Daily Brief: Keytruda and microbiome synergy, Pfizer's files PARP contender and more

Hello and welcome to another rapid round up of news from pharma, biotech and healthcare.

Going live: Keytruda and microbiome therapy combination

Just yesterday Genentech announced a deal with a UK biotech specialising in microbiome research, and today sees Merck & Co. also tapping into the wonderful world of microbes.

The big pharma company has signed a deal with Leeds, UK-based 4D pharma to conduct a clinical trial evaluating its immunotherapy blockbuster Keytruda in combination with 4D pharma's live biotherapeutic candidate MRx0518 in patients with solid tumours.

There is growing evidence to suggest that having healthy gut flora provides a clinically significant boost to patients taking checkpoint inhibitor immunotherapy – even if the mechanism is still not entirely clear.

The phase I study will evaluate the benefits in patients who progressed on prior PD-1 inhibitor therapy with renal, bladder, melanoma and non-small cell lung cancer.

"At 4D we believe there is strong scientific rationale for evaluating our lead oncology programme MRx0518, in combination with a checkpoint inhibitor," said Duncan Peyton, founder and CEO of 4D pharma plc. "We are excited to work with MSD and look forward to collaborating on this project."

ONCOLOGY

Pfizer files PARP inhibitor contender in US and Europe

There may already be three PARP inhibitor cancer drugs on the market, but Pfizer believes there is room for a fourth, which it has just submitted to the US and EU regulators.

The FDA has granted priority review designation to Pfizer’s drug talazoparib, which it has developed to treat women with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC), with the EMA also accepting the filing. The company acquired the candidate when it bought out Medivation for $14bn in 2016, and needs to recoup its investment with a successful PARP competitor.

If approved, talazoparib will be fourth to market behind Clovis Rubraca, Tesaro’s Zejula and AstraZeneca and Merck & Co’s market leader Lynparza. In January, Lynparza became the first of the class to gain approval in breast cancer, with ovarian cancer being the primary focus for the competitors.

The FDA is due to make its ruling on the Pfizer's drug in December 2018, which could help it rival AstraZeneca and Merck & Co in this patient population.

UK MARKET ACCESS

Takeda takes a lead on NICE’s new service for economic model review

England’s cost effectiveness watchdog NICE is well known for disappointing pharma companies when it rejects new medicines – and this is frequently because of ‘poor economic modelling’ in its submissions.

To try and head the problem off before it gets to this stage, the Institute’s NICE Scientific Advice (NSA) division has launched a new health economic model review service, Preliminary Independent Model Advice, (PRIMA).

PRIMA offers developers of economic models some independent expert advice on the robustness and technical rigour of their economic models. NSA says it offers a "comprehensive, peer review service to help developers of drugs, medical devices and diagnostics, and public health interventions ensure the quality of their model structure, coding, usability and transparency."

Today NICE went public with news that one major pharma company, Takeda, had endorsed the service after completing two projects with NSA.

Pharma companies have to pay NICE’s NSA for the service, but it could be worth it if it prevents that dreaded ‘not recommended for routine NHS use’ decision from NICE.

Peter Wheatley-Price, Market Access and Pricing Director at Takeda UK, said: “Demonstrating patient value is one of our strategic priorities at Takeda. The creation of robust technology appraisals is therefore an important part of our daily work. We were delighted to be one of the first companies to work with the PRIMA service, and collaborate with NICE on improving this valuable tool."

He concluded: “We appreciated the PRIMA team’s engaging and flexible approach at this pivotal stage in development, and look forward to using the service as part of our model development going forward.”

Leeza Osipenko, head of NICE Scientific Advice said: “If companies are better able to demonstrate the value of their products this can also potentially speed up patient access to them.”