed | Trial completion date: Jun 2023 --> Nov 2022 | Trial primary completion date: Jun 2023 --> Nov 2022 Active, not recruiting --> Completed
- |||| Libtayo (cemiplimab) / Regeneron
Clinical, Metastases: Cemiplimab binds to the programmed death receptor-1, blocking the PD-1/PD-L1 pathway Incredible pathological response rate for advanced skin SCCa Note imaging underestimates pathological response @AHNSinfo #AHNS2023 #otolaryngology @EbenRosenthal @MDAndersonNews @langermology (Twitter) - Jul 10, 2023
- | Libtayo (cemiplimab) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
Retrospective data, Journal: Immunotherapy response in patients with cutaneous squamous cell carcinoma of head and neck with cranial nerve involvement. (Pubmed Central) - Jul 10, 2023
Active, not recruiting --> Completed In this cohort, IO showed clinical response in 83% of patients, indicating IO can be an effective monotherapy, reserving RT for instances of local failure after IO.
- | Libtayo (cemiplimab-rwlc) / Regeneron
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy: REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma (clinicaltrials.gov) - Jul 10, 2023
P1/2, N=57, Terminated, Sponsor: Regeneron Pharmaceuticals
In this cohort, IO showed clinical response in 83% of patients, indicating IO can be an effective monotherapy, reserving RT for instances of local failure after IO. N=130 --> 57 | Trial completion date: Nov 2024 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Nov 2024 --> May 2023; Sponsor Decision
- | New trial, Adverse events, Checkpoint inhibition: EXIT: EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Database (clinicaltrials.gov) - Jul 6, 2023
P=N/A, N=141630, Active, not recruiting, Sponsor: Groupe Hospitalier Pitie-Salpetriere
- | Libtayo (cemiplimab-rwlc) / Regeneron, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Trial completion date, Trial primary completion date, Metastases: A Study of Cemiplimab With Chemotherapy and Immunotherapy in People With Head and Neck Cancer (clinicaltrials.gov) - Jul 5, 2023
P1, N=30, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
N=130 --> 57 | Trial completion date: Nov 2024 --> May 2023 | Recruiting --> Terminated | Trial primary completion date: Nov 2024 --> May 2023; Sponsor Decision Trial completion date: Jun 2023 --> Jun 2026 | Trial primary completion date: Jun 2023 --> Jun 2026
- | Libtayo (cemiplimab-rwlc) / Regeneron
New P2 trial, Surgery, Metastases: Cemiplimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery (clinicaltrials.gov) - Jul 3, 2023
P2, N=35, Not yet recruiting, Sponsor: Thomas Jefferson University
- Libtayo (cemiplimab) / Regeneron
Giant cutaneous squamous cell carcinomas (Level 6 - Hall 602) - Jul 3, 2023 - Abstract #WCD2023WCD_7249;
Trial completion date: Jun 2023 --> Jun 2026 | Trial primary completion date: Jun 2023 --> Jun 2026 Due to ineffectiveness of treatment or contraindications to other therapeutic approaches, three patients were qualified to receive a combination of cemiplimab and RP1...However, due to the size of tumors, common location in the head area, advanced patients
- Libtayo (cemiplimab) / Regeneron
Cutaneous squamous cell carcinoma in a patient with dystrophic epidermolysis bullosa () - Jul 3, 2023 - Abstract #WCD2023WCD_7231;
Cemiplimab is an option for treatment. Multiple studies and long-term follow-ups are needed to establish its effect
- hydroxyurea / Generic mfg.
Advanced cutaneous squamous cell carcinoma induced by long-term Hydroxyurea treatment () - Jul 3, 2023 - Abstract #WCD2023WCD_7206;
If the latter is impossible low-dose retinoid or immunotherapy is recommended. Multiple studies and long-term follow-ups are needed to establish the therapeutic strategy in such cases
- ||||| Libtayo (cemiplimab) / Regeneron, fianlimab (REGN3767) / Regeneron, Sanofi
Clinical, Metastases: Fianlimab + cemiplimab produced high & consistent tumor responses in pts with advanced melanoma who were PD-L1 inhibitor–naïve in the advanced setting, according to data from a phase 1 study. @OmidHamidMD @angelesclinic #melsm https://t.co/k9EuuARjGj (Twitter) - Jul 1, 2023
- | Libtayo (cemiplimab) / Regeneron
Journal, PD(L)-1 Biomarker, IO biomarker: The Additional Exclusions of ROS1 Fusions (In Addition to EGFR Mutation and ALK Fusions) in the Cemiplimab NSCLC FDA Indication (EMPOWER-Lung 1 and -Lung 3). Catching Up with Current Scientific View of Immunotherapy in Never-Smoker Predominant Actionable Driver Mutation Positive NSCLC? (Pubmed Central) - Jun 29, 2023
We review the effectiveness of ICIs in never-smoker predominant NSCLC with driver mutations (EGFR, ALK, ROS1, RET, HER2) and question whether exclusion of ROS1 fusion would put cemiplimab at a competitive disadvantage given the requirement for insurance to prove ROS1 fusion negativity. We further discuss whether the US FDA as a regulatory authority has the right and responsibility to harmonize the use of ICIs in these actionable driver mutations to standardize community practice for the benefit of patients and to advance the development of next-generation treatment for these driver mutations.
- Libtayo (cemiplimab) / Regeneron
4 years of cemiplimab in non-melanoma skin cancer: where do we stand? (Room G2) - Jun 28, 2023 - Abstract #ADO2023ADO_441;
We further discuss whether the US FDA as a regulatory authority has the right and responsibility to harmonize the use of ICIs in these actionable driver mutations to standardize community practice for the benefit of patients and to advance the development of next-generation treatment for these driver mutations. Sponsored by Sanofi-Aventis Deutschland GmbH
- Libtayo (cemiplimab) / Regeneron
Systemic drug therapy with cemiplimab for cutaneous squamous cell carcinoma (SCC) (Hall E) - Jun 28, 2023 - Abstract #ADO2023ADO_153;
- Libtayo (cemiplimab) / Regeneron
Therapy option for locally advanced cutaneous squamous cell carcinoma after cemiplimab resistance (Hall E) - Jun 28, 2023 - Abstract #ADO2023ADO_149;
- Libtayo (cemiplimab) / Regeneron
CemiSkin - second interim analysis of a non-interventional study in patients with advanced squamous cell carcinoma of the skin (CSCC) treated with cemiplimab or other therapies (Hall E) - Jun 28, 2023 - Abstract #ADO2023ADO_145;
- Libtayo (cemiplimab) / Regeneron
Occurrence of subacute cutaneous lupus erythematosus during therapy with the anti-PD-1 antibody cemiplimab (Hall E) - Jun 28, 2023 - Abstract #ADO2023ADO_143;
- || Libtayo (cemiplimab-rwlc) / Regeneron, odronextamab (REGN1979) / Regeneron
Enrollment change, Trial completion date, Trial primary completion date: CLIO-1: A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies (clinicaltrials.gov) - Jun 22, 2023
P1, N=62, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Sponsored by Sanofi-Aventis Deutschland GmbH N=172 --> 62 | Trial completion date: Aug 2026 --> Dec 2026 | Trial primary completion date: Aug 2026 --> Dec 2026
- | Libtayo (cemiplimab) / Regeneron
Journal, Tumor mutational burden, PD(L)-1 Biomarker, IO biomarker, Metastases: Variable Outcome of Immunotherapy in Advanced Multiple Cutaneous Squamous Cell Carcinomas in Two Patients with Recessive Dystrophic Epidermolysis Bullosa. (Pubmed Central) - Jun 20, 2023
Our experience and the literature suggest that cemiplimab is an option in patients with RDEB if surgery is not. Somatic mutations and the immune microenvironment should be characterized to predict therapeutic response, particularly in aggressive undifferentiated tumours.