Weekly Top News – Ovarian Cancer – May 11, 2020

May 11, 2020

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Olaparib Átlépéses vizsgálat olyan betegek számára, akik teljesítettek egy korábbi, olaparibra irányuló onkológiai vizsgálatot (clinicaltrialsregister.eu) – May 7, 2020 – P3; N=124; Ongoing; Sponsor: AstraZeneca AB


Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza (olaparib) approved by FDA as first-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer (Merck (MSD) Press Release) – May 8, 2020 – “AstraZeneca and Merck…announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA in combination with bevacizumab as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. The approval was based on a biomarker subgroup analysis of 387 patients with HRD-positive tumors from the Phase 3 PAOLA-1 trial…”


Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza approved in the US as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer (AstraZeneca Press Release) – May 11, 2020 – “Regulatory reviews are currently underway in the EU, Japan and other countries for Lynparza based on results from the PAOLA-1 trial.”


Pemazyre (pemigatinib) / Incyte; Revlimid (lenalidomide) / BMS; INCB62079 / Incyte
Incyte reports 2020 first quarter financial results and provides updates on key clinical programs (Businesswire) – May 5, 2020 – “Delays in data collection and validation, caused by COVID-19 related disruption, mean that data from the FIGHT-201 clinical trial of pemigatinib in patients with bladder cancer are now expected to be presented at a medical conference in early 2021….In February, the FDA granted Priority Review for tafasitamab in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), and set a PDUFA goal date of August 30, 2020….Incyte no longer plans to pursue the Phase 3 POD1UM-301 trial of retifanlimab in combination with chemoradiation therapy (CRT) in participants with unresectable, Stage III NSCLC….Based on emerging data from the FGFR4 inhibitor program, development of INCB62079 has been discontinued because of insufficient efficacy in the target patient population.”


Rubraca (rucaparib) / Clovis; lucitanib (E 3810) / Clovis, HaiHe Pharma, Servier
Clovis Oncology announces first quarter 2020 operating results (Clovis Oncology Press Release) – May 5, 2020 – “$42.6M in Rubraca® (rucaparib) global sales for Q1 2020; net product revenue up 8% over Q4 2019 and up 29% over Q1 2019….Following successful reimbursement negotiations, Clovis has launched Rubraca in each of Germany, United Kingdom, Italy, France and Spain, and over time expects to launch in additional smaller European markets….Supplemental NDA for Rubraca in patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer granted Priority Review by FDA with PDUFA date of May 15, 2020…Lucitanib combination studies enrolling; initial data anticipated at medical meetings in 2H 2020…Clovis is planning to submit an investigational new drug application (IND) for FAP-2286 in the second half of 2020.”


Bavencio (avelumab) / EMD Serono, Pfizer; TG4050 / Transgene
Transgene reports Q1 2020 financial position and business update (Businesswire) – May 6, 2020 – “Summary of key ongoing clinical trials and expected milestones: TG4001+ Bavencio® (avelumab) Phase 2 Targets: HPV16 E6 and E7 oncoproteins HPV-positive cancers including oropharyngeal head and neck cancer…Interim Phase 2 results on track for 2Q 2020; myvac® TG4050 Phase 1 Targets: tumor neoantigens Ovarian cancer – after first-line surgery and adjuvant therapy…First data on track for 1H 2021; myvac® TG4050 Phase 1 HPV-negative head and neck cancer – after surgery and adjuvant therapy First data on track for 1H 2021 Data demonstrating high accuracy of AI-based neoantigen prediction for the design of TG4050 will be presented at AACR.”


Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; relacorilant (CORT125134) / Corcept Therap; Keytruda (pembrolizumab) / Merck (MSD)
Corcept Therapeutics announces first quarter 2020 financial results and provides corporate update (GlobeNewswire) – May 4, 2020 – “Controlled, Phase 2 trial of relacorilant plus nab-paclitaxel (Abraxane®) to treat metastatic ovarian cancer enrolling patients at sites in the United States and Europe; results expected in first half 2021. Phase 3 trial of relacorilant plus nab-paclitaxel in metastatic pancreatic cancer (RELIANT) to start in second quarter 2020 Selection of optimum dose of exicorilant plus enzalutamide in castration-resistant prostate cancer expected by year-end, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab (Keytruda®) to treat patients with metastatic or unresectable adrenal cancer to start in third quarter 2020.”


Lynparza (olaparib) / Merck (MSD), AstraZeneca
Myriad receives FDA approval of myChoice CDx as companion diagnostic for Lynparza (olaparib) in patients with advanced ovarian cancer (GlobeNewswire) – May 11, 2020 – “Myriad Genetics, Inc…announced that the U.S. Food and Drug Administration (FDA) approved the myChoice CDx® test for use as a companion diagnostic by healthcare professionals to identify advanced ovarian cancer patients with positive homologous recombination deficiency (HRD) status, who are eligible or may become eligible, for first-line maintenance treatment with Lynparza (olaparib) in combination with bevacizumab.”

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