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Category: Ovarian Cancer

Weekly Top News – Ovarian Cancer – September 28, 2020

September 28, 2020

Lynparza (olaparib) / Merck (MSD), AstraZeneca
LYNPARZA (olaparib) Recommended for Approval in EU by CHMP as First-Line Maintenance Treatment with Bevacizumab for HRD-Positive Advanced Ovarian Cancer (Businesswire) – Sep 21, 2020 – “AstraZeneca and Merck, known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending LYNPARZA for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a BRCA1/2 mutation and/or genomic instability. The positive opinion was based on a biomarker subgroup analysis of the Phase 3 PAOLA-1 trial…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: “Five-year follow-up data from the Phase 3 SOLO-1 trial showed LYNPARZA reduced the risk of disease progression or death by 67% and improved median PFS to 56 months vs. 13.8 months for placebo in BRCAm advanced ovarian cancer patients”; Ovarian cancer (Merck (MSD)) – Sep 22, 2020 – ESMO 2020 
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Lenvima (lenvatinib) / Eisai, Merck (MSD); Keytruda (pembrolizumab) / Merck (MSD)
Merck and Eisai Present First-Time Data From Two Studies Evaluating KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) in Seven Different Tumor Types at ESMO Virtual Congress 2020 (Businesswire) – Sep 20, 2020 – P2, N=100; LEAP-004 (NCT03776136); Sponsor: Merck Sharp & Dohme Corp; P2, N=600; LEAP-005 (NCT03797326); Sponsor: Merck Sharp & Dohme Corp; “In the Phase 2 LEAP-004 trial, KEYTRUDA plus LENVIMA showed an objective response rate (ORR) of 21.4% (95% CI: 13.9-30.5) in patients with unresectable or advanced melanoma who had previously progressed on an anti-PD-1/PD-L1 therapy. In the Phase 2 LEAP-005 trial, KEYTRUDA plus LENVIMA demonstrated an ORR that ranged from 9.7-32.3% (95% CI: 2.0-51.4) in previously treated patients with triple-negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (non-microsatellite instability-high [non-MSI-H]/mismatch repair proficient [pMMR]), glioblastoma multiforme (GBM) and biliary tract cancer (BTC).”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: “Extension of indication to include the use of Lynparza tablets in combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy with bevacizumab” (European Medicines Agency) – Sep 25, 2020 – CHMP Final Minutes of the meeting on 22-25 June 2020: “The Committee adopted a 2nd request for supplementary information with a specific timetable”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza scores long-term benefit data in BRCA-mutated ovarian cancer (PharmaTimes) – Sep 21, 2020 – P3, N=450; SOLO-1 (NCT01844986); Sponsor: AstraZeneca; “AstraZeneca and MSD’s (Merck) PARP inhibitor Lynparza has demonstrated long-term progression-free survival (PFS) benefit in BRCA-mutated advanced ovarian cancer….Following five-years of follow-up in the SOLO-1 phase III trial, Lynparza reduced the risk of disease progression or death by 67% and also improved PFS to a median of 56.0 months compared to 13.8 months in the placebo group.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; Lynparza (olaparib) / Merck (MSD), AstraZeneca
GSK’s Zejula and AZ’s Lynparza leap toward broader EU approval (PharmaTimes) – Sep 22, 2020 – “GlaxoSmithKline’s Zejula and AstraZeneca’s Lynparza have both moved towards EU approval in new indications after receiving positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)…Zejula (niraparib) won a positive opinion recommending it for approval as a first-line monotherapy maintenance treatment for women with advanced ovarian cancer…Lynparza, on the other hand, has been recommended for approval in the EU for patients with metastatic castration-resistant prostate cancer…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Drug Intensive Monitoring Study of Olaparib in Clinical Practice Among Chinese Patients (clinicaltrials.gov) – Sep 23, 2020 – P; N=1500; Not yet recruiting; Sponsor: AstraZeneca

 

Lenvima (lenvatinib) / Eisai, Merck (MSD); Keytruda (pembrolizumab) / Merck (MSD)
Keytruda/Lenvima combo shows promise in hard-to-treat cancers (PharmaTimes) – Sep 21, 2020 – P2, N=100; LEAP-004 (NCT03776136); Sponsor: Merck Sharp & Dohme Corp; P2, N=600; LEAP-005 (NCT03797326); Sponsor: Merck Sharp & Dohme Corp; “MSD (Merck) and Eisai have revealed new data from two trials under the LEAP clinical programme evaluating the combination of MSD’s PD-1 inhibitor Keytruda and Eisai’s oral tyrosine kinase inhibitor Lenvima…The results, presented at the 2020 European Society for Medical Oncology (ESMO) virtual congress, showed that Keytruda (pembrolizumab) plus Lenvima (lenvatinib) demonstrated an objective response rate (ORR) of 21.4% in patients with unresectable or advance melanoma who had previously progressed on an anti-PD-1/L1 therapy…In another phase II trial, Keytruda plus Lenvima demonstrated an ORR between 9.7-32.3% in previously treated patients with triple-negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer, glioblastoma multiforme (GBM) and biliary tract cancer (BTC).”

 

Aybintio (bevacizumab biosimilar) / Samsung, Mundipharma
Aybintio: “The Committee adopted a positive opinion recommending the granting of a marketing authorisation by consensus together with the CHMP assessment report and translation timetable [Colon cancer, breast cancer and ovarian cancer]” (European Medicines Agency) – Sep 25, 2020 – CHMP Final Minutes of the meeting on 22-25 June 2020

 

Lenvima (lenvatinib) / Eisai, Merck (MSD); Keytruda (pembrolizumab) / Merck (MSD)
ESMO: Merck Sees Keytruda-Lenvima Potential In Melanoma, Hard-To-Treat Cancers (Scripintelligence) – Sep 22, 2020 – P2, N=100; LEAP-004 (NCT03776136); Sponsor: Merck Sharp & Dohme Corp; P2, N=600; LEAP-005 (NCT03797326); Sponsor: Merck Sharp & Dohme Corp; “Also Promising In Ovarian And Colorectal…Keytruda-Lenvima picked out as pick of combination therapies from the European cancer congress.”

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Weekly Top News – Ovarian Cancer – September 21, 2020

September 21, 2020

Rubraca (rucaparib) / Clovis
New Data Presented at ESMO Virtual Congress 2020 Highlight Breadth and Potential of Clovis Oncology Products and Pipeline (Businesswire) – Sep 17, 2020 – P3, N=564; ARIEL3 (NCT01968213); Sponsor: Clovis Oncology, Inc; “After two years of additional follow up for those patients who continued on treatment in the study, the safety profile remains consistent with previous reports, with no new safety signals identified. As of the current safety data cutoff (December 31, 2019), 33 of 372 and 1 of 189 patients in the safety population were still receiving Rubraca or placebo, respectively. Median treatment duration was 8.3 months in the Rubraca arm and 5.5 months in the placebo arm….The median duration of the first event of frequently reported TEAEs was generally <60 days.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Phase 3 NORA data of ZEJULA (niraparib) demonstrate significant PFS benefit, regardless of biomarker status, with an improved safety profile when given with individualized starting dose regimen in Chinese women with platinum-sensitive recurrent ovarian cancer (GlobeNewswire) – Sep 19, 2020 – P3, N=553; NORA (NCT03709316); Sponsor: Zai Lab (Shanghai) Co., Ltd; “Niraparib treatment resulted in a 68% reduction in the risk of disease progression or death in the overall population (PFS HR 0.32; 95% CI, 0.23–0.45; p<0.0001). The median progression-free survival (PFS) was significantly longer for patients treated with niraparib compared to placebo: 18.3 months (95% CI, 10.9–not evaluable) versus 5.4 months (95% CI, 3.7–5.7). PFS in gBRCA mutation subgroup: HR 0.22; 95%CI, 0.12-0.39; p<0.0001. PFS in non-gBRCA mutation subgroup: HR 0.40; 95%CI, 0.26-0.61; p<0.0001…Grade≥3 hematological adverse events of neutrophil count decrease, anemia, and platelet count decrease in patients treated with niraparib versus placebo were 20.3% vs. 8.0%, 14.7% vs. 2.3%, and 11.3% vs. 1.1%, respectively.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
European advisory group backs expanded use of Glaxo’s Zejula (SeekingAlpha) – Sep 18, 2020 – “The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of GlaxoSmithKline’s (GSK +0.0%) Zejula (niraparib) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemo.”

 

Rubraca (rucaparib) / Clovis
Rucaparib: “All patients in the rucaparib arm and 182/189 (96.3%) patients in the placebo arm experienced ≥1 TEAE“; Ovarian cancer (Clovis Oncology) – Sep 19, 2020 – ESMO 2020: “Grade ≥3 TEAEs were reported by 231/372 (62.1%) patients in the rucaparib arm and 31/189 (16.4%) patients in the placebo arm, Grade 4 TEAEs were reported by 28/372 (7.5%) and 2/189 patients (1.1%) in the rucaparib and placebo arms, respectively. The most frequent grade 4 TEAEs in the rucaparib arm were neutropenia/ decreased neutrophils and thrombocytopenia/decreased platelets (7/372 patients [1.9%] each)” 
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Lenvima (lenvatinib) / Eisai, Merck (MSD); Keytruda (pembrolizumab) / Merck (MSD)
Merck and Eisai Present First-Time Data From Two Studies Evaluating KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) in Seven Different Tumor Types at ESMO Virtual Congress 2020 (Businesswire) – Sep 20, 2020 – P2, N=100; LEAP-004 (NCT03776136); Sponsor: Merck Sharp & Dohme Corp; P2, N=600; LEAP-005 (NCT03797326); Sponsor: Merck Sharp & Dohme Corp; “In the Phase 2 LEAP-004 trial, KEYTRUDA plus LENVIMA showed an objective response rate (ORR) of 21.4% (95% CI: 13.9-30.5) in patients with unresectable or advanced melanoma who had previously progressed on an anti-PD-1/PD-L1 therapy. In the Phase 2 LEAP-005 trial, KEYTRUDA plus LENVIMA demonstrated an ORR that ranged from 9.7-32.3% (95% CI: 2.0-51.4) in previously treated patients with triple-negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (non-microsatellite instability-high [non-MSI-H]/mismatch repair proficient [pMMR]), glioblastoma multiforme (GBM) and biliary tract cancer (BTC).”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
LYNPARZA (olaparib) Improved Median Progression-Free Survival to Over Four and a Half Years Compared to 13.8 Months with Placebo for Patients with BRCA-Mutated Advanced Ovarian Cancer (Businesswire) – Sep 18, 2020 – P3, N=450; SOLO-1 (NCT01844986); Sponsor: AstraZeneca; “Five-year follow-up data from the Phase 3 SOLO-1 trial showed LYNPARZA reduced the risk of disease progression or death by 67% (HR 0.33 [95% CI 0.25–0.43]), and improved median PFS to 56 months vs. 13.8 months for placebo. At five years, 48.3% of patients treated with LYNPARZA remained free from disease progression vs. 20.5% on placebo. The median duration of treatment with LYNPARZA was 24.6 months vs. 13.9 months with placebo. Median follow-up in the LYNPARZA arm was 4.8 years and 5 years for placebo. The safety profile of LYNPARZA was consistent with previous observations in SOLO-1. The most common adverse reactions (ARs) ≥20% were nausea (77%), fatigue/asthenia (63%), vomiting (40%), anemia (39%) and diarrhea (34%).”

 

Imfinzi (durvalumab) / AstraZeneca; Zepzelca (lurbinectedin) / PharmaMar, Jazz; Opdivo (nivolumab) / Ono Pharma, BMS
PharmaMar will present data for Zepzelca (lurbinectedin) and Yondelis (trabectedin) at ESMO 2020 (Pharmamar Press Release) – Sep 14, 2020 – “At the European Society of Medical Oncology (ESMO) Congress, which will be held virtually from 17th to 19th of September, PharmaMar (MSE:PHM) will present data on lurbinectedin in second-line SCLC patients who had received previous platinum-based chemotherapy and relapsed 90 and 180 days after its completion and therefore, being candidates for platinum rechallenge. Phase I results for lurbinectedin in Japanese patients with previously treated advanced Solid Tumours, will also be presented. Results of trabectedin in combination with immunotherapy (durvalumab) in pretreated patients with advanced Soft-Tissue Sarcomas, will be presented at an oral session. In addition, results of Yondelis® (trabectedin) in combination with immunotherapy (nivolumab) for the treatment of Soft-Tissue Sarcoma, as well as results of trabectedin in combination with doxorubicin (PLD) for the treatment of Recurrent Ovarian Cancer, will be presented.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
‘OLAP’ (OLAparib Regulatory Post-marketing Surveillance) (clinicaltrials.gov) – Sep 18, 2020 – P; N=600; Not yet recruiting; Sponsor: AstraZeneca

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; dostarlimab (TSR-042) / GSK
GSK highlights scientific advances across its growing oncology portfolio at ESMO Virtual Congress 2020 (PRNewswire) – Sep 15, 2020 – “GSK presentations at ESMO will focus on research intended to improve outcomes for women with high unmet medical needs, including data related to the safety and efficacy of ZEJULA in patients with advanced, recurrent or resistant ovarian cancer. Investigators also will present a late-breaking presentation: ‘Safety and Antitumor Activity of Dostarlimab in Patients (Pts) with Advanced or Recurrent DNA Mismatch Repair Deficient (dMMR) or Proficient (MMRp) Endometrial Cancer (EC): Results from GARNET.'”

 

ALKS 4230 / Alkermes; Keytruda (pembrolizumab) / Merck (MSD)
Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 European Society for Medical Oncology (ESMO) Virtual Congress (PRNewswire) – Sep 18, 2020 – P1/2, N=347; ARTISTRY-1 (NCT02799095); Sponsor: Alkermes, Inc; “Data presented at ESMO from the combination stage of ARTISTRY-1…Of these 5 patients: One patient with platinum-resistant ovarian cancer achieved a complete response (CR) by week 45 of treatment, and a deepening of response was observed through week 81 of treatment. As of the data cut, this patient had a durable, confirmed CR and had remained on treatment for more than 18 months. Two other patients with platinum-resistant ovarian cancer achieved PRs, one confirmed and one unconfirmed. As of the data cut, the patient with the confirmed PR demonstrated a deepening of response and had remained on treatment for more than 5 months. Other tumor types Additional PRs were achieved in multiple other tumor types across the PD-1/L1 approved and unapproved cohorts, including one patient with triple-negative breast cancer and two patients with esophageal cancer (one of which is awaiting confirmation).”

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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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Weekly Top News – Ovarian Cancer – September 7, 2020

September 7, 2020

llllllllll Lynparza (olaparib) / Merck (MSD), AstraZeneca; Keytruda (pembrolizumab) / Merck (MSD); Lenvima (lenvatinib) / Eisai, Merck (MSD)
New Scientific Data at the ESMO Virtual Congress 2020 Reflect Merck’s Commitment to Advancing Cancer Research and Care (Businesswire) – Sep 2, 2020 – “Data spanning more than 15 types of cancer will be presented at the congress, with new findings from Merck’s portfolio of established medicines including KEYTRUDA, Merck’s anti-PD-1 therapy; LENVIMA® (lenvatinib, in collaboration with Eisai); and LYNPARZA (in collaboration with AstraZeneca). Pivotal Phase 3 data evaluating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal cancer from the KEYNOTE-590 trial (Abstract #LBA8) and LYNPARZA in patients with metastatic castration-resistant prostate cancer (mCRPC) from the PROfound trial (Abstract #610O) were selected for inclusion in ESMO Presidential Symposium sessions. Additionally, new findings will be shared for three of Merck’s novel investigational candidates: vibostolimab (MK-7684), an anti-TIGIT antibody; MK-4830, an antibody targeting ILT4; and MK-6482, an oral HIF-2α inhibitor.”

 

llllllllll Lynparza (olaparib) / Merck (MSD), AstraZeneca
OVAL-1: Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK (clinicaltrials.gov) – Aug 31, 2020 – P; N=350; Not yet recruiting; Sponsor: AstraZeneca

 

llllllllll SL-172154 / Shattuck
Shattuck Labs Announces Initiation of Phase 1 Clinical Trial of SL-172154 (SIRPα-Fc-CD40L) for the Treatment of Ovarian Cancer (Businesswire) – Aug 31, 2020 – “Shattuck Labs, Inc…announced initiation of a Phase 1 clinical trial of its compound SL-172154 (SIRPα-Fc-CD40L), a bi-functional fusion protein that simultaneously blocks the CD47/SIRPα checkpoint and activates the tumor necrosis factor (TNF) costimulatory receptor CD40….Initial clinical data from the trial are expected in the second half of 2021. In addition, Shattuck plans to evaluate SL-172154 in combination with other therapeutic agents in specific cancers.”

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Weekly Top News – Ovarian Cancer – August 24, 2020

August 24, 2020

llllllllll Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Regulatory decision in EU for 1L ovarian cancer (based on PAOLA trial) in H2 2020 (AstraZeneca) – Aug 21, 2020 – Post H1 Roadshow, Oslo: Regulatory decision in EU for 2L prostate cancer in H2 2020 
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llllllllll Lynparza (olaparib) / Merck (MSD), AstraZeneca
DCGI approves AstraZeneca Olaparib tablets for ovarian and breast cancer (Medicircle) – Aug 20, 2020 – “Drug firm AstraZeneca Pharma India today said it has received permission from the Drug Controller General of India (DCGI) to import and market olaparib tablets used for the treatment of ovarian and breast cancer…The permission from the DCGI is for olaparib (Lynparza) tablets in the strengths of 100 mg and 150 mg, AstraZeneca Pharma India said in a BSE filing.The tablets are a patented product of the AstraZeneca group…”

 

llllllllll Aybintio (bevacizumab biosimilar) / Samsung, Mundipharma
Samsung Bioepis Receives European Commission Approval for AYBINTIO (Bevacizumab) (GlobeNewswire) – Aug 20, 2020 – “Samsung Bioepis Co., Ltd….announced that the European Commission (EC) has granted marketing authorization for AYBINTIO® (bevacizumab) for the treatment of the same types of cancer as reference bevacizumab, including metastatic carcinoma of the colon or rectum (mCRC), metastatic breast cancer (mBC), non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer (mRCC), epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer. “

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Weekly Top News – Ovarian Cancer – August 17, 2020

August 17, 2020

llllllllll VS-6766 / Verastem; defactinib (VS-6063) / Verastem
Verastem Oncology Signs Definitive Agreement to Sell COPIKTRA (duvelisib) Rights to Secura Bio to Focus on Development of VS-6766 and Defactinib in KRAS Mutant Solid Tumors (Businesswire) – Aug 10, 2020 – “The Company has also begun preclinical combination studies investigating VS-6766 and defactinib in combination with KRAS-G12C inhibitors and initial data will be presented at the 2nd Annual RAS-Targeted Drug Development Conference. Based on the positive preclinical data presented at the AACR 2020 Virtual Annual Meeting II, Verastem plans to support a Phase 2 investigator-initiated study evaluating the combination of VS-6766 and defactinib in uveal melanoma, which is expected to begin in late 2020….The company is in a position of financial strength with a cash runway expected to fund the clinical and regulatory milestones and development of VS-6766 and defactinib in LGSOC and KRASmt NSCLC until at least 2024.”

 

llllllllll XMT-1536 / Mersana, Adimab
Mersana Therapeutics Receives FDA Fast Track Designation for XMT-1536 for the Treatment of Patients with Platinum-resistant Ovarian Cancer (GlobeNewswire) – Aug 11, 2020 – “Mersana Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for XMT-1536, for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to three prior lines of systemic therapy or patients who have received four prior lines of systemic therapy regardless of platinum status.”

 

llllllllll DPX-Survivac (EMD 640744) / IMV Inc
IMV Inc. Announces Second Quarter 2020 Financial Results (Businesswire) – Aug 12, 2020 – “DPX-Survivac: Top line Phase 2 clinical results from the DLBCL combination trial in 2020; Top line Phase 2 clinical results from the ovarian monotherapy trial in 2020; Updated Phase 2 clinical results from the basket trial in 2020.”

 

llllllllll ofranergene obadenovec (VB-111) / NanoCarrier, VBL Therapeutics
VBL Therapeutics Announces Second Successful Pre-planned Interim Analysis with a Positive Data Safety Monitoring Committee Review Looking at OS – the Primary Endpoint of the OVAL Phase 3 Potential Registration Study of VB-111 in Ovarian Cancer (GlobeNewswire) – Aug 12, 2020 – P3, N=400; OVAL (NCT03398655); Sponsor: VBL Therapeutics; “VBL Therapeutics…announced today that the independent Data Safety Monitoring Committee (DSMC) has completed its second, pre-planned interim analysis in the ongoing OVAL Phase 3 study investigating ofranergene obadenovec (VB-111) in patients with platinum-resistant ovarian cancer, and unanimously recommended that the study continue as planned. In this second interim analysis, the DSMC reviewed unblinded Overall Survival (OS) data of the first 100 randomized patients with a followup of at least 3 months. OS is the primary endpoint of the OVAL study. The committee also looked at response rate and safety information…The next DSMC review in the OVAL study is expected in the first quarter of 2021.”

 

llllllllll defactinib (VS-6063) / Verastem; VS-6766 / Verastem
Verastem Oncology Signs Definitive Agreement to Sell COPIKTRA (duvelisib) Rights to Secura Bio to Focus on Development of VS-6766 and Defactinib in KRAS Mutant Solid Tumors (Businesswire) – Aug 10, 2020 – “Verastem announced…that the company met with the FDA in July 2020 to discuss the registration-directed study design for the VS-6766/defactinib combination in patients with LGSOC…Verastem’s NSCLC study will also be an adaptive design with a focus on patients with KRAS-G12V mutant tumors…Verastem expects to commence registration-directed clinical trials for potential accelerated approval in LGSOC and KRASmt NSCLC by the end of 2020…The FRAME study is now expanding to include new cohorts in pancreatic cancer, KRASmt endometrial cancer and KRAS-G12V NSCLC… additional data from the NSCLC cohort of the FRAME study will be submitted to the International Association for the Study of Lung Cancer (IASLC) World Lung Cancer Conference, taking place in January 2021.”

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Weekly Top News – Ovarian Cancer – August 3, 2020

August 3, 2020

llllllllll Equidacent (bevacizumab biosimilar) / Fujifilm Kyowa Kirin Biologics, AstraZeneca
Centus Biotherapeutics Announces Positive CHMP Opinion for FKB238, Biosimilar Bevacizumab (Fujifilm Kyowa Kirin Biologics Press Release) – Jul 27, 2020 – “Centus Biotherapeutics…announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of EquidacentTM (Product Code: FKB238), the company’s biosimilar to Avastin® (bevacizumab), for indications including metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer, persistent, recurrent, or metastatic carcinoma of the cervix. The decision of the European Commission (EC) on the approval is expected in September 2020…”

 

llllllllll Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Regulatory decision in Japan for ovarian cancer (based on PAOLA trial) in H2 2020 (AstraZeneca) – Jul 30, 2020 – H1 2020 Results: Regulatory decision in China for BRCAm breast cancer in H2 2020 
[Screenshot]

 

llllllllll Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; dostarlimab (TSR-042) / GSK
Zejula + dostarlimab:Data from P2 MOONSTONE trial (NCT03955471) for 2L PROC ovarian cancer in H2 2021 (GSK) – Jul 29, 2020 – Q2 2020 Results 
[Screenshot]

 

llllllllll pamiparib (BGB-290) / EMD Serono
Priority Review Granted to BeiGene’s New Drug Application of Pamiparib in Ovarian Cancer in China (GlobeNewswire) – Jul 27, 2020 – “BeiGene, Ltd…today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) of pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.”

 

llllllllll GEN-1 / Celsion
Celsion Corporation Initiates Phase II OVATION 2 Study of GEN-1 in Advanced Ovarian Cancer (GlobeNewswire) – Jul 27, 2020 – “Celsion Corporation….announced the randomization of the first two patients in the Phase II portion of the Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer. The Company anticipates completing enrollment of up to 118 patients in the third quarter of 2021. Because this is an open-label study, the Company intends to provide clinical updates throughout the course of treatment including response rates and surgical resection scores.”

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Weekly Top News – Ovarian Cancer – July 20, 2020

July 20, 2020

llllllllll carboplatin / Generic mfg.; Tecentriq (atezolizumab) / Roche
Roche provides update on Phase III study of Tecentriq in women with advanced stage ovarian cancer (Roche Press Release) – Jul 13, 2020 – P3, N=1300; IMagyn050 (NCT03038100); Sponsor: Hoffmann-La Roche; “Roche…today announced that the Phase III IMagyn050 study showed that the addition of Tecentriq® (atezolizumab) to Avastin® (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS) for the front-line treatment of women with newly diagnosed advanced stage ovarian cancer….Data for the overall survival (OS) co-primary endpoint are currently immature and follow-up will continue until the next planned analysis. Results from IMagyn050 will be further evaluated in order to inform the Tecentriq gynaecologic development programme…”

llllllllll Tecentriq (atezolizumab) / Roche
Roche’s Tecentriq Disappoints In Ovarian Cancer Study (Scripintelligence) – Jul 13, 2020 – P3, N=1300; IMagyn050 (NCT03038100); Sponsor: Hoffmann-La Roche; “PD-1/PDL-1 inhibitors have not proved effective for ovarian cancer on their own or in combinations. Now Roche’s Tecentriq, combined with the firm’s blockbuster Avastin, has suffered a similar fate to Merck KGaA and Pfizer’s Bavencio in failing to improve survival.”

llllllllll pamiparib (BGB-290) / EMD Serono
BeiGene Announces Acceptance of a New Drug Application of Pamiparib in Ovarian Cancer in China (GlobeNewswire) – Jul 17, 2020 – “BeiGene, Ltd…announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a new drug application (NDA) of BeiGene’s investigational inhibitor of PARP1 and PARP2, pamiparib, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy….This NDA is supported by clinical results from a Phase 1/2 trial of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915).”

llllllllll Tecentriq (atezolizumab) / Roche
Tecentriq misses mark in ovarian cancer trial (PharmaTimes) – Jul 14, 2020 – P3, N=1300; IMagyn050 (NCT03038100); Sponsor: Hoffmann-La Roche; “Roche and Genentech’s Tecentriq (atezolizumab) has failed to hit its primary goal in a late stage trial involving patients with newly diagnosed advanced stage ovarian cancer…In the Phase III IMagyn050 study, the addition of Tecentriq to Avastin (bevacizumab), paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival…”

llllllllll Imfinzi (durvalumab) / AstraZeneca, BMS; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients. (clinicaltrials.gov) – Jul 16, 2020 – P3; N=1254; Recruiting; Sponsor: AstraZeneca; Trial primary completion date: Jan 2023 –> Jun 2023

llllllllll Keytruda (pembrolizumab) / Merck (MSD); Lenvima (lenvatinib) / Eisai, Merck (MSD)
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) (clinicaltrials.gov) – Jul 15, 2020 – P2; N=600; Recruiting; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting –> Recruiting 

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Weekly Top News – Ovarian Cancer – July 13, 2020

July 13, 2020

TG4050 / Transgene
Transgene and Hypertrust Patient Data Care Announce Successful Go-Live of the World’s First Blockchain Solution for Clinical Trials of Personalized Healthcare (Businesswire) – Jul 9, 2020 – “Transgene…and Hypertrust Patient Data Care today announced as a world premiere the first productive blockchain solution for clinical trials of personalized healthcare, leveraging the Hypertrust X-Chain for Clinical Trials product. The cloud-based solution monitors and orchestrates the supply chain processes of Transgene’s AI-enhanced TG4050 individualized therapeutic vaccine based on the myvac® technology, against ovarian, head and neck cancer providing an immutable audit trail throughout the treatment process. The innovative collaboration between Transgene and Hypertrust marks a milestone in the ongoing fight against cancer…”

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Weekly Top News – Ovarian Cancer – July 6, 2020

July 6, 2020

BI-1808 / BioInvent; Keytruda (pembrolizumab) / Merck (MSD)
BioInvent Submits a CTA for a Phase I/IIa trial of BI-1808, A First-in-class Anti-TNFR2 Antibody for the Treatment of Patients With Solid Tumors and CTCL (PRNewswire) – Jun 30, 2020 – “BioInvent International AB…announces it has submitted a clinical trial application (CTA) to begin a Phase I/IIa, first-in-human study of BI-1808, a monoclonal antibody to tumor necrosis factor receptor 2 (TNFR2), as a single agent and in combination with KEYTRUDA® (pembrolizumab) for the treatment of solid tumors and cutaneous T-cell lymphoma (CTCL)…The study will explore the safety, tolerability, and potential signs of efficacy of BI-1808 as a single agent and in combination with KEYTRUDA® in patients with ovarian cancer, non-small cell lung cancer and cutaneous T cell lymphoma….It will be conducted at several sites across Europe and the U.S. and is expected to enroll approximately 120 patients.”

 

Keytruda (pembrolizumab) / Merck (MSD); Lenvima (lenvatinib) / Eisai, Merck (MSD)
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) (clinicaltrials.gov) – Jul 2, 2020 – P2; N=600; Active, not recruiting; Sponsor: Merck Sharp & Dohme Corp.; N=180 –> 600; Trial completion date: Apr 2022 –> Feb 2024; Trial primary completion date: Apr 2022 –> Feb 2024

 

Zepzelca (lurbinectedin) / PharmaMar, Jazz
Zepzelca: Newly added patent in Orange Book (Orange Book) – Jul 3, 2020 – Expiry on December 13, 2024

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