Lenvima (lenvatinib) / Eisai, Merck (MSD) 
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  • ||||||||||  Journal, PD(L)-1 Biomarker:  Slow progression of type 1 diabetes associated with pembrolizumab and lenvatinib combination therapy in a patient with probable slowly progressive type 1 diabetes mellitus and endometrial cancer. (Pubmed Central) -  Jan 29, 2025   
    Two-and-a-half years later, she was diagnosed with endometrial cancer with pelvic lymph node metastasis and underwent surgery followed by chemotherapy with carboplatin and paclitaxel, then carboplatin and docetaxel...On DAY 36, her plasma glucose (PG) concentration was high; therefore, insulin degludec was administered once daily and self-monitoring of blood glucose commenced...Human leukocyte antigen analysis revealed two susceptibility haplotypes (DRB1*04:05-DQB1*04:01-DPB1*02:01 and DRB1*04:05-DQB1*04:01-DPB1*05:01) for type 1 diabetes (T1D). This case is notable in that pembrolizumab-related T1D progressed more slowly than previously reported, and lenvatinib may have contributed to this delay.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Trial completion date, Trial primary completion date:  Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma (clinicaltrials.gov) -  Jan 28, 2025   
    P2,  N=26, Active, not recruiting, 
    Trial completion date: Dec 2025 --> Jan 2027 | Trial primary completion date: Dec 2025 --> Jan 2027 Trial completion date: May 2026 --> Sep 2026 | Trial primary completion date: May 2025 --> Sep 2025
  • ||||||||||  MODULE 4: Current and Future Care of Patients with Non-Clear Cell RCC (San Francisco Marriott Marquis, 780 Mission Street, San Francisco, California, Golden Gate Ballroom, Salon A (B2 Level); In-Person) -  Jan 20, 2025 - Abstract #ASCOGU2025ASCO_GU_1023;    
    This activity is supported by educational grants from Bristol Myers Squibb, Eisai Inc, and Exelixis Inc. Pathophysiology, biology and incidence of various non-clear cell RCC subtypes Design, eligibility criteria and key efficacy and safety findings from the Phase II KEYNOTE-B61 trial evaluating pembrolizumab in combination with lenvatinib as first-line treatment for patients with advanced non-clear cell RCC; recent label update for pembrolizumab and lenvatinib and implications for clinical management Published research findings with and current clinical role of TKI monotherapy (eg, sunitinib, cabozantinib) and other combination strategies (eg, cabozantinib/nivolumab) for patients with non-clear cell RCC Mechanism of action of zanzalintinib; similarities and differences between zanzalintinib and cabozantinib Design, eligibility criteria and key endpoints of the Phase III STELLAR-304 trial assessing zanzalintinib/nivolumab versus sunitinib as first-line treatment for non-clear cell RCC; anticipated completion date Other promising novel agents and strategies under investigation for non-clear cell RCC
  • ||||||||||  MODULE 1: Immunotherapeutic Strategies for Localized and Metastatic Clear Cell Renal Cell Carcinoma (RCC) (San Francisco Marriott Marquis, 780 Mission Street, San Francisco, California, Golden Gate Ballroom, Salon A (B2 Level); In-Person) -  Jan 20, 2025 - Abstract #ASCOGU2025ASCO_GU_1020;    
    This activity is supported by educational grants from Bristol Myers Squibb, Eisai Inc, and Exelixis Inc. Available efficacy and safety findings from the Phase III KEYNOTE-564 trial comparing pembrolizumab to placebo as adjuvant treatment for patients with clear cell RCC at increased risk of recurrence after nephrectomy; FDA approval and current role Ongoing research studies assessing immune checkpoint inhibitors in the neoadjuvant/adjuvant setting for localized RCC Key factors, such as risk classification, age and performance status, histology, prior neoadjuvant or adjuvant therapy, number and location of metastases, and symptomatology, influencing the selection of first-line therapy for patients with newly diagnosed metastatic RCC Clinical trial database supporting the use of nivolumab/ipilimumab, pembrolizumab/axitinib, nivolumab/cabozantinib and pembrolizumab/lenvatinib for treatment-na
  • ||||||||||  Journal, Surgery, Metastases:  Advances in systemic therapy leading to conversion surgery for advanced hepatocellular carcinoma. (Pubmed Central) -  Jan 13, 2025   
    Subsequently, several systemic therapies, including lenvatinib, ramucirumab, cabozantinib, and regorafenib have been investigated and established...Although a combination of atezolizumab and bevacizumab is mostly used for initially unresectable HCC to conduct conversion surgery because of the high response rate and fewer adverse events compared to others, many trials are being conducted to assess their efficacy for initially unresectable HCC...To address these issues, a multidisciplinary team can play a vital role in determining the strategies for treating unresectable HCC. This review describes previous and current trends in the treatment of HCC, with a particular focus on conversion surgery for initially unresectable HCC.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Journal:  Identification and Therapeutic Targeting of METTL8-Mediated Lenvatinib Resistance in Hepatocellular Carcinoma Using Rabdosiin. (Pubmed Central) -  Jan 12, 2025   
    To inhibit the function of METTL8 that mediate lenvatinib resistance, we conducted a screening using a natural compound library, virtual drug screening identified Rabdosiin as a potential METTL8 inhibitor, subsequent experiments demonstrated that Rabdosiin could effectively overcome METTL8-mediated lenvatinib resistance. In conclusion, this research highlights METTL8 as a novel target for mitigating lenvatinib resistance, proposing that targeting METTL8 could restore lenvatinib sensitivity in HCC, and underscores its value as a biomarker for lenvatinib application in clinical settings.
  • ||||||||||  P-500 / Pathos, Lenvima (lenvatinib) / Eisai, Merck (MSD), PRT543 / Prelude Therap
    Journal:  PRMT5 inhibition has a potent anti-tumor activity against adenoid cystic carcinoma of salivary glands. (Pubmed Central) -  Jan 12, 2025   
    The findings underscore the importance of pharmacovigilance in identifying potential drug triggers for FT1DM and emphasize the need for close monitoring of glucose levels in patients treated with these medications. Taken together, our study underscores the role of PRMT5 in ACC oncogenesis and provides a strong rationale for the clinical development of PRMT5 inhibitors as a targeted monotherapy or combination therapy for treatment of patients with this rare disease, based on the analysis of their underlying molecular profile.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD), Cabometyx (cabozantinib tablet) / Exelixis, sorafenib / Generic mfg.
    Journal:  Modelling hepatocellular carcinoma microenvironment phenotype to evaluate drug efficacy. (Pubmed Central) -  Jan 12, 2025   
    We demonstrated that our model reproduced the Barcelona Clinic Liver Cancer (BCLC) molecular classification, displayed known alterations of epigenetic players, and responded to tyrosine kinase inhibitors (TKIs) such as sorafenib, cabozantinib, and lenvatinib in a patient-dependent manner. Importantly, we reported for the first time that our model correctly predicted 34 clinical outcomes to TKIs out of 37 case studies on 32 HCC patients confirming that patient-centric spheroids, combined with our TICK exclusion strategy, are valuable models for drug discovery and opening a near perspective to personalized care.
  • ||||||||||  Tevimbra (tislelizumab-jsgr) / BeiGene, Lenvima (lenvatinib) / Eisai, Merck (MSD)
    Trial completion date, Trial primary completion date:  TALENT: Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC (clinicaltrials.gov) -  Jan 9, 2025   
    P2,  N=80, Recruiting, 
    Importantly, we reported for the first time that our model correctly predicted 34 clinical outcomes to TKIs out of 37 case studies on 32 HCC patients confirming that patient-centric spheroids, combined with our TICK exclusion strategy, are valuable models for drug discovery and opening a near perspective to personalized care. Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2026
  • ||||||||||  Tyvyt (sintilimab) / Eli Lilly, Fumena (vorolanib) / Tyrogenex
    VORSIN-RCC: Vorolanib plus sintilimab for advanced renal cell carcinoma after failure of prior immune checkpoint inhibitors-based combination therapy. (Level 1, West Hall; Poster Bd #: K17) -  Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_619;    
    P2
    A phase Ib/II single-arm trial achieved a high objective response rate (ORR) with lenvatinib plus pembrolizumab in patients post-ICI progression (Lee CH et al., Lancet Oncol 2021)...The failures of previous ICI re-challenges may be related to the limited efficacy of PD-L1 blockade (atezolizumab) in RCC and the reduced dosage of tivozanib, whose efficacy is closely related to its blood concentration...Both ORR and DCR are assessed using RECIST 1.1 and imRECIST criteria. This study is actively recruiting.
  • ||||||||||  Leveraging tumor organoids to model drug response in clear cell renal cell carcinoma. (Level 1, West Hall; Poster Bd #: H14) -  Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_496;    
    In conclusion, by faithfully replicating the tumor microenvironment and facilitating comprehensive drug screening, this approach aims to identify optimal treatment regimens and uncover mechanisms of resistance. Ultimately, it seeks to create a personalized, predictive model that can enhance clinical decision-making in the management of ccRCC.
  • ||||||||||  olanzapine / Generic mfg.
    Olanzapine for managing side effects from tyrosine-kinase inhibitors. (Level 1, West Hall; Poster Bd #: F22) -  Jan 7, 2025 - Abstract #ASCOGU2025ASCO_GU_443;    
    Olanzapine appears to be effective in treating TKI-induced nausea, vomiting, anorexia, insomnia, and weight loss. Prospective randomized placebo-controlled studies are needed to confirm these findings.