When Eli Lilly’s Verzenio snagged an FDA go-ahead to treat certain breast cancer patients after surgery, the first-in-class nod was weakened by an unexpected limitation. Now, the company hopes longer-term follow-up data will convince U.S. regulators to remove the restriction.
Lilly has filed an FDA application to expand Verzenio’s use in HR-positive, HER2-negative early breast cancer at high risk of recurrence after surgery to include patients with low levels of the cellular proliferation marker Ki-67.
The move was based on updated results from the phase 3 monarchE trial, which were presented at the San Antonio Breast Cancer Symposium (SABCS) 2022 annual meeting. A previous analysis of the trial backed Verzenio’s nod as a post-surgery adjuvant therapy last year. The new data showed Verzenio’s benefits held up across patient subgroups after longer follow-up, although the CDK4/6 inhibitor has yet to demonstrate a significant advantage at helping patients live longer.
Nevertheless, Jake Van Naarden, CEO of Lilly’s oncology arm Loxo, said in an interview ahead of the SABCS presentation that he believes Lilly has the data to satisfy the FDA. In the original approval, FDA didn’t allow Verzenio in patients with Ki-67 below 20%. For this subgroup of patients with better prognosis, the agency was being cautious with the addition of Verzenio on top of endocrine therapy, requiring a more mature patient survival “trend” to rule, Van Naarden told Fierce Pharma at the time of the approval.
The monarchE trial hit statistical significance after a median 15.5 months of follow-up. Back then, Verzenio’s addition to post-surgery endocrine therapy significantly cut the risk of invasive cancer recurrence or death by 25.3% regardless of Ki-67 status. The drug’s magnitude of benefit was bigger, at 37.4%, in Ki-67-high patients with at least 20% expression, according to its current FDA label.