Phase III
The announcement by the NIAID, a part of the National Institutes of Health (NIH), is very unusual.
A briefing document from the U.S. FDA cites critical safety concerns with Pfizer and Eli Lilly’s anti-NGF osteoarthritis drug tanezumab, despite the fact that clinical trials have demonstrated the agent can help patients with osteoarthritis.
After touting “positive results” in December and August for its Phase III cancer drug, Tesetaxel, Odonate Therapeutics is now discontinuing drug development and closing up shop.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 23, 2021.
Roche’s checkpoint inhibitor Tecentriq (atezolizumab) hit the mark in the company’s Phase III IMpower010 trial of the drug compared to best supportive care in people with resectable early-stage lung cancer.
AstraZeneca reported that the U.S. Phase III trial of the vaccine, AZD1222, demonstrated an efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization.
A Phase III trial from Idera Pharmaceuticals did not reach the primary endpoint of ORR in patients with anti-PD-1 refractory advanced melanoma treated with a combination regimen comprising ipilimumab and the company’s investigational agent tilsotolimod.
It was a relatively quiet week in terms of clinical trial news, but there were some significant releases. Here’s a look.
Merck and Eisai announced that their combination of Merck’s checkpoint inhibitor Keytruda and Eisai’s Lenvima, a tyrosine kinase inhibitor, significantly improved progression-free survival in advanced endometrial cancer.
The results published in the NEJM state that pegcetacoplan met the study’s primary endpoint for efficacy, demonstrating an advantage over eculizumab with a statistically significant improvement in adjusted means of 3.8 g/dL of hemoglobin at week 16 (p<0.001). An impressive 85% of patients were transfusion free at 16 weeks, in contrast to only 15% of eculizumab-treated patients.
PRESS RELEASES