Celcuity’s first approved drug, Revtorpyk, is indicated for the second-line treatment of advanced HER2- breast cancer patients without PIK3CA mutations—a key use distinction that sets it apart from other PIK3/AKT blockers in the space, according to Jefferies.
The FDA has given the go-ahead to Celcuity’s kinase inhibitor gedatolisib as part of a treatment regimen for certain patients with locally advanced or metastatic breast cancer. The therapy will carry the brand name Revtorpyk.
Celcuity expects to launch Revtorpyk in the U.S. in “late Q3” and plans to put in place a “comprehensive patients support program,” according to a Tuesday release, though the company hasn’t yet specified a price for the drug. Revtorpyk is Celcuity’s first commercial product.
Revtorpyk is specifically indicated for use in combination with AstraZeneca’s Faslodex, with or without Pfizer’s Ibrance, in patients with HR-positive, HER2-negative metastatic or locally advanced disease with no detectable PI3KCA mutations after progression on or after at least one previous line of endocrine therapy.
The approval gives Celcuity a “differentiated foothold” in the breast cancer space, where other PI3K/AKT drugs focus on patients positive for PI3KCA mutations, Jefferies told investors in a note Tuesday evening. Examples of these approved competitors include Novartis’ Piqray and Gilead’s Zydelig, though Jefferies didn’t explicitly name these in the note.
Investor focus will now shift to Celcuity’s launch execution, the analysts said, as well as how well doctors adopt Revtorpyk into their practices. Investors will also be keeping an eye on Revtorpyk’s potential “to become a new targeted option for the sizeable 2L population,” Jefferies continued.
Data from the Phase 3 VIKTORIA-1 trial paved the way for Tuesday’s approval. Median progression-free survival (PFS) with the three-drug regimen reached just over nine months, as compared with two months in those on Faslodex. Revtorpyk plus Faslodex (without Ibrance) resulted in a median PFS of 7.4 months.
Additional data released earlier this summer showed that the Revtorpyk triplet elicited a 50% PFS benefit versus Faslodex plus Piqray, a current standard-of-care (SOC) regimen in the space. PFS improvement with Revtorpyk plus Faslodex was 49%. Patients in this particular cohort harbored mutations in PI3KCA.
These findings are “practice-changing in our view,” analysts at Jefferies wrote in a June 2 note to investors. The Revtorpyk triplet “doubled PFS” versus Piqray comparators, “a meaningful improvement vs SOC that could drive near-term rapid uptake,” the firm continued.
In the third quarter, Celcuity plans to file a supplemental package for Revtorpyk based on data from this PI3KCA-mutant cohort, the biotech said on Tuesday. Celcuity also continues to test Revtorpyk in the Phase 3 VIKTORIA-2 trial evaluating the drug as a first-line option for patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer.
