- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Lurbinectedin in prostatic small cell and neuroendocrine carcinoma. (Level 1, West Hall; Poster Bd # G14) - Dec 13, 2023 - Abstract #ASCOGU2024ASCO_GU_349; L is a well-tolerated and active treatment option for patients with SC/NEPC. Prospective studies are needed to determine the role of L in the treatment of SC/NEPC.
- |||||||||| Cosela (trilaciclib) / G1 Therap, Zepzelca (lurbinectedin) / PharmaMar, Jazz
SCS-04: Harnessing the Power of the Latest Clinical and Research Advances in SCLC: How to Accelerate Progress and Improve Patient Outcomes With Current and Emerging Therapies (Chicago Ballroom ABCD) - Nov 29, 2023 - Abstract #IASLCNACLC2023IASLC_NACLC_94; However, our research indicates healthcare and practice gaps persist in SCLC, partly due to the nature of the disease, the pace of scientific advancements, and their translation into practice. Addressing these gaps requires well-designed educational programs to improve the knowledge, skills, and competence of oncology and multidisciplinary professionals, ensuring that all patients with SCLC can benefit from the latest therapeutic advances.
- |||||||||| 5-fluorouracil / Generic mfg., Zepzelca (lurbinectedin) / PharmaMar, Jazz, irinotecan / Generic mfg.
Preclinical, Journal, Combination therapy: Preclinical Synergistic Combination Therapy of Lurbinectedin with Irinotecan and 5-Fluorouracil in Pancreatic Cancer. (Pubmed Central) - Nov 28, 2023 We further demonstrate that the triple combination between lurbinectedin, irinotecan, and 5-fluorouracil (5-FU) results in a highly efficient killing of tumor cells. Our results are developing insights regarding molecular mechanisms underlying the therapeutic efficacy of a novel combination drug treatment for pancreatic cancer.
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz, Tecentriq (atezolizumab) / Roche
Phase classification, Enrollment change, Metastases: 2SMALL: Study to Assess Safety,Tolerability,Efficacy of PM01183 and Atezolizumab in Patients w/ Advanced Small Cell Lung Cancer. (clinicaltrials.gov) - Nov 18, 2023 P1/2, N=184, Recruiting, Not yet recruiting --> Recruiting | Phase classification: P1b --> P1 Phase classification: P1 --> P1/2 | N=25 --> 184
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Trial completion date, Trial primary completion date: Lurbinectedin + Doxorubicin In Leiomyosarcoma (clinicaltrials.gov) - Oct 31, 2023 P1b/2, N=62, Recruiting, Phase classification: P1 --> P1/2 | N=25 --> 184 Trial completion date: Jan 2025 --> Jul 2025 | Trial primary completion date: Jan 2024 --> Jul 2024
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Journal, BRCA Biomarker, Metastases: Pooled Safety Analysis of Single-Agent Lurbinectedin in Patients With Advanced Solid Tumours. (Pubmed Central) - Sep 18, 2023 This analysis confirms a manageable safety profile for lurbinectedin in patients with advanced solid tumours. Findings are consistent with those reported in patients with relapsed SCLC, Ewing sarcoma, germline BRCA1/2 metastatic breast cancer, neuroendocrine tumours and ovarian cancer.
- |||||||||| Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Zepzelca (lurbinectedin) / PharmaMar, Jazz
Journal: Immunometabolic actions of trabectedin and lurbinectedin on human macrophages: relevance for their anti-tumor activity. (Pubmed Central) - Sep 11, 2023 Glutamine, aspartate, histidine, and proline intracellular levels are also decreased, whereas oxygen consumption is reduced. The observed immunometabolic changes explain additional antitumor activities of these compounds and open new avenues to design therapeutic interventions that specifically target the immunometabolic landscape in
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Zepzelca (lurbinectedin) / PharmaMar, Jazz, Yervoy (ipilimumab) / Ono Pharma, BMS
Review, Journal, Metastases: Managing Metastatic Extrapulmonary Neuroendocrine Carcinoma After First-Line Treatment. (Pubmed Central) - Aug 22, 2023 Simultaneously, advances in the understanding of disease biology are helping to refine patient selection and identify commonalities between NEC and their sites of origin which may eventually lead to additional targeted therapy options. While many questions remain, contemporary developments give grounds for optimism that improved outcomes for EP-NEC will soon be within reach.
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Enrollment open: LiFFT: Lurbinectedin in FET-Fused Tumors (clinicaltrials.gov) - Jul 31, 2023 P1/2, N=56, Recruiting, Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, Zepzelca (lurbinectedin) / PharmaMar, Jazz
Trial completion date, Trial primary completion date: Durvalumab and Lurbinectedin for the Treatment of Relapsed or Refractory Small Cell Lung Cancer (clinicaltrials.gov) - Jul 28, 2023 P2, N=106, Recruiting, They have all been approved for a different indication, characterizing them as the most promising candidates for repurposing to treat patients with OC. Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Journal: ATR inhibition augments the efficacy of lurbinectedin in small-cell lung cancer. (Pubmed Central) - Jul 26, 2023 P1/2 Importantly, MYC-driven non-neuroendocrine tumors which are resistant to first-line therapies show reduced CDKN1A/p21 expression and increased ERCC5/XPG indicating they are primed for response to lurbinectedin-berzosertib combination. The combination is being assessed in a clinical trial NCT04802174.
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Efficacy of Platinum after Lurbinectedin + DOX or Topotecan/CAV in Sensitive Relapsed SCLC Patients in the ATLANTIS Trial (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2369; This survival benefit could be explained by L/DOX resulting in a longer median PFS compared to topotecan/CAV. The effects of platinum rechallenge after L/DOX are similar to those previously reported (Baize et al., 2020), thereby suggesting that giving lurbinectedin as second line to platinum-sensitive relapsed SCLC patients does not affect the efficacy of subsequent platinum rechallenge, could extend the platinum-free interval and improve patient survival.
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
EFfectiveness and Safety Profile of Lurbinectedin in Second-Line Small Cell Lung Cancer: A Real-World Study (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2365; P2 The rates of neutropenia, thrombocytopenia, anemia, and febrile neutropenia tended to be lower than what was observed in the basket trial.Real-world effectiveness outcomes of lurbinectedin monotherapy in the 2L settingPatients with lurbinectedin (N=374)Best real-world overall response, n (%)Complete response2 (0.5)Partial response101 (27)Stable disease43 (11.5)Progressive disease100 (26.7)Not evaluable128 (34.2)Overall response rate (CR+PR)103 (27.5)Duration of responsea (95% CI)Median rwDoR, months2.7 (2.4, 3.3)Patients with response at 4 months, %24.2% (15.2%, 33.1%)Patients with response at 6 months, %9.4% (2.9%, 15.9%)Progression-free survival (95% CI)Median rwPFS, months2.5 (2.1, 2.3)Patients who were progression-free at 4 months, %31.5% (26.6%, 36.4%)Patients who were progression-free at 6 months, %15.6% (11.7%, 19.4%)Time to next treatment (95% CI)Median rwTTNT, months3.6 (3.2, 4.0)Patients receiving no subsequent treatment at 4 months, %45.6% (40.4%, 50.8%)Patients receiving no subsequent treatment at 6 months, %27.7% (23.0%, 32.5%)aDuration of response was evaluated in patients (n=103) with a best response of CR or PR during 2L therapy. CI, confidence interval; CR, complete response; PR, partial response; rwDoR, real-world duration of response; rwPFS, real-world progression-free survival; rwTTNT, real-world time to next treatment; 2L, second-line.
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, Zepzelca (lurbinectedin) / PharmaMar, Jazz, Tecentriq (atezolizumab) / Roche
Recent Patterns across Therapy Lines and Real-World Survival Post First Line PD-L1 Treatment for Small Cell Lung Cancer (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_2364; Treatment patterns for 1L and 2L treatment of SCLC have changed dramatically in the past four years; however, survival outcomes beyond progression on 1L therapy remain sub-optimal regardless of receipt of prior immunotherapy. There is a critical need to develop novel approaches for this patient population.
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Efficacy of Platinum Given after Lurbinectedin in Sensitive Relapsed SCLC Patients (Exhibit Hall) - Jul 25, 2023 - Abstract #IASLCWCLC2023IASLC_WCLC_1841; P2 Platinum rechallenge is an option recommended in clinical guidelines for second-line platinum-sensitive relapsed SCLC patients with median PFS 4.7 months and median OS 7.5 months (Baize et al., Lancet Oncol 2020; 21: 1224-33). Lurbinectedin is a valuable therapeutic option for sensitive SCLC patients; although based on a small sample size, the results suggest that lurbinectedin could extend the platinum-free interval without precluding the use of further platinum-based therapy and improve outcomes.
- |||||||||| Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma
Journal: Formal Synthesis of Ecteinascidin 743 from N-Cbz-l-tyrosine. (Pubmed Central) - Jul 18, 2023 Key features involve a Pictet-Spengler cyclization coupling of the tetrahydroisoquinoline and phenylalaninol moieties prepared by a common route with high yield and selectivity, a Parikh-Doering oxidation with good chemoselectivity and functionality tolerance, and a light-mediated A-ring elaboration of pentacyclic methoxyquinone substrates. By the approach, the known advanced intermediate (4-step conversion to Et-743) can be obtained conveniently in 21 total steps from N-Cbz-l-tyrosine.
- |||||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Journal, Head-to-Head: A model-based head-to-head comparison of single-agent lurbinectedin in the pivotal ATLANTIS Study. (Pubmed Central) - Jul 3, 2023 Head-to-head comparisons with predicted 3.2 mg/m lurbinectedin resulted in a positive outcome in ATLANTIS, with hazard ratio (95% prediction intervals [95% PI]) for OS of 0.54 (0.41, 0.72), and odds ratio (95% PI) for ORR of 0.35 (0.25, 0.5). These results support the superiority of lurbinectedin monotherapy for relapsed SCLC over other approved therapies.
- |||||||||| Opdivo (nivolumab) / BMS, Zepzelca (lurbinectedin) / PharmaMar, Jazz, Yervoy (ipilimumab) / BMS
Enrollment open: LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma (clinicaltrials.gov) - Jun 9, 2023 P1/2, N=40, Recruiting, These results support the superiority of lurbinectedin monotherapy for relapsed SCLC over other approved therapies. Not yet recruiting --> Recruiting
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