Weekly Top News – Ovarian Cancer – September 14, 2020

September 14, 2020

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab Announces NMPA Approval of ZEJULA (Niraparib) for First-Line Maintenance Treatment of Ovarian Cancer in China (GlobeNewswire) – Sep 10, 2020 – “Zai Lab Limited…announced that the China National Medical Products Administration (NMPA) has approved its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.”


Imfinzi (durvalumab) / AstraZeneca; adavosertib (AZD1775) / AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca
AstraZeneca aims to transform cancer treatment and advance clinical practice with data presented at ESMO 2020 (AstraZeneca Press Release) – Sep 8, 2020 – “Key presentations include:…Practice-changing overall survival (OS) data from the PROfound Phase III trial; Exploratory data from the ADAURA Phase III trial; Data from the PACIFIC Phase III trial in unresectable Stage III NSCLC and the CASPIAN Phase III trial in extensive-stage small-cell lung cancer (ES-SCLC)…AstraZeneca will also present data from several trials of the early and mid-stage pipeline, including:…A Phase II trial of Lynparza plus Imfinzi and bevacizumab (MEDIOLA); A Phase lb expansion trial of adavosertib plus Lynparza…”


Trodelvy (sacituzumab govitecan-hziy) / Immunomedics, Everest Medicines; Rubraca (rucaparib) / Clovis; Opdivo (nivolumab) / Ono Pharma, BMS; lucitanib (E 3810) / Clovis, HaiHe Biopharma, Servier
Clovis Oncology to Highlight Data for its Three Portfolio Compounds at the ESMO Virtual Congress 2020 (Businesswire) – Sep 9, 2020 – “Clovis Oncology, Inc…announced that six e-posters highlighting clinical data from the lucitanib and Rubraca® (rucaparib) clinical development programs, as well as preclinical data for FAP-2286, will be presented at the ESMO (European Society for Medical Oncology) Virtual Congress 2020, September 19 – September 21, 2020…The first presentation of preclinical data in in vivo and in vitro models for FAP-2286, a novel peptide-targeted radionucleotide therapy (PTRT) and imaging agent for which Clovis intends to file imaging and treatment Investigational New Drug applications to the FDA in late 2020.”


Rubraca (rucaparib) / Clovis
Clovis Oncology Announces Oral Plenary Session Presentation at International Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting (Businesswire) – Sep 10, 2020 – “Clovis Oncology, Inc…announced today that an abstract featuring data from an exploratory analysis of the ARIEL3 clinical study evaluating Rubraca® (rucaparib) as maintenance treatment in recurrent ovarian cancer has been accepted for presentation in an oral plenary session at the International Gynecologic Cancer Society (IGCS) Digital Annual Global Meeting taking place September 10–13. The findings of the analysis demonstrate that rucaparib maintenance treatment can lead to a clinically meaningful delay in starting subsequent therapy and lasting clinical benefits in patients with BRCA1- or BRCA2-mutant ovarian cancer.”


Vitrakvi (larotrectinib) / Bayer, Eli Lilly; Nexavar (sorafenib) / Bayer, Amgen; Keytruda (pembrolizumab) / Merck (MSD)
Bayer to Showcase New Data from Evolving Oncology Portfolio at ESMO Virtual Congress 2020 (Businesswire) – Sep 8, 2020 – “Data from Bayer’s evolving oncology portfolio will be presented at the ESMO Virtual Congress 2020, taking place September 19-21, 2020. Presentations will highlight therapies from Bayer that evaluate patient outcomes as well as safety and efficacy in different tumor types. Other presentations include investigational use of therapies in combination with immunotherapies.”


Rubraca (rucaparib) / Clovis
Analysis of the Clinical Experience With Rucaparib in the Rucaparib Access Program (RAP) in Spain – A GEICO Study (clinicaltrials.gov) – Sep 8, 2020 – P; N=70; Recruiting; Sponsor: Grupo Español de Investigación en Cáncer de Ovario


Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Takeda showcases ovarian cancer drug Zejula’s widened indication, efficacy (Korea Biomedical Review) – Sep 11, 2020 – “Takeda Pharmaceuticals Korea held an online conference Thursday to highlight expanded indication for its ovarian cancer treatment Zejula (ingredient: niraparib) as the first-line maintenance and explained the clinical efficacy. Zejula is the first poly ADP-ribose polymerase (PARP) inhibitor used regardless of mutation in the breast cancer susceptibility gene (BRCA). With the expanded indication, Zejula became the first in Korea to be used as the first-line maintenance for ovarian cancer patients…”


olvimulogene nanivacirepvec (GL-ONC1) / Genelux
Genelux Announces Oral Plenary Presentation of VIRO-15 Phase 2 Trial Data at the 2020 xDigital Annual Global Meeting of the International Gynecologic Cancer Society (PRNewswire) – Sep 10, 2020 – P2, N=64; NCT02759588; Sponsor: Genelux Corporation; “Median Progression-free Survival (PFS) is 11.0 months (95% CI: 6.7 – 13.0) and PFS-6-month is 77%. Objective Response Rate (ORR) by RECIST1.1 criteria is 54% [95% CI: 33-74%; 2 (8%) complete response (CR), 11 (46%) partial response (PR)]; median Duration of Response is 7.6 months; and 86% of patients achieved tumor shrinkage. ORR by CA-125 tumor biomarker is 85% [95% CI: 65-96%; 10 (38%) CR, 12 (46%) PR]; and 96% of patients achieved decrease of CA-125. There are no differences in PFS & ORR between platinum-resistant & -refractory patients…Translational analyses data indicate Olvi-Vec engages the immune system and induces favorable immune response (such as large intraepithelial infiltration of CD4+ & CD8+ T cells into tumors) and gene expression changes to the tumor microenvironment to aid clinical reversal of platinum resistance.”


Trodelvy (sacituzumab govitecan-hziy) / Immunomedics, Everest Medicines
basket: Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers (clinicaltrials.gov) – Sep 9, 2020 – P1/2; N=515; Completed; Sponsor: Immunomedics, Inc.; Active, not recruiting –> Completed; Trial completion date: Dec 2020 –> Aug 2020; Trial primary completion date: Dec 2020 –> Aug 2020


Lenvima (lenvatinib) / Eisai, Merck (MSD); Keytruda (pembrolizumab) / Merck (MSD)
Eisai to Present New Data Highlighting KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) Investigational Combination Therapy and Eribulin Platform at ESMO 2020 (PRNewswire) – Sep 10, 2020 – “Eisai will present two late breakers and 10 e-posters at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21, 2020. Notable data from ongoing LEAP clinical trials on the investigational lenvatinib plus pembrolizumab combination to be presented in advanced melanoma previously treated with a PD-1 or PD-L1 inhibitor (LEAP-004) (Abstract #LBA44), biliary tract cancer, triple-negative breast cancer, colorectal cancer, gastric cancer, glioblastoma and ovarian cancer (LEAP-005) (Abstract #LBA41), metastatic NSCLC (LEAP-006) (Abstract 1313P), and renal cell carcinoma previously treated with PD-1/PD-L1 inhibitor (Study 111/KEYNOTE-146) (Abstract #710P).”

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