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  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Review, Journal, IO biomarker:  Lost at SCLC: a review of potential platinum sensitizers. (Pubmed Central) -  Nov 13, 2024   
    By extension, lost at SCLC references the current confusion about how to circumvent the chemoresistance, particularly platinum resistance, which so plagues the treatment of extensive-stage small cell lung cancer (ES-SCLC) that in 2012 the US National Cancer Institute (NCI) designated it a "recalcitrant cancer." Over a decade later, despite the approval of immune checkpoint inhibitors and the conditional approval of lurbinectedin, the prognosis for ES-SCLC, and especially platinum-resistant ES-SCLC, has scarcely improved. The focus of this review, which briefly summarizes current treatment options for ES-SCLC, is on five clinical-stage therapies with the potential to successfully reverse the platinum resistance that is perhaps the biggest obstacle to better clinical outcomes.
  • ||||||||||  Aplidin (plitidepsin) / PharmaMar, Roche
    Journal:  Exploring the Biosynthetic Potential of Tistrella Species for Producing Didemnin Antitumor Agents. (Pubmed Central) -  Oct 18, 2024   
    Furthermore, we increased the titers of nordidemnin B and [hysp2]didemnin B by supplementing the fermentation medium with l-valine and l-isoleucine, respectively. Finally, both compounds undergo side-chain oxidation to enhance their biological activity, with their anticancer properties found to be as potent as plitidepsin.
  • ||||||||||  Aplidin (plitidepsin) / PharmaMar, Roche
    P3 data, Journal:  A phase III randomized controlled trial of plitidepsin, a marine derived compound, in hospitalized adults with moderate COVID-19. (Pubmed Central) -  Oct 15, 2024   
    Despite the trial limitations, these results suggest that plitidepsin may have a positive benefit-risk ratio in the management of patients requiring oxygen therapy. Further studies with plitidepsin, including those in immunosuppressed patients, are warranted.Results from this phase III trial suggest that plitidepsin, a first-in-class antiviral, may have a positive benefit-risk ratio in the management of hospitalized patients requiring oxygen therapy for moderate COVID-19.
  • ||||||||||  kahalalide F (PM-92102) / Marinomed Biotech, Medimetriks, Aplidin (plitidepsin) / PharmaMar, Roche
    Review, Journal:  Exploring the seas for cancer cures: the promise of marine-derived bioactive peptide. (Pubmed Central) -  Sep 23, 2024   
    The study delves into peptides affecting apoptosis, microtubule dynamics, and angiogenesis inhibition, offering insights into potential cancer treatment mechanisms. Marine-derived peptides hold great promise as valuable candidates for novel anticancer therapies, with ongoing research aimed at unlocking their full therapeutic benefits.
  • ||||||||||  kahalalide F (PM-92102) / Marinomed Biotech, Medimetriks, Neovastat (AE 941) / AEterna Zentaris, Aplidin (plitidepsin) / PharmaMar, Roche
    Review, Journal:  Marine bioactive peptides with anticancer potential, a narrative review. (Pubmed Central) -  Sep 23, 2024   
    While peptides like Neovastat and mycothiazole target known pathways, others such as patellamides act through unknown mechanisms, highlighting the intricate interactions of marine peptides with cancer cells. Overall, marine-derived peptides show promise as valuable candidates for developing novel anticancer therapies.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Trial completion date, Trial initiation date, Trial primary completion date, Metastases:  Neoadjuvant Lurbinectedin and Preoperative Radiation for Treating Soft Tissue Sarcomas (clinicaltrials.gov) -  Sep 19, 2024   
    P1/2,  N=70, Not yet recruiting, 
    Overall, marine-derived peptides show promise as valuable candidates for developing novel anticancer therapies. Trial completion date: Jul 2027 --> Oct 2027 | Initiation date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jan 2026 --> May 2026
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Trial completion date, Combination therapy:  LUPER: Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer. (clinicaltrials.gov) -  Aug 19, 2024   
    P1/2,  N=28, Active, not recruiting, 
    All other abstracts will be released on the day of presentation. Trial completion date: Feb 2024 --> Mar 2025
  • ||||||||||  temozolomide / Generic mfg.
    Review, Journal:  Challenges and future perspectives for the use of temozolomide in the treatment of SCLC. (Pubmed Central) -  Aug 17, 2024   
    Several studies have revealed the synergistic activity of temozolomide with poly-ADP-ribose polymerase (PARP) inhibitors, that prevent repair of TMZ-induced DNA damage. This review focuses on the rationale for the use of TMZ in ES-SCLC and provides an overview of the main trials that have evaluated and are currently investigating its role, both as a single-agent and in combinations, in relapse or refractory disease.
  • ||||||||||  Calsed (amrubicin) / BMS, Nippon Kayaku, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Chemotherapy Sensitivity for Recurrent Small-Cell Lung Cancer Based on Chemotherapy-Free Interval and Treatment Regimens (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2228;    
    The concept of sensitive relapse was established before the advent of amrubicin (available in Japan) and lurbinectedin (recommended in ESMO and NCCN guidelines), which are effective for recurrent SCLC...Thirty-four were treated by platinum-doublet re-challenge, and 29 received monotherapy of amrubicin, topotecan, or irinotecan...It is still unclear whether the response of second-line chemotherapy following ICI is elevated compared to conventional chemotherapy. Further investigation is needed.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Modulation of EMT Increases the Activity of Lurbinectedin in Small Cell Lung Cancer (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1490;    
    Further investigation is needed. Their sensitivity to cisplatin and etoposide (chemotherapeutic drugs), as well as lurbinectedin alone and combination with capmatinib (MET inhibitor), was tested using the Cell Titer-Glo
  • ||||||||||  ABBV-706 / AbbVie, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Prevalence and Prognostic Impact of SEZ6 Expression in a Real-World Cohort of Patients with Small-Cell Lung Cancer (Exhibit Hall) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1197;    
    P1
    Although the sample size was small and the study was limited to a single site, these data support SEZ6 as a potential ADC-targetable biomarker in SCLC. This real-world SCLC cohort could also be used as a borrowed control for the phase 1 single-arm study being conducted in patients with SCLC treated with ABBV-706 to help identify novel predictive biomarkers and interpret the outcomes from the study.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Teriflunomide in Vitro or Leflunomide in Vivo Treatment Increases the Efficacy of Lurbinectedin in SCLC (30A) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1106;    
    Conclusions : Collectively, our data suggest combinations of Lurbinectedin with Teriflunomide or Leflunomide are a potential therapeutic approach to suppress SCLC progression. These novel results pave the way for clinical trials in the future to validate these treatment strategies in patients with SCLC.
  • ||||||||||  SNB-101 / SN BioSci
    Journal:  Generation of anti-SN38 antibody for loading efficacy and therapeutic monitoring of SN38-containing therapeutics. (Pubmed Central) -  Jul 18, 2024   
    However, it has garnered significant scientific interest as a payload in conjugated nanomedicine platforms (e.g., SN-38lip, NK012, SNB-101, and ADCs) to enhance their effectiveness and safety...The immunization efficiency, reactivity, binding affinity, specificity, and cross-reactivity of purified pAb and mAb against Irinotecan, a model for the emergence of an SN38 derivative in clinical settings, were evaluated using ELISA and western blotting (WB) techniques...The affinity of both pAb and mAb also meets the acceptance criteria for quantifying SN38 in fluidic material, as well as in Therapeutic drug monitoring (TDM) studies, a crucial aspect of personalized medicine. The potential applications of the anti-SN38 antibodies extend to reducing SN38-induced systemic toxicity through an inverse targeting strategy, a novel approach that piques further interest in our findings.
  • ||||||||||  fimasartan/ezetimibe/atorvastatin (BR1017) / Boryung Group, Kanarb (fimasartan) - Boryung Group, R / Pharm
    Trial completion date, Trial primary completion date, Combination therapy:  A Study to Evaluate the Efficacy and Safety of BR1017A and BR1017B Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia (clinicaltrials.gov) -  Jul 18, 2024   
    P3,  N=156, Recruiting, 
    The potential applications of the anti-SN38 antibodies extend to reducing SN38-induced systemic toxicity through an inverse targeting strategy, a novel approach that piques further interest in our findings. Trial completion date: Jun 2024 --> Sep 2024 | Trial primary completion date: Jun 2024 --> Sep 2024
  • ||||||||||  teriflunomide / Generic mfg., leflunomide / Generic mfg.
    Journal:  Teriflunomide/leflunomide synergize with chemotherapeutics by decreasing mitochondrial fragmentation via DRP1 in SCLC. (Pubmed Central) -  Jul 12, 2024   
    Additionally, lurbinectedin (Lur) and Teri potently and synergistically inhibited spheroid growth and depleted uridine and DRP1 phosphorylation in mouse tumors. Our results suggest combinations of Carbo and Lur with Teri or Leflu are efficacious and underscore how the relationship between DRP1/DHODH and mitochondrial plasticity serves as a potential therapeutic target to validate these treatment strategies in SCLC clinical trials.
  • ||||||||||  Cosela (trilaciclib) / G1 Therap, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Trial completion date, Trial primary completion date:  Study of Trilaciclib and Lurbinectidin (clinicaltrials.gov) -  Jun 27, 2024   
    P2,  N=30, Recruiting, 
    In a nutshell, the present study evokes the potentiality of performing solidification through wet impregnation and successful implementation of the SeDeM-SLA expert model, which could find wide applications in pharmaceutical science. Trial completion date: Jul 2026 --> Dec 2027 | Trial primary completion date: Jul 2024 --> Dec 2025
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal, Tumor mutational burden, PD(L)-1 Biomarker:  Durable Objective Response to Lurbinectedin in Small Cell Bladder Cancer with TP53 Mutation: A Molecular-Directed Strategy. (Pubmed Central) -  Jun 26, 2024   
    A repeat biopsy following the development of lurbinectedin resistance showed a new actionable ERBB2 alteration without significant change in the tumor mutation burden (six mutations/Mb). The present report suggests that lurbinectedin may be active and should be further explored in SCBC harboring TP53 mutations and amplifications in E2F3 and MYC family complexes.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Journal:  Evolution of a Synthetic Strategy toward the Syntheses of Bis-tetrahydroisoquinoline Alkaloids. (Pubmed Central) -  Jun 14, 2024   
    ConspectusThe bis-tetrahydroisoquinoline (bis-THIQ) natural products represent a medicinally important class of isoquinoline alkaloids that exhibit broad biological activities with particularly potent antitumor properties, as exemplified by the two U.S. FDA approved molecules trabectidin and lurbinectedin...Finally, we include our unsuccessful late-stage oxygenation attempts prior to the discovery of the Pd-catalyzed C-O cross-coupling reaction. With this full disclosure of the chemistry developed for the syntheses of bis-THIQs, we hope our orthogonal synthetic tactics will provide useful information and serve as an inspiration for the future development of bis-THIQ pharmaceuticals.
  • ||||||||||  Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Trial completion, Trial completion date, Trial primary completion date, Metastases:  Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients (clinicaltrials.gov) -  Jun 9, 2024   
    P1,  N=32, Completed, 
    With this full disclosure of the chemistry developed for the syntheses of bis-THIQs, we hope our orthogonal synthetic tactics will provide useful information and serve as an inspiration for the future development of bis-THIQ pharmaceuticals. Recruiting --> Completed | Trial completion date: Dec 2024 --> Nov 2023 | Trial primary completion date: Dec 2024 --> Nov 2023
  • ||||||||||  Imfinzi (durvalumab) / AstraZeneca, Zepzelca (lurbinectedin) / PharmaMar, Jazz
    Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date:  LURBIMUNE: Lurbinectedin Combined With Durvalumab in Pre-treated Patients With Extensive Stage Small-cell Lung Cancer (clinicaltrials.gov) -  Jun 4, 2024   
    P2,  N=0, Withdrawn, 
    Our findings show that quercetin/lurbinectedin-loaded GO NPs may be a promising lung cancer treatment, opening new avenues for targeted and effective therapies. N=82 --> 0 | Trial completion date: Apr 2026 --> May 2024 | Recruiting --> Withdrawn | Trial primary completion date: Oct 2024 --> May 2024