The Digest

Pharma news roundup and Larvol updates

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The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – Breast Cancer – June 24, 2019

June 24, 2019

docetaxel / generics; carboplatin / generics
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer (clinicaltrials.gov) – Jun 18, 2019 – P3; N=580; Recruiting; Sponsor: Shanghai Institute Of Biological Products

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201 China launch estimate: By 2021 (Deutsche Bank Research) – Jun 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67458052; Page no: 1; REPORT TITLE: “China watch P322: Takeaways from ASCO – Pyrotinib, enjoy while you can”; AUTHOR: Hu, Jack, et al; DATE: 06/06/2019

 

Talzenna (talazoparib) / Pfizer
European Commission approves Talzenna (talazoparib) for patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (Businesswire) – Jun 21, 2019 – “Pfizer Inc…today announced that the European Commission approved TALZENNA®(talazoparib)…as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy…The European Commission’s approval of TALZENNA…is based on results from the EMBRACA trial…”

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from KEYNOTE-242 trial for adjuvant TNBC in 2026 or later (Merck (MSD)) – Jun 21, 2019 – Investor Day: Data from P3 KEYNOTE-630 trial (NCT03833167) for high-risk locally advanced cutaneous squamous cell carcinoma in 2026 or later

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from P3 KEYNOTE-412 trial (NCT03040999) for locally advanced HNSCC in 2023 (Merck (MSD)) – Jun 21, 2019 – Investor Day: Data from P3 KEYNOTE-756 trial (NCT03725059) for ER+/HER2- breast cancer in 2026 or later

 

HLX02 (trastuzumab biosimilar) / Fosun Pharma
European Medicines Agency accepted first “China-developed” biosimilar – Henlius HLX02 Marketing Authorization Application for review (PRNewswire) – Jun 21, 2019 – “Henlius…announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02….HLX02 is indicated for human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer, HER2+ metastatic breast cancer, and untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer.”

 

Halaven (eribulin mesylate) / Eisai
Eisai’s breast cancer treatment Halaven enters Peru (GBI Health) – Jun 20, 2019 – “Uruguay-based Biotoscana this week obtained clearance from Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) to market Japan-based Eisai’s microtubule inhibitor Halaven (eribulin mesylate), GBI analysis reveals. While the agency does not disclose approved indications, the drug is developed as a treatment for metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens.”

 

Rozlytrek (entrectinib) / Roche
Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek (Roche Press Release) – Jun 18, 2019 – “Roche…announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours…Rozlytrek is also undergoing regulatory review in Japan for the treatment of people with ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer….The data package for this first approval of Rozlytrek includes the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, as well as data from the Phase I/II STARTRK-NG study in paediatric patients.”

 

Verzenio (abemaciclib) / Eli Lilly
proMONARCH: A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer (clinicaltrials.gov) – Jun 17, 2019 – P4; N=650; Not yet recruiting; Sponsor: Eli Lilly and Company

 

ORIN1001 / Fosun Pharma
Breast cancer drug gets FDA’s fast-track treatment (China Daily) – Jun 17, 2019 – “Shanghai Fosun Pharmaceutical Group Co Ltd announced on Sunday its experimental drug ORIN1001 has received fast-track designation from the US Food and Drug Administration for the treatment of patients with relapsed, refractory and metastatic breast cancer, including triple-negative breast cancer, or TNBC.”

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Weekly Top News – IBD – June 24, 2019

June 24, 2019

filgotinib (GLPG0634) / Gilead
Filgotinib launch estimate: 2023/2024 for Crohn’s disease in US/EU (J.P. Morgan) – Jun 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67468537; Page no: 4; REPORT TITLE: “Galapagos NV: Filgotinib US filing scenario analysis suggests balanced risk/ reward into FDA pre-filing discussions”; AUTHOR: Quigley, James, et al; DATE: 06/09/2019

 

etrasimod (APD334) / Arena
ELEVATE UC 12: Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Jun 24, 2019 – P3; N=330; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

etrasimod (APD334) / Arena
Etrasimod launch estimate: 2022 for ulcerative colitis (RBC Capital Markets (Canada)) – Jun 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67280044; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals, Inc. – Q1:19 post-call: Etras’ Ph3 takes focus with ARNA estimates a year ahead of ours”; AUTHOR: Mackay, Kennen, et al; DATE: 05/08/2019

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals announces first subject dosed in ELEVATE UC 52 global phase 3 trial evaluating etrasimod in ulcerative colitis (Arena Press Release) – Jun 17, 2019 – “Arena…today announced that the first subject has been dosed in ELEVATE UC 52, the first of two pivotal trials within the Phase 3 ELEVATE UC registrational program evaluating etrasimod 2 mg in subjects with moderately to severely active ulcerative colitis (UC). ELEVATE UC 52 is a treat-through trial with a 12-week induction period followed by 40 weeks of maintenance.”

 

Entyvio SC (vedolizumab SC) / Takeda
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn’s Disease (clinicaltrials.gov) – Jun 17, 2019 – P3; N=644; Completed; Sponsor: Takeda; Active, not recruiting –> Completed; Trial completion date: Dec 2019 –> May 2019

 

vidofludimus (IMU-838) / Immunic
Immunic, Inc. to present previously unpublished data regarding lead program, IMU-838, at the GI Inflammatory Diseases Summit in Boston (PRNewswire) – Jun 24, 2019 – “Immunic…announced that Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present today previously unpublished data regarding the company’s lead program, IMU-838, at the GI Inflammatory Diseases Summit (GIIDS) in Boston….Preclinical data shows that IMU-838 appears selective towards those T cells producing high amounts of the pro-inflammatory cytokines, IFNγ and IL-17….In a phase 2a clinical study in steroid dependent UC and Crohn’s disease patients, the active moiety of IMU-838 (vidofludimus) has shown activity in the ability to wean off steroids, with a total response rate of 88.5%.”

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Weekly Top News – Psoriasis – June 24, 2019

June 24, 2019

ANB019 / AnaptysBio
ANB019: Top-line data from P2 GALLOP trial (NCT03619902) for generalized pustular psoriasis in mid-2019 (Jefferies 2019 Healthcare Conference, AnaptysBio) – Jun 19, 2019

 

MP1032 / MetrioPharm
Last patient last visit in MetrioPharm’s phase II clinical trial in psoriasis (MetrioPharm Press Release) – Jun 17, 2019 – “MetrioPharm AG, a pharmaceutical development company, announces that the last patient was now examined during the currently ongoing clinical psoriasis Phase II study (Last Patient Last Visit)….The team at MetrioPharm is now awaiting the validation of the data. Afterwards we will immediately start the data analysis. We are expecting the study’s final results within the next few months.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $25M (consensus: $10M) for Q2 2019 and $215M (consensus: $147M) for FY2019 (UBS) – Jun 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67498196; Page no: 1; REPORT TITLE: “AbbVie Inc – First read: AbbVie “Weekly Skyrizi tracker” (neutral) Jacob”; AUTHOR: Jacob, Navin, et al; DATE: 06/14/2019

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – Jun 17, 2019 – P3; N=150; Recruiting; Sponsor: AbbVie; Trial primary completion date: Dec 2019 –> Apr 2020

 

Otezla (apremilast) / Celgene
Otezla share value: $15/share to Celgene (Barclays) – Jun 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67458401; Page no: 3; REPORT TITLE: ” CELG/BMY – Thoughts on ozanimod NDA acceptance”; AUTHOR: Meacham, Geoffrey, et al; DATE: 06/06/2019

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
EULAR data will support new indication for brodalumab (The Pharma Letter) – Jun 17, 2019 – Subscription required

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Weekly Top News – Psoriasis – June 17, 2019

June 17, 2019

benvitimod (GSK2894512) / Roivant
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002) (clinicaltrials.gov) – Jun 12, 2019 – P3; N=500; Recruiting; Sponsor: Dermavant Sciences GmbH

 

Taltz (ixekizumab) / Eli Lilly
Lilly to present 5-year sustained efficacy and safety results for Taltz (ixekizumab) in patients with plaque psoriasis at the World Congress of Dermatology (Eli Lilly Press Release) – Jun 11, 2019 – “Eli Lilly and Company…announced today the company will present positive, five-year Phase 3 data for Taltz® (ixekizumab). Patients with moderate- to severe plaque psoriasis who continued to receive Taltz maintained high levels of skin clearance with no unexpected safety outcomes…will be presented at the World Congress of Dermatology (WCD) in Milan, Italy on June 11….Four-year data from UNCOVER-3 will also be presented at the WCD….Later this year, Lilly plans to announce the results from IXORA-R, a clinical trial designed to evaluate superiority between Taltz and Tremfya® (guselkumab) in adult patients with moderate- to severe plaque psoriasis.”

 

Cosentyx (secukinumab) / Novartis
FUTURE 2: Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis (clinicaltrials.gov) – Jun 12, 2019 – P3; N=399; Completed; Sponsor: Novartis Pharmaceuticals; Active, not recruiting –> Completed; Trial primary completion date: May 2014 –> Jan 2019

 

Tremfya (guselkumab) / J&J
Janssen reports top-line phase 3 results for Tremfya (guselkumab) in adults with active psoriatic arthritis(Businesswire) – Jun 14, 2019 – P3, N=383, DISCOVER-1 (NCT03162796); P3, N=741; DISCOVER-2 (NCT03158285); Sponsor: Janssen Research & Development; “The Janssen Pharmaceutical…today announced top-line results from the Phase 3 DISCOVER 1 and 2 studies…in adult patients with active moderate to severe psoriatic arthritis (PsA). Both studies met their primary endpoints of American College of Rheumatology 20% improvement (ACR20), and the safety profiles observed for guselkumab in the DISCOVER programme were consistent…Data from the two DISCOVER studies will serve as the basis of submissions to the U.S. Food and Drug Administration and European Medicines Agency seeking approval of guselkumab as a treatment for psoriatic arthritis, which are anticipated for later this year.”

 

Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) vs. Humira (adalimumab) in a head-to-head (SPIRIT-H2H) superiority study in patients with active psoriatic arthritis at the European Congress of Rheumatology (Eli Lilly Press Release) – Jun 14, 2019 – P4, N=566; SPIRIT-H2H (NCT03151551); Sponsor: Eli Lilly and Company; Eli Lilly and Company…announced today that the company will present positive findings from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study in patients with active psoriatic arthritis (PsA) as a late-breaking abstract at the European Congress of Rheumatology (EULAR) in Madrid, Spain on June 15….The primary endpoint of the study was superiority for Taltz compared to Humira…achieved a reduction by at least 50 percent in disease activity as defined by the American College of Rheumatology (ACR50) and complete skin clearance as measured by the Psoriasis Area and Severity Index (PASI 100)….No new safety signals were detected.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
New two-year data at the 24th World Congress of Dermatology shows Skyrizi (risankizumab) maintains complete skin clearance (AbbVie Press Release) – Jun 11, 2019 – P3, N=507; IMMHance (NCT02672852); Sponsor: Abbvie; “AbbVie…today announced new results showing a significant number of patients treated with SKYRIZI™ (risankizumab) experienced complete skin clearance at week 94….These two-year results (up to 104 weeks) from the Phase 3 IMMhance study, evaluating the efficacy and safety of SKYRIZI in adult patients with moderate to severe psoriasis, will be presented today at the 24th World Congress of Dermatology (WCD) in Milan….No new safety findings observed at two years (104 weeks)…”

 

Cosentyx (secukinumab) / Novartis
Novartis Cosentyx first to show efficacy in all key manifestations of psoriatic arthritis (GlobeNewswire) – Jun 12, 2019 – P3b, N=502; MAXIMISE(NCT02721966); Sponsor: Novartis Pharmaceuticals; “Novartis…announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The ongoing 52-week Phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300 mg and 66.3% of Cosentyx 150 mg patients achieving ASAS20 at Week 12 (versus 31.3% for placebo) respectively. Rapid onset of relief was seen as early as week four, with the trial demonstrating a favorable safety profile consistent with previous clinical trials…These data…will be presented at the Annual European Congress of Rheumatology (EULAR) on 12-15 June in Madrid, Spain.”

 

pegcantratinib (SNA-120) / Bio3 Research, Sienna
SNA-120, A Novel Topical Non-steroidal Therapy for Psoriasis and Associated Pruritus that Targets the NGF/TrkA Pathway: Results from a Multicenter Phase 2b Study (WCD 2019) – Jun 10, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma announces late-breaking phase 2 data showing potential of Ilumya (tildrakizumab-asmn) to improve joint and skin symptoms of psoriatic arthritis (PRNewswire) – Jun 14, 2019 – “Sun Pharmaceutical…today announced interim results from a Phase 2 study of…ILUMYA (tildrakizumab-asmn) in patients with active psoriatic arthritis that was presented in a late-breaking oral presentation at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (abstract #LB-0002). The interim analysis revealed that over 71 percent of patients treated with ILUMYA™ experienced a 20 percent improvement in joint and skin symptoms (ACR20), meeting the primary endpoint of the study….We are now exploring a possible Phase 3 trial for psoriatic arthritis with regulatory authorities.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx provides long lasting inhibition of radiographic progression in psoriatic arthritis, new Novartis data show (GlobeNewswire) – Jun 12, 2019 – P3, N=998; FUTURE 5 (NCT02404350); Sponsor: Novartis Pharmaceuticals; “Novartis…announced today new data from the FUTURE 5 trial showing no radiographic progression (mTSS)

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Weekly Top News – IBD – June 17, 2019

June 17, 2019

Entyvio (vedolizumab) / Takeda
Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitis (clinicaltrialsregister.eu) – Jun 16, 2019 – P3; N=292; Sponsor: Takeda

 

Entyvio (vedolizumab) / Takeda
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn’s Disease (clinicaltrials.gov) – Jun 12, 2019 – P3; N=157; Completed; Sponsor: Takeda; Active, not recruiting –> Completed

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi sales projection: $150M in H2 2019 (Zacks) – Jun 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67443474; Page no: 6; REPORT TITLE: “AbbVie Inc.(ABBV) Zacks Company report”; AUTHOR: Research Department; DATE: 06/03/2019

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz US sales projection: $2.7B in 2024 (Infinata) – Jun 15, 2019 – A subscription to Thomson ONE is required to gain full access to report 67021619; Page no: 10; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 06/03/2019

 

Humira (adalimumab) / Eisai, AbbVie
Humira sales projection: Guidance of $21B in 2020 (Credit Suisse) – Jun 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67443417; Page no: 16; REPORT TITLE: “US Pharmaceuticals industry overview – June 2019”; AUTHOR: Divan, Vamil, et al; DATE: 06/03/2019

 

ozanimod (RPC1063) / Celgene
Ozanimod sales projection: $1.8B (consensus: $1.3B) by 2023 (Barclays) – Jun 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67458401; Page no: 1; REPORT TITLE: “CELG/BMY – Thoughts on Ozanimod NDA acceptance”; AUTHOR: Meacham, Geoffrey, et al; DATE: 06/06/2019

 

Perianal Fistula (PAF) Validation and Burden of Illness Study (clinicaltrials.gov) – Jun 12, 2019 – P; N=600; Not yet recruiting; Sponsor: Takeda

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