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Month: April 2019

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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Weekly Top News – IBD – April 22, 2019

April 22, 2019

etrolizumab (RG7413) / Roche
Etrolizumab: NME submission for ulcerative colitis in US in 2021 (Roche) – Apr 17, 2019 – Q1 2019 Results: Regulatory submission for ulcerative colitis in EU in 2021; Regulatory submissions for Crohn’s disease in US and EU in 2022 or later
BLA • European regulatory
[Screenshot]

 

TD-1473 / J&J
TD-1473 clinical estimate: Data from P2b/3 RHEA trial (NCT03758443) for ulcerative colitis in 2020 (Cantor Fitzgerald) – Apr 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67081612; Page no: 1; REPORT TITLE: “Theravancer Biopharma Inc – Don’t get JAK’d, invest in the right one”; AUTHOR: Research Department; DATE: 04/09/2019
P2/3 data

 

TD-1473 / J&J
TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study (clinicaltrials.gov) – Apr 18, 2019 – P2/3; N=500; Not yet recruiting; Sponsor: Theravance Biopharma
Clinical • New P2/3 trial

 

ozanimod (RPC1063) / Celgene
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – Apr 16, 2019 – P2/3; N=195; Not yet recruiting; Sponsor: Celgene
Clinical • New P2/3 trial

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2 Divergence2 trial (NCT03077412) for Crohn’s disease in mid-2019 (RBC Capital Markets (Canada)) – Apr 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67047741; Page no: 2; REPORT TITLE: “Galapagos NV – Takeaways from the road: High aspirations following FINCH data”; AUTHOR: Abrahams, Brian, et al; DATE: 04/04/2019
P2 data

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2 trial (NCT03046056) for small bowel Crohn’s disease in mid-2019 (RBC Capital Markets (Canada)) – Apr 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67047741; Page no: 2; REPORT TITLE: “Galapagos NV – Takeaways from the road: High aspirations following FINCH data”; AUTHOR: Abrahams, Brian, et al; DATE: 04/04/2019
P2 data

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Expanded Access to Risankizumab (clinicaltrials.gov) – Apr 16, 2019 – P; N=N/A; Available; Sponsor: AbbVie
New trial

 

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Weekly Top News – Psoriasis – April 22, 2019

April 22, 2019

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Health Canada approves Skyrizi (risankizumab) for the treatment of moderate to severe plaque psoriasis (Canada Newswire) – Apr 18, 2019 – “AbbVie…announced today that Health Canada has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy….SKYRIZI received Health Canada approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.”
Canadian regulatory

 

KD025  / Kadmon
KD025 US launch estimate: 2021 in plaque psoriasis (Jefferies) – Apr 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 66898956; Page no: 4; REPORT TITLE: “Kadmon Holdings Inc – Q4 ’18: Pivotal study readout for KD025 in cgvhd expected at YE ’19”; AUTHOR: Amin, Biren, et al; DATE: 03/08/2019
Launch US

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
NICE publishes final recommendation for Ilumetri (Pharmafield) – Apr 17, 2019 – “NICE has published final recommendation for ILUMETRI (Tildrakizumab), as a cost-effective option for adults with moderate-to-severe plaque psoriasis.”
NICE

 

Tremfya (guselkumab) / J&J
A brighter future for psoriasis patients in Egypt (Egypt Today) – Apr 15, 2019 – “Ministry of health approved the first biological treatment of moderate to severe plaque psoriasis patients….Tremfya is the first biologic treatment approved by the ministry of health under resolution 820, which allows the registration of FDA-approved treatments and European EMEA in a short period of up to three months, which confirms the ministry’s mission to provide advanced biological treatments that help to heal the Egyptian patient as soon as possible.”
Non-US regulatory

 

Enbrel (etanercept) / Takeda, Pfizer, Amgen
A RANDOMIZED, PHASE 3, DOUBLE-BLIND TRIAL EXAMINING METHOTREXATE AND ETANERCEPT AS MONOTHERAPY OR IN COMBINATION FOR TREATING PSORIATIC ARTHRITIS: A COMPARISON OF THE COMPOSITE MEASURES USED TO EVALUATE DISEASE ACTIVITY (EULAR 2019) – Apr 16, 2019 – Abstract #OP0111; Pres time: Jun 13, 2019; 10:50 AM – 11:00 AM; Location: Hall 8; No abstract available.
Clinical • Monotherapy • P3 data

 

Cosentyx (secukinumab) / Novartis
SECUKINUMAB IMPROVES AXIAL MANIFESTATIONS IN PATIENTS WITH PSORIATIC ARTHRITIS AND INADEQUATE RESPONSE TO NSAIDS: PRIMARY ANALYSIS OF THE MAXIMISE TRIAL (EULAR 2019) – Apr 16, 2019 – Abstract #OP0235; Pres time: Jun 14, 2019; 11:00 AM – 11:10 AM; Location: Hall 7A; No abstract available.
Clinical

 

Taltz (ixekizumab) / Eli Lilly
IXEKIZUMAB IMPROVES SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS IN PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO 1 OR 2 TUMOR NECROSIS FACTOR INHIBITORS (EULAR 2019) – Apr 16, 2019 – Abstract #OP0110; Pres time: Jun 13, 2019; 10:40 AM – 10:50 AM; Location: Hall 8; No abstract available.
Clinical

 

Cosentyx (secukinumab) / Novartis
MACHINE LEARNING TOOLS IDENTIFY PATIENT CLUSTERS AND SWOLLEN AND TENDER JOINT CORRELATION PATTERNS IN A LARGE DATABASE FROM THE SECUKINUMAB PSORIATIC ARTHRITIS CLINICAL DEVELOPMENT PROGRAM (EULAR 2019) – Apr 16, 2019 – Abstract #OP0114; Pres time: Jun 13, 2019; 11:20 AM – 11:30 AM; Location: Hall 8; No abstract available.
Clinical

 

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Weekly Top News – Breast Cancer – April 9, 2019

April 9, 2019

Ibrance (palbociclib) / Pfizer
U.S. FDA approves Ibrance (palbociclib) for the treatment of men with HR+, HER2- metastatic breast cancer (Businesswire) – Apr 4, 2019 – “Pfizer…announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indications for IBRANCE® (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. The approval is based on data from electronic health records and postmarketing reports of the real-world use of IBRANCE in male patients sourced from three databases: IQVIA Insurance database, Flatiron Health Breast Cancer database and the Pfizer global safety database.”
sNDA

 

Verzenio (abemaciclib) / Eli Lilly
NICE nod for Lilly’s breast cancer drug Verzenio via CDF (PMLive) – Apr 2, 2019 – “Thousands of women with advanced breast cancer could get access to treatment with Eli Lilly’s CDK 4/6 inhibitor Verzenio, after NICE backed its use via the Cancer Drugs Fund (CDF). The cost-effectiveness watchdog has opted to make Verzenio (abemaciclib) plus fulvestrant available to around 4,800 women with hormone receptor (HR) positive, HER2-negative breast cancer which has spread to other parts of the body, provided they have already received endocrine treatment.”
NICE

 

U3-1402 / Daiichi Sankyo; Herceptin (trastuzumab) / Roche
U3-1402, a novel HER3-targeting antibody-drug conjugate, exhibits its antitumor activity through increased payload intracellular delivery via highly efficient drug internalization (AACR 2019) – Apr 5, 2019 – Abstract #LB-275/21; Pres time: Apr 3, 2019; 08:00 AM – 12:00 PM; Location: Section 40; “…U3-1402 is a novel HER3-targeting antibody-drug conjugate (ADC) consisting of a fully human anti-HER3 antibody (patritumab), a tetrapeptide-based linker, and a topoisomerase I inhibitor payload…In vitro molecular dynamics were compared between U3-1402 and trastuzumab (anti-HER2 antibody) using the MDA-MB-453 cell line, which expresses both HER2 and HER3… U3-1402 has a high internalization property for effective payload delivery to HER3-expressing cancer cells, resulting in a favorable ADC-driven efficacy.”
Late-breaking abstract

 

Verzenio (abemaciclib) / Eli Lilly; Ibrance (palbociclib) / Pfizer; Kisqali (ribociclib) / Novartis
Multi-omics profiling establishes the polypharmacology of FDA Approved CDK4/6 inhibitors and its impact on drug response (AACR 2019) – Apr 5, 2019 – Abstract #4432/26; Pres time: Apr 2, 2019; 01:00 PM – 05:00 PM; Location: Section 37; “We find that the three drugs differ at a cellular level and that abemaciclib has targets and activities not shared by palbociclib or ribociclib including: induction of cell death (even in pRb-deficient cells), arrest in the G2 phase of the cell cycle, reduced drug adaptation, and unique transcriptional effects in vitro and in vivo. These activities appear to arise from inhibition of CDKs other than CDK4/6 including CDK2/Cyclin A/E and CDK1/Cyclin B. We propose that inhibition of these kinases by abemaciclib target known mechanisms of resistance to CDK4/6 inhibition and thus elicit a response in cell lines that are resistant to palbociclib or ribociclib.”
FDA event

 

Zoladex (goserelin acetate implant) / AstraZeneca, TerSera Therap; Kisqali (ribociclib) / Novartis; Arimidex (anastrozole) / AstraZeneca, Remedica
Genetic landscape of premenopausal HR+/HER2- advanced breast cancer (ABC) based on comprehensive circulating tumor DNA analysis and association with clinical outcomes in the Phase III MONALEESA-7 trial (AACR 2019) – Apr 5, 2019 – Abstract #CT141/7; Pres time: Apr 2, 2019; 08:00 AM – 12:00 PM; Location: Section 16; P3; “…The Phase III MONALEESA-7 study (NCT02278120), the first trial of endocrine therapy ± a cyclin-dependent kinase 4/6 inhibitor for premenopausal patients (pts) with HR+/human epidermal growth factor receptor 2-negative (HER2-) ABC, demonstrated that the addition of ribociclib (RIB) to a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen (TAM) + goserelin (GOS) significantly extended progression-free survival (PFS; Tripathy D, et al…We conducted a comprehensive ctDNA genomic analysis from MONALEESA-7. Premenopausal pts with HR+/HER2- ABC were randomized 1:1 to RIB or placebo (PBO) + NSAI (letrozole [LET] or anastrozole) or TAM + GOS… RIB + NSAI/TAM + GOS provided PFS benefit irrespective of baseline biomarker alteration status and represents recommended first-line therapy for pts with premenopausal HR+/HER2- ABC. The genetic landscape of premenopausal ABC might modulate the magnitude of therapeutic benefit; these novel findings require confirmation in…”
Clinical • Clinical data • P3 data

 

Ibrance (palbociclib) / Pfizer
Tyrosine phosphorylation of p27Kip1 associates with Palbociclib responsiveness in breast cancer (AACR 2019) – Apr 5, 2019 – Abstract #LB-224/3; Pres time: Apr 2, 2019; 01:00 PM – 05:00 PM; Location: Section 41; “Thus, we hypothesized the pY88-p27 status may serve as a biomarker for patients that can respond to cdk4i therapy. We analyzed paraffin-embedded archival breast cancer biopsies from a 13 patient cohort of HR+, Her2- patients who had received Palbociclib/Letrozole in the front line metastatic setting. Our data suggest that pY88-p27 status, as a surrogate marker for cdk4 activity, associates with responsiveness to CDK4i treatment. Clinical use of the pY88 biomarker may identify patients responsive or resistant to Cdk4 targeting drugs.”
Late-breaking abstract

 

sacituzumab govitecan (IMMU-132) / Immunomedics
Study of IMMU-132 in HR+/HER2- MBC (TROPICS-02) (clinicaltrials.gov) – Apr 3, 2019 – P3; N=400; Not yet recruiting; Sponsor: Immunomedics, Inc.
Clinical • New P3 trial

 

Ibrance (palbociclib) / Pfizer
Molecular analysis for therapy choice (NCI-MATCH, EAY131) arm Z1B: Phase II trial of palbociclib for CCND1, 2 or 3 amplified tumors (AACR 2019) – Apr 5, 2019 – Abstract #LB-010/2; Pres time: Mar 31, 2019; 01:00 PM – 05:00 PM; Location: Section 41; “In a cohort of heavily pretreated pts with non-breast solid tumors selected for CCND1, 2 or 3 amplification and treated with palbociclib, prolonged stable disease was noted in 13% of patients. CCND1 or 3 amplification may not predict response to palbociclib in this cohort. No new palbociclib-related safety signals were observed.”
Biomarker • Late-breaking abstract • P2 data

 

Herceptin (trastuzumab) / Roche
NBE-002, an anthracycline-based immune-stimulatory antibody drug conjugate (iADC) targeting ROR1 for the treatment of triple-negative breast cancer (AACR 2019) – Apr 5, 2019 – Abstract #LB-197/15; Pres time: Apr 2, 2019; 08:00 AM – 12:00 PM; Location: Section 42; “…Anti-tumor activity of PNU-ADCs involved activation of the immune system, as shown by evaluation of NBE-002 or a Trastuzumab-PNU conjugate (T-PNU) in ROR1- or HER2-positive syngeneic breast cancer models, respectively… Our results demonstrate that NBE-002 is a highly effective and promising targeted therapeutic for the treatment of ROR1 positive TNBC and potentially other solid tumor indications that warrants clinical development. Considering the pronounced immune-modulatory functions of the PNU payload, NBE-002 may be particularly well suited for combination therapy with immune checkpoint inhibitors. NBE-002 is currently undergoing GMP manufacturing and initiation of clinical studies is expected in mid-2020.”
Late-breaking abstract

 

Nerlynx (neratinib) / Puma
Puma Biotechnology and Pierre Fabre enter into exclusive license agreement to develop and commercialize Nerlynx (neratinib) in Europe (Businesswire) – Apr 1, 2019 – “Puma Biotechnology…and Pierre Fabre have entered into an exclusive license agreement under which Pierre Fabre will develop and commercialize NERLYNX® (neratinib) within Europe and part of Africa…Pierre Fabre will have exclusive commercialization rights for NERLYNX in European countries excluding Russia and Ukraine, along with countries in North Africa and francophone countries of West Africa. Pierre Fabre will also be responsible for conducting additional clinical studies and leading regulatory activities in connection with the European Medicines Agency (EMA).”
Licensing / partnership

 

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Weekly Top News – IBD – April 9, 2019

April 9, 2019

Idacio (adalimumab biosimilar) / Fresenius Kabi
Fresenius Kabi receives European Commission approval for adalimumab biosimilar Idacio (Fresenius Kabi Press Release) – Apr 3, 2019 – “Fresenius Kabi…announced today that the European Commission (EC) granted marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine.”
European regulatory

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 US launch estimate: 2023 (H.C. Wainwright & Co) – Apr 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 66838015; Page no: 1; REPORT TITLE: “RedHill Biopharma Ltd.- Focus on Talicia; Adjusting PT to $16.00 on changes to RHB-104 outlook; Reiterate buy”; AUTHOR: Ramakanth, Swayampakula, et al; DATE: 02/27/2019
Launch US

 

Entyvio SC (vedolizumab SC) / Takeda
European Medicines Agency accepts Takeda’s Marketing Authorization application for a subcutaneous formulation of vedolizumab for maintenance therapy in moderately to severely active ulcerative colitis and Crohn’s Disease (Businesswire) – Apr 1, 2019 – “Takeda…announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Line Extension Application for a subcutaneous (SC) formulation of the gut-selective biologic vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.”
European regulatory

 

Remsima SC (infliximab biosimilar SC) / Celltrion
Celltrion completes FDA application for phase 3 trial of Remsima SC (Yonhap News Agency) – Apr 1, 2019 – “South Korea’s leading biopharmaceutical firm Celltrion announced Monday that it has completed the U.S. Food and Drug Administration’s investigational new drug (IND) application for Remsima SC….Celltrion plans to further expand its phase 3 clinical trials of Remsima SC to other countries with the aim to win U.S. FDA approval by 2020….Remsima SC will be under patent protection until 2037…”
BLA • IND • Patent

 

Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine
Prescription of antibiotics for adults with acute diarrhoeal infections in Korea: a population-based study (ECCMID 2019) – Apr 5, 2019 – Abstract #P2034; Pres time: Apr 15, 2019; 01:30 PM – 02:30 PM; “…The antibiotics most frequently prescribed for both monotherapy and combination regimens in patients with ADI were fluoroquinolones (29.80%), rifaximin (26.82%), second-generation cephalosporins (9.21%), third-generation cephalosporins (7.25%), trimethoprim/sulfamethoxazole (5.54%), and ß-lactam/ß-lactamase inhibitors (5.30%)… This study revealed differences between the antibiotics used to treat ADI in Korea and those recommended by the guidelines for treatment of ADI. Multifaceted efforts are necessary to strengthen physicians’ adherence to the published guidelines.”
Clinical

 

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Weekly Top News – Psoriasis – April 9, 2019

April 9, 2019

Idacio (adalimumab biosimilar) / Fresenius Kabi
Fresenius Kabi receives European Commission approval for adalimumab biosimilar Idacio (Fresenius Kabi Press Release) – Apr 3, 2019 – “Fresenius Kabi…announced today that the European Commission (EC) granted marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine.”
European regulatory

 

bimekizumab (UCB4940) / UCB
Bimekizumab clinical trial estimate: Data from P3 BE SURE trial (NCT03412747) for psoriasis in H1 2019 (Infinata) – Apr 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 66478978; Page no: 2; REPORT TITLE: “UCB S.A. – Company report”; AUTHOR: Infinata, et al; DATE: 03/05/2019
P3 data

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasi (clinicaltrials.gov) – Apr 1, 2019 – P3; N=136; Not yet recruiting; Sponsor: Sun Pharma Global FZE
Clinical • New P3 trial

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
Risankizumab regulatory estimate: PDUFA date for psoriasis on April 26, 2019 (William Blair) – Apr 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67011697; Page no: 5; REPORT TITLE: “William Blair Biopharma Catalyst watch second quarter 2019”; AUTHOR: Xu, Yu Katherine, et al; DATE: 03/29/2019
PDUFA date

 

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 1, 2019 – P3; N=390; Not yet recruiting; Sponsor: UCB Biopharma S.P.R.L.
Clinical • New P3 trial

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis (clinicaltrials.gov) – Apr 1, 2019 – P3; N=146; Not yet recruiting; Sponsor: Sun Pharma Global FZE
Clinical • New P3 trial

 

Cosentyx (secukinumab) / Novartis
Novartis first-in-class Cosentyx approved in China for psoriasis patients (Novartis Press Release) – Apr 2, 2019 – “Novartis…announced today that the China Health Authority NMPA approved Cosentyx® (secukinumab), the first-in-class interleukin-17A (IL-17A) inhibitor for moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy…Positive China data presented recently makes us hopeful for the clinical use of secukinumab in China.”
Non-US regulatory

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