Weekly Top News – Ovarian Cancer – May 18, 2020

May 18, 2020

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.”


Lynparza (olaparib) / Merck (MSD), AstraZeneca
Maintenance olaparib provides significant long-term OS benefit in relapsed ovarian cancer (Targeted Oncology) – May 14, 2020 – P3, N=327; SOLO2 (NCT01874353); Sponsor: AstraZeneca; “Maintenance treatment with olaparib (Lynparza) demonstrated an improved median overall survival (OS) of 12.9 months over placebo in patients with platinum-sensitive relapsed ovarian cancer harboring a BRCA1/2 mutation, according to final OS results from the phase III SOLO2/ENGOT-ov21 trial. Poveda presented updated survival results after approximately 5 years of follow-up in a press briefing ahead of the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting…At 5 years, 42.1% of patients in the olaparib group were still alive compared with 33.2% in the placebo group. However, 39% of patients in the placebo arm crossed over to receive PARP inhibition.”


mirvetuximab soravtansine (IMGN 853) / ImmunoGen
ImmunoGen announces initial data from FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin in recurrent ovarian cancer, regardless of platinum status (Immunogen Press Release) – May 13, 2020 – P3, N=366; FORWARD II (NCT02631876); Sponsor: ImmunoGen; “ImmunoGen…announced initial data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin® (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate. These findings will be highlighted in an oral presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program on May 29, 2020. Three “trial in progress” posters will also be presented during the meeting….In the overall patient population, objective responses were seen in 26 patients and the confirmed overall response rate (ORR) was 43% (95% CI, 31, 57).”


Lynparza (olaparib) / Merck (MSD), AstraZeneca; entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers (clinicaltrials.gov) – May 14, 2020 – P1/2; N=73; Suspended; Sponsor: Vanderbilt-Ingram Cancer Center; Trial completion date: Mar 2025 –> Sep 2025; Not yet recruiting –> Suspended; Trial primary completion date: Mar 2023 –> Sep 2023


Keytruda (pembrolizumab) / Merck (MSD); DPX-Survivac (EMD 640744) / IMV Inc
IMV Inc. provides clinical and operational update and announces first quarter 2020 financial results (Businesswire) – May 15, 2020 – “Translational and updated clinical response data from Phase 2 DeCidE1 study of DPX-Survivac in advanced ovarian cancer to be presented by Oliver Dorigo, MD, Ph.D., at the upcoming 2020 ASCO Virtual Scientific Program….Upcoming Milestones: Top line Phase 2 clinical results update in the DLBCL combination trial in 2020, Update on the Phase 2 clinical results in the ovarian monotherapy trial at ASCO 2020, Updated Phase 2 clinical results for Basket trial in 2H 2020.”


AZD4635 / AstraZeneca; Recentin (cediranib) / AstraZeneca; capivasertib (AZD5363) / Otsuka, AstraZeneca; tremelimumab (CP-675206) / AstraZeneca, Pfizer; Calquence (acalabrutinib) / AstraZeneca; gefitinib / Generic mfg.; Imfinzi (durvalumab) / AstraZeneca, BMS; Lynparza (olaparib) / Merck (MSD), AstraZeneca
AstraZeneca advances the science of cancer medicine with practice-changing data at the ASCO20 Virtual Scientific Program (AstraZeneca Press Release) – May 13, 2020 – “AstraZeneca will present ground-breaking new results across its broad portfolio of cancer medicines during the 2020 American Society of Clinical Oncology ASCO20 Virtual Scientific Program, 29 to 31 May 2020. AstraZeneca will present 98 abstracts, including 19 oral presentations with one plenary and 10 late-breakers. Presentations will showcase the Company’s leadership in the treatment of early lung cancer with a late-breaking plenary presentation of the unprecedented results from the Phase III ADAURA trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB, II and IIIA epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). Data from the DESTINY programme will highlight the transformative potential of Enhertu (trastuzumab deruxtecan) across HER2-driven tumours, including in lung, breast, gastric and colorectal cancers.”


Keytruda (pembrolizumab) / Merck (MSD); Tecentriq (atezolizumab) / Roche
Phase 1/2 Study of IMC-F106C in Advanced PRAME-Positive Cancers (clinicaltrialsregister.eu) – May 12, 2020 – P1/2; N=63; Ongoing; Sponsor: Immunocore Ltd.


Lynparza (olaparib) / Merck (MSD), AstraZeneca; Imfinzi (durvalumab) / AstraZeneca, BMS
MEDIOLA: A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors. (clinicaltrials.gov) – May 12, 2020 – P1/2; N=427; Active, not recruiting; Sponsor: AstraZeneca; Recruiting –> Active, not recruiting
Clinical • Combination therapy • Enrollment closed • BARD1 • BRCA • BRIP1 • CHEK1 • CHEK2 • HER-2 •


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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