Real-World Evidence Returns ‘Limited,’ EU Review Finds

Hundreds of millions of public dollars in pursuit of real-world evidence (RWE) has produced “limited” returns, left wide knowledge “gaps” and often “diminish returns on the public funds invested,” a team of European researchers has concluded.

Researchers at the European Medicines Agency (EMA) examined 65 publicly funded initiatives based on their primary and secondary objectives to determine whether the EMA could mine the initiatives’ data for RWE. “At the time of evaluation,” corresponding author Kelly Plueschke wrote for the team, “the published public information was limited, data access was not explicit and their sustainability was unclear.” The European Union spent some 734 million euros ($862 million) to pay for the initiatives, Plueschke wrote.

“From our review, there is an apparent lack of an overarching vision for an infrastructure that would provide sustainable access to the data generated by the projects,” Plueschke wrote.

There may be a saving grace, however: the researchers noted that many of the recent initiatives “include roadmaps as part of their deliverables which may potentially assist in delivering sustainability in the future.”

Read the research team’s findings here: www.fdanews.com/07-06-18-initiatives.pdf.

FDA Removes Hold on Phase III Trials for Invossa, Company Announces

The FDA lifted a clinical hold on the Phase III trial of Invossa, an investigational osteoarthritis drug produced by Kolon TissueGene, the South Korea-based company announced Friday, July 6.

Kolon TissueGene will begin enrollment of some 1,020 patients across 50 sites in the U.S. The basic design of the study was approved by the FDA in May 2015.

Researchers are hoping to assess Invossa’s ability to treat pain and improve function in patients with osteoarthritis. There is also hope that Invossa is an effective disease-modifying osteoarthritis drug; it would be the first of its kind in the world.

Kolon TissueGene is a division of Kolon Life Science, also based in South Korea.

Roche’s Tecentriq-Chemo Combo Meets Co-Primary Endpoint

Roche announced that its Phase III study, which assessed a combination treatment of Tecentriq (atezolizumab) plus Abraxane (paclitaxel protein-bound) as a first-line treatment for triple negative breast cancer, has met its co-primary endpoint of progression-free survival.

The drugmaker said that Tecentriq, when paired with Abraxane, a chemotherapy medication, was found to significantly reduce the risk of disease worsening or death in a PD-L1 positive population with metastatic or unresectable locally advanced triple negative breast cancer.

The company said the multicenter, randomized double-blind study, Impassion130, is the first positive Phase III immunotherapy study for triple negative breast cancer, a disease with limited treatment options.

“Overall survival is encouraging in the PD-L1 positive population at this interim analysis,” and follow-up will continue, Roche said.

Paperwork Errors May be Skewing Results, Study Finds

Paperwork requirements may be a barrier to improving access to novel treatments, a recent study concluded.

A team of researchers led by the Cleveland Clinic’s Abby Statler analyzed more than 2,300 patients in 13 different leukemia trials. They found that 60 percent of those who were ineligible for the trials were ineligible because of paperwork errors.

Most of the disqualifying paperwork errors involved specimens for correlative studies, Statler and her colleagues found.

It suggests to the team that eligibility requirements may be too strict. If those criteria are loosened, “access to novel treatments could increase dramatically, ultimately improving the generalizability of these trials’ results, minimizing protocol violations and accelerating the time it takes to bring new products to market,” Statler wrote in the latest edition of Blood, a medical journal.