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26 Diseases |  |
31 Trials |
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31 Trials |  |
1838 News |  |
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- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
FDA event: Congrats to @VivekSubbiah @AnnaFaragoMD and the other investigators who were part of the lurbinectedin studies. Fantastic news to have a new option FDA approved for relapsed #sclc. We need many more... #LCSM (Twitter) - Jun 15, 2020
- ||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Such a persisting area of high unmet need @FDAOncology despite new 1L IO-chemo. #lurbinectedin data are promising for sure ! @charlesrudin (Twitter) - Jun 15, 2020
- ||||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
FDA event: Hear Ye, hear Ye!! FDA Accelerates Approval of Lurbinectedin in Metastatic Small Cell Lung Cancer. Decreases transcription of IL6, IL8, CCL2 and VEGF https://t.co/oixEDwOE89 (Twitter) - Jun 15, 2020
- |||||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
FDA event: Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca™ (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer . #pharmamar #zepzelca @JazzPharma @StephenVLiu @JackWestMD #lungcancer https://t.co/iSuVsWoxrn (Twitter) - Jun 15, 2020
- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: Efficacy and safety of lurbinectedin (PM1183) in Ewing sarcoma: Final results from a phase 2 study. https://t.co/raOtlsgCwL (Twitter) - Jun 15, 2020
- ||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Robust activity for Lurbinectedin, an oncogenic transcription inhibitor with immune modulating properties, in a difficult to treat proliferative malignancy-small-cell lung cancer-suggests a potential role in other similar malignancies? (Twitter) - Jun 15, 2020
- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
FDA event: FDA approval of lurbinectedin for 2L SCLC and how the level of onco-enthusiasm for it is not exactly the same as the level of excitement around ADAURA. (Twitter) - Jun 15, 2020
- ||||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
FDA event: Jazz Pharmaceuticals Announces U.S. FDA Accelerated Approval of Zepzelca™ (lurbinectedin) for the Treatment of Metastatic Small Cell #LungCancer https://t.co/7mDTsQbJ1h (Twitter) - Jun 15, 2020
- || Zepsyre (lurbinectedin) / PharmaMar, Jazz
I agree. I think the level of enthusiasm is best summed up as "what's lurbinectedin?". (Twitter) - Jun 15, 2020
- ||||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical, FDA event: FDA APPROVED!!! Today the @US_FDA approved to lurbinectedin (ZEPZELCA, @PhrmMar) w metastatic #small cell #lungcancer. #lcsm. So honored to be involved in the development of this drug. Thankful to all patients & researchers. Published @TheLancetOncol https://t.co/0aDB50rAnv (Twitter) - Jun 15, 2020
- ||||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical, FDA event: 🥁FDA APPROVED✅!!! Today the @US_FDA approved to lurbinectedin (ZEPZELCA, @PhrmMar) w metastatic #small cell #lungcancer. #lcsm. So honored to be involved in the development of this drug. Thankful to all patients & researchers. Published @TheLancetOncol https://t.co/0aDB50rAnv (Twitter) - Jun 15, 2020
- || Zepsyre (lurbinectedin) / PharmaMar, Jazz
Congrats to Pascal Besman and everyone at PharmaMar on the approval of lurbinectedin! 🎉 (Twitter) - Jun 15, 2020
- ||| topotecan / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
Lurbinectedin, now christened Zepzelca, approved by @US_FDA in relapsed SCLC. Indication doesn't specify single agent vs. combo w/chemo. Many will welcome this option in a setting where topotecan has been historical but vy unloved SOC. Await more data w/lurbi. #LCSM (Twitter) - Jun 15, 2020
- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical, P2 data, Monotherapy: #OncoAlert Lurbinectedin approved today by the @US_FDA for previously treated #SCLC. Phase II trial of monotherapy showed RR 35% (45% in platinum-sensitive, 22% in platinum-resistant). Randomized trial results pending. Glad to have more options post chemo-IO. #OncoAlert (Twitter) - Jun 15, 2020
- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
FDA event: Lurbinectedin now FDA approved option for small cell #lungcancer! Excited to have a novel approval! #LCSM https://t.co/wrfmHOfhmO (Twitter) - Jun 15, 2020
- || Zepsyre (lurbinectedin) / PharmaMar, Jazz
Stifel: Zepsyre could emerge as new standard of care in 2nd-line SCLC $PHM.MC $JAZZ (Twitter) - Jun 10, 2020
- |||| doxorubicin hydrochloride / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical, P3 data, Combination therapy: I’ve been using lurbinectedin for years, and yes, it’s an active agent. Eager to see the ATLANTIS phase III trial in combination with doxorubicin in relapsed second-line SCLC. #ASCO20 #LCSM (Twitter) - May 30, 2020
- |||||| topotecan / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical, P2 data, P3 data, Pan Tumor: Presenting a 👉Pooled safety analysis of single-agent #lurbinectedin VS topotecan (Results from a randomized phase III trial CORAIL & a phase II basket trial). Started this study for Ewing #sarcoma👉& found that lurbinectedin is active in #small cell #lungcancer @ASCO #ASCO20 (Twitter) - May 30, 2020
- |||||| topotecan / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
Retrospective data, Pan Tumor: Whats new in #small cell #lungcancer ? Lurbinectedin as 2nd-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial was published in @TheLancetOncol @ASCO #ASCO20 We present the pooled analysis vs topotecan https://t.co/Xw4JJIRWUy (Twitter) - May 28, 2020
- || Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical, P1/2 data, PK/PD data, Journal: Population-Pharmacokinetic and Covariate Analysis of Lurbinectedin (PM01183), a New RNA Polymerase II Inhibitor, in Pooled Phase I/II Trials in Patients with Cancer. (Pubmed Central) - May 25, 2020
A chronic inflammation pattern characterized by decreased albumin and increased C-reactive protein and α-1-acid glycoprotein levels led to high lurbinectedin exposure. Co-administration of cytochrome P450 3A inhibitors increased lurbinectedin exposure.
- ||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Enrollment open: PM1183-A-014-15: Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors (clinicaltrials.gov) - May 21, 2020
P1/2, N=150, Recruiting, Sponsor: PharmaMar
Co-administration of cytochrome P450 3A inhibitors increased lurbinectedin exposure. Active, not recruiting --> Recruiting
- | Opdivo (nivolumab) / Ono Pharma, BMS
Review, Journal: Emerging therapies for small cell lung cancer. (Pubmed Central) - May 17, 2020
Future prospects for even better outcomes in SCLC lie in novel ways to integrate immunotherapy and small-molecule TKI drugs. Innovative clinical trial designs are needed to efficiently explore the increasing number of options with new drugs and new combinations thereof for SCLC.
- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: May issue @TheLancetOncol ✅Lurbinectedin active as 2nd-line therapy for #smallcell #lungcancer. ✅Lurbinectedin potential NEW treatment SCLC ✅Overall response seen in 37 patients (35·2%; 95% CI 26·2–45·2). #LCSM More safety data at #ASCO20 @PhrmMar https://t.co/QIsYEQ9P2C (Twitter) - May 14, 2020
- ||| topotecan / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical, Pan Tumor: Meeting Library | Pooled safety analysis of single-agent lurbinectedin versus topotecan (Results from a randomized phase III trial CORAIL and a phase II basket trial). https://t.co/Xw4JJIRWUy (Twitter) - May 14, 2020
- || Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Zepsyre (lurbinectedin) / PharmaMar, Jazz
#Tumore, 7 nuovi studi di #PharmaMar su lurbinectedina e trabectedina al Congresso #ASCO20 https://t.co/pmHcaxLyDN (Twitter) - May 14, 2020
- ||||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: Just an FYI-especially for Tri-State area pts/oncs as I am told we are the only site open -Lurbinectedin now available @MontefioreNYC on expanded access protocol for pts with ES-SCLC post at least 1 line of chemo. See attached info on drug from @JazzPharma. I am jazzed..are you? (Twitter) - May 12, 2020
- ||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
M&A: #BionicalEmas and #JazzPharmaceuticals Enter into an Agreement for Expanded Access to #Lurbinectedin in Relapsed #SmallCellLungCancer in the United States $JAZZ https://t.co/q9sbLtENLt (Twitter) - May 12, 2020
- || Zepzelca (lurbinectedin) / PharmaMar, Jazz
Enrollment closed: PM1183-A-014-15: Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors (clinicaltrials.gov) - May 12, 2020
P1/2, N=150, Active, not recruiting, Sponsor: PharmaMar
Innovative clinical trial designs are needed to efficiently explore the increasing number of options with new drugs and new combinations thereof for SCLC. Recruiting --> Active, not recruiting
- | Zepsyre (lurbinectedin) / PharmaMar, Jazz
Journal: Immunoregulatory effects of Lurbinectedin in chronic lymphocytic leukemia. (Pubmed Central) - May 11, 2020
Altogether, these results indicate that Lurbinectedin might have antitumor activity in CLL due to its direct action on leukemic cells in combination with its effects on the tumor microenvironment. Our findings encourage further investigation of Lurbinectedin as a potential therapy for CLL.
- topotecan / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
[VIRTUAL] Pooled safety analysis of single-agent lurbinectedin versus topotecan (Results from a randomized phase III trial CORAIL and a phase II basket trial). (Poster Board 365) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1584;
P2, P3
A significant safety advantage was observed when lurbinectedin was compared with topotecan in the CORAIL trial in terms of hematological toxicities. With the limitations of indirect comparisons, in the pooled safety analysis, fewer lurbinectedin-treated pts had severe hematological toxicities, SAEs, dose adjustments, treatment discontinuations and use of supportive treatments than topotecan-treated pts.
- Zepsyre (lurbinectedin) / PharmaMar, Jazz, irinotecan / Generic mfg.
[VIRTUAL] Lurbinectedin (LUR) in combination with Irinotecan (IRI) in patients (pts) with advanced solid tumors: Updated results from a phase Ib-II trial. (Poster Board 244) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1465;
P1/2
Transient myelosuppression was dose-limiting. The RD is LUR 2.0 mg/m2 on D1 + IRI 75 mg/m2 on D1 and D8 q3w with G-CSF.
- || Keytruda (pembrolizumab) / Merck (MSD), Zepzelca (lurbinectedin) / PharmaMar, Jazz
New P1/2 trial, PD(L)-1 Biomarker: LUPER: Lurbinectedin (PM01183) Combined With Pembrolizumab in Small Cell Lung Cancer. (clinicaltrials.gov) - Apr 23, 2020
P1/2, N=42, Not yet recruiting, Sponsor: Antonio Calles Blanco
- | Zepsyre (lurbinectedin) / PharmaMar, Jazz, Aplidin (plitidepsin) / PharmaMar, Roche
La realidad es Lurbinectedin, Aplidin de momento nos hace ganar tiempo. (Twitter) - Apr 23, 2020
- | Zepsyre (lurbinectedin) / PharmaMar, Jazz
Journal: Lurbinectedin Is Safe and Active in Relapsed Small-Cell Lung Cancer. (Pubmed Central) - Apr 13, 2020
The RD is LUR 2.0 mg/m2 on D1 + IRI 75 mg/m2 on D1 and D8 q3w with G-CSF. Lurbinectedin produced responses in 35.2% of 105 patients with relapsed small-cell lung cancer.
- ||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Lurbinectedin in the Prestigious Magazine The LANCET ONCOLOGY . #pharmamar #lurbinectedin @jazzpharma #LSCL #lungcancer #oncology #Boryung #SpecialisedTherapeutics #luye_pharma https://t.co/bd0tO55Ye1 (Twitter) - Apr 3, 2020
- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
New opportunities in a challenging disease: lurbinectedin for relapsed small-cell lung cancer. Congrats Oscar and Lucy, Great Job!!!! (Twitter) - Mar 31, 2020
- ||||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: Phase 2 basket trial of second-line #lurbinectedin in small-cell #LungCancer by @josemtrigo @VivekSubbiah & colleagues now published in @TheLancetOncol https://t.co/JnHJGRXy1A Read our report from when data were presented at #ASCO last year #SCLC https://t.co/qYstvB51iq (Twitter) - Mar 30, 2020
- |||| topotecan / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: #OncoAlert Lurbinectedin given IV q3w. Primary tox was hematologic but only 2% discontinued for treatment related AEs (expect > 25% with topotecan). Await randomized trial data. Great work by @VivekSubbiah @dr_ponce_aix @peters_solange @BenjaminBesseMD @sands_jacob @PhrmMar et al (Twitter) - Mar 28, 2020
- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: #OncoAlert Single arm phase II study of lurbinectedin in relapsed #SCLC now online @TheLancetOncol. RR 35.2% but perhaps most compelling data is in the chemo-resistant population where we have no effective options (RR 22.2%, DOR 4.7m). #LCSM https://t.co/RLp3mYlPvf (Twitter) - Mar 28, 2020
- ||| topotecan / Generic mfg., doxorubicin hydrochloride / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
Monotherapy: The completed rand ph 3 (ATLANTIS) is doxorubicin/lurbinectedin combo vs. topotecan or CAV, dealer's choice. Should see data soon, but would love to have had a lurbinectedin monotherapy arm instead of doxo/lurbi combo. (Twitter) - Mar 28, 2020
- ||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: Agree with that, but this is 105 patients, & most of the trials you're talking about have been significantly smaller, most pts also not as heavily pre-treated. No question we need more data, but I remain more optimistic that lurbinectedin will have utility (tho not miraculous). (Twitter) - Mar 28, 2020
- ||||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: Non-#COVID19 read for the weekend ➡️Hot off the press➡️Presenting Lurbinectedin as 2nd line small-cell #lungcancer : a single-arm, open-label, phase 2 basket trial @TheLancetOncol https://t.co/oEc2IqY2Ug @PhrmMar @BenjaminBesseMD #LCSM (Twitter) - Mar 28, 2020
- |||| Zepsyre (lurbinectedin) / PharmaMar, Jazz
Clinical: Lurbinectedin as second-line treatment for patients with small-cell #lungcancer : a single-arm, open-label, phase 2 basket trial https://t.co/fQWz5WPd3m @TheLancetOncol (Twitter) - Mar 28, 2020
- || Yondelis (trabectedin) / Otsuka, PharmaMar, Valeo Pharma, Zepsyre (lurbinectedin) / PharmaMar, Jazz, Aplidin (plitidepsin) / PharmaMar, Roche
Pharma Mar To Carry Out Buy-Back Program For Up To 3% Of Co's Share Capital . #lurbinectedin @jazzpharma #yondelis #Boryung #aplidin @genomica_sau #sylentis #SpecialisedTherapeutics #luye_pharma #pharmamar (Twitter) - Mar 25, 2020
- | paclitaxel / Generic mfg., Zepsyre (lurbinectedin) / PharmaMar, Jazz
Preclinical, Journal, Cancer stem cells: Lurbinectedin (PM01183), a selective inhibitor of active transcription, effectively eliminates both cancer cells and cancer stem cells in preclinical models of uterine cervical cancer. (Pubmed Central) - Mar 24, 2020
Lurbinectedin downregulated stem cell-related gene expression (Oct4, Nanog, and SOX2), inhibited HDAC1 activity, and effectively eliminated ALDH-high CSCs. Conclusions Lurbinectedin is highly effective on uterine cervical cancer because it eliminates CSCs, and lurbinectedin is a promising agent to overcome platinum resistance in cervical cancer.
- | Journal: Advances and challenges in immunotherapy of small cell lung cancer. (Pubmed Central) - Mar 21, 2020
Some traditional chemotherapeutic drugs or targeted drugs, such as alkylating agent temozolomide and transcription inhibitor lurbinectedin, have been found to have immunomodulatory effects and are expected to become new immunotherapeutic agents. In this study, we aimed to review the efficacy of new treatments for SCLC and discuss the current challenges and application prospect in the treatment of SCLC patients.
- || Zepsyre (lurbinectedin) / PharmaMar, Jazz
Review, Journal, Orphan drug: Orphan Drugs in Development for the Treatment of Small-Cell Lung Cancer: Emerging Data on Lurbinectedin. (Pubmed Central) - Mar 19, 2020
Lurbinectedin, a novel RNA-polymerase II inhibitor has shown promising results in pretreated SCLC patients as single agent and in combination with other chemotherapeutic drugs leading to an orphan drug designation from the FDA. This article reviews the current data on this emerging substance and its impact on the treatment of SCLC.
- || Zepzelca (lurbinectedin) / PharmaMar, Jazz
Trial completion date, Trial primary completion date, Metastases: PM1183-B-005-14: Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors (clinicaltrials.gov) - Mar 13, 2020
P2, N=345, Active, not recruiting, Sponsor: PharmaMar
This article reviews the current data on this emerging substance and its impact on the treatment of SCLC. Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Jan 2020 --> Jan 2021
- ||||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
Trial completion: ATLANTIS: Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (clinicaltrials.gov) - Mar 10, 2020
P3, N=613, Completed, Sponsor: PharmaMar
Trial completion date: Jan 2020 --> Jan 2021 | Trial primary completion date: Jan 2020 --> Jan 2021 Active, not recruiting --> Completed
- |||||| Zepzelca (lurbinectedin) / PharmaMar, Jazz
New trial: A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA (clinicaltrials.gov) - Mar 1, 2020
P, N=0, Available, Sponsor: PharmaMar