Celcuity Enters Commercial Stage as FDA Approves REVTORPYK for Advanced Breast Cancer

Key Points

• Celcuity won full FDA approval for gedatolisib, now branded REVTORPYK, in a specific advanced breast cancer population, moving the company into the commercial stage. The drug is approved for HR-positive, HER2-negative, PIK3CA-wild-type locally advanced or metastatic breast cancer after endocrine therapy progression.
• VIKTORIA-1 trial results supported the approval, showing meaningful progression-free survival gains versus fulvestrant alone. The triplet regimen cut the risk of progression or death by 76%, while the doublet reduced it by 67%.
• Celcuity is preparing a broad launch, with a 100-person sales force and an expected commercial rollout later in the third quarter, depending on drug supply. The company also plans additional filings for PIK3CA-mutant disease in the U.S. and abroad, and says pricing will be set at a premium to current therapies.

Celcuity NASDAQ: CELC said the U.S. Food and Drug Administration has granted full approval to gedatolisib, now branded as REVTORPYK, for certain patients with advanced breast cancer, marking the company’s transition to a commercial-stage business.

Brian Sullivan, Celcuity’s co-founder and chief executive officer, said on a conference call that REVTORPYK was approved in the United States for the treatment of HR-positive, HER2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after one or more lines of endocrine therapy in the metastatic setting.

“This approval is a transformative milestone for Celcuity as we now transition to a fully integrated commercial stage company,” Sullivan said.

FDA Label Covers Use With Fulvestrant, With Or Without Palbociclib

Igor Gorbatchevsky, Celcuity’s chief medical officer, said REVTORPYK is approved in combination with fulvestrant, with or without palbociclib, for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, after progression on or after at least one line of endocrine therapy in the metastatic setting.

The recommended dose is 180 mg administered as an intravenous infusion over 30 minutes once weekly on days one, eight and 15 of each 28-day cycle, in combination with fulvestrant, with or without palbociclib. Treatment continues until disease progression or unacceptable toxicity, Gorbatchevsky said.

Sullivan described REVTORPYK as the first and only FDA-approved multi-target PI3K/AKT/mTOR, or PAM pathway, inhibitor. He said the company believes the therapy has a “best-in-class benefit risk profile” for patients with locally advanced and metastatic breast cancer.

VIKTORIA-1 Data Supported Approval

The approval was based on results from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 trial, an open-label, global, randomized study evaluating REVTORPYK plus fulvestrant, with or without palbociclib, in patients whose disease progressed on or after CDK4/6 therapy and an aromatase inhibitor.

Gorbatchevsky said 392 patients were randomized equally among three arms: REVTORPYK plus fulvestrant and palbociclib; REVTORPYK plus fulvestrant; and fulvestrant monotherapy.

For the triplet regimen of REVTORPYK, palbociclib and fulvestrant, median progression-free survival was 9.3 months compared with 2 months for fulvestrant alone. Gorbatchevsky said that represented a 7.3-month improvement, a hazard ratio of 0.2 and a 76% reduction in the risk of disease progression or death. The objective response rate was 32% for the triplet regimen compared with 1% for fulvestrant, and the median duration of response was 17.5 months.

For the doublet regimen of REVTORPYK plus fulvestrant, median progression-free survival was 7.4 months compared with 2 months for fulvestrant. Gorbatchevsky said that reflected a 5.4-month improvement and a 67% reduction in the risk of progression or death. The objective response rate was 28%, and the median duration of response was 12 months.

Gorbatchevsky said safety data showed REVTORPYK was generally well tolerated, with most adverse reactions classified as Grade 1 or 2. He said there were no dose reductions or treatment discontinuations due to hyperglycemia. Serious adverse reactions occurring in more than 1% of patients included pneumonia, thrombosis and stomatitis.

Company Outlines Launch Strategy

Eldon Mayer, Celcuity’s chief commercial officer, said the company expects REVTORPYK to be positioned for strong market adoption in PIK3CA wild-type advanced breast cancer and, if approved, in PIK3CA mutant disease as well.

Mayer said about 37,000 U.S. patients with HR-positive, HER2-negative advanced breast cancer receive second-line treatment each year after progression on CDK4/6 inhibitors. He said roughly 60% of those patients are PIK3CA wild type and 40% are PIK3CA mutant. If both indications were approved, Mayer said REVTORPYK could address the full second-line market with a single PIK3CA-agnostic approach.

The company estimates a served market opportunity of more than $6 billion across wild-type and mutant populations in the second-line setting, excluding potential first-line use. Mayer also said second-line and two first-line patient segments together represent a potential U.S. market opportunity exceeding $10 billion.

Mayer said Celcuity has engaged more than 1,500 key opinion leaders and community breast cancer experts, more than 200 key accounts and major oncology organizations, including group purchasing organizations, state societies and patient advocacy groups. He said the company has deployed a 100-person sales organization, including sales management, strategic accounts, payer and reimbursement teams, key opinion leader-focused teams and medical science liaisons.

The sales force will cover about 9,000 healthcare providers who treat HR-positive, HER2-negative advanced breast cancer, with a focus on 2,000 high-volume breast cancer providers, Mayer said.

Questions Address Pricing, Access And Launch Timing

During the question-and-answer session, Sullivan said Celcuity had not yet announced a specific price for REVTORPYK because pricing information would first be submitted to drug-pricing compendia. He added that the price “will be a premium relative to what currently available therapies are.”

Asked about launch timing, Sullivan said the company expects to launch commercially later in the third quarter and that the main gating factor is ensuring sufficient drug supply. He also said Celcuity plans to use a temporary J-code at launch and has put programs in place to help accounts manage reimbursement timing for the buy-and-bill product.

Sullivan said Celcuity plans to submit a supplemental new drug application in the third quarter seeking approval for patients with HR-positive, HER2-negative advanced breast cancer with PIK3CA mutations. He also said the company plans to submit VIKTORIA-1 PIK3CA wild-type data to NCCN this quarter and expects to present additional clinical program updates later this year, including data from a Phase 1b metastatic castration-resistant prostate cancer study in the fourth quarter.

Celcuity also intends to submit a marketing authorization application to the European Medicines Agency for both wild-type and mutant data, along with similar filings outside the United States, following submission of the sNDA to the FDA, Sullivan said.

About Celcuity NASDAQ: CELC

Celcuity, Inc is a clinical-stage biotechnology company specializing in precision oncology diagnostics. The company develops and commercializes predictive biomarker assays designed to identify which patients are most likely to benefit from targeted cancer therapies. By integrating functional profiling of tumor cells with molecular analyses, Celcuity seeks to optimize treatment selection and improve outcomes for patients with solid tumors.

Celcuity’s proprietary platform evaluates tumor cell sensitivity to various therapeutic agents using ex vivo assays that measure DNA damage response and other critical pathways.

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