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Month: September 2020

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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Weekly Top News – IBD – September 28, 2020

September 28, 2020

etrasimod (APD334) / Arena
Etrasimod: Completion of enrollment of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in Q4 2020 (Arena) – Sep 24, 2020 – Jefferies Virtual Next Generation IBD Therapeutics Summit: Top-line data from P3 ELEVATE UC 52 trial for ulcerative colitis in Q4 2021; Top-line data from P3 ELEVATE UC 12 trial (NCT03996369) for ulcerative colitis in Q4 2021 
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Jyseleca (filgotinib) / Gilead
Stock market look: Galapagos on track in Japan and EU [Google Translation] (DeAandeelhouder.nl) – Sep 24, 2020 – “The filing for ulcerative colitis in the United States will depend on the results the Manta study produces in the first half of 2021…The Phase 3 Diversity study of filgotinib with Crohn’s disease is expected to provide data in 2022.”

 

etrasimod (APD334) / Arena
Etrasimod: Initiation of trial for ulcerative colitis in early 2021 (Arena) – Sep 24, 2020 – Jefferies Virtual Next Generation IBD Therapeutics Summit 
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Entyvio (vedolizumab) / Takeda
CHRONOS: A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants With Ulcerative Colitis (UC) or Crohn´s Disease (CD) (clinicaltrials.gov) – Sep 25, 2020 – P=N/A; N=60; Completed; Sponsor: Takeda; Active, not recruiting –> Completed; N=150 –> 60

 

ABX464 / Abivax
Abivax Presents First-Half 2020 Financial Results and Operations Update (Yahoo Finance) – Sep 26, 2020 – “77% (180/232) of patients randomized in ABX464 Phase 2b ulcerative colitis study, recruitment expected to be completed by the end of 2020. ABX464 pivotal Phase 2b/3 trial for Crohn’s disease planned with anticipated start of patient recruitment in Q1 2021….”

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Weekly Top News – Psoriasis – September 28, 2020

September 28, 2020

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces the launch of ILUMYA (tildrakizumab) for treatment of Plaque Psoriasis in Japan (Equitybulls) – Sep 23, 2020 – “Sun Pharmaceutical…today announced that its wholly-owned Japanese subsidiary has launched ILUMYA® Subcutaneous Injection 100 mg Syringe (Nonproprietary name: tildrakizumab (genetical recombination), ‘ILUMYA’) in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies.”

 

bimekizumab (UCB4940) / UCB
UCB Achieves Important Regulatory Milestone for Bimekizumab (UCB Press Release) – Sep 22, 2020 – “UCB…today announced that the FDA and EMA have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis; This accepted submission is supported by a robust data package including three Phase 3 studies which demonstrate superiority of bimekizumab to placebo, Stelara[®] (ustekinumab) and Humira[®] (adalimumab) in achieving skin clearance at week 16.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx: “Extension of indication to include the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy [Plaque psoriasis]” (European Medicines Agency) – Sep 25, 2020 – CHMP Final Minutes of the meeting on 22-25 June 2020: “The Committee adopted a positive opinion by consensus together with the CHMP assessment report and translation timetable”

 

Tremfya (guselkumab) / J&J
Tremfya: “Addition of a new indication for the treatment of active psoriatic arthritis in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy [Psoriatic arthritis]” (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”

 

piclidenoson (CF101) / Can-Fite, China Medical System
Can-Fite to Participate in Two BioPharma Partnering Conferences (Businesswire) – Sep 22, 2020 – “Can-Fite BioPharma Ltd….today announced the Company’s VP of Business Development, Dr. Sari Fishman, is participating in two conferences where she will conduct one-on-one meetings with pharmaceutical companies for potential distribution and partnerships for the Company’s drug candidates, Piclidenoson and Namodenoson. Both conferences include scheduled virtual partner meetings for Can-Fite, live sessions, and virtual networking….Additional trials are ongoing or expected to start in COVID-19 and liver cancer.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasi (clinicaltrials.gov) – Sep 22, 2020 – P3; N=214; Active, not recruiting; Sponsor: Sun Pharma Global FZE; Recruiting –> Active, not recruiting; Trial completion date: Aug 2022 –> Feb 2022; Trial primary completion date: Jun 2021 –> Jan 2021

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Daily Top News – September 28, 2020

September 28, 2020

Zynrelef (bupivacaine/meloxicam ER) / Heron Therapeutics
Heron Therapeutics Receives European Commission Authorization for ZYNRELEF (HTX-011) for the Treatment of Postoperative Pain (PRNewswire) – Sep 28, 2020 – “Heron Therapeutics, Inc….today announced that the European Commission has granted a marketing authorization for ZYNRELEF (formerly known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The marketing authorization follows the European Medicines Agency’s (EMA) positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in July 2020. Heron currently expects to make ZYNRELEF available to patients in the European Union (EU) during 2021.”

 

troriluzole (BHV-4157) / Portage; Nurtec ODT (rimegepant ODT) / Portage
BioShin, Biohaven’s Asia-Pacific Subsidiary, Raises $60M in Series A Funding to Advance Neuroscience Pipeline in Asia-Pacific Region (PRNewswire) – Sep 28, 2020 – “Biohaven Pharmaceutical Holding Company Ltd….announced today that BioShin Limited…has closed a $60M Series A investment round. The financing was led by OrbiMed, with participation from Cormorant Asset Management LLC….The Series A funds will be used to build out BioShin in China and advance the Biohaven clinical portfolio in the Asia-Pacific region, including the imminent start of the NURTEC™ ODT (rimegepant) Phase 3 study for the acute treatment of migraine in China and Korea. BioShin also plans to initiate sites in China to participate in the global registrational trial of troriluzole in Spinocerebellar Ataxia (SCA). BioShin expects to begin both Asia-Pacific studies in the fourth quarter of 2020.”

 

Epidaza (chidamide) / Chipscreen, Meiji Seika, Eisai, HUYA Bioscience, GNT Biotech
HUYA Bioscience International Announces Orphan Drug Designation for HBI-8000 Monotherapy Adult T-cell Leukemia-Lymphoma ATL in Japan (PRNewswire) – Sep 28, 2020 – “HUYA Bioscience…announced today the Ministry of Health, Labour and Welfare (MHLW) granted HBI-8000 orphan drug designation (ODD) in Japan as monotherapy for relapsed or refractory Adult T-cell Leukemia-Lymphoma or (ATL)…We are now preparing an application to the PMDA for approval of HBI-8000 as monotherapy for the treatment for R/R ATL.”

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COVID-19 Top News – September 28, 2020

September 28, 2020

Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research Institute
India trials for Russia’s ‘Sputnik-V’ vaccine could start in next few weeks: exec (Reuters) – Sep 22, 2020 – “Dr Reddy’s Laboratories Ltd could begin late-stage Indian clinical trials of Russia’s potential coronavirus vaccine in the next few weeks….Indian trials of the Sputnik-V vaccine candidate…will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country….Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India….The RDIF has also reached agreements with Indian manufacturers to produce 300 million doses of the shot in India.”

 

remdesivir / Generic mfg.
Veklury: “The Committee adopted a positive opinion recommending the granting of a conditional marketing authorization by consensus together with the CHMP assessment report and translation timetable [Coronavirus disease]” (European Medicines Agency) – Sep 25, 2020 – CHMP Final Minutes of the meeting on 22-25 June 2020

 

aviptadil intravenous (RLF-100 IV) / Relief Therap, NeuroRx
Relief partner NeuroRx submits request for Emergency Use Authorization for RLF-100 (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy (PharmiWeb) – Sep 23, 2020 – P=NA, N=51; SAMICARE (NCT04453839); Sponsor: NeuroRx, Inc.; “…NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments….The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement.”

 

favipiravir / Generic mfg.
Japanese approval sought for Avigan to treat COVID-19 (Nikkei) – Sep 21, 2020 – “Fujifilm Holdings will soon apply to produce and sell its Avigan antiviral drug as a treatment for the new coronavirus in Japan….The health ministry could give the go-ahead this year, making Avigan the third drug overall and the first domestically developed drug to receive such approval….The health ministry has said it plans to fast-track approval for the drug. ‘If the data from the clinical trials looks good, we could approve it in a month from when Fujifilm submits an application,’ a ministry source said.”

 

remdesivir / Generic mfg.
Cabinet may reduce remdesivir injection price (Dawn) – Sep 22, 2020 – “According to sources in the Ministry of National Health Services (NHS), the cabinet will consider reducing the price of remdesivir 100mg injection which is given to Covid-19 patients. ‘At present, each injection is being sold for Rs10,873 but it has been decided to reduce the price to ensure that it would become affordable for all patients,’ an official of the health ministry said requesting not to be quoted….The official said the cabinet will also consider the grant of exemption from section 23(1)(a)(VII) of the Drugs Act 1976.”

 

favipiravir / Generic mfg.
Hetero launches pack of generic COVID-19 drug favipiravir at Rs 2,640 (The Economic Times) – Sep 26, 2020 – “Drug firm Hetero…said it has launched a pack of its generic oral antiviral drug– Favivir 800/200– for the treatment of mild-to-moderate symptomatic COVID-19 patients in India. Favivir 800/200 will be available in a pack containing 16 tablets of favipiravir 800 mg and 2 tablets of favipiravir 200 mg priced at Rs 2,640 per pack….The higher strength of Favipiravir 800 mg by the company has been approved by the Drug Controller General of India (DCGI). The product will be marketed and distributed by Hetero Healthcare Ltd, it added.”

 

Early Covid-19 treatments could be ‘bridge’ to vaccine, says Anthony Fauci (Hindustan Times) – Sep 27, 2020 – “Anthony Fauci said 100 million doses of vaccine may be produced by December, with all six companies supplying the US slated to have made 700 million doses by next April.”

 

Coronavirus vaccines: US, China and Russia absent from WHO’s equal access COVAX coalition – Sep 22, 2020 – “However, numerous countries that have signed their own bilateral deals with vaccine makers have declined to participate or to use the facility to secure their own vaccines, including China, Russia, and the United States….Tedros Adhanom Ghebreyesus said the Covax facility, which WHO is heading up alongside with vaccines alliance GAVI and the Coalition for Epidemic Preparedness and Innovations (CEPI), will help bring the COVID-19 pandemic under control. Dr Richard Hatchett…said that ‘COVID-19 cannot be beaten one country at a time. We must be able to share lifesaving vaccines globally at the same time.'”

 

CDC’s Messonnier Says She Trusts COVID Vaccine Process (WebMD) – Sep 21, 2020 – “Nancy Messonnier, MD…We are working in partnership with Operation Warp Speed and my colleagues say that there will be vaccine available this fall but that they expect the quantities of vaccine to be limited. By next year, we should have much larger quantities of vaccine available. So, on the delivery side, we’re working to ready the country for the first implementation of vaccine this fall, but then also getting ready for a much larger availability of vaccine next year.”

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Daily Top News – September 25, 2020

September 25, 2020

Kalydeco (ivacaftor) / Vertex
FDA Approves KALYDECO (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age (Businesswire) – Sep 25, 2020 – “Vertex…today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO based on clinical and/or in vitro assay data….This FDA approval is based on data from a cohort in the 24-week Phase 3 open-label safety cohort (ARRIVAL)…”

 

Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZeneca
ENHERTU Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer (Daiichi Sankyo Press Release) – Sep 25, 2020 – “Daiichi Sankyo…today announced the approval of ENHERTU® (trastuzumab deruxtecan), a HER2 directed antibody drug conjugate (ADC), in Japan for the treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy….Approval of ENHERTU in Japan is based on the results of the open-label, randomized phase 2 DESTINYGastric01 trial…”

 

Jyseleca (filgotinib) / Gilead
European Commission Grants Marketing Authorization for Jyseleca (Filgotinib) for the Treatment of Adults With Moderate to Severe Active Rheumatoid Arthritis (Businesswire) – Sep 25, 2020 – “Gilead Sciences, Inc….and Galapagos NV…today announced that the European Commission (EC) has granted marketing authorization for Jyseleca® (filgotinib 200 mg and 100 mg tablets), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis (RA) who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs (DMARDs). Jyseleca may be used as monotherapy or in combination with methotrexate (MTX)….The EC’s decision is supported by data from over 3,500 patients treated with Jyseleca across the Phase 3 FINCH and Phase 2 DARWIN programs….’We look forward to bringing this important treatment to physicians and patients across Europe as quickly as possible.'”

 

Ayvakit (avapritinib) / Blueprint Medicines
Blueprint Medicines Announces European Commission Approval of AYVAKYT (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA D842V Mutant Gastrointestinal Stromal Tumors (Blueprint Medicines Press Release) – Sep 25, 2020 – “Blueprint Medicines Corporation…announced that the European Commission (EC) has granted conditional marketing authorization to AYVAKYT® (avapritinib) as a monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring the platelet-derived growth factor receptor alpha (PDGFRA) D842V mutation. For the first time in Europe, there is an approved therapy for patients with PDGFRA D842V mutant GIST specifically designed to target the underlying molecular driver of their disease. The EC approval is based on efficacy results from the Phase 1 NAVIGATOR trial as well as combined safety results from the NAVIGATOR and Phase 3 VOYAGER trials.”

 

Abilify Maintena (aripiprazole depot formulation) / Otsuka, Lundbeck
Otsuka’s ABILIFY MAINTENA approved for the additional indication of bipolar I disorder in Japan (Otsuka Press Release) – Sep 25, 2020 – “Otsuka Pharmaceutical Co., Ltd. announces that it has received regulatory approval in Japan for the additional indication of suppression of recurrence and relapse of mood episodes in bipolar I disorder for ABILIFY MAINTENA (aripiprazole), a long-acting injectable suspension. The approved indication covers the 300 mg and 400 mg vials (for injection) and the 300 mg and 400 mg dual-chamber syringes…”

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Daily Top News – September 24, 2020

September 24, 2020

Zercepac (trastuzumab biosimilar) / Fosun Pharma, Intas
Accord Healthcare Launches Zercepac (trastuzumab) biosimilar in the UK (PRNewswire) – Sep 24, 2020 – “Accord Healthcare (Accord) today announced the launch of Zercepac® (trastuzumab) as a biosimilar of the reference product Herceptin®, in the UK, following approval by the European Commission in July 2020….Zercepac is indicated for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer…will be available in a 150mg single-dose vial.”

 

DKN-01 / Eli Lilly, Leap Therap
Leap Therapeutics Announces FDA Fast Track Designation Granted to DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer (PRNewswire) – Sep 24, 2020 – “Leap Therapeutics, Inc…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy.”

 

Orkambi (lumacaftor/ivacaftor) / Vertex; Trikafta (elexacaftor/tezacaftor/ivacaftor) / Vertex; Kalydeco (ivacaftor) / Vertex
Vertex to Present New Data at European and North American Virtual Cystic Fibrosis Conferences Highlighting Long-Term Use of CFTR Modulators (Businesswire) – Sep 24, 2020 – “An oral presentation at the ECFS Digital Conference will highlight, for the first time, interim results from the TRIKAFTA open-label extension study, which showed safety and efficacy consistent with the results of the Phase 3 pivotal studies in patients with CF ages 12 and older…Four additional scientific abstracts for ORKAMBI® and TRIKAFTA® were published in the Journal of Cystic Fibrosis as part of the ECFS conference. In addition, six scientific presentations will occur at NACFC regarding KALYDECO,® ORKAMBI and TRIKAFTA, including new data from KALYDECO in infants ages 4 to less than 6 months old.”

 

meloxicam/rizatriptan (AXS-07) / Axsome Therap
Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine (GlobeNewswire) – Sep 24, 2020 – P3, N=1,594; MOMENTUM (NCT03896009); Sponsor: Axsome Therapeutics, Inc.; “Axsome Therapeutics, Inc….today announced that AXS-07…rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial. These findings were presented at the live sessions of the 2020 American Academy of Neurology (AAN) Science Highlights platform held virtually September 23-24….AXS-07 demonstrated faster and more durable relief of migraine pain as compared to rizatriptan. The probability of achieving pain relief with AXS-07 was greater than with rizatriptan within 30 minutes after dosing and at every time point thereafter, with a median time to migraine pain relief that was nearly 3x faster for AXS-07 compared to rizatriptan (1.5 vs. 4.0 hours, p<0.001).”

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Daily Top News – September 23, 2020

September 23, 2020

aviptadil intravenous (RLF-100 IV) / Relief Therap, NeuroRx
Relief partner NeuroRx submits request for Emergency Use Authorization for RLF-100 (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy (PharmiWeb) – Sep 23, 2020 – P=NA, N=51; SAMICARE (NCT04453839); Sponsor: NeuroRx, Inc.; “…NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments….The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces the launch of ILUMYA (tildrakizumab) for treatment of Plaque Psoriasis in Japan (Equitybulls) – Sep 23, 2020 – “Sun Pharmaceutical…today announced that its wholly-owned Japanese subsidiary has launched ILUMYA® Subcutaneous Injection 100 mg Syringe (Nonproprietary name: tildrakizumab (genetical recombination), ‘ILUMYA’) in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies.”

 

Xalkori (crizotinib) / Pfizer
FDA Accepts Supplemental New Drug Application for Pfizer’s XALKORI (crizotinib) for the Treatment of Pediatric ALK-positive Anaplastic Large Cell Lymphoma (Businesswire) – Sep 23, 2020 – “Pfizer Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application(sNDA)for XALKORI® (crizotinib) for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive…The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is January 2020…The FDA submission is supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588)….This FDA submission is in addition to the European Medicines Agency’s agreement on a Pediatric Investigational Plan (PIP) for XALKORI including the treatment of pediatric patients with relapsed or refractory systemic ALK-positive ALCL.”

 

Zynteglo (betibeglogene autotemcel) / bluebird bio
bluebird bio’s LentiGlobin for Sickle Cell Disease Gene Therapy (bb1111) Granted Priority Medicines (PRIME) Designation by European Medicines Agency (Businesswire) – Sep 23, 2020 – “bluebird bio, Inc….announced today that its investigational treatment for sickle cell disease (SCD), LentiGlobin™ for SCD gene therapy (bb1111), was granted eligibility to the Priority Medicines (PRIME) program by the European Medicines Agency (EMA)….Clinical data from the completed Phase 1/2 HGB-205 study, the ongoing Phase 1/2 HGB-206 study and ongoing long-term safety and efficacy follow-up study LTF-303 supported the PRIME application for LentiGlobin for SCD.”

 

Epidiolex (cannabidiol) / GW Pharma
GW Pharmaceuticals receives Australian Therapeutic Goods Administration (TGA) approval for EPIDYOLEX (cannabidiol) for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy (GlobeNewswire) – Sep 23, 2020 – “GW Pharmaceuticals plc…today announces that the Australian Therapeutic Goods Administration (TGA) has approved EPIDYOLEX® (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age and older….The approval of GW’s cannabidiol is based on results from four randomised, controlled Phase 3 trials. These studies incorporate data from more than 714 patients with either LGS or Dravet syndrome, two rare forms of epilepsy with high morbidity and mortality rates, which place a significant burden on families and caregivers.”

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Daily Top News – September 22, 2020

September 22, 2020

bimekizumab (UCB4940) / UCB
UCB Achieves Important Regulatory Milestone for Bimekizumab (UCB Press Release) – Sep 22, 2020 – “UCB…today announced that the FDA and EMA have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis; This accepted submission is supported by a robust data package including three Phase 3 studies which demonstrate superiority of bimekizumab to placebo, Stelara[®] (ustekinumab) and Humira[®] (adalimumab) in achieving skin clearance at week 16.”

 

CTX001 / Vertex, CRISPR Therap, Molecular Templates
CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001 for the Treatment of Sickle Cell Disease (GlobeNewswire) – Sep 22, 2020 – “CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001™ for the Treatment of Sickle Cell Disease (SCD)….PRIME designation was granted based on clinical data from CRISPR and Vertex’s ongoing Phase 1/2 trial of CTX001 in patients with severe SCD.”

 

ifenprodil (NP-120) / Algernon Pharma
Algernon Announces 50% Enrollment in Multinational 2b/3 Human Study of Ifenprodil for Treatment of COVID-19 (GlobeNewswire) – Sep 22, 2020 – “Algernon Pharmaceuticals Inc….is pleased to announce that it has now enrolled 75 patients, which is 50% of its enrollment target, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The Company is now projecting that the study will be completed in November 2020 with a planned data readout before the end of Q4, 2020.”

 

Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research Institute
India trials for Russia’s ‘Sputnik-V’ vaccine could start in next few weeks: exec (Reuters) – Sep 22, 2020 – “Dr Reddy’s Laboratories Ltd could begin late-stage Indian clinical trials of Russia’s potential coronavirus vaccine in the next few weeks….Indian trials of the Sputnik-V vaccine candidate…will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country….Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India….The RDIF has also reached agreements with Indian manufacturers to produce 300 million doses of the shot in India.”

 

idecabtagene vicleucel (bb2121) / bluebird bio, BMS
U.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) (Businesswire) – Sep 22, 2020 – “Bristol Myers Squibb…and bluebird bio, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review their Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2021…The BLA is based on results from the pivotal Phase 2 KarMMa study…”

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Weekly Top News – Ovarian Cancer – September 21, 2020

September 21, 2020

Rubraca (rucaparib) / Clovis
New Data Presented at ESMO Virtual Congress 2020 Highlight Breadth and Potential of Clovis Oncology Products and Pipeline (Businesswire) – Sep 17, 2020 – P3, N=564; ARIEL3 (NCT01968213); Sponsor: Clovis Oncology, Inc; “After two years of additional follow up for those patients who continued on treatment in the study, the safety profile remains consistent with previous reports, with no new safety signals identified. As of the current safety data cutoff (December 31, 2019), 33 of 372 and 1 of 189 patients in the safety population were still receiving Rubraca or placebo, respectively. Median treatment duration was 8.3 months in the Rubraca arm and 5.5 months in the placebo arm….The median duration of the first event of frequently reported TEAEs was generally <60 days.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
Phase 3 NORA data of ZEJULA (niraparib) demonstrate significant PFS benefit, regardless of biomarker status, with an improved safety profile when given with individualized starting dose regimen in Chinese women with platinum-sensitive recurrent ovarian cancer (GlobeNewswire) – Sep 19, 2020 – P3, N=553; NORA (NCT03709316); Sponsor: Zai Lab (Shanghai) Co., Ltd; “Niraparib treatment resulted in a 68% reduction in the risk of disease progression or death in the overall population (PFS HR 0.32; 95% CI, 0.23–0.45; p<0.0001). The median progression-free survival (PFS) was significantly longer for patients treated with niraparib compared to placebo: 18.3 months (95% CI, 10.9–not evaluable) versus 5.4 months (95% CI, 3.7–5.7). PFS in gBRCA mutation subgroup: HR 0.22; 95%CI, 0.12-0.39; p<0.0001. PFS in non-gBRCA mutation subgroup: HR 0.40; 95%CI, 0.26-0.61; p<0.0001…Grade≥3 hematological adverse events of neutrophil count decrease, anemia, and platelet count decrease in patients treated with niraparib versus placebo were 20.3% vs. 8.0%, 14.7% vs. 2.3%, and 11.3% vs. 1.1%, respectively.”

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda
European advisory group backs expanded use of Glaxo’s Zejula (SeekingAlpha) – Sep 18, 2020 – “The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending approval of GlaxoSmithKline’s (GSK +0.0%) Zejula (niraparib) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemo.”

 

Rubraca (rucaparib) / Clovis
Rucaparib: “All patients in the rucaparib arm and 182/189 (96.3%) patients in the placebo arm experienced ≥1 TEAE“; Ovarian cancer (Clovis Oncology) – Sep 19, 2020 – ESMO 2020: “Grade ≥3 TEAEs were reported by 231/372 (62.1%) patients in the rucaparib arm and 31/189 (16.4%) patients in the placebo arm, Grade 4 TEAEs were reported by 28/372 (7.5%) and 2/189 patients (1.1%) in the rucaparib and placebo arms, respectively. The most frequent grade 4 TEAEs in the rucaparib arm were neutropenia/ decreased neutrophils and thrombocytopenia/decreased platelets (7/372 patients [1.9%] each)” 
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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 (olaparib) Improved Median Progression-Free Survival to Over Four and a Half Years Compared to 13.8 Months with Placebo for Patients with BRCA-Mutated Advanced Ovarian Cancer (Businesswire) – Sep 18, 2020 – P3, N=450; SOLO-1 (NCT01844986); Sponsor: AstraZeneca; “Five-year follow-up data from the Phase 3 SOLO-1 trial showed LYNPARZA reduced the risk of disease progression or death by 67% (HR 0.33 [95% CI 0.25–0.43]), and improved median PFS to 56 months vs. 13.8 months for placebo. At five years, 48.3% of patients treated with LYNPARZA remained free from disease progression vs. 20.5% on placebo. The median duration of treatment with LYNPARZA was 24.6 months vs. 13.9 months with placebo. Median follow-up in the LYNPARZA arm was 4.8 years and 5 years for placebo. The safety profile of LYNPARZA was consistent with previous observations in SOLO-1. The most common adverse reactions (ARs) ≥20% were nausea (77%), fatigue/asthenia (63%), vomiting (40%), anemia (39%) and diarrhea (34%).”

 

Imfinzi (durvalumab) / AstraZeneca; Zepzelca (lurbinectedin) / PharmaMar, Jazz; Opdivo (nivolumab) / Ono Pharma, BMS
PharmaMar will present data for Zepzelca (lurbinectedin) and Yondelis (trabectedin) at ESMO 2020 (Pharmamar Press Release) – Sep 14, 2020 – “At the European Society of Medical Oncology (ESMO) Congress, which will be held virtually from 17th to 19th of September, PharmaMar (MSE:PHM) will present data on lurbinectedin in second-line SCLC patients who had received previous platinum-based chemotherapy and relapsed 90 and 180 days after its completion and therefore, being candidates for platinum rechallenge. Phase I results for lurbinectedin in Japanese patients with previously treated advanced Solid Tumours, will also be presented. Results of trabectedin in combination with immunotherapy (durvalumab) in pretreated patients with advanced Soft-Tissue Sarcomas, will be presented at an oral session. In addition, results of Yondelis® (trabectedin) in combination with immunotherapy (nivolumab) for the treatment of Soft-Tissue Sarcoma, as well as results of trabectedin in combination with doxorubicin (PLD) for the treatment of Recurrent Ovarian Cancer, will be presented.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca
‘OLAP’ (OLAparib Regulatory Post-marketing Surveillance) (clinicaltrials.gov) – Sep 18, 2020 – P; N=600; Not yet recruiting; Sponsor: AstraZeneca

 

Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; dostarlimab (TSR-042) / GSK
GSK highlights scientific advances across its growing oncology portfolio at ESMO Virtual Congress 2020 (PRNewswire) – Sep 15, 2020 – “GSK presentations at ESMO will focus on research intended to improve outcomes for women with high unmet medical needs, including data related to the safety and efficacy of ZEJULA in patients with advanced, recurrent or resistant ovarian cancer. Investigators also will present a late-breaking presentation: ‘Safety and Antitumor Activity of Dostarlimab in Patients (Pts) with Advanced or Recurrent DNA Mismatch Repair Deficient (dMMR) or Proficient (MMRp) Endometrial Cancer (EC): Results from GARNET.'”

 

ALKS 4230 / Alkermes; Keytruda (pembrolizumab) / Merck (MSD)
Alkermes Presents New Clinical Data on ALKS 4230 in Mini Oral Presentation at 2020 European Society for Medical Oncology (ESMO) Virtual Congress (PRNewswire) – Sep 18, 2020 – P1/2, N=347; ARTISTRY-1 (NCT02799095); Sponsor: Alkermes, Inc; “Data presented at ESMO from the combination stage of ARTISTRY-1…Of these 5 patients: One patient with platinum-resistant ovarian cancer achieved a complete response (CR) by week 45 of treatment, and a deepening of response was observed through week 81 of treatment. As of the data cut, this patient had a durable, confirmed CR and had remained on treatment for more than 18 months. Two other patients with platinum-resistant ovarian cancer achieved PRs, one confirmed and one unconfirmed. As of the data cut, the patient with the confirmed PR demonstrated a deepening of response and had remained on treatment for more than 5 months. Other tumor types Additional PRs were achieved in multiple other tumor types across the PD-1/L1 approved and unapproved cohorts, including one patient with triple-negative breast cancer and two patients with esophageal cancer (one of which is awaiting confirmation).”

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