ODAC recommends AstraZeneca Truqap for hormone-sensitive prostate cancer

The FDA Oncologic Drugs Advisory Committee, or ODAC, has recognized a favorable benefit risk profile for AstraZeneca’s (AZN) Truqap in combination with abiraterone and androgen deprivation therapy, or ADT, for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer, based on the CAPItello-281 Phase III trial. The committee voted 7 to 1, with 1 abstaining. Results from the primary analysis of the CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death and a clinically meaningful improvement in median radiographic progression-free survival of 7.5 months with the Truqap combination versus treatment with abiraterone and ADT with placebo. Median rPFS was 33.2 months for the Truqap combination versus 25.7 months for the comparator arm. A consistent benefit was observed with the Truqap combination versus treatment with abiraterone and ADT with placebo in key secondary endpoints of the trial, including prolonged time to castration resistance and prostate-specific antigen progression, and fewer and delayed events in terms of symptomatic skeletal event-free survival. Overall survival data were immature at the time of primary analysis; however, subsequent interim results for OS numerically favored the Truqap combination versus the comparator arm. The trial will continue as planned to further assess OS as a key secondary endpoint. The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine. Consistent with the addition of a targeted treatment to background therapy, Grade 3 or higher adverse events occurred in 67% of patients treated with the Truqap combination versus 40.4% of patients treated with abiraterone and ADT with placebo. The most common Grade 3 or higher adverse events in the Truqap arm were rash, hyperglycemia, hypokalemia, diarrhea, hypertension and anemia. The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the feedback as it reviews the submission and is not bound by the Committee’s recommendation. A regulatory application for Truqap in combination with abiraterone and ADT for the treatment of PTEN-deficient mHSPC is under review in the EU based on the CAPItello-281 Phase III trial.