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 – Psoriasis – May 6, 2019

May 6, 2019

Psoriasis

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
European Commission approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis (AbbVie Press Release) – Apr 30, 2019 – “AbbVie…today announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SKYRIZI (150 mg) is approved to be administered by two subcutaneous injections every 12 weeks…This approval allows for the marketing of SKYRIZI in all member states of the European Union, as well as Iceland, Liechtenstein and Norway….SKYRIZI received EC approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Long-term safety of tildrakizumab in patients with moderate-to-severe psoriasis: incidence of major adverse cardiovascular events through 148 weeks from reSURFACE 1 and reSURFACE 2 phase 3 trials (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 03:10 PM – 03:20 PM; Location: BROWN 3; No abstract available.

 

Otezla (apremilast) / Celgene
A Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy (clinicaltrials.gov) – Apr 29, 2019 – P3b; N=150; Not yet recruiting; Sponsor: Celgene

 

bimekizumab (UCB4940) / UCB
BE COMPLETE: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – Apr 30, 2019 – P3; N=390; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Not yet recruiting –> Recruiting

 

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) – May 3, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.

 

Otezla (apremilast) / Celgene
DISCREET: An Efficacy and Safety Study of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis (clinicaltrials.gov) – May 1, 2019 – P3; N=332; Recruiting; Sponsor: Celgene; Not yet recruiting –> Recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab is Associated With Low and Consistent Infection Rates in Patients With Moderate-to-Severe Psoriasis: Analysis of Short-Term and Long-Term Pooled Clinical Trial Data (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 02:50 PM – 03:00 PM; Location: BROWN 3; No abstract available.

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Skyrizi pricing: Wholesales acquisition cost of $59,000/year for maintenance dose and $88,500/year for therapy of new patients (UBS) – May 2, 2019 – A subscription to Thomson ONE is required to gain full access to report 67166772; Page no: 1; REPORT TITLE: “AbbVie Inc.- First read: AbbVie “Skyrizi approval is incrementally positive; Clean …”; AUTHOR: Jacob, Navin, et al; DATE: 04/23/2019

 

mirikizumab (LY3074828) / Eli Lilly
Improvement in Psoriasis Scalp Severity Index (PSSI) during Maintenance Treatment with Mirikizumab (WCD 2019) – May 3, 2019 – Pres time: Jun 12, 2019; 03:50 PM – 04:00 PM; Location: BROWN 3; No abstract available.

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Weekly Top News – Breast Cancer – April 29, 2019

April 29, 2019

Faslodex (fulvestrant) / AstraZeneca; SHR6390 / Jiangsu Hengrui Medicine

A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (clinicaltrials.gov) – Apr 25, 2019 – P3; N=288; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P3 trial

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive, unresectable and/or metastatic breast cancer in 2020 or later (AstraZeneca) – Apr 26, 2019 – Q1 2019 Results: Data from P3 DESTINY-Breast04 trial (NCT03734029) for HER2-low, unresectable and/or metastatic breast cancer in 2020 or later
P3 data
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Regulatory submission in US for HER2 positive metastatic breast cancer in H1 FY 2019 (Daiichi Sankyo) – Apr 26, 2019 – FY 2018 Results: Regulatory submissions in Japan for HER2 positive metastatic breast cancer in H2 FY 2019, EU in H1 FY 2020
BLA • European regulatory • Japanese regulatory
[Screenshot]

 

Talzenna (talazoparib) / Pfizer

Pfizer receives positive CHMP opinion for Talzenna (talazoparib) for patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (Pfizer Press Release) – Apr 26, 2019 – “Pfizer Inc….announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA® (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU). The indication the CHMP adopted is for TALZENNA 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)….The Marketing Authorization Application was submitted based on results from the EMBRACA trial, the largest Phase 3 trial performed to date of a PARP inhibitor in patients with gBRCA-mutated LA or MBC.”
European regulatory

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Approval and launch in US/EU/Japan/Asia for HER2 positive breast cancer in FY 2020 (Daiichi Sankyo) – Apr 26, 2019 – FY 2018 Results
BLA • European regulatory • Japanese regulatory • Launch Europe • Launch Japan • Launch non-US • Launch US • Non-US regulatory
[Screenshot]

 

margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche

SOPHIA primary analysis: A phase 3 (P3) study of margetuximab (M) + chemotherapy (C) versus trastuzumab (T) + C in patients (pts) with HER2+ metastatic (met) breast cancer (MBC) after prior anti-HER2 therapies (Tx). (ASCO 2019) – Apr 26, 2019 – Abstract #1000; Pres time: Jun 4, 2019; 09:45 AM – 09:57 AM; Location: Hall D1; No abstract available.
Clinical • P3 data

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Acceptance of regulatory submission in US for HER2 positive metastatic breast cancer previously treated with T-DM1 (based on DESTINY-Breast01 trial) in H2 2019 (AstraZeneca) – Apr 26, 2019 – Q1 2019 Results
BLA
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Data from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer in H2 2019 (AstraZeneca) – Apr 26, 2019 – Q1 2019 Results: Data from P3 DESTINY-Breast02 trial (NCT03523585) for pre-treated HER2 breast cancer in 2020 or later
P2 data • P3 data
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo

DS-8201: Data presentation from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer at SABCS (December 10-14, 2019) (Daiichi Sankyo) – Apr 27, 2019 – FY 2018 Results
P2 data
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo; Keytruda (pembrolizumab) / Merck (MSD)

DS-8201 + Keytruda: Initiation of P1b trial for breast cancer in Q3 FY 2019 (Daiichi Sankyo) – Apr 26, 2019 – FY 2018 Results
New P1 trial
[Screenshot]

 

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Weekly Top News – IBD – April 29, 2019

April 29, 2019

mirikizumab (LY3074828) / Eli Lilly

VIVID-1: A Study of Mirikizumab (LY3074828) in Participants With Crohn’s Disease (clinicaltrials.gov) – Apr 24, 2019 – P3; N=1100; Not yet recruiting; Sponsor: Eli Lilly and Company
Clinical • New P3 trial

 

amiselimod (MT 1303) / Mitsubishi Tanabe, Bausch Health

Salix enters into exclusive license agreement with Mitsubishi Tanabe Pharma to develop and commercialize late stage investigational S1P modulator for the treatment of inflammatory bowel disease (PRNewswire) – Apr 25, 2019 – “Salix Pharmaceuticals…announced today that its affiliate has entered into an exclusive licensing agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) (TSE: 4508) to develop and commercialize MT-1303 (amiselimod), a late-stage oral compound that targets the sphingosine 1-phosphate (S1P) receptor that plays a role in autoimmune diseases, such as Inflammatory Bowel Disease (IBD) and ulcerative colitis.”
Licensing / partnership

 

Alofisel (darvadstrocel) / Takeda

Drugmaker Takeda to introduce value-based pricing in Europe (Nikkei) – Apr 29, 2019 – “Takeda is looking to adopt the pricing mechanism for a stem cell therapy called Alofisel for a complication of Crohn’s disease. Because of the complex production method that involves cell cultivation, the drug is expected to carry a price tag of an estimated 60,000 euros ($67,000)….The drug is expected to go on sale by the end of fiscal 2019 in the U.K. and elsewhere in Europe.”
Commercial • Pricing

 

Entyvio (vedolizumab) / Takeda

DEVELOPMENT AND VALIDATION OF A CLINICAL SCORING TOOL FOR PREDICTING TREATMENT OUTCOMES WITH VEDOLIZUMAB IN PATIENTS WITH ULCERATIVE COLITIS (DDW 2019) – Apr 24, 2019 – Abstract #334; Pres time: May 19, 2019; 10:15 AM – 10:30 AM; Location: Room: 30 – San Diego Convention Center; No abstract available.
Clinical

 

Humira (adalimumab) / Eisai, AbbVie

Drug Induced Renal Granulomatous Disease – poor outcone of a rare clinical condition (NKF-CSM 2019) – Apr 23, 2019 – Abstract #166; “…We report such a case of granulomatous interstitial nephritis in a patient with Crohn’s disease after being treated with Adalimumab for 8 months…She was treated with prednisone 1 mg/kg/day, however renal function continued to decline and dialysis was initiated as inpatient…Renal recovery following such insults have been historically mixed, even with appropriate use of steroids. As such, TNF-α inhibitors should be used with caution with frequent monitoring of kidney function.”
Clinical

 

Entyvio (vedolizumab) / Takeda

VEDOLIZUMAB TARGETS LYMPHOID AGGREGATES IN THE GASTROINTESTINAL TRACT OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE, REFLECTED BY A DRAMATIC DROP IN GUT-HOMING PLASMABLASTS IN CIRCULATION (DDW 2019) – Apr 24, 2019 – Abstract #335; Pres time: May 19, 2019; 10:30 AM – 10:45 AM; Location: Room: 30 – San Diego Convention Center; No abstract available.
Clinical

 

Remicade (infliximab) / Mitsubishi Tanabe, J&J

EARLY INFLIXIMAB PHARMACOKINETICS AND WEEK ONE CLINICAL RESPONSE IN PEDIATRIC ACUTE SEVERE ULCERATIVE COLITIS: THE ARCH STUDY (DDW 2019) – Apr 24, 2019 – Abstract #235; Pres time: May 19, 2019; 08:25 AM – 08:35 AM; Location: Room: 31BC – San Diego Convention Center; No abstract available.
Clinical • PK/PD data

 

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Weekly Top News – Psoriasis – April 29, 2019

April 29, 2019

BMS-986165 / BMS

An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis (clinicaltrials.gov) – Apr 23, 2019 – P3; N=80; Recruiting; Sponsor: Bristol-Myers Squibb
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis

Cosentyx: 5-year data from P3 FUTURE 2 trial (NCT01752634) for psoriatic arthritis at ACR (November 8-13, 2019) (Novartis) – Apr 24, 2019 – Q1 2019 Results: 2-year data from P3 FUTURE 5 trial (NCT02404350) for psoriatic arthritis at EULAR (June 12- 15, 2019)
P3 data
[Screenshot]

 

Eticovo (etanercept biosimilar) / Samsung, Merck (MSD), Ewopharma, Yuhan, Biogen

Samsung Bioepis wins FDA approval for biosimilar (Yonhap News Agency) – Apr 26, 2019 – “…Samsung Bioepis…has won approval from the U.S. Food and Drug Administration to sell one of its biosimilar in the United States. Etanercept — a biosimilar referencing the immunology drug Enbrel developed by U.S.-based Amgen Inc. — will be used in the treatment of rheumatoid arthritis and psoriatic arthritis, the company said in a press release. However, it is undecided yet when Etanercept will go on sale in the U.S. as the patent for Enbrel is to expire in 2029.”
BLA • Patent

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim

AbbVie expands immunology portfolio in the U.S. with FDA approval of Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis (PRNewswire) – Apr 23, 2019 – “AbbVie…announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy….The approval of SKYRIZI is supported by results from AbbVie’s global Phase 3 psoriasis program, which assessed the safety and efficacy of SKYRIZI in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent.”
BLA

 

Humira (adalimumab) / Eisai, AbbVie

The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis (clinicaltrials.gov) – Apr 25, 2019 – P3; N=330; Not yet recruiting; Sponsor: Sinocelltech Ltd.
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis

Cosentyx: Launch in China for psoriasis in H2 2019 (Novartis) – Apr 24, 2019 – Q1 2019 Results
Launch non-US
[Screenshot]

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin; Stelara (ustekinumab) / J&J

New data show that LEO Pharma’s Kyntheum (brodalumab) sustains PASI 100 scores longer than ustekinumab for people with moderate-to-severe plaque psoriasis (Businesswire) – Apr 25, 2019 – P3, N=1,831; AMAGINE-2 (NCT01708603); P3, N=1,881; AMAGINE-3 (NCT01708629); Sponsor: Amgen; “LEO Pharma…today announced that new data presented this week at the 6th Congress of the Skin Inflammation and Psoriasis International Network (SPIN) in Paris demonstrate that more patients with moderate-to-severe psoriasis who received treatment with brodalumab maintained a PASI (Psoriasis Area Severity Index) 100 score for longer than those who were treated with ustekinumab over 52 weeks.”
Retrospective data

 

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Weekly Top News – Breast Cancer – April 22, 2019

April 22, 2019

Kisqali (ribociclib) / Novartis
In-depth gene expression analysis of premenopausal patients with HR+/HER2 advanced breast cancer (ABC) treated with ribociclib-containing therapy in the Phase III MONALEESA-7 trial. (ASCO 2019) – Apr 21, 2019 – Abstract #1018; Pres time: Jun 2, 2019; 08:00 AM – 11:00 AM; Location: Poster Board: 99, Hall A; No abstract available.
Clinical • P3 data

 

Kadcyla (ado-trastuzumab emtansine) / Roche; Perjeta (pertuzumab) / Roche
A phase III study comparing trastuzumab emtansine with trastuzumab, pertuzumab, and docetaxel in elderly patients with advanced stage HER2-positive breast cancer: (JCOG1607 HERB TEA study). (ASCO 2019) – Apr 21, 2019 – Abstract #TPS1100; Pres time: Jun 2, 2019; 08:00 AM – 11:00 AM; Location: Poster Board: 181a, Hall A; No abstract available.
Clinical • P3 data

 

Afinitor (everolimus) / Novartis
Everolimus plus aromatase inhibitors vs aromatase inhibitors as maintenance therapy after first-line chemotherapy in HR+/HER2- metastatic breast cancer: final results of the Phase III randomized MAIN-A trial (ESMO-BC 2019) – Apr 18, 2019 – Abstract #LBA2; Pres time: May 3, 2019; 05:30 PM – 05:45 PM; Location: Maritim Hall; No abstract available.
Clinical • Late-breaking abstract • P3 data

 

Herceptin (trastuzumab) / Roche; Perjeta (pertuzumab) / Roche
End-of-study analysis from the phase III, randomized, double-blind, placebo (Pla)-controlled CLEOPATRA study of first-line (1L) pertuzumab (P), trastuzumab (H), and docetaxel (D) in patients (pts) with HER2-positive metastatic breast cancer (MBC). (ASCO 2019) – Apr 21, 2019 – Abstract #1020; Pres time: Jun 2, 2019; 08:00 AM – 11:00 AM; Location: Poster Board: 101, Hall A; No abstract available.
Clinical • P3 data

 

cisplatin/vinblastine formulation with cell penetration enhancer (INT230-6) / Intensity Therap
Intensity Therapeutics receives Fast Track Designation from U.S. FDA for development of INT230-6 as treatment for relapsed or metastatic triple negative breast cancer (GlobeNewswire) – Apr 17, 2019 – “Intensity Therapeutics…announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s development program evaluating INT230-6 for the treatment of patients with relapsed or metastatic triple negative breast cancer (TNBC) who have failed at least two prior lines of therapy….’we look forward to working closely with the FDA this year to initiate a Phase 2 clinical study for this indication.’”
Fast track designation • New P2 trial

 

Ibrance (palbociclib) / Pfizer
ROIS: UK Ibrance Patient Program (IPP) Study (clinicaltrials.gov) – Apr 19, 2019 – P; N=250; Not yet recruiting; Sponsor: Pfizer
Clinical • New trial

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