The Digest

Pharma news roundup and Larvol updates

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The Digest features recent news that Larvol Pulse™ subscribers receive as well as the latest from the Larvol Team. Use the categories on the left for news in your therapeutic area of interest.

Weekly Top News – Breast Cancer – August 19, 2019

August 19, 2019

Faslodex (fulvestrant) / AstraZeneca; Ibrance (palbociclib) / Pfizer
A Multicentre, International Neoadjuvant (NA), Randomized, Double-blind Phase III Trial comparing FULVESTRANT to a combination of FULVESTRANT and PALBOCICLIB in patients with operable Luminal Breast Cancer (SAFIA Trial) (ESMO 2019) – Aug 18, 2019 – Abstract #198P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
Interim Results From CompLEEment-1 (A Phase 3b Study of Ribociclib and Letrozole as First-Line Therapy for Advanced Breast Cancer in an Expanded Population): Spanish cohort results (ESMO 2019) – Aug 18, 2019 – Abstract #336P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

Kisqali (ribociclib) / Novartis
First Canadian Interim Analysis from the Phase IIIb CompLEEment-1 Ribociclib + Letrozole HR+ HER2- Advanced Breast Cancer Trial (ESMO 2019) – Aug 18, 2019 – Abstract #337P; Pres time: Sep 29, 2019; 12:00 PM – 01:00 PM; Location: Poster Area (Hall 4); No abstract available.

 

margetuximab (MGAH 22) / MacroGenics
Margetuximab: Final OS data from P3 SOPHIA trial (NCT02492711) in HER2 positive metastatic breast cancer in 2020 (Wedbush PacGrow Healthcare Conference, Macrogenics) – Aug 16, 2019  
[Screenshot]

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Roche wins additional indication for breast cancer treatment Kadcyla (Korea Biomedical Review) – Aug 12, 2019 – “Roche Korea said that it has received additional indication approval for Kadcyla, its HER2+ breast cancer drug, from the Ministry of Food and Drug Safety…hospitals can now use Kadcyla as postoperative adjuvant therapy in patients with HER2-positive early breast cancer with invasive residual lesions after receiving taxane and trastuzumab-based preoperative adjuvant therapy…The ministry approved the expanded indication after Roche confirmed the treatment’s efficacy through a global phase 3 KATHERINE clinical trial…”

 

LiPlaCis (liposomal cisplatin) / Oncology Venture
FDA grants IDE approval to use Oncology Venture’s LiPlaCis DRP for patient selection in a pivotal phase 3 study (GlobeNewswire) – Aug 15, 2019 – “Oncology Venture A/S…informs that the US Food & Drug administration (FDA) has approved an IDE (Investigational Device Exemption) application for use of the company’s drug response predictor LiPlaCis DRP® in a planned pivotal Phase 3 study. In parallel, the FDA is evaluating Oncology Venture’s IND (Investigational New Drug) application for the drug substance LiPlaCis®, which is primarily being developed as a potential new treatment of metastatic breast cancer in heavily pre-treated patients.”

 

Onconova Therapeutics, Inc. reports business highlights and second quarter 2019 financial results (GlobeNewswire) – Aug 14, 2019 – “‘Enrollment in our global Phase 3 INSPIRE Trial with IV rigosertib in second-line, higher-risk MDS patients is progressing. Our goal is to complete enrollment by the end of 2019 and we anticipate reporting top-line data in the first half of 2020…our Special Protocol Assessment (SPA) request to the FDA for a Phase 3 combination trial of oral rigosertib plus azacitidine in first-line higher-risk MDS patients is being pursued. We also have plans to target cancers driven by mutated Ras genes…and a Phase 1 study of rigosertib in combination with a PD-1 inhibitor for patients with progressive K-Ras mutated non-small cell lung cancer is expected to commence in 2019….We are also working toward filing an IND for a Phase 1 trial of ON 123300, our investigational, first-in-class, dual inhibitor of CDK4/6 + ARK5, which we believe has the potential to treat various cancers including refractory metastatic breast cancer.'”

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Weekly Top News – IBD – August 19, 2019

August 19, 2019

Stelara (ustekinumab) / J&J
USTEKINUMAB IMPROVED WORK PRODUCTIVITY IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS FROM THE PHASE 3 UNIFI INDUCTION AND MAINTENANCE STUDIES (UEGW 2019) – Aug 18, 2019 – Abstract #P1115; Pres time: Oct 22, 2019; 09:00 AM – 05:00 PM; Location: Poster Exhibition – Hall 7; “This abstract will be published on September 27, 2019”

 

etrasimod (APD334) / Arena
Etrasimod clinical trial estimate: Data from P3 ELEVATE UC 52 trial (NCT03945188) for ulcerative colitis in H2 2021 (Wells Fargo) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67741783; Page no: 2; REPORT TITLE: “Update from San Francisco biotech access day”; AUTHOR: Research Department; DATE: 08/02/2019

 

Myoconda (clarithromycin/clofazimine/rifabutin) / RedHill
RHB-104 clinical trial estimate: Initiation of P3 trial for Crohn’s disease in Q1 2020(Ladenburg, Thalmann) – Aug 19, 2019 – A subscription to Thomson ONE is required to gain full access to report 67673924; Page no: 1; REPORT TITLE: “Redhill Biopharma Ltd 2Q19 results; Talica PDUFA November 2, 2019; Buy and $24 PT”; AUTHOR: Kaplan, Matthew, et al; DATE: 07/24/2019

 

mirikizumab (LY3074828) / Eli Lilly
EFFICACY AND IMPROVED HEALTH-RELATED QUALITY OF LIFE AFTER 52-WEEKS OF MIRIKIZUMAB TREATMENT IN PATIENTS WITH ULCERATIVE COLITIS: AN UPDATE FROM A RANDOMISED, DOUBLE-BLIND, CONTROLLED, PHASE 2 STUDY (UEGW 2019) – Aug 18, 2019 – Abstract #P1102; Pres time: Oct 22, 2019; 09:00 AM – 05:00 PM; Location: Poster Exhibition – Hall 7; “This abstract will be published on September 27, 2019”

 

Skyrizi (risankizumab) / AbbVie, Boehringer Ingelheim
LONG-TERM EFFECT OF RISANKIZUMAB ON IMPROVED AND SUSTAINED HEALTH-RELATED QUALITY OF LIFE OVER 3 YEARS IN PATIENTS WITH MODERATE TO SEVERE CROHN’S DISEASE: INTERIM ANALYSIS OF A PHASE 2 OPEN-LABEL EXTENSION STUDY(UEGW 2019) – Aug 18, 2019 – Abstract #P0399; Pres time: Oct 21, 2019; 10:30 AM – 05:00 PM; Location: Poster Exhibition – Hall 7; “This abstract will be published on September 27, 2019”

 

filgotinib (GLPG0634) / Gilead
Filgotinib clinical trial estimate: Data from P2b/3 SELECTION1 trial (NCT02914522) for ulcerative colitis in H1 2020 (UBS) – Aug 15, 2019 – A subscription to Thomson ONE is required to gain full access to report 67716086; Page no: 4; REPORT TITLE: “Galapagos NV “More on offer; upgrade to Buy” (Buy) Sutcliffe”; AUTHOR: Sutcliffe, Laura, et al; DATE: 07/31/2019

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Weekly Top News – Psoriasis – August 19, 2019

August 19, 2019

BMS-986165 / BMS
BMS-986165 clinical trial estimate: Data from P3 trials POETYK-PSO-1 (NCT03624127) and POETYK-PSO-2 (NCT03611751) for moderate-to-severe plaque psoriasis in late 2020 (William Blair) – Aug 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67531579; Page no: 22; REPORT TITLE: “Bristol-Myers Squibb Co.: BMY: CheckMate-459 failure and deal closing delay for Otezla divestiture a double hit to sentiment”; AUTHOR: Phipps, Matt, et al; DATE: 06/24/2019

 

Taltz (ixekizumab) / Eli Lilly; Tremfya (guselkumab) / J&J
Lilly announces superiority of Taltz (ixekizumab) versus Tremfya (guselkumab) in delivering total skin clearance at week 12 in topline results from head-to-head (IXORA-R) trial in people living with moderate to severe plaque psoriasis (Eli Lilly Press Release) – Aug 13, 2019 – P4, N=1,027; IXORA-R (NCT03573323); Sponsor: Eli Lilly and Company; “Eli Lilly and Company…announced today Taltz® (ixekizumab) met the primary and all major secondary endpoints up to week 12 in the Phase 4 IXORA-R study, which evaluated the efficacy and safety of Taltz versus TREMFYA® (guselkumab) in people living with moderate to severe plaque psoriasis (PsO)….At 12 weeks, Taltz met the primary endpoint by demonstrating superiority in the proportion of patients achieving complete skin clearance compared to TREMFYA as measured by PASI 100….Lilly plans to share results on the remaining key secondary endpoint of proportion of patients achieving PASI 100 at 24 weeks in 2020….Lilly plans to submit detailed data from the IXORA-R study for disclosure at scientific meetings and in peer-reviewed journals.”

 

Cosentyx (secukinumab) / Novartis; Tremfya (guselkumab) / J&J
Tremfya tops Cosentyx in late-stage study (PharmaTimes) – Aug 12, 2019 – P3, N=1,048; ECLIPSE (NCT03090100); Sponsor: Janssen Research & Development, LLC; “Johnson & Johnson’s Janssen has announced results from a Phase III ECLIPSE study, demonstrating superior long-term efficacy of Tremfya (guselkumab) compared with Cosentyx (secukinumab) in adults with moderate to severe plaque psoriasis.”

 

bimekizumab (UCB4940) / UCB
Bimekizumab launch estimate: For psoriatic arthritis in 2022 (Kepler Cheuvreux) – Aug 12, 2019 – A subscription to Thomson ONE is required to gain full access to report 67604813; Page no: 19; REPORT TITLE: “UCB SA – Q&A report | UCB | Buy | What can really get UCB shares moving?”; AUTHOR: Evans, David, et al; DATE: 07/21/2019

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
Sun, CSIR-IICT ink global licensing pact for patents (The Economic Times) – Aug 15, 2019 – “…the company is preparing to launch it in Japan. Sun in its analyst presentation said these launches reflect its global aspirations for speciality business.”

 

Siliq (brodalumab) / Bausch Health, Leo Pharma, Kyowa Hakko Kirin
LEO Pharma A/S acquires rights to develop and market brodalumab for moderate-to-severe psoriasis outside of Europe (Businesswire) – Aug 13, 2019 – “LEO Pharma…today announced it has acquired the exclusive rights to develop and market brodalumab (marketed as Kyntheum® in the European Union) for the treatment of moderate-to-severe psoriasis outside of Europe through a new sub-licencing agreement with Bausch Health Ireland Limited. The new agreement includes countries with significantly high unmet need, such as Australia, Brazil, Egypt, Mexico, Russia and Saudi Arabia….Under the new arrangement terms, Bausch Health has granted LEO Pharma A/S an exclusive license to its global rights to brodalumab but continues to hold the rights for the US and Canada.”

 

M923 (adalimumab biosimilar) / Baxter Healthcare, Momenta
Momenta drops Humira biosimilar, pays GSK $43m in manufacturing hit (BioProcess International)- Aug 12, 2019 – “Momenta says planned runs at manufacturing partner GSK could be reattributed to another product as it ends development of M923, a biosimilar candidate to Humira (adalimumab)….the firm has now made the decision to drop the adalimumab program M923.”

 

Ilumya (tildrakizumab-asmn) / Sun Pharma, Almirall
SMC rejects Orkambi, accepts four medicines (PharmaTimes) – Aug 13, 2019 – “The Scottish Medicines Consortium (SMC) has published advice accepting four new medicines…Illumetri (tildrakizumab), an Almirall drug for moderate to severe plaque psoriasis in adults….’Our decision on tildrakizumab for plaque psoriasis means another treatment option is available for patients who have failed to respond to previous therapies.'”

 

Stelara (ustekinumab) / J&J
Stelara patent expiry: 2023 in US and 2024 in EU (BTIG) – Aug 17, 2019 – A subscription to Thomson ONE is required to gain full access to report 67737390; Page no: 5; REPORT TITLE: “Protagonist Therapeutics, Inc. – Additional results from phase 1 study with pn-943 provide support; details to be presented at ACG Conference in October”; AUTHOR: Chiang, Timothy, et al; DATE: 08/02/2019

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Weekly Top News – Breast Cancer – August 12, 2019

August 12, 2019

Verzenio (abemaciclib) / Eli Lilly
Verzenio (abemaciclib) available in Canada for metastatic breast cancer (Canada Newswire) – Aug 8, 2019 – “Eli Lilly Canada Inc…is pleased to announce the availability of VERZENIO™ (abemaciclib). VERZENIO is indicated for the treatment of estrogen and/or progesterone hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (mBC)….The approval of VERZENIO is based on the efficacy and safety demonstrated in the pivotal MONARCH 3, MONARCH 2 and MONARCH 1 clinical trials.”

 

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 clinical trial estimate: Data from P3 DESTINY-Breast03 trial (NCT03529110) for HER2-positive breast cancer patients previously treated with Kadcyla at SABCS (December 10-14, 2019) (J.P. Morgan) – Aug 5, 2019 – A subscription to Thomson ONE is required to gain full access to report 67723679; Page no: 2; REPORT TITLE: “Daiichi Sankyo Company Limited – Daiichi Sankyo (4568): Strong start; Next catalyst is WCLC (in September)”; AUTHOR: Kumagai, Naomi, et al; DATE: 07/31/2019

 

Kadcyla (ado-trastuzumab emtansine) / Roche
Roche wins additional indication for breast cancer treatment Kadcyla (Korea Biomedical Review) – Aug 12, 2019 – “Roche Korea said that it has received additional indication approval for Kadcyla, its HER2+ breast cancer drug, from the Ministry of Food and Drug Safety…hospitals can now use Kadcyla as postoperative adjuvant therapy in patients with HER2-positive early breast cancer with invasive residual lesions after receiving taxane and trastuzumab-based preoperative adjuvant therapy…The ministry approved the expanded indication after Roche confirmed the treatment’s efficacy through a global phase 3 KATHERINE clinical trial…”

 

Herceptin (trastuzumab) / Roche; Nerlynx (neratinib) / Puma
New early breast cancer option recommended by NICE (PharmaTimes) – Aug 7, 2019 – “The National Institute for Health and Care Excellence (NICE) has published draft guidance recommending Pierre Fabre’s Nerlynx (neratinib) as an additional treatment for some people with early hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive breast cancer….The governing body announced that the drug is only recommended provided that Herceptin (trastuzumab) is the only HER2-directed adjuvant treatment people have had.”

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Entinostat: NDA submission in combination with exemestane for HR+ metastatic breast cancer in 2020 (Syndax) – Aug 8, 2019 – Q2 2019 Results  
[Screenshot]

 

entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Syndax Pharmaceuticals reports second quarter 2019 financial results and provides clinical and business update (PRNewswire) – Aug 7, 2019 – “…’We look forward to the near-term completion of E2112, the Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, which we anticipate will occur either in the fourth quarter of 2019 or the first half of 2020. A positive survival benefit at either assessment will enable us to file an NDA with the FDA and take us one step closer to improving outcomes for patients with this difficult to treat disease’.”

 

Nerlynx (neratinib) / Puma
Puma Biotechnology reports second quarter 2019 financial results (Businesswire) – Aug 8, 2019 – P2, N=650; CONTROL (NCT02400476); Sponsor: Puma Biotechnology; “…’We anticipate the following key milestones during the remainder of 2019: (i) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the third quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries’.”

 

Nerlynx (neratinib) / Puma
Knight Therapeutics Reports Second Quarter 2019 Results (GlobeNewswire, Knight Therapeutics)- Aug 8, 2019 – Received regulatory approval from Health Canada for NERLYNX® for the treatment of HER2-positive breast cancer. Reached an agreement with the pan-Canadian Pharmaceutical Alliance (“pCPA”) regarding Probuphine® and to date have obtained reimbursement through public insurance plans administered by Alberta, Saskatchewan and the Non-insured Health Benefit Program (“NIHB”). We have advanced our commercial presence and product pipeline with the regulatory approval of NERLYNX® and the submission of Ibsrela™…Knight plans to launch NERLYNX® in late 2019.

 

Tecentriq (atezolizumab) / Roche
Tecentriq clinical trial estimate: Primary completion of P3 IMpassion030 trial (NCT03498716) for TNBC on January 15, 2022 (Barclays) – Aug 9, 2019 – A subscription to Thomson ONE is required to gain full access to report 67703402; Page no: 1; REPORT TITLE: “Roche Holding Ltd: ROG: (neo)adjuvant TNBC: Beaten to the punch…”; AUTHOR: Papadakis, Emmanuel, et al; DATE: 07/29/2019

 

EDP1503 / Evelo Biosci; Keytruda (pembrolizumab) / Merck (MSD)
Evelo Biosciences announces positive interim phase 1b clinical data and provides second quarter 2019 financial results (GlobeNewswire) – Aug 6, 2019 – “Oncology: Clinical Studies and Anticipated Milestones – EDP1503 – Phase 1/2; Evelo is conducting a Phase 1/2 clinical trial of EDP1503 in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in microsatellite stable colorectal cancer, triple-negative breast cancer, and patients with other tumor types that have relapsed on prior PD-1/L1 inhibitor treatment. Initial clinical data is expected in the first half of 2020.”

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Weekly Top News – IBD – August 12, 2019

August 12, 2019

Stelara (ustekinumab) / J&J
Ustekinumab Improved Work Productivity in Patients With Moderate to Severe Ulcerative Colitis: Results From the Phase 3 UNIFI Induction and Maintenance Studies (ACG 2019) – Aug 8, 2019 – Abstract #P1393; Pres time: Oct 28, 2019; 10:30 AM – 04:15 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline, patients had a mean percent work time missed ranging from 17.7% to 19.3%, impairment while working from 39.1% to 45.3%, overall work impairment from 43.7% to 49.1%, and activity impairment from 51.8% to 52.8%. At Wk8, patients who received UST IV had significantly greater improvement in WPAI domains and daily productivity VAS compared with PBO (Table). In the maintenance study, UST-treated patients generally maintained or numerically improved WPAI scores, while scores for patients in the PBO group worsened.”

 

Stelara (ustekinumab) / J&J
Effects of Ustekinumab Maintenance Therapy on Endoscopic Improvement and Histologic Improvement in the UNIFI Phase 3 Study in Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #56; Pres time: Oct 30, 2019; 08:40 AM – 08:50 AM; Location: Stars at Night Ballroom – B2; “At maintenance Week 44, EI was achieved in 28.6%, 43.6%, and 51.1% of pts treated with placebo, UST q12w (p=0.002 vs placebo), and UST q8w (p< 0.001), respectively. HI was achieved at Week 44 in 32.9%, 54.0%, and 59.3% of pts treated with placebo, UST q12w, and UST q8w, respectively (p< 0.001 for both q12w and q8w). MH was achieved at Week 44 in 24.1%, 38.8%, and 45.9% of pts treated with placebo, UST q12w (p=0.002), and UST q8w (p,0.001), respectively.”

 

Stelara (ustekinumab) / J&J
Molecular Response to Ustekinumab in Moderate-to-Severe Ulcerative Colitis by Serum Protein and Colon Transcriptomic Analysis: Results From the UNIFI Phase 3 Maintenance Study (ACG 2019) – Aug 8, 2019 – Abstract #P0454; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At Wk44 after the start of maintenance therapy, expression of colonic genes dysregulated in UC was altered towards normal levels in all treatment groups, with the greatest improvements among those receiving UST and those in clinical remission (p< 0.05 for Wk44 versus start of maintenance). No dose effect was observed between q8w and q12w UST doses, and no significant improvements in disease signature occurred in non-responders to placebo or UST. UST maintenance therapy magnified the normalization of serum proteins following UST induction; among pts receiving q8w UST who were in remission at Wk44, the proteins IFNγ, IL-17A, MMP3, and SAA reached concentrations comparable to those seen in healthy controls.”

 

Stelara (ustekinumab) / J&J
Safety of Ustekinumab in Inflammatory Bowel Diseases: Integrated Safety Analysis of Results From Phase 2 and 3 Studies in Crohn’s Disease and Ulcerative Colitis (ACG 2019) – Aug 8, 2019 – Abstract #P0505; Pres time: Oct 27, 2019; 03:30 PM – 07:00 PM; Location: Exhibit Halls 3 and 4 (Street Level); “At induction baseline (2370 pts in pooled phase 3 IBD studies), median age was 38.0 years, 46.9% were receiving corticosteroids, 30.8% were receiving IMM, 53.0% had failed biologics, and 37.1% were naïve to biologics. In phase 3 IBD studies, through Wk8 of PBO-controlled induction, the frequency of key safety events was similar between UST and PBO (Table 1). In addition, through 1 year across phase 2/3 IBD studies (Table 2), numbers of pts per 100 PY with key safety events were similar between treatment groups.”

 

Entyvio SC (vedolizumab SC) / Takeda
Takeda submits New Drug Application for a subcutaneous formulation of vedolizumab for patients with moderately to severely active ulcerative colitis in Japan (Takeda Press Release) – Aug 8, 2019 – “Takeda…announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare in Japan for a subcutaneous (SC) formulation of vedolizumab, a gut-selective biologic for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). Takeda proposes to make vedolizumab SC available in both syringe and pen options.”

 

PTG-200 / Protagonist Therapeutics, J&J
Protagonist Therapeutics reports second quarter 2019 financial results (PRNewswire) – Aug 7, 2019 – “Protagonist and Janssen are jointly conducting the development of PTG-200 through completion of a Phase 2 proof-of-concept study in Crohn’s disease. Protagonist and Janssen Biotech completed the filing of a U.S. Investigational New Drug (IND) application to support the global Phase 2 clinical study with initiation expected in the fourth quarter of 2019.”

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