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Month: May 2019

Weekly Top News – IBD – May 27, 2019

May 27, 2019

etrasimod (APD334) / Arena
Etrasimod: “Etrasimod 2 mg induced significantly higher rates of endoscopic improvement, histologic improvement and remission, and mucosal healing”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019
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etrasimod (APD334) / Arena
Etrasimod: “Patients who received etrasimod 2 mg exhibited significant decreases in both fecal calprotectin and C-reactive protein versus placebo”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019
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brazikumab (AMG 139) / Allergan
Open-label Extension Study of Brazikumab in Crohn’s Disease (clinicaltrials.gov) – May 23, 2019 – P3; N=1000; Not yet recruiting; Sponsor: Allergan

 

Entyvio (vedolizumab) / Takeda
Entyvio (vedolizumab) approved in Japan for the treatment of patients with moderately to severely active Crohn’s disease (Takeda Press Release) – May 22, 2019 – “Takeda…announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication for Entyvio…for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) in Japan.”

 

brazikumab (AMG 139) / Allergan
Brazikumab launch estimate: 2024 for Crohn’s disease and 2025 for ulcerative colitis (Jefferies) – May 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67117095; Page no: 32; REPORT TITLE: “Allergan Plc – Initiating coverage – Allergan at the crossroads; Initiate coverage at hold”; AUTHOR: Steinberg, David, et al; DATE: 04/15/2019

 

mirikizumab (LY3074828) / Eli Lilly
Lilly’s mirikizumab met primary endpoint and key secondary endpoints in phase 2 study, including reductions of gastrointestinal lesions (PRNewswire) – May 21, 2019 – P2, N=180; SERENITY (NCT02891226); Sponsor: Eli Lilly; “Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing….We look forward to initiating Phase 3 trials to further evaluate mirikizumab’s benefit-risk profile for the treatment of Crohn’s disease.”

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P3; N=372; Recruiting; Sponsor: Arena Pharmaceuticals; Not yet recruiting –> Recruiting

 

mirikizumab (LY3074828) / Eli Lilly
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P2; N=240; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed

 

Xeljanz (tofacitinib) / Pfizer
EU regulators slap safety restriction on Pfizer’s Xeljanz (pharmaphorum) – May 20, 2019 – “European safety regulators have placed restrictions on Pfizer’s Xeljanz, saying it should not be used in the higher dose in patients with ulcerative colitis because of concerns of increased risk of blood clots on the lung and increased mortality.”

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Weekly Top News – Psoriasis – May 27, 2019

May 27, 2019

Cosentyx (secukinumab) / Novartis
Cosentyx: Regulatory approval in China for psoriasis at the end of 2019 (Novartis) – May 25, 2019 – Investor Event: Regulatory approval in China for ankylosing spondylitis at the end of 2020
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Cosentyx (secukinumab) / Novartis
Cosentyx: Data from P3 EXCEED trial (NCT02745080) for psoriatic arthritis in 2019/2020 (Novartis) – May 25, 2019 – Investor Event: Data from P3 SURPASS trial (NCT03259074) for ankylosing spondylitis in 2022
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benvitimod (GSK2894512) / Roivant
Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001) (clinicaltrials.gov) – May 20, 2019 – P3; N=500; Not yet recruiting; Sponsor: Dermavant Sciences GmbH

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Data from P2 ARROW trial (NCT03553823) for plaque psoriasis at the end of 2019 (Novartis) – May 25, 2019 – Investor Event
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ANB019 / AnaptysBio
ANB019: Top-line data from P2 POPLAR trial (NCT03633396) for palmoplantar pustulosis in H1 2020 (Bank of America Merrill Lynch Health Care Conference 2019, AnaptysBio) – May 23, 2019
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ABBV-157 / AbbVie, Inventiva
ABBV-157: Initiation of P1 trial (NCT03922607) for chronic plaque psoriasis in May 2019 (Inventiva) – May 21, 2019 – Company presentation: Completion of P1 trial for chronic plaque psoriasis in September 2020
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PF-06700841 / Pfizer
A Study to Evaluate the Efficacy and Safety of PF-06700841 in Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – May 24, 2019 – P2b; N=196; Not yet recruiting; Sponsor: Pfizer

 

Stelara (ustekinumab) / J&J
A Case of Eosinophilic Pneumonia Secondary to Ustekinumab in the Treatment of Crohn’s Disease (ATS 2019) – May 24, 2019 – Abstract #A1476/P475; Pres time: May 19, 2019; 11:15 AM – 01:00 PM; Location: Area D (Hall F, Level 2), KBHCCD; “…His treatment regimen included methotrexate for over one year and he had received his first dose of ustekinumab 6 weeks prior to presentation…Cefepime, metronidazole, azithromycin and vancomycin were initiated…The patient was treated with Methylprednisolone 500 mg IV for 3 days, tapered to 125 mg IV for 3 days, followed by a six week prednisone taper…Ustekinumab has also been associated with hypersensitivity pneumonitis and interstitial lung disease with a granulomatous component. In patients taking ustekinumab with respiratory failure and parenchymal opacities on chest radiograph, eosinophilic pneumonia should be considered.”

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Weekly Top News – Breast Cancer – May 27, 2019

May 27, 2019

etrasimod (APD334) / Arena
Etrasimod: “Etrasimod 2 mg induced significantly higher rates of endoscopic improvement, histologic improvement and remission, and mucosal healing”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019
[Screenshot]

 

etrasimod (APD334) / Arena
Etrasimod: “Patients who received etrasimod 2 mg exhibited significant decreases in both fecal calprotectin and C-reactive protein versus placebo”; Ulcerative colitis (Arena) – May 22, 2019 – DDW 2019

[Screenshot]

 

brazikumab (AMG 139) / Allergan
Open-label Extension Study of Brazikumab in Crohn’s Disease (clinicaltrials.gov) – May 23, 2019 – P3; N=1000; Not yet recruiting; Sponsor: Allergan

 

Entyvio (vedolizumab) / Takeda
Entyvio (vedolizumab) approved in Japan for the treatment of patients with moderately to severely active Crohn’s disease (Takeda Press Release) – May 22, 2019 – “Takeda…announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for an additional indication for Entyvio…for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) in Japan.”

 

brazikumab (AMG 139) / Allergan
Brazikumab launch estimate: 2024 for Crohn’s disease and 2025 for ulcerative colitis (Jefferies) – May 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67117095; Page no: 32; REPORT TITLE: “Allergan Plc – Initiating coverage – Allergan at the crossroads; Initiate coverage at hold”; AUTHOR: Steinberg, David, et al; DATE: 04/15/2019

 

mirikizumab (LY3074828) / Eli Lilly
Lilly’s mirikizumab met primary endpoint and key secondary endpoints in phase 2 study, including reductions of gastrointestinal lesions (PRNewswire) – May 21, 2019 – P2, N=180; SERENITY (NCT02891226); Sponsor: Eli Lilly; “Patients treated with mirikizumab in the SERENITY Phase 2 study achieved significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. The maintenance phase of this study is ongoing….We look forward to initiating Phase 3 trials to further evaluate mirikizumab’s benefit-risk profile for the treatment of Crohn’s disease.”

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P3; N=372; Recruiting; Sponsor: Arena Pharmaceuticals; Not yet recruiting –> Recruiting

 

mirikizumab (LY3074828) / Eli Lilly
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis (clinicaltrials.gov) – May 24, 2019 – P2; N=240; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting –> Completed

 

Xeljanz (tofacitinib) / Pfizer
EU regulators slap safety restriction on Pfizer’s Xeljanz (pharmaphorum) – May 20, 2019 – “European safety regulators have placed restrictions on Pfizer’s Xeljanz, saying it should not be used in the higher dose in patients with ulcerative colitis because of concerns of increased risk of blood clots on the lung and increased mortality.”

Read More …

Weekly Top News – Breast Cancer – May 20, 2019

May 20, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo; capivasertib (AZD5363) / Otsuka, AstraZeneca; Lynparza (olaparib) / Merck (MSD), AstraZeneca; Imfinzi (durvalumab) / AstraZeneca, Celgene; Faslodex (fulvestrant) / AstraZeneca
AstraZeneca continues to redefine cancer treatment at the 2019 ASCO Annual Meeting (AstraZeneca Press Release) – May 16, 2019 – “AstraZeneca will present new research across an industry-leading Oncology portfolio, including data for its transformational cancer medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US, 31 May to 4 June 2019….In all, the Company will present 93 abstracts spanning multiple tumour types, including 12 oral presentations with one plenary session and four late-breakers.”

 

Verzenio (abemaciclib) / Eli Lilly
Serious side effects of cancer drug Verzenio suspected in Japan (The Mainichi Daily News) – May 17, 2019 – “Japan’s health ministry Friday warned medical personnel of a potential side effect of breast cancer drug Verzenio on the lungs after 14 patients in the country taking the drug developed a serious lung disease and three of them died…Of the 14 cases, the drug’s adverse effects were suspected in at least four of them including one that died, according to the ministry.”

 

Abraxane (albumin-bound paclitaxel) / Celgene, Otsuka
Nab-Paclitaxel improves disease-free survival in early breast cancer: GBG 69–GeparSepto (J Clin Oncol) – May 13, 2019 – P3, N=1,200; GeparSepto (NCT01583426); “At 4 years, overall patients treated with NAB-paclitaxel had a significantly better iDFS compared with sb-paclitaxel (84.0% v 76.3%; hazard ratio, 0.66; 95% CI, 0.51 to 0.86; P = .002), whereas overall survival did not significantly differ between the two treatment arms (89.7% v 87.2%, respectively; hazard ratio, 0.82; 95% CI, 0.59 to 1.16; P = .260). Long-term follow-up of the treatment-related peripheral sensory neuropathy (PSN) showed a significant decrease of the median time to resolve PSN after NAB-paclitaxel 125 mg/m2 compared with NAB-paclitaxel 150 mg/m2.”

 

Kisqali (ribociclib) / Novartis; capmatinib (INC280) / Incyte, Novartis
Novartis data at ASCO and EHA demonstrate novel approaches to reimagining medicine in cancer and serious blood disorders (PRNewswire) – May 16, 2019 – P3, N=672; MONALEESA-7 (NCT02278120); P2, N=364; GEOMETRY mono-1 (NCT02414139); Sponsor: Novartis Pharmaceuticals; “Overall survival results from MONALEESA-7 with Kisqali (ribociclib) plus endocrine therapy in premenopausal women with HR+/HER2- advanced breast cancer, to be presented at ASCO. Primary results of GEOMETRY study for capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC) at ASCO”

 

Keytruda (pembrolizumab) / Merck (MSD)
Biothera Pharmaceuticals to present clinical data from phase 2 triple negative breast cancer study at ASCO 2019 Annual Meeting (Biothera Press Release) – May 16, 2019 – P2, N=64; NCT02981303; Sponsor: Biothera Pharmaceuticals; “Biothera Pharmaceuticals…announced today that it will present primary clinical data from its phase 2 study in chemo-refractory metastatic triple negative breast cancer at the American Society of Clinical Oncology (ASCO) 2019 annual meeting, May 31-June 4 in Chicago. The study is evaluating Imprime PGG in combination with KEYTRUDA (pembrolizumab)…in triple negative breast cancer patients whose disease has progressed following treatment with one or more lines of chemotherapy for metastatic disease.”

 

ME-344 / MEI; Avastin (bevacizumab) / Roche
MEI Pharma to present new clinical results on ME-401 and ME-344 programs at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (MEI Pharma Press Release) – May 15, 2019 – “Study investigators will present updated results from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma and complete results from the investigator-initiated study of ME-344 in combination with Avastin® in patients with HER2-negative breast cancer…The company also announced that an abstract on the PI3Kδ inhibitor ME-401 was selected for an oral presentation at the 15th International Conference on Malignant Lymphoma (15-ICML)….The abstract relates to updated data from the Phase 1b study evaluating ME-401 in relapsed/refractory follicular lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma, both as a monotherapy and in combination with rituximab.”

 

Verzenio (abemaciclib) / Eli Lilly
New cancer drugs approved for NHS use in Scotland (Belfast Telegraph) – May 13, 2019 – “The Scottish Medicines Consortium (SMC) has accepted Abemaciclib (Vernezios), a drug that can prolong the time breast cancer takes to progress and delay the need for chemotherapy, allowing patients more quality time with their family…The decision on Abemaciclib (Vernezios) was welcomed by Health Secretary Jeane Freeman.”

 

margetuximab (MGAH 22) / MacroGenics; Herceptin (trastuzumab) / Roche
MacroGenics Announces Positive Results from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer (GlobeNewswire, MacroGenics, Inc.) – May 15, 2019 – P3, N=530; SOPHIA (NCT02492711); Sponsor: MacroGenics; “The study met its first sequential primary endpoint of progression-free survival (PFS). The median PFS of patients treated with margetuximab and chemotherapy was 5.8 months compared to 4.9 months in patients treated with trastuzumab and chemotherapy (hazard ratio [HR]=0.76; 95% CI: 0.59-0.98; P=0.033). Among the approximately 85% of patients carrying the CD16A 158F allele, a pre-specified exploratory subpopulation in the study, PFS was prolonged by 1.8 months in the margetuximab arm compared to the trastuzumab arm (6.9 months versus 5.1 months; HR=0.68; 95% CI: 0.52-0.90; P=0.005). The objective response rate (ORR), a secondary outcome measure in the SOPHIA study, was 22% in the margetuximab arm (95% CI: 17.3-27.7%) compared to 16% in the trastuzumab arm (95% CI: 11.8-21.0%). The data cut-off date for the primary PFS analysis of the study was October 10, 2018.”

 

Nerlynx (neratinib) / Puma; Tykerb (lapatinib) / Novartis
Puma’s Nerlynx edges out Novartis’ Tykerb in late-stage breast cancer study (SeekingAlpha) – May 16, 2019 – P3, N=621; NALA (NCT01808573); Sponsor: Puma Biotechnology, Inc; “Results from a Phase 3 clinical trial, NALA, evaluating Puma Biotechnology’s (PBYI +3.2%) Nerlynx (neratinib) + Roche chemo agent Xeloda (capecitabine) (N + C) compared to Novartis’ (NVS +1.6%) Tykerb (lapatinib) + Xeloda (L + C) showed a treatment advantage…The overall response rate (ORR) in patients with measurable disease at study entry in the N + C arm was 33% but the difference (27% in the L + C arm) was not statistically significant….On the safety front, the incidences of treatment-related adverse events were comparable, although the rate of serious (Grade 3) diarrhea was 24% in the N + C group versus 13% in the L + C group.”

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Weekly Top News – IBD – May 20, 2019

May 20, 2019

etrasimod (APD334) / Arena
ELEVATE UC OLE: An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis(clinicaltrials.gov) – May 15, 2019 – P3; N=702; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

Tremfya (guselkumab) / J&J
Tremfya: Regulatory submissions in US/EU for Crohn’s disease and ulcerative colitis between 2019-2023(J&J) – May 16, 2019 – Pharmaceutical Business Review: Regulatory submissions in US/EU for personalized dosing psoriasis between 2019-2023  
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Entyvio (vedolizumab) / Takeda
Entyvio: Regulatory approval in Japan for Crohn’s disease in H1 FY2019 (Takeda) – May 15, 2019 – FY 2018 Results  
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JNJ-64304500 / J&J
JNJ-64304500: Regulatory submissions in US/EU for Crohn’s disease between 2019-2023 (J&J) – May 16, 2019 – Pharmaceutical Business Review  
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Simponi (golimumab) / Merck (MSD), Mitsubishi Tanabe, J&J
Simponi: Regulatory submissions in US/EU for pediatric ulcerative colitis between 2019-2023 (J&J) – May 16, 2019 – Pharmaceutical Business Review  
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Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104: FDA meeting related to P3 trial design and path to approval in Crohn’s disease in mid-2019(RedHill) – May 16, 2019 – Corporate Presentation  
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PTG-200 / Protagonist Therapeutics, J&J
PTG-200 launch estimate: 2027 (BMO) – May 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67255938; Page no: 8; REPORT TITLE: “Protagonist Therapeutics Inc – Catalyst-rich pipeline highlighted during investor meetings”; AUTHOR: Farmer, George, et al; DATE: 05/06/2019

 

brazikumab (AMG 139) / Allergan
Brazikumab launch estimate: 2024 for Crohn’s disease and 2025 for ulcerative colitis (Jefferies) – May 20, 2019 – A subscription to Thomson ONE is required to gain full access to report 67117095; Page no: 32; REPORT TITLE: “Allergan Plc – Initiating coverage – Allergan at the crossroads; Initiate coverage at hold”; AUTHOR: Steinberg, David, et al; DATE: 04/15/2019

 

Cyltezo (adalimumab biosimilar) / Boehringer Ingelheim
BI 695501 Versus Humira in Patients With Active Crohn’s Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity (clinicaltrials.gov) – May 15, 2019 – P3; N=147; Completed; Sponsor: Boehringer Ingelheim; Active, not recruiting –> Completed

 

Entyvio (vedolizumab) / Takeda
New exploratory data from VARSITY, first head-to-head ulcerative colitis biologic study which demonstrated superiority of vedolizumab to adalimumab in clinical remission at week 52, presented at 2019 Digestive Disease Week (Businesswire) – May 19, 2019 – P3b, N=770; VARSITY (NCT02497469); Sponsor: Takeda; “New exploratory data showed that a greater proportion of patients receiving vedolizumab intravenous (IV) achieved clinical response at week 14 compared to those treated with adalimumab subcutaneous (SC), 67.1% vs. 45.9% respectively. A separation between the treatment groups was seen as early as week 6, favoring vedolizumab. These results were announced in a Distinguished Abstract Plenary Lecture Presentation at the 2019 Digestive Disease Week…”

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Weekly Top News – Psoriasis – May 20, 2019

May 20, 2019

Tremfya (guselkumab) / J&J
Tremfya: Regulatory submissions in US/EU for Crohn’s disease and ulcerative colitis between 2019-2023 (J&J) – May 16, 2019 – Pharmaceutical Business Review: Regulatory submissions in US/EU for personalized dosing psoriasis between 2019-2023
[Screenshot]

 

benvitimod (GSK2894512) / Roivant
A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Plaque Psoriasis in Adults (clinicaltrials.gov) – May 20, 2019 – P3; N=500; Not yet recruiting; Sponsor: Dermavant Sciences GmbH

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
Psoriasis, brodalumab is redeemable in Italy (AboutPharma) – May 17, 2019 – “The first biological drug from LEO Pharma arrives in Italy: a monoclonal antibody against moderate-severe plaque psoriasis. In fact, brodalumab was repaid in Italy…The OK of the Italian Drug Agency, approved in recent weeks, was announced yesterday in Rome by LEO Pharma.”

 

Cosentyx (secukinumab) / Novartis; bimekizumab (UCB4940) / UCB
BE RADIANT: A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) – May 13, 2019 – P3; N=743; Active, not recruiting; Sponsor: UCB Biopharma S.P.R.L.; Recruiting –> Active, not recruiting

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
A Study to Assess Usability of Risankizumab Autoinjector Combination Product in Participants With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) – May 14, 2019 – P3; N=100; Recruiting; Sponsor: AbbVie; Not yet recruiting –> Recruiting

 

Otezla (apremilast) / Celgene
Otezla pricing: Wholesale acquisition cost of $3398/month (Jefferies) – May 15, 2019 – A subscription to Thomson ONE is required to gain full access to report 67209046; Page no: 67; REPORT TITLE: “Initiating microbiome-based therapeutics: Novel science poised for NT success”; AUTHOR: Song, Roger, et al; DATE: 04/30/2019

 

ABBV-157 / AbbVie, Inventiva
Q1 2019 financial information and corporate business update (GlobeNewswire) – May 15, 2019 – “AbbVie continues the clinical development of ABBV-157, the drug candidate resulting from its collaboration with Inventiva. Following a first Phase I clinical trial, AbbVie recently reported its intention to initiate a new clinical study with ABBV-157, aiming at assessing the compound’s pharmacokinetics, safety and tolerance in healthy volunteers and in patients with chronic plaque psoriasis.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Ilumya sales projection: $120M (consensus: $200-300M) peak (Credit Suisse) – May 14, 2019 – A subscription to Thomson ONE is required to gain full access to report 67226255; Page no: 4; REPORT TITLE: “Credit Suisse India Daily: Top stories and ideas”; AUTHOR: Gupta, Ashish, et al; DATE: 05/02/2019

 

Stelara (ustekinumab) / J&J
“Ustekinumab Offers Better Drug Survival to Treat Pediatric Psoriasis https://t.co/0qjn7PNced @NPF” (@NPFjim) – May 17, 2019

 

MP1032 / MetrioPharm
EQS-News: MetrioPharm AG: MetrioPharm AG publishes annual report for 2018 (Business Insider) – May 16, 2019 – “In the past fiscal year, we were able to decisively advance the development of our lead compound MP1032. Phase II clinical trial successfully initiated…for the indication psoriasis started. Patient recruitment has now been completed to our satisfaction.”

 

Cosentyx (secukinumab) / Novartis
Cosentyx TRx trend: +38% till date in Q2 2019 (J.P. Morgan) – May 18, 2019 – A subscription to Thomson ONE is required to gain full access to report 67253598; Page no: 1; REPORT TITLE: “European Pharmaceuticals: Weekly chartbook: TRx for week ending 26th April”; AUTHOR: Vosser, Richard, et al; DATE: 05/06/2019

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Weekly Top News – Breast Cancer – May 13, 2019

May 13, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
Pivotal phase II DESTINY-Breast01 trial met primary endpoint, supporting global regulatory submission plan to start in H2 2019 (AstraZeneca Press Release) – May 7, 2019 – P2, N=230; DESTINY-Breast01 (NCT03248492); Sponsor: Daiichi Sankyo, Inc; “The HER2-targeting antibody drug conjugate (ADC) and potential new medicine was evaluated in patients with HER2-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine….The safety and tolerability profile of trastuzumab deruxtecan was also consistent with previous experience. These results are expected to support planned global regulatory submissions, including a Biologics License Application with the US Food and Drug Administration (FDA) anticipated in the second half of 2019.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: Interim OS analysis from P3 E2112 trial (NCT02115282) in combination with exemestane for advanced HR+ breast cancer in Q4 2019 (Syndax) – May 7, 2019 – Q1 2019 Results: Final OS analysis in Q2 2020
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entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: NDA submission for advanced HR+, HER2- breast cancer in 2020 (Syndax) – May 7, 2019 – Q1 2019 Results
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Avastin (bevacizumab) / Roche; Tecentriq (atezolizumab) / Roche; Kadcyla (ado-trastuzumab emtansine) / Roche; Venclexta (venetoclax) / Roche, AbbVie; Perjeta (pertuzumab) / Roche; entrectinib (RXDX-101) / Roche
Roche to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Roche Press Release) – May 10, 2019 – “Roche….announced that new data from clinical trials of 17 approved and investigational medicines across 27 cancer types, including hard-to-treat and rare tumours, will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, United States, from 31 May– 4 June, 2019. A total of 155 abstracts that include a Roche medicine will be presented at this year’s meeting.”

 

Herceptin Hylecta (trastuzumab/hyaluronidase-oysk) / Roche, Halozyme Therapeutics; pegvorhyaluronidase alfa (PEGPH20) / Halozyme Therapeutics
Halozyme reports first quarter 2019 results (PRNewswire) – May 7, 2019 – “‘We enjoyed a strong start to 2019 as our first quarter included a new ENHANZE® collaboration with argenx, positive phase III data from Janssen’s COLUMBA study evaluating a subcutaneous formulation of DARZALEX®, and FDA approval of Herceptin Hylecta™’….On ENHANZE® we anticipate regulatory submissions by ENHANZE® partner Janssen for the subcutaneous formulation of DARZALEX®, a new phase 3 trial initiation by one of our ENHANZE® partners and multiple Phase 1 trial initiations. On PEGPH20, we project the announcement of topline results from our HALO-301 pivotal phase 3 trial in pancreas cancer in the second half of the year.'”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports first quarter 2019 financial results (Businesswire) – May 9, 2019 – “…’During 2019, we anticipate the following key milestones for Puma: (i) filing a new drug application for neratinib based on the results of the Phase III trial in third-line metastatic breast cancer in the summer of 2019; (ii) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the summer of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in other countries in the second half of 2019.”

 

Tecentriq (atezolizumab) / Roche; Herceptin (trastuzumab) / Roche; Perjeta (pertuzumab) / Roche
Genentech to present new data highlighting comprehensive approach to cancer care at 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Businesswire) – May 10, 2019 – P3, N=900; IMpassion130 (NCT02425891); P3, N=808; CLEOPATRA (CLEOPATRA); Sponsor: Hoffmann-La Roche; “Key presentations in breast cancers: Key data to be presented at ASCO include…second interim analysis of overall survival (OS) results, updated safety data and patient-reported outcomes (PROs) from the Phase III IMpassion130 study of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane…) for the treatment of PD-L1-positive, metastatic triple-negative breast cancer (TNBC)…Additional data include an eight-year, end-of-study analysis from the Phase III CLEOPATRA study of Perjeta® (pertuzumab) plus Herceptin® (trastuzumab) and chemotherapy for first-line treatment of HER2-positive metastatic breast cancer.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports first quarter 2019 financial results (Businesswire) – May 9, 2019 – P3, N=621; NALA (NCT01808573); P2, N=392; SUMMIT (NCT01953926); P2, N=650; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “…’During 2019, we anticipate the following key milestones for Puma: (i) presenting data from the Phase III trial of neratinib in third-line metastatic breast cancer patients in the second quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the second quarter of 2019; and (iii) reporting Phase II data from the SUMMIT basket trial in patients with HER2 mutations in the second half of 2019′.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports fourth quarter 2018 financial results and provides clinical and business update (Syndax Press Release) – May 6, 2019 – P3, N=600; NCT02115282; “The Company continues to anticipate the next interim OS analysis for E2112, its NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, in the second quarter of 2019. Additional interim analyses will be conducted by ECOG-ACRIN approximately every six months until either an OS benefit is observed, or the final target number of events occur. Any positive OS assessment would enable the Company to file for full regulatory approval.”

 

HLX02 (trastuzumab biosimilar) / Fosun Pharma
Henlius biosimilar HLX02 gets NDA acceptance from NMPA (Biospectrumasia) – May 8, 2019 – “Shanghai Henlius Biotech, Inc., subsidiary of Shanghai Fosun Pharmaceutical Group Co. has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its biosimilar HLX02, a trastuzumab for injection.”

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Weekly Top News – IBD – May 13, 2019

May 13, 2019

Remsima SC (infliximab biosimilar SC) / Celltrion
A Phase 3 Study to Evaluate the Efficacy and Safety of the CT-P13 SC in Patients With Moderately to Severely Active Crohn’s Disease (clinicaltrials.gov) – May 10, 2019 – P3; N=600; Not yet recruiting; Sponsor: Celltrion

 

etrasimod (APD334) / Arena
Etrasimod: Initiation of P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis by mid-2019 (Arena) – May 11, 2019 – Q1 2019 Results: Data from P3 trial for ulcerative colitis in 2021

 

etrasimod (APD334) / Arena
ELEVATE UC 52: Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis (clinicaltrials.gov) – May 10, 2019 – P3; N=372; Not yet recruiting; Sponsor: Arena Pharmaceuticals

 

Entyvio (vedolizumab) / Takeda
A Phase 3 Study of Vedolizumab for Induction and Maintenance Therapy in Japanese Patients with Moderate to Severe Crohn’s Disease (DDW 2019) – May 9, 2019 – Abstract #Tu1746; Pres time: May 21, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; P3; “It additionally showed numerically greater clinical remission at Week 60 compared with PBO. VDZ is well-tolerated in induction and maintenance therapy in Japanese pts with moderate to severe CD with a safety profile consistent with non-Japanese studies.”

 

Entyvio (vedolizumab) / Takeda
Vedolizumab Use is Not Associated with Increased Malignancy Incidence: Gemini Long-Term Safety Study Results and Post-Marketing Data (DDW 2019) – May 9, 2019 – Abstract #Su1835; Pres time: May 19, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – San Diego Convention Center; P3; “As observed numbers are small, individual malignancy data should not be over-interpreted, and the limitation that standardization does not correct for other potential confounders (e.g. smoking and body mass index) should be considered. Although limitations of post-marketing safety reports, including incomplete data and voluntary reporting of events, must be considered when interpreting post-marketing data, the number of malignancies with VDZ appeared low.”

 

Entyvio SC (vedolizumab SC) / Takeda
Effects of Subcutaneous Vedolizumab on Health-Related Quality of Life and Work Productivity in Patients with Ulcerative Colitis: Results from the Phase 3 Visible 1 Trial (DDW 2019) – May 9, 2019 – Abstract #Sa1878; Pres time: May 18, 2019; 12:00 PM – 02:00 PM; Location: Room: Halls C-E – SDCC; “Similarly, signifi- cant improvements in work productivity measures were observed among patients treated with vedolizumab SC. Further investigation of the effects of vedolizumab SC on quality of life is needed to validate these findings.”

 

mirikizumab (LY3074828) / Eli Lilly
Efficacy and Safety of Mirikizumab (LY3074828) in a Phase 2 Study of Patients with Crohn’s Disease (DDW 2019) – May 9, 2019 – Abstract #1003; Pres time: May 21, 2019; 10:00 AM – 10:15 AM; Location: Room: 20BCD – SDCC; P2; “Sustained efficacy and safety are currently being evaluated in a maintenance study. S-216AGA”

 

Idacio (adalimumab biosimilar) / Fresenius Kabi
Eye on Pharma: Fresenius Kabi launches biosimilar adalimumab, Idacio (Center for Biosimilars) – May 6, 2019 – “Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.”

 

Stelara (ustekinumab) / J&J
STELARA CD PMS: Post-Marketing Surveillance for Crohn’s Disease Participants Treated With Stelara (Ustekinumab) (clinicaltrials.gov) – May 8, 2019 – P; N=600; Recruiting; Sponsor: Janssen Korea, Ltd., Korea

 

Entyvio SC (vedolizumab SC) / Takeda
U.S. Food & Drug Administration accepts Takeda’s Biologics License Application for a subcutaneous formulation of vedolizumab (Entyvio) for maintenance therapy in moderately to severely active ulcerative colitis (Takeda Press Release) – May 9, 2019 – “Takeda…announced that the U.S. Food & Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for a subcutaneous (SC) formulation of vedolizumab for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both pre-filled syringe and pen options.”

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Weekly Top News – Psoriasis – May 13, 2019

May 13, 2019

Cosentyx (secukinumab) / Novartis
SUBCUTANEOUS SECUKINUMAB 300MG AND 150MG PROVIDES SUSTAINED INHIBITION OF RADIOGRAPHIC PROGRESSION IN PSORIATIC ARTHRITIS OVER 2 YEARS: RESULTS FROM THE PHASE 3 FUTURE-5 TRIAL (EULAR 2019) – May 10, 2019 – Abstract #LB0006; Pres time: Jun 15, 2019; 08:18 AM – 08:24 AM; Location: Hall 7B; No abstract available.

 

Taltz (ixekizumab) / Eli Lilly
IXEKIZUMAB IMPROVES THE SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS REGARDLESS OF SEX, DURATION OF DISEASE, OR BODY MASS INDEX IN TWO RANDOMIZED, PHASE 3 CLINICAL TRIALS (EULAR 2019) – May 10, 2019 – Abstract #FRI0430; Pres time: Jun 14, 2019; No abstract available.

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE, PHASE 2B STUDY TO DEMONSTRATE THE SAFETY AND EFFICACY OF TILDRAKIZUMAB, A HIGH-AFFINITY ANTI–INTERLEUKIN-23P19 MONOCLONAL ANTIBODY, IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS (EULAR 2019) – May 10, 2019 – Abstract #LB0002; Pres time: Jun 12, 2019; 05:35 PM – 05:45 PM; Location: Hall 6; No abstract available.

 

Idacio (adalimumab biosimilar) / Fresenius Kabi
Eye on Pharma: Fresenius Kabi launches biosimilar adalimumab, Idacio (Center for Biosimilars) – May 6, 2019 – “Fresenius Kabi, maker of the EU-authorized biosimilar adalimumab, Idacio, has launched its product in Germany. Fresenius Kabi has made the biosimilar available for sale in pre-filled syringe, pre-filled pen, and vial presentations.”

 

Humira (adalimumab) / Eisai, AbbVie; bimekizumab (UCB4940) / UCB
BE OPTIMAL: A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (clinicaltrials.gov) – May 7, 2019 – P3; N=840; Recruiting; Sponsor: UCB Biopharma S.P.R.L.; Not yet recruiting –> Recruiting

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Weekly Top News – Breast Cancer – May 6, 2019

May 6, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Updated OS data from P3 IMpassion031 trial (NCT03197935) for TNBC at ASCO 2019 (May 31 – June 4, 2019) (Cantor Fitzgerald) – May 3, 2019 – A subscription to Thomson ONE is required to gain full access to report 67171383; Page no: 1; REPORT TITLE: “Cantor daily research highlights”; AUTHOR: Research Department, et al; DATE: 04/24/2019

 

Tecentriq (atezolizumab) / Roche
GeparDouze/NSABP B-59: A randomized double-blind phase III clinical trial of neoadjuvant chemotherapy with atezolizumab or placebo in patients with triple negative breast cancer (TNBC) followed by adjuvant atezolizumab or placebo (ESMO-BC 2019) – May 5, 2019 – Abstract #122TiP; Pres time: May 3, 2019; 12:15 PM – 01:00 PM; Location: Exhibition area; P3; “…Accrual will be 1,520 randomized patients stratified by region (North America; Europe), tumor size (1.1-3.0 cm; > 3.0 cm), epirubicin or doxorubicin/cyclophosphamide (EC; AC) schedule (q2w; q3w), and nodal status (positive; negative). Patients are randomized 1:1 to receive atezolizumab 1200 mg or placebo IV every 3 weeks concurrently with sequential regimens of weekly paclitaxel 80 mg/m2 IV for 12 doses and every 3 week carboplatin AUC of 5 IV for 4 doses followed by AC/EC every 2-3 weeks (per investigator discretion) for 4 cycles…Main secondary endpoints include pCR breast, overall survival, distant disease-free survival, safety and toxicity. GeparDouze is performed as an academic collaboration between NSABP and GBG.”

 

Ibrance (palbociclib) / Pfizer
Ibrance: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in H2 2020 (Pfizer) – Apr 30, 2019 – Q1 2019 Results: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in H2 2020
[Screenshot]

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from P3 KEYNOTE-522 trial (NCT03036488) for TNBC in 2019 (Merck (MSD)) – Apr 30, 2019 – Q1 2019 Results: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in 2019
[Screenshot]

 

Talzenna (talazoparib) / Pfizer
Impact of objective response (OR) on patient-reported outcomes (PRO) in patients (pts) with advanced breast cancer (ABC) and a germline BRCA1/2 (gBRCA) mutation in the phase III EMBRACA trial (ESMO-BC 2019) – May 5, 2019 – Abstract #154O; Pres time: May 2, 2019; 05:20 PM – 05:25 PM; Location: Vienna Hall; “…Background: In EMBRACA, a randomised 2:1 phase 3 open-label study of pts with ABC and a gBRCA mutation, a statistically significant higher OR rate was observed with talazoparib (TALA) (n = 219) vs physician’s choice of chemotherapy (PCT; n = 114) (62.6% vs 27.2%; odds ratio, 5.0; 95% CI, 2.9, 8.8; P < 0.001)… Overall change from baseline and greater delay in TTD in GHS/QoL were observed favouring pts who experienced OR vs those who did not have OR. These results suggest that higher OR rates may lead to better overall improvement from baseline and greater delay in TTD in GHS/QoL in pts with ABC and a gBRCA mutation.”

 

Kadcyla (ado-trastuzumab emtansine) / Roche
FDA approves Genentech’s Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (Roche Press Release) – May 3, 2019 – “Genentech…announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin® (trastuzumab)-based treatment…The FDA rapidly reviewed and approved the application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs…This approval is based on results of the Phase III KATHERINE study…”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: Data from P2 monarcHER trial (NCT02675231) in metastatic breast cancer at the end of 2019 (Eli Lilly) – May 1, 2019 – Q1 2019 Results

 

capecitabine / generics; Avastin (bevacizumab) / Roche
Continuous chemotherapy improves outcomes and quality of life in advanced breast cancer [ESMO press release] (ESMO.org) – Apr 30, 2019 – P3, N=420; Stop&Go (NCT01935492); “The phase III study randomised 420 patients with advanced HER2-negative breast cancer to either an intermittent schedule (four cycles – ‘treatment holiday’ – another four cycles) or a continuous schedule comprised of the same eight cycles administered consecutively. Both first line treatment (paclitaxel plus bevacizumab) and second line treatment (capecitabine or non-pegylated liposomal doxorubicin) followed these schedules….Patients who started second line treatment (n=270; 131 vs. 139 in intermittent vs. continuous arms) demonstrated a median PFS in second line of 3.5 vs. 5.0 months respectively, with a hazard ratio (HR) of 1.04 (95%CI 0.69-1.57).”

 

Tecentriq (atezolizumab) / Roche
IMpassion031: A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer (clinicaltrials.gov) – Apr 29, 2019 – P3; N=324; Recruiting; Sponsor: Hoffmann-La Roche; Active, not recruiting –> Recruiting; N=204 –> 324; Trial completion date: Sep 2021 –> Jan 2023; Trial primary completion date: Mar 2019 –> Sep 2020

 

Prolia (denosumab) / Amgen, Daiichi Sankyo, GSK
A pragmatic, randomised, multicentre trial comparing 4-weekly vs. 12-weekly administration of bone-targeted agents (denosumab, zoledronate or pamidronate) in patients with bone metastases (ESMO-BC 2019) – May 5, 2019 – Abstract #LBA3; Pres time: May 2, 2019; 04:30 PM – 04:35 PM; Location: Vienna Hall; P4; “The findings of this trial are consistent with those previously reported for de-escalating ZA. This trial also included pts receiving de-escalated DN and PAM. While the results of the REDUSE trial are awaited, the data presented would suggest that de-escalation of commonly used BTAs is a reasonable treatment option.”

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