Libtayo (cemiplimab-rwlc) / Regeneron 
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 1 Disease   67 Trials   67 Trials   1555 News 


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  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Review, Journal:  Efficacy and Safety of Cemiplimab for the Management of Non-Melanoma Skin Cancer: A Drug Safety Evaluation. (Pubmed Central) -  May 11, 2024   
    Moreover, the collaboration among specialists will allow them to best manage the TEAEs, reducing the risk of treatment suspension or discontinuation. Certainly, ongoing studies and more and more emerging real-world evidence, will allow us to better characterize the role of cemiplimab for the management of advanced non-melanoma skin cancer.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Journal, Metastases:  Neoadjuvant-Intent Immunotherapy in Advanced, Resectable Cutaneous Squamous Cell Carcinoma. (Pubmed Central) -  May 9, 2024   
    Outside of clinical trials, it is not infrequent for patients to opt out of surgery for regressing tumors. The inclusion of higher-risk patients and preference for nonsurgical treatment are 2 factors that might explain the numerically lower pathologic response rate in this institutional experience.
  • ||||||||||  tolododekin alfa (ANK-101) / Ankyra Therap
    Enrollment change:  ANCHOR: Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors (clinicaltrials.gov) -  May 8, 2024   
    P1,  N=92, Recruiting, 
    The inclusion of higher-risk patients and preference for nonsurgical treatment are 2 factors that might explain the numerically lower pathologic response rate in this institutional experience. N=46 --> 92
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Erivedge (vismodegib) / Roche
    FDA event, Journal, Adverse events, Real-world evidence, Real-world:  Beyond the Label: Real-World Side Effects Experienced With FDA-Approved Drugs for Non-Melanoma Skin Cancers. (Pubmed Central) -  May 6, 2024   
    Logistic regression analysis showed males on vismodegib for BCC having greater odds of experiencing muscle spasms (aOR 1.33, P<0.001) and ageusia (aOR 1.34,  P<0.001) versus females, who were more likely to exhibit alopecia (aOR 1.82, P<0.001) and nausea (aOR 1.96, P<0.001)...Patients taking cemiplimab-rwlc for BCC compared to SCC were more likely to experience disease progression (aOR 10.98, P=0.02)...2024;23(5):301-305. doi:10.36849/JDD.7968.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
    Trial completion, Trial completion date, Trial primary completion date:  R3767-ONC-1613: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers (clinicaltrials.gov) -  May 1, 2024   
    P1,  N=333, Completed, 
    Initiation date: Oct 2023 --> Feb 2024 Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Apr 2024 | Trial primary completion date: Dec 2024 --> Apr 2024
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Praluent (alirocumab) / Sanofi, Regeneron
    New P2 trial:  TOP 2301: Neoadjuvant Chemo for NSCLC (clinicaltrials.gov) -  Apr 25, 2024   
    P2,  N=126, Not yet recruiting, 
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Immunotherapy for local/regional control of locally advanced orbital and periocular squamous cell carcinoma. () -  Apr 24, 2024 - Abstract #ASCO2024ASCO_6665;    
    IO either as single drug or in combination with chemotherapy has a fairly high response rate in patients with ocular adnexal, conjunctival or orbital SCC and in patients with periocular SCC with perineural spread in the orbit and skull base. Future prospective trails using IO for orbital and ocular adnexal SCC should be planned and should aim to correlate molecular data such as TMB with response.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Ulcer-related cutaneous squamous cell carcinoma: New kid on the block. () -  Apr 24, 2024 - Abstract #ASCO2024ASCO_4934;    
    This study suggests immunotherapy is less beneficial in ulcer-related SCC. More work is needed to verify our findings and explore other treatment options including chemoimmunotherapy.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Can TTMV clearance predict recurrence in HPV HNSCC? (Hall A; Poster Bd #: 382) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_3517;    
    P1
    3/11 (27%) with persistently elevated TTMV after cycle 1 relapsed as of this time point. This small study was not large enough to be practice-changing.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
    A phase 1 study of fianlimab (anti (Hall A; Poster Bd #: 341) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_3489;    
    P1
    This small study was not large enough to be practice-changing. Fianlimab + cemiplimab in pts with HNSCC showed signs of clinical activity with durable responses among pts with anti
  • ||||||||||  ubamatamab (REGN4018) / Regeneron, Libtayo (cemiplimab-rwlc) / Regeneron
    A phase 1/2 study of ubamatamab (REGN4018), a MUC16 (Hall A; Poster Bd #: 497b) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_1944;    
    P1/2
    Exploratory objectives include clinical correlation with serum CA-125, MUC16 IHC, and immune markers. The study is currently enrolling to these OC and EC expansion cohorts.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, ISA101 / ISA Pharma
    Combination of cemiplimab and ISA101b vaccine for the treatment of recurrent/metastatic HPV16 cervical cancer. (Hall A; Poster Bd #: 393) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_1836;    
    P2
    The study is currently enrolling to these OC and EC expansion cohorts. Results from this phase 2 study of cemiplimab + ISA101b in patients with recurrent HPV16 cervical cancer show clinical benefit, especially in patients with high PD-L1 expression, and no unexpected safety signals, supporting further research.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, fianlimab (REGN3767) / Regeneron
    A phase 2/3 study of fianlimab, cemiplimab, plus chemotherapy versus cemiplimab plus chemotherapy in first-line treatment of advanced non-small cell lung cancer. (Hall A; Poster Bd #: 518a) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_1533;    
    P1, P2/3
    The secondary endpoints include efficacy (ORR, disease control rate, time to tumor response, duration of response, progression-free survival, and overall survival), safety and tolerability, immunogenicity (anti-drug antibodies and neutralizing antibodies against fianlimab or cemiplimab in serum), patient-reported outcomes, and pharmacokinetics. This study and a parallel study of fianlimab + cemiplimab in patients with aNSCLC with tumors expressing PD-L1 ?50% (NCT05785767) are currently open for enrollment.
  • ||||||||||  Incidence and time to onset of immunotherapy-related adrenal insufficiency in the I-SPY2 trial. (Hall A; Poster Bd #: 176) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_1312;    
    P2
    No correlation was observed with age; correlation of AI with response predictive subtype and other clinicopathologic features is ongoing and will be presented. Given the high incidence of AI in EBC, close monitoring in the peri/postoperative setting and education of pts and providers is critical, as risk persists even after completion of tx.
  • ||||||||||  Trends in prices of checkpoint inhibitors in the US, 2016-2023. (Hall A; Poster Bd #: 270) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_1007;    
    Competition among these brand-name cancer drugs did not meaningfully affect prices. Regulators should investigate why price competition has not emerged, and policymakers should grant more opportunities to negotiate lower prices for patients and the health care system, as is being rolled out this year in Medicare following passage of the Inflation Reduction Act.
  • ||||||||||  A phase 3 trial of fixed dose combinations of fianlimab (anti (Hall A; Poster Bd #: 389a) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_916;    
    P1, P3
    The primary endpoint is ORR and key secondary endpoints are PFS and overall survival. Additional secondary endpoints are duration of response, disease control rate, investigator-assessed ORR and PFS, safety, pharmacokinetics, and immunogenicity.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron, Keytruda (pembrolizumab) / Merck (MSD)
    Primary immunotherapy monotherapy (PRIMO) in locally advanced cutaneous squamous cell carcinoma. (Hall A; Poster Bd #: 369) -  Apr 24, 2024 - Abstract #ASCO2024ASCO_890;    
    The use of PRIMO for locally advanced cSCC produces impressive response rates that appear durable without any additional therapy. This attractive alternative to the emerging neoadjuvant paradigm deserves prospective validation with longer term follow up.
  • ||||||||||  Odomzo (sonidegib) / Sun Pharma, Libtayo (cemiplimab-rwlc) / Regeneron, Erivedge (vismodegib) / Roche
    Review, Journal, Metastases:  Treatments on the horizon for locally advanced basal cell carcinoma. (Pubmed Central) -  Apr 22, 2024   
    PD-1 inhibitor immunotherapy (cemiplimab) is indicated for cases that progressed on or could not tolerate hedgehog inhibitors or when hedgehog inhibitors are contraindicated. Given the modest response and bothersome side effects of some of the agents above, there are reports of novel treatments, and clinical trials are currently evaluating multiple agents.
  • ||||||||||  Review, Journal:  Promising immunotherapy targets: TIM3, LAG3, and TIGIT joined the party. (Pubmed Central) -  Apr 10, 2024   
    Currently, seven ICIs, namely ipilimumab (anti-cytotoxic T lymphocyte-associated protein 4 [CTLA4]), pembrolizumab, nivolumab (anti-programmed cell death protein 1 [PD-1]), atezolizumab, avelumab, durvalumab, and cemiplimab (anti-PD-L1), have been approved for various cancer types. Consequently, ongoing studies are evaluating the next generation of ICIs, such as lymphocyte activation gene-3 (LAG3), T