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Daily Brief, CAR-T update, new leukaemia treatments, universal flu hope and more

Highlights from the world of pharma, biotech and healthcare


Hello and welcome to Monday’s Daily Brief.

New data from across haematology at EHA

There was plenty of new data being presented at Europe’s big haematology congress EHA in Stockholm over the weekend, in one of the industry’s fastest moving therapy areas.

While Bluebird Bio impressed with further strong data on beta thalassemia and sickle cell disease on Friday, the following day saw Novartis and Celgene both unveil longer-term data in DLBCL – with Celgene insisting that its JCARO17 still has ‘best in class’ potential.

Meanwhile Daiichi Sankyo is now gearing up to file its acute myeloid leukaemia (AML) treatment quizartinib after it showed extended survival in a phase 3 trial of patients with FLT2-ITD mutations.

Results from the pivotal QuANTUM-R study were presented at EHA on Saturday, and showed patients with relapsed/refractory AML with FLT3-ITD reached a median overall survival of 6.2 months compared to 4.7 months for patients treated with salvage chemotherapy.

These results give it the edge over the only other treatment already approved in the same class, Novartis’ Rydapt, and looks set to give the Japanese company its first entry into oncology.

BMS also scored a hit in the crowded field of multiple myeloma, with its Empliciti extending progression free survival in relapsing and remitting patients.

The company's ELOQUENT-3 trial combined the drug with pomalidomide and low-dose dexamethasone (EPd) in patients with relapsed/refractory multiple myeloma (RRMM). It achieved a 46% reduction in risk of disease progression compared with patients in pomalidomide and dexa alone, with a median PFS, the study’s primary endpoint, of 10.3 months compared with 4.7 months.  More on EHA to follow soon.

Read more here on the CAR-T latest:

New trial results suggest CAR-T effects are durable in lymphoma


Universal flu vaccine shows promise in phase 2

UK next-generation vaccines company hVIVO has unveiled promising results for its universal flu vaccine candidate.

The phase IIb field study of FLU-v (FLU-v 003) hit its primary and secondary endpoints of achieving induction of long-lasting T and B cell immunological responses.

Promisingly, it also achieved a reduction in influenza infection rates and severity and duration of symptoms observed, with a 60% reduction in confirmed flu infections and an 83% reduction in the number of confirmed cases with severe symptoms compared to placebo.

The treatment was also well tolerated, and the company says FLU-v is now ready for phase III development.

FLU-v is a broad spectrum vaccine covereing A, B and Pandemic strains, and is administered in a stand-alone, single injection influenza vaccine. By overcoming a number of key issues with current annual influenza vaccines, the company believes it has the potential to address a much larger patient population and says it has blockbuster sales potential. FLU-v is being developed by Imutex, hVIVO's 49% joint venture with PepTcell Limited, trading as the SEEK Group.


"We are pleased that a second Phase IIb study has reported positive results for FLU-v. It is our view that FLU-v is now positioned to enter phase III, with clear disease and symptom-based endpoints identified,” says Trevor Phillips, executive chairman of hVIVO (pictured).

"The market potential for a broad spectrum universal influenza vaccine is significant. Along with our joint venture partner SEEK, and with a differentiated data-package, we will endeavour to maximise the strategic options available to the Company from FLU-v while still focusing on our other revenue streams.”


NICE decides on Dupixent and Opdivo

England’s cost effectiveness watchdog NICE is to pass judgement on two big products this week – Sanofi’s eczema drug Dupixent and BMS’ Opdivo in bladder cancer.

NICE has already rejected both drugs in its first round appraisals - but dealmaking on prices from the companies could help them to persuade it to change its mind.  A yes is particularly important for Opdivo as MSD’s rival Keytruda gained NICE approval in bladder cancer patients in March.

The Dupixent decision is due on Wednesday and Opdivo’s comes on Friday.

Article by
Andrew McConaghie

18th June 2018

From: Regulatory



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