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Month: June 2019

Weekly Top News – Breast Cancer – June 24, 2019

June 24, 2019

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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Weekly Top News – IBD – June 24, 2019

June 24, 2019

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

 

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

 

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

 

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

 

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

 

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

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Weekly Top News – Psoriasis – June 24, 2019

June 24, 2019

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

 

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

 

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

 

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

 

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

 

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

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Weekly Top News – Psoriasis – June 17, 2019

June 17, 2019

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

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Weekly Top News – IBD – June 17, 2019

June 17, 2019

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

 

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

 

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

 

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

 

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

 

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

 

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

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Weekly Top News – Breast Cancer – June 17, 2019

June 17, 2019

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in late 2020 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Data from P3 PENELOPE-B trial (NCT01864746) for breast cancer in late 2020 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201: BLA submission for HER2 positive metastatic breast cancer previously treated with T-DM1 (based on DESTINY-Breast01 trial) in H1 FY2019 (Daiichi Sankyo) – Jun 13, 2019 – ASCO 2019: NDA submission in Japan for HER2 positive gastric cancer (based on DESTINY-Gastric01 trial) in H1 FY2020 
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Herceptin (trastuzumab) / Roche; pyrotinib (HTI-1001) / Jiangsu Hengrui Medicine
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (clinicaltrials.gov) – Jun 11, 2019 – P3; N=1192; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

 

Kanjinti (trastuzumab biosimilar) / Amgen, Daiichi Sankyo, Allergan
FDA approves Amgen and Allergan’s Kanjinti (trastuzumab-anns), a biosimilar to Herceptin (trastuzumab) (PRNewswire) – Jun 13, 2019 – “Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab): for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma…Approval based on totality of evidence demonstrating Kanjinti is biosimilar to Herceptin.”

 

Ibrance (palbociclib) / Pfizer
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate (clinicaltrials.gov) – Jun 14, 2019 – P3; N=131; Completed; Sponsor: Pfizer; Active, not recruiting –> Completed

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Primary completion of P3 PENELOPE-B trial (NCT01864746) for breast cancer in December 2020 and final completion of trial in November 2023 (Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

 

Kisqali (ribociclib) / Novartis; Afinitor (everolimus) / Novartis
Triplet therapy confers benefit among certain patients with advanced breast cancer (Healio) – Jun 13, 2019 – P1/2, N=107; TRINITI-1 (NCT02732119); Sponsor: Novartis Pharmaceuticals; ‘”Preclinical evidence suggests that the addition of everolimus (an mTOR inhibitor) to ribociclib (a CDK4/6 inhibitor) and exemestane (an aromatase inhibitor) may restore sensitivity to both CDK4/6 inhibitor and endocrine-based therapy,’ Aditya Bardia, MD, MPH…told HemOnc Today….Ninety-five patients (median age, 58 years; 81% white) who were refractory to endocrine-based therapy and progressed after receiving CDK4/6 inhibitors were evaluable as of Oct. 24, 2018…The triplet therapy [everolimus, ribociclib and exemestane] demonstrated a clinical benefit rate of 41.1% (95% CI, 31.1-51.5) at 24 weeks, which was four times the minimum threshold for the study. The disease control rate was 61.1% (95% CI, 50.7-70.9), and the overall response rate was 8.4% (95% CI, 3.7-15.9), including one complete response and seven partial responses. Median PFS was 5.7 months (95% CI, 3.6-9.1), with a 1-year…

 

Ibrance (palbociclib) / Pfizer
Ibrance clinical trial estimate: Primary completion of P3 PALLAS trial (NCT02513394) for HR+/HER2- breast cancer in September 2020 and final completion of trial in September 2025(Morgan Stanley) – Jun 13, 2019 – A subscription to Thomson ONE is required to gain full access to report 67445936; Page no: 10; REPORT TITLE: “Pfizer: Resuming at overweight ahead of accelerating growth”; AUTHOR: Risinger, David, et al; DATE: 06/04/2019

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Weekly Top News – Breast Cancer – June 10, 2019

June 10, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: “Tecentriq + nab-paclitaxel was well tolerated, with no cumulative toxicities and no new or late-onset safety signals”; Metastatic triple negative breast cancer (Roche) – Jun 4, 2019 – ASCO 2019: “Although not formally testable due to the pre-specified statistical analysis plan, updated median OS improvement from 18 to 25 months was observed in the PD-L1+ population (HR 0.71)”  
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Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P3 IMpassion 131 trial (NCT03125902) for 1L TNBC in H1 2020 (Cowen & Co) – Jun 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67405938; Page no: 1; REPORT TITLE: “Roche Holding Ltd.- Estimates raised on higher new product sales forecasts”; AUTHOR: Scala, Stephen, et al; DATE: 05/29/2019

 

Focus V (anlotinib) / Advenchen, Sino Biopharmaceutical; Keytruda (pembrolizumab) / Merck (MSD)
Clinical Study on the Second-line and Above Treatment of Advanced Solid Tumor With Anlotinib Combined With Pd-1 Antibody (clinicaltrials.gov) – Jun 5, 2019 – P2/3; N=100; Recruiting; Sponsor: Henan Cancer Hospital

 

Nerlynx (neratinib) / Puma
Puma Biotechnology presents results from phase III NALA trial of neratinib in patients with HER2-positive metastatic breast cancer at the ASCO 2019 Annual Meeting (Businesswire) – Jun 4, 2019 – P3, N=621; NALA (NCT01808573); Sponsor: Puma Biotechnology; “For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (hazard ratio=0.76, p=0.0059) compared to treatment with lapatinib plus capecitabine…For the primary analyses of OS, neratinib plus capecitabine resulted in an improvement in OS that trended positively in favor of the neratinib plus capecitabine arm of the study (hazard ratio = 0.88, p=0.21)…Puma plans to submit its New Drug Application to the U.S. Food and Drug Administration based on the Phase III NALA trial results in the second quarter/third quarter of 2019.”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: “Margetuximab plus chemotherapy improved PFS (CBA: HR=0.76, P=0.033; Inv: HR=0.70, P=0.001), ORR, and CBR, compared with trastuzumab plus chemotherapy”; Breast cancer(Macrogenics) – Jun 5, 2019 – ASCO 2019: “Enhanced PFS benefit with margetuximab in exploratory subpopulation of low-affinity CD16A-158F carriers (HR=0.68, P=0.005)”  
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Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Data from P3 IMpassion 131 trial (NCT03125902) for 1L TNBC in September 2020 (Barclays) – Jun 6, 2019 – A subscription to Thomson ONE is required to gain full access to report 67382590; Page no: 13; REPORT TITLE: “European Pharmaceuticals: IO: Bringing its power to bear in the realm of curative intent”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 05/24/2019

 

Kadcyla (ado-trastuzumab emtansine) / Roche; tucatinib (ARRY-380) / Seattle Genetics
A Study of Tucatinib vs. Placebo in Combination With Trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer (clinicaltrials.gov) – Jun 5, 2019 – P3; N=460; Not yet recruiting; Sponsor: Seattle Genetics, Inc.

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Regulatory approval in US for 3/4 L HER2 positive metastatic breast cancer in 2020(Macrogenics) – Jun 5, 2019 – ASCO 2019: Regulatory submission in EU in 3/4 L HER2 positive metastatic breast cancer in 2020  
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Tecentriq (atezolizumab) / Roche
Roche presents data from across its breast cancer portfolio at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Roche Press Release) – Jun 3, 2019 – P3, N=900; IMpassion130 (NCT02425891); Sponsor: Hoffmann-La Roche; “Data include results from the second overall survival (OS) interim analysis from the phase III IMpassion130 study evaluating Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®[paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the initial (first-line) treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)….At the second interim analysis, statistical significance was not met for overall survival (OS) in the intention-to-treat (ITT) population (median OS=21.0 vs 18.7 months; HR=0.86, 95% CI: 0.72-1.02, p=0.078).”

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Weekly Top News – IBD – June 10, 2019

June 10, 2019

ozanimod (RPC1063) / Celgene
Ozanimod clinical trial estimate: Primary data from study 1 of P3 trial (NCT03440372) for moderate to severe Crohn’s disease in mid-2020 (Credit Suisse) – Jun 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407582; Page no: 8; REPORT TITLE: “BMY: Conversation evolving on “Brist-ene”, but we remain on the sidelines”; AUTHOR: Divan, Vamil, et al; DATE: 05/29/2019

 

ozanimod (RPC1063) / Celgene
Ozanimod exclusivity expiry: 2034 (Credit Suisse) – Jun 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407582; Page no: 9; REPORT TITLE: “BMY: Conversation evolving on “Brist-ene”, but we remain on the sidelines”; AUTHOR: Divan, Vamil, et al; DATE: 05/29/2019

 

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

 

ravagalimab (ABBV-323) / AbbVie
A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy (clinicaltrials.gov) – Jun 7, 2019 – P2; N=40; Recruiting; Sponsor: AbbVie; N=68 –> 40

 

ozanimod (RPC1063) / Celgene
Ozanimod clinical trial estimate: Primary data from P3 trial (NCT03464097) for moderate to severe Crohn’s disease in mid-to-late 2021 (Credit Suisse) – Jun 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67407582; Page no: 8; REPORT TITLE: “BMY: Conversation evolving on “Brist-ene”, but we remain on the sidelines”; AUTHOR: Divan, Vamil, et al; DATE: 05/29/2019

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Weekly Top News – Psoriasis – June 10, 2019

June 10, 2019

pegcantratinib (SNA-120) / Bio3 Research, Sienna
SNA-120, A Novel Topical Non-steroidal Therapy for Psoriasis and Associated Pruritus that Targets the NGF/TrkA Pathway: Results from a Multicenter Phase 2b Study (WCD 2019) – Jun 9, 2019 – Pres time: Jun 15, 2019; 10:35 AM – 10:45 AM; Location: YELLOW 3; No abstract available.

 

Taltz (ixekizumab) / Eli Lilly
Lilly to present new data and commitment to patient-centered solutions at the Annual European Congress of Rheumatology (Eli Lilly Press Release) – Jun 6, 2019 – “Eli Lilly…will present data for Taltz® (ixekizumab) and Olumiant® (baricitinib) at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid from June 12-15, 2019….The data include clinical studies of Taltz in the treatment of patients with psoriatic arthritis…Lilly will share in a late-breaking oral presentation the detailed results from the SPIRIT-H2H study…”

 

mirikizumab (LY3074828) / Eli Lilly; Taltz (ixekizumab) / Eli Lilly
Lilly to showcase scientific innovation within dermatology portfolio at 24th World Congress of Dermatology (Eli Lilly Press Release) – Jun 5, 2019 – “Eli Lilly and Company…will present data for Taltz (ixekizumab)…mirikizumab at the 24th World Congress of Dermatology (WCD) taking place June 10-15, 2019 in Milan, Italy….The data include 11 abstracts reflecting clinical studies of Taltz…Lilly will share short- and long-term health outcomes data, as well as long-term data on efficacy in patients with scalp psoriasis, from the Phase 2 clinical program of its investigational medicine mirkizumab for the treatment of moderate-to-severe plaque psoriasis.”

 

Tremfya (guselkumab) / J&J
Tremfya pricing: Average retail price of $11,800/1ml in US and €12,000/1ml in Portugal (Infinata) – Jun 7, 2019 – A subscription to Thomson ONE is required to gain full access to report 67022679; Page no: 14; REPORT TITLE: “AbbVie Inc. – Company Report”; AUTHORInfinata, et al; DATE: 06/03/2019

 

piclidenoson (CF101) / Can-Fite, China Medical System
Can-Fite participating in one-on-one partnering meetings at the BIO International Convention on June 3-6, 2019 (Can-Fite Biopharma Press Release) – Jun 4, 2019 – “Can-Fite BioPharma…announced today that the Company’s VP of Business Development, Sari Fishman, is conducting one-on-one meetings with pharmaceutical companies for potential distribution and partnerships for the Company’s drug candidates, Piclidenoson and Namodenoson, at the BIO International Convention 2019 on June 3-6, 2019 in Philadelphia….The Company currently has out-licensing agreements in several territories and has received approximately $17 million in upfront and milestone payments to date.”

 

Otezla (apremilast) / Celgene
Otezla sales projection: Tracking at $507M (US: $411M, ex-US: $96M) in Q2 2019 (RBC Capital Markets (Canada)) – Jun 4, 2019 – A subscription to Thomson ONE is required to gain full access to report 67384271; Page no: 3; REPORT TITLE: “Biotech: Noteworthy wkly Rx trends/forecast (HIV, HCV, MS, CGRP, TKI, Otezla): RBC biotech coverage w/e 5/17 – Wk 7 of 2Q”; AUTHOR: Abrahams, Brian, et al; DATE: 05/24/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx sales projection: $6B in 2022 (Jefferies) – Jun 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67382641; Page no: 1; REPORT TITLE: “Novartis AG – Our key takeaways from upbeat meet the management event”; AUTHOR: Welford, Peter, et al; DATE: 05/24/2019

 

Otezla (apremilast) / Celgene
Otezla sales projection: $1.9B in 2019 (Zacks) – Jun 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67403127; Page no: 6; REPORT TITLE: “Celgene Corporation(CELG) Zacks company report”; AUTHOR: Research Department; DATE: 05/28/2019

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Weekly Top News – Breast Cancer – June 3, 2019

June 3, 2019

letrozole / generics
A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer (clinicaltrials.gov) – May 29, 2019 – P3; N=426; Not yet recruiting; Sponsor: Jiangsu HengRui Medicine Co., Ltd.

 

Keytruda (pembrolizumab) / Merck (MSD)
Imprime PGG + Keytruda: “Imprime PGG in combination with pembrolizumab shows promising clinical benefit in previously-treated, metastatic TNBC patients”; Triple negative breast cancer (Biothera) – Jun 2, 2019 – ASCO 2019: “Clinical response is evident as early as 6 weeks on treatment”  

 

 

Ibrance (palbociclib) / Pfizer
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer (clinicaltrials.gov) – May 31, 2019 – P3; N=200; Not yet recruiting; Sponsor: Kyoto Breast Cancer Research Network

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda clinical trial estimate: Data from P3 KEYNOTE-355 trial (NCT02819518) for 1L TNBC in Q4 2019 (Barclays) – Jun 1, 2019 – A subscription to Thomson ONE is required to gain full access to report 67382590; Page no: 33; REPORT TITLE: “European Pharmaceuticals: IO: Bringing its power to bear in the realm of curative intent”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 05/24/2019

 

Hervelous (trastuzumab biosimilar) / Alvogen, Prestige BioPharma Pte Ltd, Hanwha Chem
European Medicines Agency accepts Marketing Authorisation Application for Prestige BioPharma’s trastuzumab biosimilar HD201 for review (PharmiWeb) – May 28, 2019 – “Prestige BioPharma (herein, Prestige) announced that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue®). HD201…is indicated for the treatment of adult patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma….positive top-line results from the Phase I / Phase III global clinical trial of HD201 confirm that HD201 is exceptionally biosimilar to Herceptin in terms of clinical response and PK, in addition to a comparable safety profile to the range previously observed in other trastuzumab biosimilar trials.”

 

Kisqali (ribociclib) / Novartis
Novartis Kisqali significantly extends life in women with HR+/HER2- advanced breast cancer in MONALEESA-7 trial (GlobeNewswire) – Jun 1, 2019 – P3, N=672; MONALEESA-7 (NCT02278120); Sponsor: Novartis Pharmaceuticals; “The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy…as initial treatment compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer…The significant extension in survival met the early efficacy stopping criteria at a pre-specified interim analysis following 192 deaths (median OS, not reached vs. 40.9 [95% CI: 37.8-NE] months; HR=0.712 [0.535-0.948]; p=0.00973). Overall survival rates in the intent-to-treat population (n=672) at 42 months were 70.2% for Kisqali combination therapy compared to 46.0% for endocrine therapy alone. At the time of data cut-off, 35% of women taking Kisqali combination therapy were continuing the treatment. No new safety signals were observed.”

 

Halaven (eribulin mesylate) / Eisai
New study investigating Halaven (eribulin) in metastatic breast cancer (Pharmafield) – May 31, 2019 – “Eisai Europe Ltd and MedSIR have announced a new study investigating Halaven ® (eribulin) treatment efficacy in metastatic breast cancer (MBC)…The REVERT study will investigate the clinical activity of Halaven® (eribulin) in MBC and will investigate the efficacy of a combined endocrine-chemotherapy therapeutic approach in the condition….The first data readout from the REVERT study investigating Halaven ® (eribulin) treatment efficacy in metastatic breast cancer is estimated to be in late 2021.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology presents interim results of phase II CONTROL trial of neratinib in extended adjuvant treatment of HER2-positive early stage breast cancer at the ASCO 2019 Annual Meeting (Businesswire) – Jun 2, 2019 – P2, N=137; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “The results of the trial showed that the incidence of grade 3 diarrhea for the 137 patients who received the loperamide prophylaxis was 30.7% and that for the 137 patients in this cohort, 20.4% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 3 days. For the 64 patients who received the combination of loperamide plus budesonide, the results of the trial showed that the incidence of grade 3 diarrhea was 28.1% and that for the 64 patients in this cohort, 10.9% discontinued neratinib due to diarrhea. The median cumulative duration of grade 3 diarrhea was 2.5 days.”

 

Kisqali (ribociclib) / Novartis
BioItaLEE: Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole(clinicaltrials.gov) – May 28, 2019 – P3; N=287; Active, not recruiting; Sponsor: Novartis Pharmaceuticals; Recruiting –> Active, not recruiting; Trial completion date: Oct 2021 –> Nov 2022; Trial primary completion date: Oct 2021 –> Dec 2020

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