Pipeline Watch: Phase III Results With Tagrisso, Biosimilar Rituximab And Vonvendi
Executive Summary
Pipeline Watch has been updated to bring greater depth and detail to a potential therapeutic product’s progress through the R&D pipeline. The table brings you a snapshot of selected late-stage clinical trial events in the pharma and biotech industries.
The table records clinical developments using data from Informa Pharma Intelligence’s Biomedtracker. It lists drugs for which an important event was recorded between Dec. 2 and Dec. 8, 2016, divided by event type.
Events can include Phase II and Phase III trial initiations, development discontinuations, and the release of top-line and full clinical trial results. A brief summary of product approvals is also included.
A companion resource, The Pink Sheet’s regulatory-focused FDA Performance Tracker, follows regulatory milestones such as new submissions and user fee calculations, complete response letters and breakthrough therapy designations.
Pipeline Watch – Dec. 2 to Dec. 8, 2016
|
Lead company/partner |
Compound |
Indication |
Comments |
|
Phase III Results |
|||
|
Tagrisso (osimertinib) |
non-small cell lung cancer (NSCLC), second-line |
AURA3 study; reduced disease progression and improved PFS. |
|
|
Phase III Interim/Top-line Results |
|||
|
Bosulif (bosutinib) |
Ph+-chronic myeloid leukemia |
BEFORE; Better than imatinib as first-line therapy. |
|
|
ropeginterferon alfa-2b |
polycythemia vera |
PROUD-PV; non-inferior to hydroxyurea, and better tolerability. |
|
|
TX-001HR (bio-identical estradiol and progesterone) |
postmenopausal vasomotor symptoms |
Met all co-primary efficacy and safety endpoints. |
|
|
biosimilar rituximab (GP2013) |
indolent non-Hodgkin’s lymphoma |
ASSIST-FL; Novartis’s first biosimilar MAb, shown equivalence to reference rituximab. |
|
|
biosimilar rituximab (CT-P10) |
follicular lymphoma |
Equivalent to reference rituximab. |
|
|
Xultophy (insulin degludec and liraglutide) |
type 2 diabetes |
DUAL VII; non-inferior to insulin glargine with insulin aspart. |
|
|
Vonvendi (von Willebrand factor, recombinant) |
Von Willebrand disease |
Met primary endpoints in surgical procedures. |
|
|
Phase III Initiated |
|||
|
isatuximab |
multiple myeloma |
ICARIA-MM; primary endpoint is PFS. |
|
|
LentiGlobin |
transfusion dependent beta thalassemia |
Northstar-2; involving a gene therapy. |
|
|
RT002 (daxibotulinumtoxinA) |
glabellar lines in adults. |
SAKURA-1,-2. |
|
|
LPCN 1021 (oral testosterone) |
hypogonadism |
A dosing validation study. |
|
|
Phase III Announced |
|||
|
GNbAC1 (MAb against MSRV-Env) |
multiple sclerosis |
ANGEL-MS, a long-term extension study. |
|
|
Phase II Suspended |
|||
|
CERC-501 |
nicotine withdrawal |
Did not improve time to start smoking or reduce cigarette use. |
|
|
Phase II Results |
|||
|
gilteritinib |
acute myeloid leukemia |
CHRYSALIS; well tolerated and prolonged responses. |
|
|
pracinostat |
acute myeloid leukemia |
Plus azacitidine, prolongs survival in elderly patients. |
|
|
AbbVie Inc./Janssen Biotech Inc. |
Imbruvica (ibrutinib) |
chronic graft versus host disease |
Clinically effective in patients undergoing a stem cell transplant. |
|
luspatercept |
beta-thalassemia |
Increases hemoglobin levels. |
|
|
JCAR017 |
acute lymphocytic leukemia |
||
|
F17464 |
acute schizophrenia |
FAST; positive efficacy and well tolerated. |
|
|
WTX101 |
Wilson disease |
||
|
Phase II Interim/Top-line Results |
|||
|
nintedanib |
unresectable mesothelioma |
LUME-Meso; increased PFS and significantly reduced disease progression |
|
|
Celgene Corp. |
Abraxane (paclitaxel) |
first-line triple negative breast cancer |
tenAcity; encouraging results, switching to combining with immuno-oncology agents. |
|
Novartis AG |
Afinitor (everolimus) plus fulvestrant |
breast cancer |
PrECOG 0102; improved PFS. |
|
tesevatinib |
brain, leptomeningeal metastases |
Encouraging signs of no CNS progression. |
|
|
AbbVie Inc./Janssen Biotech Inc. |
Imbruvica |
diffuse large B cell lymphoma, follicular lymphoma |
Clinical benefit in combination therapy. |
|
AbbVie Inc./Janssen Biotech Inc. |
Imbruvica |
marginal zone lymphoma |
48% of patients had complete or partial responses. |
|
AbbVie Inc./Roche |
Venetoclax |
chronic lymphocytic leukemia |
Active after ibrutinib or idelalisib. |
|
Seattle Genetics Inc./Bristol-Myers Squibb Co. |
Adcetris (brentuximab vedotin) and Opdivo (nivolumab) |
classical Hodgkin lymphoma |
|
|
CPX-351 (cytarabine, daunorubicin liposomes) |
acute myeloid leukemia |
Signs of clinical benefit. |
|
|
ReN001 |
ischemic stroke |
||
|
Lexicon Pharmaceuticals Inc./Sanofi |
sotagliflozin |
type 1 diabetes |
A dual SGLT-1 and -2 inhibitor, well tolerated |
|
Acceleron Pharma Inc./Celgene Corp. |
sotatercept |
myelofibrosis |
Improves haemoglobin levels and transfusion independence. |
|
fitusiran |
hemophilia A or B without inhibitors |
Well tolerated, on track to start Phase III in early 2017. |
|
|
guadecitabine (SGI-110) |
myelodysplastic syndrome |
Well tolerated and active agent. |
|
|
NS-018 (JAK2 inhibitor) |
refractory myelofibrosis |
Showed clinical benefits and well tolerated. |
|
|
Novartis AG |
CTL019 (a CAR-T cell therapy) |
acute lymphocytic leukemia |
|
|
Novartis AG |
crizanlizumab |
sickle cell anemia |
|
|
Pfizer Inc. |
glasdegib |
acute myeloid leukemia, high-risk myelodysplastic syndrome |
Improved overall survival. |
|
ZX008, low-dose fenfluramine |
Lennox-Gastaut syndrome, Dravet syndrome |
Effective and no cardiovascular adverse events. |
|
|
Pfizer Inc./Spark Therapeutics Inc. |
Factor IX gene therapy |
hemophilia B |
A single dose produced near-normal levels of clotting factors. |
|
Betalutin (177Lu satetraxetan lilotomab) |
non-Hodgkin lymphoma |
Promising safety and efficacy |
|
|
Phase II Initiation |
|||
|
TG4010 with nivolumab |
non-small cell lung cancer, second line |
||
|
seladelpar |
primary biliary cholangitis |
Taking place in US, UK, Canada and Germany. |
|
|
AIR001 (sodium nitrite) inhalation |
heart failure with preserved ejection fraction |
INABLE-TRAINING; to amplify effects of exercise training. |
|
|
NY-ESO Spear T-cells |
myxoid/round cell liposarcoma |
An open-label pilot study. |
|
|
Noveome Biotherapeutics |
ST266 (a secretome solution) |
allergic conjunctivitis |
As ophthalmic drops. |
|
Lycera Corp./Celgene Corp. |
LYC-30937 |
psoriasis |
UPRISE; using enteric coated tablets. |
|
istaroxime |
heart failure |
Taking place in China. |
|
Source: Informa Pharma Intelligence’s BiomedTracker.
Marketing Approvals – Dec. 2 to Dec. 8, 2016 Source: Biomedtracker.
|
Lead Company |
Partner Company |
Drug |
Indication |
Market |
Comments |
|
SUPPLEMENTAL REGULATORY APPROVAL |
|||||
|
Novartis AG |
Roche |
Lucentis (ranibizumab) |
choroidal neovascularization |
EU |
Associated with causes other than neovascular age-related macular degeneration or secondary to pathologic myopia. |
|
Dinagest (dienogest) |
pain caused by adenomyosis |
Japan |
Marketed since 2008 for endometriosis. |
||
|
Opdivo |
classical Hodgkin lymphoma |
Japan |
In patients with relapsed or refractory disease. |
||
|
GlaxoSmithKline PLC |
Relvar Ellipta (fluticasone, vilanterol) |
chronic obstructive pulmonary disease |
Japan |
Already approved for bronchial asthma. |
|
|
Roche |
- |
Avastin (bevacizumab) |
platinum-sensitive recurrent ovarian cancer |
US |
Already approved for platinum-resistant disease. |
|
Boehringer Ingelheim GMBH |
Jardiance (empagliflozin) |
Reduction of cardiovascular risk in type 2 diabetes |
US |
||
|
Teva Pharmaceutical Industries Ltd. |
- |
Copaxone (glatiramer) |
multiple sclerosis |
EU |
No longer contra-indicated in pregnancy. |
|
ACCELERATED/CONDITIONAL APPROVAL |
|||||
|
AbbVie Inc. |
Roche |
Venclyxto (venetoclax) |
chronic lymphocytic leukemia |
EU |
Already approved in the US. |
Data is from Biomedtracker, the pharmaceutical and biotechnology industries’ window into the FDA approval process, offering real-time intelligence for clinical and regulatory events. For more information on the research covered in this article, click here.