Small Phase I melanoma study testing a combination of Zelboraf and Yervoy was closed early due to an unexpectedly high rate of liver toxicity, investigators report in letter to the editor of the New England Journal of Medicine. A sequential study of Yervoy and Zelboraf and other combination studies proceed as planned.
An eagerly awaited Phase I/II study of Roche’s Zelboraf and Bristol-Myers Squibb Co.’s Yervoy has been terminated due to liver toxicity, but the drugs still could find a role for use in immediate sequence.
Both Bristol’s CTLA inhibitor Yervoy (ipilimumab) and Roche’s BRAF inhibitor Zelboraf (vemurafenib) revolutionized the melanoma field when they cleared FDA in 2011, and the two drugs’ different mechanisms of action were expected to be complementary
EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.
