fbpx

The Digest

Pharma news roundup and Larvol updates

Contact Us
Category: Ovarian Cancer

Weekly Top News – Ovarian Cancer – March 30, 2020

March 30, 2020

Recentin (cediranib) / AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza + cediranib: Acceptance of regulatory submission in US for recurrent platinum-resistant ovarian cancer (based on CONCERTO trial) in H2 2020 (AstraZeneca) – Mar 22, 2020 – Annual Report 2019 
[Screenshot]

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Acceptance of regulatory submission in US for BRCA mutated ovarian cancer (based on SOLO-3 trial) in H2 2020 (AstraZeneca) – Mar 22, 2020 – Annual Report 2019 
[Screenshot]

 

ofranergene obadenovec (VB-111) / VBL Therapeutics
VBL therapeutics announces positive outcome of the interim analysis in the OVAL phase 3 ovarian cancer pivotal study (GlobeNewswire) – Mar 26, 2020 – P3, N=400; OVAL (NCT03398655); Sponsor:VBL Therapeutics; “VBL Therapeutics…announced an encouraging outcome of the planned interim analysis in the OVAL study, a double-blind controlled potential-registration study in patients with platinum-resistant ovarian cancer…The DSMC confirmed that the study met the interim pre-specified efficacy criterion, of an absolute percentage advantage of 10% or higher CA-125 response rate for the VB-111 treatment arm, and recommended the study continuance. The 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 who had post-dosing fever, which is a marker for VB-111 treatment, the response rate is 69%.”

 

Bavencio (avelumab) / EMD Serono, Pfizer; magrolimab (Hu5F9-G4) / Forty Seven Inc, Ono Pharma
Magrolimab + Bavencio: “The combination of magrolimab + avelumab has a tolerable safety profile and no maximum tolerated dose was reached”; Solid tumor (Forty Seven) – Mar 26, 2020 – ASCO-SITC 2020: “Ovarian cancer pt had SD by RECIST but had -46% reduction in tumor size and was a PR by irRECIST and GCIG CA-125 criteria and remains on treatment for 9+ months” 
[Screenshot]

 

Paclical (micellar paclitaxel) / Oasmia, HLB Bio Group
Elevar Therapeutics acquires global rights to European approved Apealea from Oasmia Pharmaceutical (PRNewswire) – Mar 25, 2020 – “Elevar Therapeutics, Inc…announced…an agreement with Swedish-based Oasmia Pharmaceutical AP to obtain global rights for Apealea®, except in Nordics, Russia, and certain countries in Eastern Europe….The companies are also in discussions with the FDA to determine the best route for a New Drug Application (NDA) in the US.”

 

Opdivo (nivolumab) / Ono Pharma, BMS; Yervoy (ipilimumab) / Ono Pharma, BMS
CheckMate 032: A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) – Mar 24, 2020 – P1/2; N=1131; Active, not recruiting; Sponsor: Bristol-Myers Squibb; N=1620 –> 1131

Read More …

Weekly Top News – Ovarian Cancer – March 23, 2020

March 23, 2020

Recentin (cediranib) / AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza + cediranib: Acceptance of regulatory submission in US for recurrent platinum-resistant ovarian cancer (based on CONCERTO trial) in H2 2020 (AstraZeneca) – Mar 22, 2020 – Annual Report 2019 
[Screenshot]

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Acceptance of regulatory submission in US for BRCA mutated ovarian cancer (based on SOLO-3 trial) in H2 2020 (AstraZeneca) – Mar 22, 2020 – Annual Report 2019 
[Screenshot]

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab announces acceptance of sNDA submission of Zejula (niraparib) for first-line maintenance treatment of ovarian cancer in China by the NMPA (GlobeNewswire) – Mar 16, 2020 – “Zai Lab Limited…announced the China National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib) 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….GSK submitted a sNDA to the U.S. FDA for the use of ZEJULA in ovarian cancer as first-line maintenance treatment based on the PRIMA study…”

 

ofranergene obadenovec (VB-111) / VBL Therapeutics
VBL Therapeutics announces year ended december 31, 2019 financial results and provides corporate update (GlobeNewswire) – Mar 19, 2020 – “‘The ongoing Phase 3 OVAL trial in platinum resistant ovarian cancer continues to enroll patients as planned and we expect the readout from an important interim analysis by the end of the first quarter….We now look forward to 2020 as a potential turn around year for the company, with three parallel clinical trials for VB-111 and upcoming results from our MOSPD2 programs for inflammation and oncology.'”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Expiry of patents in US in 2028, between 2022- 2024 and 2024- 2031 (AstraZeneca) – Mar 21, 2020 – Annual Report 2019: Expiry of patents in China between 2021- 2024 and 2024- 2029; Expiry of patents in EU between 2021- 2029 and between 2024- 2029; Expiry of patents in Japan between 2021- 2029 and 2024- 2033 
[Screenshot]

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zejula: Expiry of patents in US in 2030 and EU in 2028 (GSK) – Mar 21, 2020 – Annual Report 2019 
[Screenshot]

 

veliparib (ABT-888) / AbbVie
Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Subjects With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) – Mar 16, 2020 – P3; N=1140; Active, not recruiting; Sponsor: AbbVie; Trial primary completion date: Jul 2020 –> May 2019

Read More …

Weekly Top News – Ovarian Cancer – March 9, 2020

March 16, 2020

Recentin (cediranib) / AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca
Update on Phase 3 GY004 for cediranib and Lynparza (olaparib) in platinum-sensitive relapsed ovarian cancer (Businesswire) – Mar 12, 2020 – “AstraZeneca and Merck…announced high-level results from the Phase 3 GY004 trial, led by NRG Oncology and sponsored by the U.S. National Cancer Institute (NCI), that examined primarily the efficacy and safety of investigational medicine cediranib in combination with LYNPARZA versus platinum-based chemotherapy in patients with platinum-sensitive relapsed ovarian cancer….The trial did not meet the primary endpoint in the intent-to-treat (ITT) population of a statistically significant improvement in progression-free survival (PFS) with cediranib in combination with LYNPARZA vs. platinum-based chemotherapy.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Zai Lab announces acceptance of sNDA submission of Zejula (niraparib) for first-line maintenance treatment of ovarian cancer in China by the NMPA (GlobeNewswire) – Mar 16, 2020 – “Zai Lab Limited…announced the China National Medical Products Administration (NMPA) has accepted its supplemental New Drug Application (sNDA) for ZEJULA® (niraparib) 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….GSK submitted a sNDA to the U.S. FDA for the use of ZEJULA in ovarian cancer as first-line maintenance treatment based on the PRIMA study…”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; ceralasertib (AZD6738) / AstraZeneca
DUETTE: A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5’Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment. (clinicaltrials.gov) – Mar 10, 2020 – P2; N=256; Not yet recruiting; Sponsor: AstraZeneca; N=192 –> 256

 

eribulin/farletuzumab ADC (MORAB-202) / Eisai
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types (clinicaltrials.gov) – Mar 9, 2020 – P1/2; N=196; Not yet recruiting; Sponsor: Eisai Inc.

 

Opdivo (nivolumab) / Ono Pharma, BMS; COM701 / Compugen
Compugen announces updated clinical data from ongoing COM701 phase 1 study (PRNewswire) – Mar 9, 2020 – P1, N=140; NCT03667716; Sponsor: Compugen Ltd; “COM701 was well-tolerated and with no reported dose-limiting toxicities in both treatment arms…A confirmed partial response in a patient from the COM701 monotherapy dose escalation arm with microsatellite stable primary peritoneal cancer, a type of challenging-to-treat ovarian cancer that was selected as a tumor type for the COM701 monotherapy expansion study based on our preclinical biomarker prediction of likely response to treatment with COM701; the patient is one of the three patients enrolled in the eighth cohort and is continuing on study treatment (more than 18 weeks).”

Read More …

Weekly Top News – Ovarian Cancer – March 9, 2020

March 9, 2020

Zirabev (bevacizumab biosimilar) / Pfizer
Anvisa approves the biosimilar Zirabev (bevacizumab) [Google translation] (Pfarma) – Mar 4, 2020 – “Metastatic colorectal cancer (mCRC) Zirabev (bevacizumab), in combination with fluoropyrimidine-based chemotherapy, is indicated for the treatment of patients with metastatic colorectal carcinoma….Zirabev was approved with the same therapeutic indications currently approved for the Avastin® reference product, based on the totality of evidence, which indicates the high similarity between these two products.”

 

Rubraca (rucaparib) / Clovis
Clovis Oncology announces availability and reimbursement for Rubraca (rucaparib) tablets for women with relapsed ovarian cancer in Spain (Businesswire) – Mar 2, 2020 – “Clovis Oncology, Inc…announced that Rubraca® (rucaparib) is now available and reimbursed in Spain following the Spanish Interministerial Commission on Prices of Medicines and Health Products approval of rucaparib for reimbursement. Rucaparib is now available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy…The European Union (EU) authorization is based on data from the pivotal phase 3 ARIEL3 clinical trial…”

 

mirvetuximab soravtansine (IMGN 853) / Immunogen
SORAYA: A Study of Mirvetuximab Soravtansine in Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (clinicaltrials.gov) – Mar 5, 2020 – P3; N=110; Not yet recruiting; Sponsor: ImmunoGen, Inc.

Read More …

Weekly Top News – Ovarian Cancer – March 2, 2020

March 2, 2020

ejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
U.S. FDA accepts GSK’s sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer (GSK Press Release) – Feb 24, 2020 – “GlaxoSmithKline plc…announced that the U.S. Food and Drug Administration (FDA) accepted the company’s submission of a supplemental New Drug Application (sNDA) seeking approval of Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program…The application is supported by data from the PRIMA study (ENGOT-OV26/GOG-3012)…”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
European Medicines Agency accepts submission of GSK’s Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer (PRNewswire) – Feb 27, 2020 – “GlaxoSmithKline plc announced that the European Medicines Agency (EMA) has validated the company’s Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. Validation of the T2V confirms that the submission is accepted and begins the formal review process by the EMA’s Committee for Human Medicinal Products (CHMP). The submission is based on data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically meaningful outcomes of niraparib treatment in the first-line maintenance setting.”

 

Rubraca (rucaparib) / Clovis
Clovis Oncology announces availability and reimbursement for Rubraca (rucaparib) tablets for women with relapsed ovarian cancer in Spain (Businesswire) – Mar 2, 2020 – “Clovis Oncology, Inc…announced that Rubraca® (rucaparib) is now available and reimbursed in Spain following the Spanish Interministerial Commission on Prices of Medicines and Health Products approval of rucaparib for reimbursement. Rucaparib is now available as an option for monotherapy maintenance treatment for adults with relapsed, platinum-sensitive high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to platinum-based chemotherapy…The European Union (EU) authorization is based on data from the pivotal phase 3 ARIEL3 clinical trial…”

 

Nexavar (sorafenib) / Bayer, Amgen
Novocure reports fourth quarter and full year 2019 financial results and provides company update (Businesswire) – Feb 27, 2020 – “Anticipated clinical milestones….Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (H2 2020); Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (2021); Data from phase 3 pivotal METIS trial in brain metastases (2021); Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021); Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2022); Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022); Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022); Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2024)”

 

Rubraca (rucaparib) / Clovis
Rubraca: Patent protection in EU with supplementary protection certificate until 2033 (Clovis Oncology) – Feb 27, 2020 – Annual Report 2019: Patent term extension in US related to composition of matter until Q4 2023; Expiry of patents in 2035; Regulatory exclusivity in EU until 2028- 2029

 

Rubraca (rucaparib) / Clovis; lucitanib (E 3810) / Clovis, HaiHe Pharma, Servier
Clovis Oncology announces 2019 operating results (Clovis Oncology Press Release) – Feb 24, 2020 – “Rubraca® (rucaparib) net product revenue totaled $143.0M for 2019 and $39.3M for Q4 2019; Net product revenue for 2019 up 50% over 2018; Lucitanib combination studies enrolling; initial data anticipated at medical meetings in 2020; Acquired rights to FAP-2286, a radiopharmaceutical therapy targeting FAP; plan to submit an IND in 2H 2020.”

 

Keytruda (pembrolizumab) / Merck (MSD); FPA150 / Five Prime
Five Prime Therapeutics reports fourth quarter and full year 2019 results (Five Prime Therap Press Release) – Feb 27, 2020 – “2020 Milestones and Review of 2019 Business Highlights: Bemarituzumab is being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial. The company has paused enrollment in the FIGHT trial pending the occurrence of a sufficient number of events to trigger a futility analysis that is expected to occur in mid-2020; The company remains on track to generate data by mid-2020 from the Phase 1 combination of FPA150 plus pembrolizumab in a cohort of ovarian cancer patients with B7-H4 overexpression; FPT155 – The company remains on track to generate early monotherapy efficacy data in 2020.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
Lynparza: Patent expiry in US in 2028 (Merck (MSD)) – Feb 29, 2020 – Annual report 2019: Patent expiry in China/EU in 2024 and SPC in EU until 2029; Patent expiry in Japan between 2028 -2029 
[Screenshot]

Read More …

Weekly Top News – Ovarian Cancer – February 24, 2020

February 24, 2020

AVB-500 / Aravive
Aravive announces dose escalation of AVB-500 in recurrent platinum resistant ovarian cancer phase 1b trial (GlobeNewswire) – Feb 18, 2020 – “Aravive, Inc…announced that the independent Data Monitoring Committtee (DMC) has reviewed the open-label data following the first 28-day treatment cycle for the three patients in each of the two 15 mg/kg dosing cohorts of the Phase 1b portion of the Phase 1b/Phase 2 clinical trial of AVB-500 in patients with platinum-resistant recurrent ovarian cancer (PROC) and unanimously recommended the study continue as planned with enrollment of patients into the 20mg/kg dose cohorts. The DMC did not identify any safety concerns with AVB-500….The company anticipates reporting safety and pharmacokinetic data from this Phase 1b trial in mid-2020 with plans to present preliminary efficacy in 2H 2020. The company plans to initiate a randomized Phase 2/3 study in PROC by end of 2020.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
L-MOCA: Olaparib Tablets Maintenance Monotherapy Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy (clinicaltrials.gov) – Feb 18, 2020 – P3; N=19; Active, not recruiting; Sponsor: AstraZeneca; N=240 –> 19

 

Keytruda (pembrolizumab) / Merck (MSD); Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; relacorilant (CORT125134) / Corcept Therap
Corcept Therapeutics announces fourth quarter and full-year 2019 audited financial results and provides corporate update (GlobeNewswire, Corcept Therapeutics Incorporated) – Feb 20, 2020 – “Solid Tumors: (i) Controlled, Phase 2 trial of relacorilant plus nab-paclitaxel to treat metastatic ovarian cancer actively enrolling patients at sites in the United States and Europe, on track to produce results in first half of 2021; (ii) Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with metastatic pancreatic cancer to start in second quarter; (iii) Phase 1b trial of relacorilant plus the immunotherapeutic agent pembrolizumab (Keytruda®) to treat patients with metastatic or unresectable adrenocortical cancer to start in second quarter.”

 

Zepsyre (lurbinectedin) / PharmaMar, Jazz
Zepsyre: Protection of use patent in US/EU until 2031 (Pharmamar) – Feb 20, 2020 – Corporate Presentation: Protection of composition-of-matter patent in US/EU until 2024/2022 
[Screenshot]

 

tisotumab vedotin (HuMax-TF-ADC) / Genmab, Seattle Genetics
Tisotumab vedotin: Expiry of patents in US and EU between 2022 and 2032 (Seattle Genetics, Inc) – Feb 16, 2020 – Annual Report 2019

 

pamiparib (BGB-290) / EMD Serono; AiTan (rivoceranib) / HLB Bio Group
Hengrui files for new indication for apatinib, gets trial nod for PARPi (GBI Health) – Feb 17, 2020 – “China’s Jiangsu Hengrui Medicine Co., Ltd (600276.SH) announced its is seeking market approval for a new indication for the Category 1 drug apatinib. A related filing has been accepted for review by the National Medical Products Administration (NMPA). The aim is to allow apatinib to be used against advanced hepatocellular carcinoma (HCC) unresponsive to or intolerable of first-line and above systemic therapies…Meanwhile, the company got the green light from the NMPA to carry out a Phase III clinical study for its poly adp-ribose polymerase-1 (PARP-1) inhibitor pamiparib as a monotherapy or in combination with apatinib as maintenance treatment in first-line platinum-containing chemotherapy for advanced ovarian cancer.”

Read More …