Pharmaceuticals & Healthcare News

NICE backs Lilly’s JAK inhibitor Olumiant for RA

A novel treatment option for some patients with rheumatoid arthritis (RA) could soon be routinely available on the NHS, after cost regulators ruled Eli Lilly’s Olumiant to be cost-effective.

Draft guidelines by the National Institute for Health and Care Excellence recommend Olumiant (baricitinib) as an option for treating severe active RA in adults whose disease has responded inadequately to intensive therapy with conventional disease-modifying antirheumatic drugs (DMARDs).

The drug is also recommended in adults who have had an inadequate response to, or who cannot have other DMARDs, including at least one biological DMARD.

Olumiant was approved earlier this year as the first JAK inhibitor to treat rheumatoid arthritis, after clinical trials showed a significant improvement in the signs and symptoms of disease compared to standard of care therapies.

Data from the Phase III RA-BEAM trial showed that baricitinib scored significantly better than placebo on the ACR20 response, a standard clinical measure that represents at least a 20 percent improvement in RA disease activity, as well as demonstrating superiority to AbbVie’s multi-billion-dollar blockbuster Humira (adalimumab), the world’s biggest selling drug.

After 24 weeks, the drug was also superior to placebo in preventing progressive radiographic structural joint damage, and its treatment benefits were maintained through 52 weeks of therapy.

In the RA-BEGIN trial, the drug also outperformed methotrexate on the ACR20 measure while, elsewhere, data showed efficacy in RA patients with inadequate responses to traditional disease-modifiying anti-rheumatic drugs (in the RA-BUILD trial) and biological therapies (in RA-BEACON).

RA affects around 450,000 people in the UK, of whom around 15 percent have the severe form of the disease.

The average cost of Olumiant per patient per year is estimated at £10,501 based on the list price, but its cost to the NHS will be reduced through a confidential patient access scheme.


 

AZ, Chi-Med test savolitinib in kidney cancer

AstraZeneca and Hutchison China MediTech (Chi-Med) have begun trialling savolitinib in patients with a particular type of kidney cancer in a global, open-label, randomised Phase III registration study.

Savolitinib (AZD6094/HMPL-504) is a potential first-in-class selective inhibitor of c-MET (also known as mesenchymal epithelial transition factor) receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumours.

It was discovered by Chi-Med and is being developed in partnership with AZ as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with other selective c-MET inhibitors, such as renal toxicity.

“The data building across our early development studies are encouraging, that savolitinib has the potential to be an important treatment option for c-MET driven cancers including kidney, lung and gastric cancers,” noted Susan Galbraith, SVP IMED Oncology, AZ.

SAVOIR is the first pivotal study ever conducted in c-MET-driven papillary renal cell carcinoma and the first molecularly selected trial in renal cell carcinoma.

Initiation of the trial has triggered a $5 million milestone payment to Chi-Med from AZ under the terms of the license and collaboration agreement signed between them in 2011.


 

 

CRT expands drug discovery deal with Merck

Cancer Research Technology is extending its deal with Germany’s Merck to discover new cancer drugs targeting the Hippo signalling pathway, which regulates cell proliferation and apoptosis to control tissue growth.

The move follows a successful one-year target validation and drug discovery feasibility partnership between CRT’s Discovery Laboratories in London and Cambridge and Merck at Darmstadt in Germany, during which the alliance sought to increase understanding of the role of the Hippo pathway in cancer.

Abnormal activation of proteins controlled by this pathway has been linked to the development of a range of cancers, making it an attractive area for the discovery of novel therapies, the parties concluded.

As a result, the partnership has now moved into drug discovery with the aim of identifying molecules to take into preclinical studies and clinical trials.

Under the terms of the deal, CRT, the commercial arm of Cancer Research UK, will receive royalties and milestone payments to be invested into charity’s research.

“We’ve brought together leading academics in the field and industry to build on world-class research, and we’re now focused on developing these early projects for the benefit of cancer patients,” said Dr Iain Foulkes, CRT’s chief executive.


 

Novartis bags first-line approval for Zykadia

The European Commission has expanded the scope of Novartis’ Zykadia to include the first line treatment of patients with non-small cell lung cancer (NSCLC) whose tumours are anaplastic lymphoma kinase (ALK)-positive.

The drug was originally cleared in the region in 2015 to treat patients with ALK+ metastatic non-small cell lung cancer who have progressed on or are intolerant to Pfizer’s Xalkori (crizotinib).

Its wider approval comes on the back of data from the Phase III ASCEND-4 trial, which showed a 45 percent reduction in the risk of disease progression patients taking Zykadia verus those taking chemotherapy.

Those treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.

The drug also showed a benefit in patients with brain metastases with a median PFS of 10.7 months compared to 6.7 months in the chemotherapy arm.

Around 3-7 percent of all patients with NSCLC have an ALK gene rearrangement.


 

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