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Category: Ovarian Cancer

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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Weekly Top News – Ovarian Cancer – June 29, 2020

June 29, 2020

Aybintio (bevacizumab biosimilar) / Samsung, Mundipharma
Samsung Bioepis Receives Positive CHMP Opinion for AYBINTIO (Bevacizumab) (GlobeNewswire) – Jun 26, 2020 – “Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AYBINTIO®, a biosimilar candidate referencing Avastin®i (bevacizumab). AYBINTIO® has been recommended for approval for the treatment of the same types of cancer as reference bevacizumab in the European Union (EU) 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 – June 22, 2020

June 22, 2020

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Overview of the Updated NCCN Guidelines on Ovarian Cancer (Journal of Clinical Pathways) – Jun 17, 2020 – “The Guidelines added niraparib to maintenance therapy options for those with complete or partial remission if they have BRCA1/2 wild-type or unknown and did not use bevacizumab as primary therapy or for those with germline or somatic BRCA1/2 mutation (category 1 if bevacizumab was not used as a primary therapy, and category 2A if it was). The Guidelines modified a category of evidence for olaparib for patients with a germline or somatic BRCA1/2 mutation who did not receive bevacizumab during primary therapy…”

 

Rubraca (rucaparib) / Clovis
Rubraca: Newly added patents in Orange Book (Orange Book) – Jun 17, 2020 – Expiry on July 23, 2024, August 12, 2027, August 4, 2031 and August 17, 2035

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; dostarlimab (TSR-042) / GSK
A Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer (clinicaltrials.gov) – Jun 18, 2020 – P3; N=1228; Recruiting; Sponsor: Tesaro, Inc.; Trial completion date: Jan 2023 –> Jul 2026; Trial primary completion date: Jul 2021 –> Feb 2023

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Weekly Top News – Ovarian Cancer – June 15, 2020

June 15, 2020

Lynparza (olaparib) / Merck (MSD), AstraZeneca
ROSY-O: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib (clinicaltrials.gov) – Jun 9, 2020 – P3; N=124; Not yet recruiting; Sponsor: AstraZeneca

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient (clinicaltrials.gov) – Jun 12, 2020 – P3; N=265; Active, not recruiting; Sponsor: Zai Lab (Shanghai) Co., Ltd.; Recruiting –> Active, not recruiting

 

mirvetuximab soravtansine (IMGN 853) / ImmunoGen
FORWARD I: A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer (clinicaltrials.gov) – Jun 9, 2020 – P3; N=366; Completed; Sponsor: ImmunoGen, Inc.; Active, not recruiting –> Completed

 

Rubraca (rucaparib) / Clovis; Opdivo (nivolumab) / Ono Pharma, BMS
Clovis Oncology announces completion of target enrollment in the ATHENA trial, a phase 3 maintenance treatment study in front-line, newly-diagnosed advanced ovarian cancer (Clovis Oncology Press Release) – Jun 10, 2020 – “Clovis Oncology…announced today the completion of target patient enrollment in the Clovis-sponsored Phase 3 ATHENA trial evaluating the combination of Clovis’ Rubraca®(rucaparib)…and Bristol-Myers Squibb’s PD-1 inhibitor, OPDIVO® (nivolumab), as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer. ATHENA is the first front-line switch maintenance study designed to show PARP monotherapy and PARP/PD-1 combination therapy in one study design….Topline data for the Rubraca monotherapy versus placebo arm in all study populations is expected in the second half of 2021 and, if supportive, would serve as the basis of an sNDA for the maintenance treatment of front-line, newly-diagnosed, advanced ovarian cancer patients.”

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Weekly Top News – Ovarian Cancer – June 8, 2020

June 8, 2020

 Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: “Median OS improved by 12.9 months with maintenance Lynparza over placebo (p-value: 0.0537)”; Ovarian cancer (AstraZeneca) – Jun 2, 2020 – ASCO 2020

 

Rubraca (rucaparib) / Clovis
Rubraca: Data from monotherapy portion of P3 ATHENA trial (NCT03522246) for 1L ovarian cancer in H2 2021 (Clovis Oncology) – Jun 5, 2020 – Corporate Presentation

 

olvimulogene nanivacirepvec (GL-ONC1) / Genelux
Genelux announces formation of clinical advisory board on gynecologic cancers (PRNewswire) – Jun 4, 2020 – “Genelux Corporation…announced that it has formed a Clinical Advisory Board (CAB) on gynecologic cancers that will guide clinical development of its lead clinical-stage candidate, Olvi-Vec (olvimulogene nanivacirepvec). Genelux has completed enrollment of VIRO-15, a multi-center, open-label, Phase 2 study (NCT02759588) testing Olvi-Vec in platinum-resistant/refractory ovarian cancer and is in the follow up phase of the trial….’we look forward to their insight and expertise in helping the company advance our promising Olvi-Vec program into Phase 3….Abbreviated biographies of Genelux’s inaugural CAB members are as follows…Robert L. Coleman, MD…Thomas J. Herzog, MD…”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Clinical Trial Evaluating the Efficacy and Safety of ZL-2306 (Niraparib) in Ovarian Cancer Patient (clinicaltrials.gov) – Jun 2, 2020 – P3; N=265; Recruiting; Sponsor: Zai Lab (Shanghai) Co., Ltd.; Trial completion date: Jun 2020 –> Apr 2021; Trial primary completion date: Jun 2020 –> Feb 2020

 

ofranergene obadenovec (VB-111) / NanoCarrier, VBL Therapeutics
VBL presents positive interim data from the OVAL phase 3 pivotal study in ovarian cancer at the ASCO20 Annual Meeting, showing 58% or higher objective response rate (GlobeNewswire) – Jun 1, 2020 – P3, N=400; NCT03398655; Sponsor: VBL Therapeutics; “OVAL independent Data Safety Monitoring Committee (DSMC) reviewed un-blinded data and determined that the study has met the interim pre-specified criterion of an absolute percentage advantage of 10% or higher in CA-125 response in the VB-111 treated arm compared to control. The DSMC recommended that the study proceed without modification. Overall CA-125 response rate in the first 60 randomized evaluable patients is 53%. Assuming a balanced randomization, the response rate in the treatment arm (VB-111 in addition to weekly paclitaxel) is 58% or higher. In patients with post-treatment fever, the CA-125 response is 69%. Fever is frequently observed after VB-111 treatment. The next interim analysis in the OVAL study is expected in 3Q 2020.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Newly added patent in Orange Book (Orange Book) – Jun 5, 2020 – Expiry on March 12, 2024

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Weekly Top News – Ovarian Cancer – June 1, 2020

June 1, 2020

 Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab announces positive topline results from the NORA phase 3 study of Zejula as maintenance therapy for chinese patients with platinum-sensitive, recurrent ovarian cancer (GlobeNewswire) – May 28, 2020 – P3, N=381; NORA (NCT03709316); Sponsor: Zai Lab (Shanghai) Co., Ltd; “Zai Lab Limited…announced positive topline results from the NORA study, the Phase 3 randomized, double-blind, placebo-controlled, study of ZEJULA (niraparib) as a maintenance therapy in Chinese patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (collectively termed as ovarian cancer) who are in a complete or partial response to platinum-based chemotherapy….The study met its primary endpoint of a statistically significant improvement in progression free survival for patients with ovarian cancer regardless of their biomarker status. The safety profile was consistent with what was observed from the global NOVA study with lower rates of anemia and thrombocytopenia.”

 

AsiDNA (etidaligide) / Onxeo; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Onxeo announces approval of the REVocan study by regulatory authorities (GlobeNewswire) – May 29, 2020 – “Onxeo S.A…announced that the REVocan1 phase 1b/2 designed to evaluate the effect of AsiDNA™, Onxeo’s first-in-class DDR inhibitor, on the acquired resistance to PARP inhibitor (PARPi) niraparib for 2nd line maintenance treatment of relapsed ovarian cancer, has received approval from the French National Agency for the Safety of Medicines and Health Products (ANSM) and the Ethics Committee (CPP)….The first patients could be recruited as early as the third quarter of 2020, with the aim of obtaining preliminary results at the end of 2020 or early in 2021.”

 

Bavencio (avelumab) / EMD Serono, Pfizer; Talzenna (talazoparib) / Pfizer
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors (clinicaltrials.gov) – May 27, 2020 – P1b/2; N=214; Active, not recruiting; Sponsor: Pfizer; Recruiting –> Active, not recruiting

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Weekly Top News – Ovarian Cancer – May 25, 2020

May 25, 2020

Rubraca (rucaparib) / Clovis
Clovis Oncology announces presentations at 2020 ASCO Virtual Scientific Program (Businesswire) – May 21, 2020 – “Clovis Oncology…announced today that six abstracts featuring data from clinical and real-world evidence studies evaluating Rubraca® (rucaparib) in multiple tumor types have been accepted for presentation or publication at the American Society of Clinical Oncology 2020 Virtual Scientific Program taking place May 29 – 31….The accepted abstracts summarize findings from clinical trials in which Rubraca was evaluated as a single-agent therapy in ovarian cancer, metastatic castration-resistant prostate cancer (mCRPC) and malignant mesothelioma, and in combination with irinotecan in multiple advanced solid tumors, as well as findings from real-world evidence studies of the epidemiology and current treatment landscape of mCRPC.”

 

dostarlimab (TSR-042) / GSK; GSK3377794 / GSK; Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
GSK highlights scientific innovation and advances in its growing oncology portfolio at ASCO 2020 (PRNewswire) – May 20, 2020 – “As part of its ongoing work to advance potentially transformational medicines, GlaxoSmithKline plc will present new data at the upcoming 2020 American Society of Clinical Oncology (ASCO) Annual Meeting from 29-31 May 2020. The depth and breadth of the presentations represent GSK’s progress in helping people affected by cancer achieve better outcomes and build on the recent US Food and Drug Administration (FDA) approval of a new indication for Zejula® (niraparib).”

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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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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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Weekly Top News – Ovarian Cancer – May 4, 2020

May 4, 2020

 Lynparza (olaparib) / Merck (MSD), AstraZeneca; Recentin (cediranib) / AstraZeneca
Lynparza + Recentin: Data from P2/3 trial (NCT02502266) for recurrent platinum resistant/refractory ovarian cancer in 2021 or later (AstraZeneca) – Apr 29, 2020 – Q1 2020 Results

 

 

llllllllll Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
FDA approves Zejula (niraparib) as the only once-daily PARP inhibitor in first-line monotherapy maintenance treatment for women with platinum-responsive advanced ovarian cancer regardless of biomarker status (PRNewswire) – Apr 29, 2020 – “GlaxoSmithKline plc…announced the US Food and Drug Administration (FDA) approved the company’s supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. Until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting….This new indication is supported by data from the phase III PRIMA study (ENGOT-OV26/GOG-3012)…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Regulatory decision in US (based on PAOLA trial) for ovarian cancer in Q2 2020 (AstraZeneca) – Apr 29, 2020 – Q1 2020 Results: Regulatory decision in US for 2L prostate cancer in Q2 2020

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; dostarlimab (TSR-042) / GSK
Zejula + dostarlimab: Regulatory submission for 2L+ ovarian cancer (based on MOONSTONE trial) in H2 2021 (GSK) – Apr 30, 2020 – Q1 2020 Results

 

 

NEO-PTC-01 / Neon Therapeutics
Neon Therapeutics announces acceptance of European Clinical Trial Authorization application for NEO-PTC-01 (GlobeNewswire) – Apr 30, 2020 – “Neon Therapeutics, Inc…announced the acceptance of its Clinical Trial Authorization (CTA) from the Dutch Health Authority (DHA) for its personal neoantigen-targeted T cell therapy candidate, NEO-PTC-01. Neon’s initial Phase 1 clinical trial of NEO-PTC-01 will be in patients with metastatic melanoma who are not responsive to checkpoint inhibitors. The Phase 1 dose-finding clinical trial in metastatic melanoma will be conducted in collaboration with the Netherlands Cancer Institute and is expected to begin in the third quarter of 2020… Neon is also planning for a second indication for NEO-PTC-01 in metastatic ovarian cancer, as well as for the potential to both expand to other solid tumor types and pursue clinical development in the United States.”

 

mirvetuximab soravtansine (IMGN 853) / ImmunoGen; IMGN151 / ImmunoGen
ImmunoGen reports recent progress and first quarter 2020 financial results (Businesswire) – May 1, 2020 – “ANTICIPATED UPCOMING EVENTS: Present updated data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab in the fall; Continue enrollment in IMGN632 monotherapy and combination cohorts; File IND for IMGC936 at the end of Q2; Transition IMGN151 into pre-clinical development.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Cost-effectiveness of upfront maintenance therapies for advanced ovarian cancer (Journal of Clinical Pathways) – Apr 29, 2020 – “…researchers found the estimated cost of olaparib in metastatic BRCA patients was $16,178 per month for 2 years of maintenance, based on the data from SOLO-1. With an estimated 48-month improvement in PFS, the ICER of olaparib would be $96,000 per progression-free life-year saved. Finally, assuming hypothetical results of PAOLA-1 at a 36-, 48, and 60-month improvements in PFS, the ICER of bevacizumab plus olaparib would be $347,428, $270,222, and $221,090 per progression-free life-year saved, respectively.”

 

mirvetuximab soravtansine (IMGN 853) / ImmunoGen; IMGN151 / ImmunoGen
ImmunoGen reports recent progress and first quarter 2020 financial results (Businesswire) – May 1, 2020 – “ANTICIPATED UPCOMING EVENTS: Continue patient enrollment in pivotal SORAYA and confirmatory MIRASOL trials; Support initiation of an additional platinum-sensitive investigator sponsored trial evaluating mirvetuximab in combination with carboplatin in over 100 patients; Present initial data from the FORWARD II platinum-agnostic doublet cohort evaluating mirvetuximab in combination with bevacizumab in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) Annual Meeting in May; Present pre-clinical data evaluating our next generation anti-folate receptor alpha (FRα) ADC, IMGN151, in ovarian cancer and other tumor types in a poster at the virtual American Association for Cancer Research (AACR) Annual Meeting in June.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
SOLO-2: Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy (clinicaltrials.gov) – Apr 28, 2020 – P3; N=327; Active, not recruiting; Sponsor: AstraZeneca; Trial completion date: Apr 2020 –> Feb 2022

 

ovapuldencel-T (AVOVA-1) / Caladrius, AiVita Biomedical
AIVITA Biomedical presents updates from ongoing ovarian cancer and glioblastoma clinical studies at 2020 AACR Virtual Annual Meeting (Businesswire) – Apr 27, 2020 – P2, N=99; NCT02033616; Sponsor: Aivita Biomedical, Inc; “The presentation from Lisa Abaid, MD, principal investigator of the Phase 2 clinical trial of AVOVA-1 in advanced ovarian cancer, showed the trial is progressing as planned and the treatment has been well-tolerated. Enrollment for the study continues for both tumor collection and randomization.”

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