Shionogi shared positive clinical cure rates from their ongoing trial of Fetroja (cefiderocol) for difficult-to-treat Gram-negative infections.
Today, Shionogi shared real-world trial data demonstrating a 63% clinical cure rate for patients with Acinetobacter baumannii or Pseudomonas aeruginosa infection. In early use experience, including for patients with limited treatment options, 80% of patients treated with cefiderocol cleared their difficult-to-treat Gram-negative infections.
Antimicrobial resistance is a growing public health concern, with dangerous pathogens learning to evade treatment and causing approximately 700000 deaths each year. There is a significant need for novel therapies to combat these difficult-to-treat bacteria.
Shionogi’s PROVE (Retrospective Cefiderocol Chart Review) trial is an ongoing international retrospective study of the safety and efficacy of cefiderocol in hospitalized patients with highly resistant Gram-negative bacterial infections.
The participants included 76 with Acinetobacter baumannii infections and 120 with Pseudomonas aeruginosa infections. Among these cohorts, 96% those infected with Acinetobacter baumannii were resistant to carbapenems, and 97% of those with Pseudomonas aeruginosa had carbapenem resistance.
The safety and efficacy of cefiderocol was consistent with other studies. Adverse event data was reported for 53 patients, with 24.5% reporting adverse events and 75.5% not reporting adverse events. Of all participants, 5 experienced adverse drug reactions, among whom 2 had rashes, 1 saw a severe increase in liver function test values, and 2 had diarrhea. In 2 patients, cefiderocol treatment was withdrawn.
For both the Acinetobacter baumannii and Pseudomonas aeruginosa patients, 79% were alive and 21% died within 30 days of initiating cefiderocol treatment (30-day all-cause mortality).
Previous studies found cefiderocol was the only treatment option with demonstrated activity against more than 80% of all the tested difficult-to-treat, Gram-negative pathogens.
The investigators concluded that this real-world study of cefiderocol therapy yielded high rates of clinical cure and microbiological eradication, with most patients alive after treatment. “Cefiderocol appears to be a promising therapy for patients with Gram-negative bacteria infections who have limited treatment options,” they wrote.