fbpx

The Digest

Pharma news roundup and Larvol updates

Contact Us
Month: October 2019

Weekly Top News – Breast Cancer – October 28, 2019

October 28, 2019

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory submissions in Japan for ovarian cancer, muscle-invasive urothelial cancer (adjuvant) and hepatocellular cancer in 2020 (Chugai) – Oct 25, 2019 – Q3 2019 Results: Regulatory submissions in Japan for early breast cancer and NSCLC (neoadjuvant) in 2021 
[Screenshot]

 

Imfinzi (durvalumab) / AstraZeneca, Celgene
Imfinzi: P2 data from P1/2 BEGONIA trial (NCT03742102) for 1L metastatic TNBC in H2 2020 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P1/2 STUDY 1108 (NCT01693562) in advanced solid tumors in H2 2019 
[Screenshot]

 

Piqray (alpelisib) / Novartis
Piqray: CHMP opinion in EU for breast cancer in H1 2020 (Novartis) – Oct 22, 2019 – Q3 2019 Results 
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data from P3 DESTINY-Breast02 trial (NCT03523585) for pre-treated HER2 breast cancer in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive, unresectable and/or metastatic breast cancer in 2021 
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data from P3 DESTINY-Breast04 trial (NCT03734029) for HER2-low, unresectable and/or metastatic breast cancer in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Data from P2 DESTINY-Gastric01 trial (NCT03329690) for HER2-overexpressing advanced gastric cancer in H1 2020 
[Screenshot]

 

Kisqali (ribociclib) / Novartis
Kisqali: Regulatory submission for HR+, HER2(-) breast cancer (adjuvant) in 2023 or later (Novartis) – Oct 22, 2019 – Q3 2019 Results 
[Screenshot]

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Acceptance of regulatory submission for pre-treated HER2 breast cancer (based on DESTINY-Breast02 trial) in 2021 (AstraZeneca) – Oct 24, 2019 – Q3 2019 Results: Acceptance of regulatory submission for HER2-positive/negative unresectable and/or metastatic breast cancer (based on DESTINY-Breast03, DESTINY-Breast04 trial) in 2021 or later 
[Screenshot]

 

margetuximab (MGAH 22) / MacroGenics
MacroGenics Announces Second Interim Overall Survival Data from Phase 3 SOPHIA Study of Margetuximab in Patients with HER2-Positive Metastatic Breast Cancer (GlobeNewswire, MacroGenics, Inc.) – Oct 22, 2019 – P3, N=624; SOPHIA (NCT02492711); Sponsor: MacroGenics; “Among the approximately 85% of patients carrying a CD16A 158F allele, the median OS was prolonged by 4.3 months in the margetuximab arm compared to the trastuzumab arm (23.7 months versus 19.4 months; HR=0.793; 95% CI: 0.607-1.035; p=0.087). Among the approximately 15% of patients who were homozygous for the CD16A 158V allele, the trastuzumab arm performed better than the margetuximab arm. The final pre-specified OS analysis is planned after 385 events have accrued, which is projected to occur in 2020. The first sequential primary endpoint of progression-free survival (PFS) in the ITT population was achieved, with statistical significance as previously reported.”

 

Kisqali (ribociclib) / Novartis
Women living with metastatic breast cancer in British Columbia now have public access to Kisqali (Canada Newswire) – Oct 23, 2019 – “Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that British Columbia will now reimburse KISQALI® (ribociclib) for eligible patients in combination with an aromatase inhibitor (letrozole) under its provincial public drug program (complete British Columbia reimbursement criteria can be accessed here). For women living with metastatic breast cancer, also known as Stage IV breast cancer, the cancer has spread beyond the breast to other areas of the body, such as the lungs, liver, bones or brain.”

 

Herzuma (trastuzumab biosimilar) / Nippon Kayaku, Pfizer, Mundipharma, Celltrion, Teva
Celltrion launches Herzuma in Brazil (Korea Biomedical Review) – Oct 25, 2019 – “Celltrion Healthcare said that it has launched its anticancer antibody biosimilar Herzuma in Brazil…Brazil is a primary pharmaceutical market for the trastuzumab medicine worth about 270 billion won ($230 million)….company is preparing for direct sales of Herzuma, also in Colombia, Mexico, Chile, and Peru.”

Read More …

Weekly Top News – IBD – October 28, 2019

October 28, 2019

Stelara (ustekinumab) / J&J
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (PRNewswire) – Oct 21, 2019 – “The Janssen Pharmaceutical Companies…announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission.”

 

filgotinib (GLPG0634) / Gilead
Filgotinib: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in Q2 2020 (Gilead) – Oct 25, 2019 – Q3 2019 Results 
[Screenshot]

 

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Initiation of P2b/3 CULTIVATE trial for Crohn’s disease in Q4 2019 (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68024735; Page no: 3; REPORT TITLE: “Companies, catalysts and controversies: Top questions for management at our upcoming global healthcare conference”; AUTHOR: Research Department; DATE: 09/29/2019

 

Stelara (ustekinumab) / J&J
Stelara (ustekinumab) data demonstrate long-term efficacy and safety results in adults with moderately to severely active ulcerative colitis in phase 3 extension trial (Businesswire) – Oct 21, 2019 – P3, N=399; UNIFI (NCT02407236); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies…announced new two-year data from the long-term extension of the Phase 3 UNIFI study, demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis (UC). These data are being presented today as a late-breaking data presentation (LB01) at the 27th UEGW congress…Results showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission…Results from the UNITI Crohn’s disease (CD) clinical trial programme are also being presented at the congress.”

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals presented new data analyses demonstrating the long-term safety and efficacy of once-daily etrasimod in patients with moderately to severely active ulcerative colitis at UEG Week (PRNewswire) – Oct 22, 2019 – P2, N=156; OASIS (NCT02447302); Sponsor: Arena Pharmaceuticals; “Arena Pharmaceuticals, Inc…resented new open-label extension data from the Phase 2 OASIS trial for its investigative drug candidate etrasimod…in patients with moderately to severely active ulcerative colitis (UC) at the 25th Annual United European Gastroenterology (UEG) Week…’We are delighted to see that most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 experienced sustained or improved effects up to week 46….Etrasimod also demonstrated a favorable safety profile, consistent with safety findings reported in the double-blind portion of OASIS,'”

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 VIVID-1 trial (NCT03926130) for Crohn’s disease in Feb 2022 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 VIVID-1 trial for Crohn’s disease in Jul 2023; Completion of P3 OASIS-1 trial (NCT03482011) in moderate-to-severe plaque psoriasis in Feb 2020 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 1 trial (NCT03518086) in moderate-to-severe ulcerative colitis in Sep 2020 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 LUCENT 1 trial in moderate-to-severe ulcerative colitis in Dec 2021; Primary completion and completion of P2 SHINE 1 trial (NCT04004611) in children and teenagers with ulcerative colitis in Aug 2022 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 LUCENT 2 trial (NCT03524092) in moderate-to-severe ulcerative colitis in Jun 2021 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 LUCENT 2 trial in moderate-to-severe ulcerative colitis in Jun 2023; Primary completion and completion of P3 LUCENT 3 trial (NCT03519945) in moderate-to-severe ulcerative colitis in Aug 2023 
[Screenshot]

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma to present new phase 3 data on RHB-105 and RHB-104 at the American College of Gastroenterology 2019 Annual Meeting (GlobeNewswire) – Oct 28, 2019 – “RedHill Biopharma Ltd…announced that two oral presentations and two posters on two of the Company’s leading drug candidates, RHB-1051 (Talicia®, H. pylori infection) and RHB-104 (Crohn’s disease) will be presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting, being held October 25-30, in San Antonio, Texas.”

 

etrasimod (APD334) / Arena
Etrasimod US sales projection: $665M peak for ulcerative colitis (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68047432; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals Inc – Management dinner takeaways”; AUTHOR: Research Department; DATE: 10/03/2019

Read More …

Weekly Top News – Psoriasis – October 28, 2019

October 28, 2019

Tremfya (guselkumab) / J&J
Janssen brings to Spain Tremfya One-Press for the treatment of psoriasis [Google Translation] (Redacción Médica) – Oct 22, 2019 – “Janssen Pharmaceutical Companies of Johnson & Johnson has announced the commercialization in Spain of the Tremfya One-Press pre-filled pen, a new self-injectable administration device for guselkumab, indicated for the treatment of moderate to severe plaque psoriasis in adult candidates for systemic treatment….Designed to facilitate the time of the self-injection of patients with psoriasis.”

 

Tremfya (guselkumab) / J&J
Janssen seeks to expand use of Tremfya (guselkumab) in the treatment of adults with active psoriatic arthritis (Businesswire) – Oct 23, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Type II Variation Application to the European Medicines Agency (EMA) seeking first-in-class approval of TREMFYA (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA).”

 

Cosentyx (secukinumab) / Novartis
Novartis delivered another strong quarter with double digit sales growth and core1 margin expansion; 2019 sales and profit guidance raised; Beovu launched in US (GlobeNewswire) – Oct 22, 2019 – “Continuing operations net sales up 13% (cc1, +10% USD) driven by: Cosentyx sales of USD 937 million (+27% cc), with strong demand across indications and regions…Cosentyx met primary endpoints in nr-axSpA…FDA submission planned for Q4.”

 

Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) in pediatric patients with moderate to severe plaque psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (GlobeNewswire) – Oct 28, 2019 – P3, N=201; “Eli Lilly and Company announced that TALTZ met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis…Results of the study were presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain. Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.”

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 VIVID-1 trial (NCT03926130) for Crohn’s disease in Feb 2022 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 VIVID-1 trial for Crohn’s disease in Jul 2023; Completion of P3 OASIS-1 trial (NCT03482011) in moderate-to-severe plaque psoriasis in Feb 2020 
[Screenshot]

 

mirikizumab (LY3074828) / Eli Lilly
Mirikizumab: Primary completion of P3 OASIS-2 trial (NCT03535194) in moderate-to-severe plaque psoriasis in Mar 2020 (Eli Lilly) – Oct 23, 2019 – Q3 2019 Results: Completion of P3 OASIS-2 trial in moderate-to-severe plaque psoriasis in Dec 2020; Primary completion and completion of P3 OASIS-3 trial (NCT03556202) in moderate-to-severe plaque psoriasis in May 2024 
[Screenshot]

 

GSK2831781 / GSK
GSK2831781 clinical trial estimate: Primary completion of P1 trial for healthy volunteers in Japan in January 2020 (GlobalData) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67598395; Page no: 176; REPORT TITLE: “Immutep Ltd (IMM) – Financial analysis review”; AUTHOR: Globaldata; DATE: 09/24/2019

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Completion of P3b trial (NCT03504852) for psoriasis in H2 2020 (Novartis) – Oct 22, 2019 – Q3 2019 Results: Completion of P3 MATURE trial (NCT03589885) for psoriasis in H2 2020 
[Screenshot]

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Completion of P3 trial (NCT02471144) for psoriasis in 2023 (Novartis) – Oct 22, 2019 – Q3 2019 Results: Completion of P3 trial (NCT03668613) for psoriasis in 2023 
[Screenshot]

 

Cosentyx (secukinumab) / Novartis
Cosentyx: Completion of P3 trial (NCT03031782) for psoriatic arthritis in 2021 (Novartis) – Oct 22, 2019 – Q3 2019 Results 
[Screenshot]

Read More …

Weekly Top News – Breast Cancer – October 21, 2019

October 21, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
Trastuzumab deruxtecan granted FDA Priority Review for treatment of patients with HER2-positive metastatic breast cancer (AstraZeneca Press Release) – Oct 16, 2019 – “AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date for trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-positive metastatic breast cancer, is set for the second quarter of 2020.”

 

Lynparza (olaparib) / Merck (MSD), AstraZeneca; Keytruda (pembrolizumab) / Merck (MSD)
Olaparib Plus Pembrolizumab as Post-Induction Therapy in Triple Negative Breast Cancer Olaparib plusz pembrolizumab posztindukciós terápiaként tripla negatív emlőrákban (clinicaltrialsregister.eu) – Oct 17, 2019 – P2/3; N=317; Ongoing; Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc

 

Tecentriq (atezolizumab) / Roche
Tecentriq: Regulatory submissions in US/EU for neoadjuvant HER2+ breast cancer in 2022 or later (Roche) – Oct 16, 2019 – Q3 2019 Results: Regulatory submissions in US/EU in combination with capecitabine or carboplatin/gemicitabine for TNBC in 2022 or later 
[Screenshot]

 

Piqray (alpelisib) / Novartis
Piqray: Regulatory approval in EU for HR+/HER2- advanced breast cancer in 2020 (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
[Screenshot]

 

Kisqali (ribociclib) / Novartis
Kisqali: “The P value of 0.00455 crossed the prespecified boundary to claim superior efficacy (P < 0.01129)”; Advanced breast cancer (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
[Screenshot]

 

Zejula (niraparib) / GSK, J&J, Takeda
Clovis’ Rubraca approved for Cancer Drugs Fund (PharmaTimes) – Oct 14, 2019 – “NICE has also recently recommended niraparib as a treatment for this patient group and olaparib tablets for the BRCA-positive subgroup, both for use in the CDF.”

 

Keytruda (pembrolizumab) / Merck (MSD)
Keytruda regulatory estimate: Approval for TNBC in 2020 (J.P. Morgan) – Oct 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 68079155; Page no: 5; REPORT TITLE: “Merck & Co., Inc.: Does Keytruda concentration cap MRK’s multiple? We see shares as cheap on sotp basis”; AUTHOR: Schott, Christopher, et al; DATE: 10/10/2019

 

Perjeta (pertuzumab) / Roche; Tecentriq (atezolizumab) / Roche; Rozlytrek (entrectinib) / Roche
Roche reports very strong sales growth in the first nine months of 2019 – outlook raised (GlobeNewswire) – Oct 16, 2019 – “Pharmaceuticals Division sales up 12%, driven by high demand for recently launched medicines, mainly Ocrevus, Hemlibra, Tecentriq and Perjeta…New treatment options and diagnostic test approved in the third quarter….in the US Rozlytrek for lung cancer with a specific gene mutation and solid tumours carrying a certain gene fusion; in the EU three new indications for Tecentriq: for a certain type of breast cancer; for the initial treatment of non-small cell as well as small cell lung cancer”

 

Keytruda (pembrolizumab) / Merck (MSD); AE 37 / Generex
Generex Biotechnology announces merger with public vehicle for public trading of NuGenerex Immuno-Oncology (GlobeNewswire) – Oct 15, 2019 – “Generex has positioned its wholly-owned cancer subsidiary NuGenerex Immuno-Oncology to be merged with the public company, thereby completing the company’s go-public strategy to realize the value of the Ii-Key technology and AE37 immunotherapeutic vaccine program. NGIO is currently enrolling a Phase II trial to establish the recommended biologic dose for AE37 Peptide Vaccine in combination with Keytruda® (Pembrolizumab) that will enhance the tumor-specific immune response and demonstrate efficacy in patients with advanced triple-negative breast cancer (NSABP FB-14); the trial is currently screening and enrolling patients at multiple clinical research sites.”

 

Opdivo (nivolumab) / Ono Pharma, BMS; Keytruda (pembrolizumab) / Merck (MSD)
Uruguay to request inclusion of Opdivo, Keytruda into PAHO’s Strategic Fund (GBI Health) – Oct 14, 2019 – “According to Alicia Ferreira, head of Uruguay’s National Resources Fund (FNR), the country will call for the Pan American Health Organization (PAHO) to include Bristol-Myers Squibb (BMS)’s Opdivo (nivolumab) and Merck, Sharp & Dohme (MSD)’s Keytruda (pembrolizumab) into the Strategic Fund. The petition will be made at the next meeting of member countries, to which Janssen and MSD, the main manufacturers of Opdivo and Keytruda respectively, will be invited…The drugs, which have a monthly cost of about USD 13,000, will initially be used to treat melanoma, although their coverage will later be extended to include breast cancer and other tumors.”

Read More …

Weekly Top News – IBD – October 21, 2019

October 21, 2019

Stelara (ustekinumab) / J&J
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis (PRNewswire) – Oct 21, 2019 – “The Janssen Pharmaceutical Companies…announced today the U.S. Food and Drug Administration’s (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The approval for this new indication is based on the pivotal Phase 3 UNIFI clinical trial which achieved its primary endpoint of clinical remission.”

 

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Initiation of P2b/3 CULTIVATE trial for Crohn’s disease in Q4 2019 (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68024735; Page no: 3; REPORT TITLE: “Companies, catalysts and controversies: Top questions for management at our upcoming global healthcare conference”; AUTHOR: Research Department; DATE: 09/29/2019

etrolizumab (RG7413) / Roche
Etrolizumab: Regulatory submissions in US/EU for Crohn’s disease in 2022 or later (Roche) – Oct 16, 2019 – Q3 2019 Results 
[Screenshot]

 

Stelara (ustekinumab) / J&J
Stelara (ustekinumab) data demonstrate long-term efficacy and safety results in adults with moderately to severely active ulcerative colitis in phase 3 extension trial (Businesswire) – Oct 21, 2019 – P3, N=399; UNIFI (NCT02407236); Sponsor: Janssen Research & Development, LLC; “The Janssen Pharmaceutical Companies…announced new two-year data from the long-term extension of the Phase 3 UNIFI study, demonstrating the efficacy and safety of ustekinumab through two years of treatment in adults with moderately to severely active ulcerative colitis (UC). These data are being presented today as a late-breaking data presentation (LB01) at the 27th UEGW congress…Results showed that the majority of patients were able to sustain remission through to week 92 as assessed by symptomatic remission…Results from the UNITI Crohn’s disease (CD) clinical trial programme are also being presented at the congress.”

 

Alofisel (darvadstrocel) / Takeda
Approved a drug with stem cells for Crohn’s fistulas [Google Translation] (Webconsultas Healthcare) – Oct 18, 2019 – “Spanish researchers have discovered and developed a drug, darvadstrocel (marketed as Alofisel ), made with stem cells obtained from donor fat to treat complex perianal fistulas in patients with Crohn’s disease…This medicine…is the first allogeneic cell therapy approved in Europe, is already approved by the Ministry of Health, Consumption and Social Welfare and will be funded by Social Security.”

 

BMS-986165 / BMS
BMS-986165 sales projection: $2.4B in 2027 (Guggenheim) – Oct 15, 2019 – A subscription to Thomson ONE is required to gain full access to report 68074910; Page no: 19; REPORT TITLE: “3Q global pharma preview: Another solid quarter likely tempered by politics & policy”; AUTHOR: Fernandez, Seamus, et al; DATE: 10/09/2019

 

etrasimod (APD334) / Arena
Arena Pharmaceuticals’ presence at United European Gastroenterology Week bolsters commitment to the gastrointestinal disease community (Arena Press Release) – Oct 18, 2019 – “Arena Pharmaceuticals, Inc…will present new open-label extension data from the Phase 2 OASIS trial for its investigative drug candidate etrasimod…in patients with moderately to severely active ulcerative colitis (UC) at the 25th Annual United European Gastroenterology (UEG) Week…UEG Week is taking place October 19-23, 2019, in Barcelona, Spain.”

 

etrasimod (APD334) / Arena
Etrasimod US sales projection: $665M peak for ulcerative colitis (Cantor Fitzgerald) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 68047432; Page no: 2; REPORT TITLE: “Arena Pharmaceuticals Inc – Management dinner takeaways”; AUTHOR: Research Department; DATE: 10/03/2019

 

Otezla (apremilast) / Amgen
Otezla WW revenue projection: $1,917M in 2019 (Jefferies) – Oct 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 68079059; Page no: 30; REPORT TITLE: “Q3 EPS and thoughts into year-end”; AUTHOR: Yee, Michael, et al; DATE: 10/10/2019

 

Rinvoq (upadacitinib) / AbbVie; Xeljanz (tofacitinib) / Pfizer
In a U-turn, ICER takes more positive view of AbbVie’s Rinvoq (PMLive) – Oct 14, 2019 – “The Institute for Clinical and Economic Review (ICER) has shifted its position on the value of AbbVie’s Rinvoq (upadacitinib), bringing the rheumatoid arthritis drug under its quality-adjusted life-year (QALY) threshold….ICER has changed some of the parameters and inputs for the value models described in the report…Under the revised model, the incremental QALY for Rinvoq versus Humira came in at $92,000, below the $150,000 threshold used by ICER….Notably, the statement that Rinvoq ‘provided marginal clinical benefit…The revised report also retains a skeptical view about the value of Xeljanz and Olumiant….One of ICER’s independent committees will discuss the document and hold a vote on it in December.”

Read More …

Weekly Top News – Psoriasis – October 21, 2019

October 21, 2019

Tremfya (guselkumab) / J&J
Janssen presents new four-year Tremfya (guselkumab) data demonstrating maintained rates of skin clearance in adult patients with moderate to severe plaque psoriasis (PRNewswire) – Oct 17, 2019 – P3, N=837; VOYAGE 1 (NCT02207231); Sponsor: Janssen; “The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the Phase 3 VOYAGE 1 clinical trial. These data showed that 82 percent of patients receiving TREMFYA® (guselkumab) in the combined group of patients initially randomized to TREMFYA or to placebo with crossover to TREMFYA at week 16 achieved at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90) response and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at week 204 (4 years)….The data are being presented at the 39th Fall Clinical Dermatology Conference in Las Vegas, Nevada.”

 

Tremfya (guselkumab) / J&J
Guselkumab, an Anti-interleukin-23p19 Monoclonal Antibody, in Biologic-naïve Patients with Active Psoriatic Arthritis: Week 24 Results of the Phase 3, Randomized, Double-blind, Placebo-controlled Study (ACR-ARHP 2019) – Oct 19, 2019 – Pres time: Nov 12, 2019; 09:00 AM – 11:00 AM; Location: Hall B5; “In pts with active PsA, GUS Q4W and Q8W significantly improved joint and skin symptoms, physical function, and quality of life, and resolved enthesitis/dactylitis. GUS Q4W significantly reduced radiographic damage progression vs. PBO.”

 

Tremfya (guselkumab) / J&J
Guselkumab, an Anti-interleukin-23p19 Monoclonal Antibody, in Biologic-naïve Patients with Active Psoriatic Arthritis: Week 24 Results of the Phase 3, Randomized, Double-blind, Placebo-controlled Study (ACR-ARHP 2019) – Oct 19, 2019 – Abstract #L13; Pres time: Nov 12, 2019; 09:00 AM – 11:00 AM; Location: Hall B5; “In pts with active PsA, GUS Q4W and Q8W significantly improved joint and skin symptoms, physical function, and quality of life, and resolved enthesitis/dactylitis. GUS Q4W significantly reduced radiographic damage progression vs. PBO.”

 

Stelara (ustekinumab) / J&J; bimekizumab (UCB4940) / UCB
Bimekizumab phase 3 psoriasis study meets all endpoints, achieving significantly greater efficacy versus placebo and ustekinumab (PRNewswire) – Oct 17, 2019 – P3, N=570; BE VIVID (NCT03370133); Sponsor: UCB Biopharma; “UCB…today announced positive results from BE VIVID, the first of three Phase 3 studies evaluating the efficacy and safety of bimekizumab…in the treatment of adults with moderate-to-severe chronic plaque psoriasis….We look forward to sharing further findings from the bimekizumab clinical development program in the coming months.”

 

Xeljanz (tofacitinib) / Pfizer
Tofacitinib as Monotherapy Following Methotrexate Withdrawal in Patients with Psoriatic Arthritis Previously Treated with Open-label Tofacitinib + Methotrexate: A Randomized, Placebo-controlled Sub-study of OPAL Balance (ACR-ARHP 2019) – Oct 19, 2019 – Abstract #L14; Pres time: Nov 12, 2019; 09:00 AM – 11:00 AM; Location: Hall B5; P3; “In general, no clinically meaningful differences in efficacy and safety were observed in pts with PsA who received OL tofacitinib 5 mg BID as monotherapy after MTX withdrawal vs with continued MTX. No new safety risks were identified. Limitations include that the sub‑study was designed as an estimation study and not powered for hypothesis testing, and only pts on long-term treatment who had responded well to, and tolerated, tofacitinib and MTX were included.”

 

Xeljanz (tofacitinib) / Pfizer
Tofacitinib as Monotherapy Following Methotrexate Withdrawal in Patients with Psoriatic Arthritis Previously Treated with Open-label Tofacitinib + Methotrexate: A Randomized, Placebo-controlled Sub-study of OPAL Balance (ACR-ARHP 2019) – Oct 19, 2019 – Pres time: Nov 12, 2019; 09:00 AM – 11:00 AM; Location: Hall B5; P3; “In general, no clinically meaningful differences in efficacy and safety were observed in pts with PsA who received OL tofacitinib 5 mg BID as monotherapy after MTX withdrawal vs with continued MTX. No new safety risks were identified. Limitations include that the sub‑study was designed as an estimation study and not powered for hypothesis testing, and only pts on long-term treatment who had responded well to, and tolerated, tofacitinib and MTX were included.”

 

GSK2831781 / GSK
GSK2831781 clinical trial estimate: Primary completion of P1 trial for healthy volunteers in Japan in January 2020 (GlobalData) – Oct 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67598395; Page no: 176; REPORT TITLE: “Immutep Ltd (IMM) – Financial analysis review”; AUTHOR: Globaldata; DATE: 09/24/2019

 

MP1032 / MetrioPharm
MetrioPharm AG phase II data in psoriasis show dose-response, disease modifying activity and outstanding safety profile (MetrioPharm Press Release) – Oct 16, 2019 – P2, N=153; NCT03706209; Sponsor: MetrioPharm AG; “MetrioPharm AG…reports positive results from its recently completed Phase II dose finding study of MP1032 in psoriasis patients….The overall response rate (defined as PASI 50 and 75) more than doubled over placebo with even a 4-fold increase in PASI 75 responders….High dose MP1032 showed a statistically significant reduction in all-cause AEs over placebo thereby confirming the expected benign safety profile.”

 

Otezla (apremilast) / Amgen
Otezla ex-US sales projection: $300-400M in 2019 (Jefferies) – Oct 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 68079059; Page no: 30; REPORT TITLE: “Q3 EPS and thoughts into year-end”; AUTHOR: Yee, Michael, et al; DATE: 10/10/2019

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin; Duobrii (halobetasol/tazarotene) / Bausch Health; Jemdel (halobetasol propionate topical) / Bausch Health
Bausch Health’s Ortho Dermatologics business to present data at the Fall Clinical Dermatology Conference (PRNewswire) – Oct 15, 2019 – “Bausch Health Companies…Ortho Dermatologics…today announced the presentation of 18 posters during the Fall Clinical Dermatology Conference in Las Vegas (Oct. 17-20, 2019). The presentations will feature analyse…BRYHALI® (halobetasol propionate 0.01%) Lotion, DUOBRII® (halobetasol propionate 0.01% and tazarotene 0.045%) Lotion and SILIQ (brodalumab) injection, as well as a new data on the investigational drug IDP-123 (tazarotene 0.045%) Lotion.”

Read More …

Weekly Top News – Breast Cancer – October 14, 2019

October 14, 2019

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax’s entinostat advances in late-stage breast cancer study (SeekingAlpha) – Oct 7, 2019 – “Syndax Pharmaceuticals…announces the fifth and final successful interim futility analysis of survival data in the Cancer Research Group-sponsored Phase 3 clinical trial, E2112, evaluating the combination of lead drug entinostat and exemestane (Pfizer’s Aromasin) in patients with advanced HR+/HER2- breast cancer. The study will continue until 410 of the 608 participants have died, currently expected to occur in Q2 2020. If all goes well, the company expects to file a U.S. marketing application in late 2020.”

 

Kisqali (ribociclib) / Novartis
Kisqali: “The P value of 0.00455 crossed the prespecified boundary to claim superior efficacy (P < 0.01129)”; Advanced breast cancer (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
[Screenshot]

 

Piqray (alpelisib) / Novartis
Piqray: Regulatory approval in EU for HR+/HER2- advanced breast cancer in 2020 (Novartis) – Oct 14, 2019 – Kisqali MONALEESA-3 ESMO Data Investor Call 
[Screenshot]

 

Tecentriq (atezolizumab) / Roche
Roche’s atezolizumab is first breast cancer immunotherapy in Argentina (GBI Health) – Oct 12, 2019 – “Switzerland-based Roche has obtained an indication extension approval from Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) for its immuno-oncology product Tecentriq (atezolizumab) in combination with nab-paclitaxel or paclitaxel to treat triple negative breast cancer. The monoclonal antibody (mAb) was originally indicated against urothelial carcinoma (UC) and metastatic non-small cell lung cancer (NSCLC).”

 

triptorelin / Generic Mfg.; Xtandi (enzalutamide) / Pfizer, Astellas; pertuzumab/trastuzumab (RG6264) / Roche; Keytruda (pembrolizumab) / Merck (MSD)
SMC accepts lymphoma, lung cancer treatments in latest meeting (PharmaTimes) – Oct 8, 2019 – “In the latest Scottish Medicines Consortium (SMC) meeting, the committee has recommended four new medicines and rejected two…Among the positive opinions are Kite pharma’s Yescarta (axicabtagene ciloleucel), MSD’s cancer blockbuster Keytruda (pembrolizumab), Decapeptyl SR (triptorelin acetate)…Keytruda was approved for metastatic non-squamous non-small cell lung cancer (NSCLC), also through the PACE process…The committee also accepted Decapeptyl for the treatment of early stage breast cancer….On top of the four acceptances, the committee rejected Perjeta (pertuzumab) and Xtandi (enzalutamide) for the treatment of early stage breast cancer and prostate cancer, respectively.”

 

Zejula (niraparib) / GSK, J&J, Takeda
Clovis’ Rubraca approved for Cancer Drugs Fund (PharmaTimes) – Oct 14, 2019 – “NICE has also recently recommended niraparib as a treatment for this patient group and olaparib tablets for the BRCA-positive subgroup, both for use in the CDF.”

 

Tecentriq (atezolizumab) / Roche
Tecentriq sales projection: CHF3,683M in 2023 (Deutsche Bank Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68025177; Page no: 2; REPORT TITLE: “Roche Holding ltd- Roche: ESMO feedback: IMpowering the Tecentriq brand”; AUTHOR: Parkes, Richard, et al; DATE: 09/30/2019

 

AVID100 / Formation Biologics
Forbius: phase 2 clinical data with tumor-selective anti-EGFR ADC AVID100 featured at AACR-NCI-EORTC and World ADC San Diego (Businesswire) – Oct 10, 2019 – “Forbius…will today present the first clinical data from its Phase 2 development program with novel, tumor-selective anti-EGFR ADC AVID100 at the 10th Annual World ADC in San Diego (Oct. 8 – 11). AVID100 clinical data will also be featured in an upcoming poster presentation at the AACR-NCI-EORTC meeting in Boston (Oct. 26 – 30).”

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab sales projection: $300-400M peak for 3L HER2+ breast cancer setting (Cowen & Co) – Oct 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 67965816; Page no: 2377; REPORT TITLE: “Biotechnology quarterly”; AUTHOR: Cowen Biotechnology Team, et al; DATE: 09/16/2019

 

Ibrance (palbociclib) / Pfizer
Ibrance sales projection: $8.7B in 2023 (Infinata) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68065169; Page no: 1; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 10/07/2019

Read More …

Weekly Top News – IBD – October 14, 2019

October 14, 2019

ozanimod (RPC1063) / Celgene
Ozanimod clinical trial estimate: Data from P3 TRUE NORTH trial (NCT02435992) for moderate-to-severe ulcerative colitis in mid-2020 (Guggenheim) – Oct 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68001013; Page no: 2; REPORT TITLE: “Highlights from our autoImmune/immunology KOL series Part 3: Emerging treatment landscape in Crohn’s Disease and ulcerative colitis”; AUTHOR: Fernandez, Seamus, et al; DATE: 09/24/2019

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Topline data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in H1 2020 (Cantor Fitzgerald) – Oct 10, 2019 – A subscription to Thomson ONE is required to gain full access to report 68016498; Page no: 1; REPORT TITLE: “Cantor conference class of 2019: Top questions, catalysts, and who is most likely to….”; AUTHOR: Research Department; DATE: 09/26/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RedHill Biopharma Announces Full Results from Positive MAP US Phase 3 Study and Supportive Top-Line Results from MAP US2 Open-Label Extension Study with RHB-104 in Crohn’s Disease (GlobeNewswire, RedHill Biopharma Ltd.) – Oct 11, 2019 – P3, N=330; MAPUS (NCT01951326); P3, N=331; MAPUS2 (NCT03009396); Sponsor: NCT01951326; “RedHill Biopharma Ltd…announced full Week 52 results for all subjects in the previously announced positive Phase 3 randomized, controlled study of RHB-104 in Crohn’s disease (the ‘MAP US study’) and supportive top-line results from the open-label extension Phase 3 study (the ‘MAP US2 study’). The full Week 52 results of blinded treatment in the MAP US Phase 3 study….continued to meet its primary endpoint…”

 

Xeljanz (tofacitinib) / Pfizer
Xeljanz US sales projection: $2.7B in 2024 (Infinata) – Oct 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 68065169; Page no: 14; REPORT TITLE: “Pfizer, Inc. – Company report”; AUTHOR: Infinata, et al; DATE: 10/07/2019

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: September 2023 in US (Edison Investment Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68038761; Page no: 4; REPORT TITLE: “Formycon – H119 results – FYB201 FDA filing imminent”; AUTHOR: Savin, John, et al; DATE: 10/02/2019

 

Humira (adalimumab) / Eisai, AbbVie; Remicade (infliximab) / Mitsubishi Tanabe, J&J
HLA-DQA1*05 carriage associated with development of anti-drug antibodies to infliximab and adalimumab in patients with Crohn’s disease (Gastroenterology) – Oct 7, 2019 – P=NA, N=1,240; “We performed a genome-wide association study to identify variants associated with time to development of anti-drug antibodies in…patients with Crohn’s disease starting infliximab or adalimumab therapy…In an observational study, we found a genome-wide significant association between HLA-DQA1*05 and the development of antibodies against anti-TNF agents.”

 

Otezla (apremilast) / Amgen
Otezla sales projection: $4B in 2027 (Oppenheimer) – Oct 8, 2019 – A subscription to Thomson ONE is required to gain full access to report 68004961; Page no: 1; REPORT TITLE: “Amgen Inc- Key takeaways from meeting with management”; AUTHOR: Research Department; DATE: 09/24/2019

Read More …

Weekly Top News – Psoriasis – October 14, 2019

October 14, 2019

Stelara (ustekinumab) / J&J
Janssen submits application to U.S. FDA seeking approval of Stelara (ustekinumab) for the treatment of pediatric patients with moderate to severe plaque psoriasis (PRNewswire) – Oct 7, 2019 – “The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO)….The STELARA sBLA is based on results from the Phase 3 CADMUS Jr study…”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun Pharma presents long-term study results that show significant skin clearance with Ilumya (tildrakizumab-asmn) maintained over four years in people with moderate-to-severe plaque psoriasis (PRNewswire) – Oct 9, 2019 – P3, N=772; reSURFACE 1 (NCT01722331); Sponsor: Sun Pharma; P3, N=1,090; reSURFACE 2 (NCT01729754); Sponsor: Sun Pharma; “Sun Pharmaceutical Industries…today announced that one of its wholly owned subsidiaries presented long-term follow-up data from ILUMYA

® (tildrakizumab-asmn) Phase 3 reSURFACE 1 and 2 trials at the 28th European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.”

Taltz (ixekizumab) / Eli Lilly
Lilly presents positive results for Taltz (ixekizumab) in pediatric patients with moderate to severe plaque psoriasis at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (Eli Lilly Press Release) – Oct 12, 2019 – P3, N=201; Ixora-peds (NCT03073200); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area…Results of the study are being presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain….Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
NHS Scotland accepts AbbVie’s Skyrizi (risankizumab) (Pharmafield) – Oct 8, 2019 – “NHS Scotland accepts AbbVie’s SKYRIZI (risankizumab) in a positive Detailed Advice Document published by the Scottish Medicine Consortium….It confirms that SKYRIZI (risankizumab) is recommended for the treatment of moderate to severe psoriasis in adult patients”

 

Cosentyx (secukinumab) / Novartis
Novartis real-world evidence confirms high efficacy, long-term response and favorable safety profile of Cosentyx in clinical practice (Novartis Press Release) – Oct 9, 2019 – “These extensive results confirm what has been previously observed in Phase 3 clinical trials, and support our continued use of Cosentyx in psoriatic disease…Real-world evidence and observational studies help to bridge the gap in knowledge that exists between clinical trials and clinical practice….These data are being presented at the 28th Congress of the European Academy of Dermatology and Venereology (EADV), 9-13 October 2019, Madrid, Spain.”

 

bimekizumab (UCB4940) / UCB; Cimzia (certolizumab pegol) / Astellas, Dermira, UCB
UCB showcases wealth of new psoriasis research at EADV 2019 (UCB Press Release) – Oct 9, 2019 – “UCB…today announced new data on…CIMZIA® (certolizumab pegol), in psoriasis and psoriatic arthritis (PsA) will be presented at the 28th European Academy of Dermatology and Venereology congress (EADV) in Madrid, October 9-13, 2019….New 60-week data on novel investigational molecule bimekizumab, from the BE ABLE Phase 2 clinical development program, will be shared in an oral presentation.”

 

Stelara (ustekinumab) / J&J; Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
LEO Pharma to highlight data at 28th Congress of the European Academy of Dermatology (EADV) (LEO Pharma Press Release) – Oct 9, 2019 – “LEO Pharma…today announced that data from company-sponsored, health economic outcome and investigator-initiated studies will be presented at the 28th annual Congress of the European Academy of Dermatology (EADV), Oct. 9-13, in Madrid, Spain.”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim; Humira (adalimumab) / Eisai, AbbVie
AbbVie announces new data from its dermatology portfolio and pipeline at the 28th European Academy of Dermatology and Venereology (EADV) congress (PRNewswire) – Oct 9, 2019 – “AbbVie…today announced that it will present new results evaluating the safety and efficacy of SKYRIZI™ (risankizumab) at 2.5 years in adult patients with moderate to severe plaque psoriasis, as well as…upadacitinib, at the 28th European Academy of Dermatology and Venereology (EADV) Congress, October 9-13, in Madrid….In addition, Phase 2b results evaluating time to treatment response with upadacitinib…under investigation for patients with moderate to severe atopic dermatitis will be shared as an oral presentation.”

 

Taltz (ixekizumab) / Eli Lilly; mirikizumab (LY3074828) / Eli Lilly
Lilly to unveil new data for the treatments of complex dermatological conditions at the 28th Annual European Academy of Dermatology and Venereology (EADV) Congress (PRNewswire) – Oct 8, 2019 – “Eli Lilly and Company…announced today that it will present new data for Taltz® (ixekizumab), Olumiant® (baricitinib) and mirikizumab at the 28th annual European Academy of Dermatology and Venereology (EADV) Congress taking place Oct. 9-13 in Madrid, Spain…Lilly will present findings from a Phase 3 trial of Taltz for pediatric patients with moderate to severe psoriasis….Posters to be shared around Lilly’s investigational compound, mirikizumab, include research from a study measuring patient outcomes and health-related elements of quality of life for individuals with moderate to severe psoriasis.”

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: September 2023 in US (Edison Investment Research) – Oct 11, 2019 – A subscription to Thomson ONE is required to gain full access to report 68038761; Page no: 4; REPORT TITLE: “Formycon – H119 results – FYB201 FDA filing imminent”; AUTHOR: Savin, John, et al; DATE: 10/02/2019

Read More …

Weekly Top News – Breast Cancer – October 7, 2019

October 7, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Safety data consistent with known safety profile of Verzenio”; Metastatic breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
[Screenshot]

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: Data from P3 monarchE trial (NCT03155997) in HR+/HER2- breast cancer in mid-2021 (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
[Screenshot]

 

Verzenio (abemaciclib) / Eli Lilly
Health-related quality of life in MONARCH 3: Abemaciclib plus an aromatase inhibitor as initial therapy in women with HR-positive (HR +), HER2-negative (HER2) advanced breast cancer (DGHO 2019) – Sep 30, 2019 – Abstract #P1006; Pres time: Oct 14, 2019; 12:00 PM – 12:05 PM; Location: A6; P3; “Abemaciclib plus AI resulted in clinically meaningful and statistically significant changes in diarrhea, and clinically not meaningful differences in other symptom scores. Increased GI-related symptoms were consistent with the manageable, reversible AE profile. No clinically meaningful differences in global health status or functional scores were observed.”

 

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Abemaciclib + NSAI and Abemaciclib + fulvestrant showed significant PFS benefit in predominantly Chinese HR +/HER –advanced breast cancer patients”; Breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019
P3 data
[Screenshot]

Verzenio (abemaciclib) / Eli Lilly
Verzenio: “Verzenio significantly extended life by 9.4 months”; Breast cancer (Eli Lilly) – Oct 3, 2019 – ESMO 2019 
[Screenshot]

 

Tecentriq (atezolizumab) / Roche
Tecentriq by Roche not approved on NHS for triple negative breast cancer (Pharmafield) – Oct 3, 2019 – “Draft guidance published by NICE does not recommend atezolizumab, Tecentriq by Roche, for treating people with a type of breast cancer that has spread to other parts of the body….Atezolizumab with nab-paclitaxel does not meet NICE’s Cancer Drugs Fund criteria because it does not have a plausible potential to be cost-effective and there is no clear evidence that further trial data would resolve the uncertainties associated with this appraisal.”

 

Ibrance (palbociclib) / Pfizer; Verzenio (abemaciclib) / Eli Lilly; Faslodex (fulvestrant) / AstraZeneca
CDK4/6 inhibitor+fulvestrant combo nears getting benefit (Korea Biomedical Review) – Oct 2, 2019 – “The combination therapy of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor and fulvestrant for advanced or metastatic breast cancer has taken the first step to receive insurance benefits. The Health Insurance Review and Assessment Service (HIRA)’s Cancer Drug Review Committee decided in September to grant reimbursement for Pfizer’s Ibrance (ingredient: palbociclib) plus fulvestrant and Lilly’s Verzenio (abemaciclib) plus fulvestrant, sources said on Monday.”

 

Tecentriq (atezolizumab) / Roche
A small molecule triple-negative breast cancer immunotherapy that targets the Liver-X-Receptor. (CRI-CIMT-EATI-AACR 2019) – Oct 4, 2019 – Abstract #A203; “There is only FDA-approved immunotherapy for TNBC, Atezolizumab for patients with high PD-L1 expression, which unfortunately only marginally improves patient survival (~2 months)…Lastly, through extracellular flux analysis and mitochondrial activity profiling we have determined that LXR activation severely disrupts mitochondrial function in CD8+ T-cells. Our discoveries implicate LXR as a central mediator of TNBC immune evasion and as a promising treatment target for the development of novel small molecule immunotherapies for TNBC.”

 

 

Verzenio (abemaciclib) / Eli Lilly; Faslodex (fulvestrant) / AstraZeneca
Abemaciclib in combination with fulvestrant in patients with HR + / HER2- advanced breast cancer who had demonstrated primary or secondary resistance to previous endocrine therapy (DGHO 2019) – Sep 30, 2019 – Abstract #P1008; Pres time: Oct 14, 2019; 12:10 PM – 12:15 PM; Location: A6; P3; “Abemaciclib+F improved PFS and ORR with a generally tolerable safety profile in pts with HR+/HER2- ABC and primary/secondary ETR. Although pts with primary ETR typically have poor prognosis, the benefit from abemaciclib+F was maintained in this population. Previously presented at ESMO 2018, FPN 329P, Grischke E et al.”

 

Verzenio (abemaciclib) / Eli Lilly
Management of abemaciclib-associated adverse events in patients with HR + / HER2- advanced breast cancer: analysis of MONARCH studies (DGHO 2019) – Sep 30, 2019 – Abstract #P1007; Pres time: Oct 14, 2019; 12:05 PM – 12:10 PM; Location: A6; P2, P3; “Introduction: Abemaciclib is a CDK4/6 inhibitor dosed continuously, with demonstrated efficacy and an acceptable safety profile in patients (pts) with HR+/HER2- advanced breast cancer (ABC) alone (MONARCH 1, NCT02102490) or in combination with fulvestrant (MONARCH 2, NCT02107703) or non-steroidal aromatase inhibitors (MONARCH 3, NCT02246621). Abemaciclib dose adjustments and/or supportive medication were effective in managing AEs in pts with ABC in the MONARCH trials. Understanding the safety profile of abemaciclib can inform AE management and can extend time on treatment. Previously presented at ESMO 2018, FPN 339P, Rugo HS et al.”

Read More …
« Older Entries