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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