FDA Fast-Tracks INX-315 in Ovarian Cancer
INX-315, a CDK2 inhibitor, gained FDA fast track status in CCNE1-positive platinum-resistant/refractory ovarian cancer.
US FDA
- The FDA granted fast track status to INX-315 for the potential treatment of CCNE1-amplified, platinum-resistant/refractory ovarian cancer.
- INX-315 is a novel CDK2 inhibitor targeting a resistance mechanism to other therapies.
- INX-315 is being evaluated in a phase 1/2 trial, including an ovarian cancer expansion cohort.
The FDA granted fast track designation to INX-315, a novel CDK2 inhibitor for treating adult patients with CCNE1-amplified, platinum-resistant or refractory ovarian cancer.1
Ovarian cancer: © Dr_Microbe - stock.adobe.com
CDK2 is a protein whose activity is often abnormally high in cancer, particularly when the CCNE1 gene is amplified or the cyclin E1 protein is overexpressed.2 This is significant because increased CCNE1 or cyclin E1 can make tumors resistant to common oral CDK4/6 inhibitor drugs. Notably, CCNE1 amplification is seen across many solid tumors and in a portion of high-grade serous ovarian cancer, conditions often linked to worse outcomes.1 This genetic change is also associated with resistance to platinum-based chemotherapy.
INX-315 is a small molecule being studied in the phase 1/2 INX-315-01 trial (NCT05735080) as a potent and selective inhibitor of CDK2. The agent is currently not FDA-approved.1
“The FDA’s decision to grant fast track designation for INX-315 reflects the best-in-class potential of our CDK2 inhibitor, the strength of our preclinical and early clinical data and the urgency to address significant unmet need in patients with CCNE1-amplified platinum-resistant/refractory ovarian cancer,” said Patrick Roberts, PharmD, PhD, chief executive officer and co-founder of Incyclix Bio, in a press release. “We look forward to working closely with the FDA to advance the clinical development of INX-315 to bring it to patients as soon as possible.”
The fast track designation from the FDA is designed to help bring treatments for serious conditions with unmet medical needs to patients faster. It offers advantages like more frequent FDA communication and potential eligibility for accelerated approval and priority review.
About the Phase 1/2 INX-315-01 Trial
INX-315-01 is an ongoing, first-in-human, open-label trial evaluating the safety, tolerability, pharmacokinetics, and early efficacy of INX-315 when used for the treatment of patients with recurrent advanced or metastatic cancer, including those with CDK4/6 inhibitor-resistant, estrogen receptor (ER)-positive, HER2-negative breast cancer or those with CCNE1-amplified solid tumors who progressed on or after standard-of-care therapy.3
Those enrolled in the study must be aged 18 years or older with an ECOG performance status of 0 or 1, measurable disease per RECIST 1.1 criteria, and adequate organ function. ER-positive/HER2-negative breast cancer that has progressed on or after CDK4/6 inhibition, CCNE1-amplified platinum-resistant/refractory epithelial ovarian cancer, and other solid tumors with known CCNE1 amplification make up the eligible tumor types for investigation in the study.
This clinical trial consists of 3 parts. Part A involves dose escalation of oral INX-315 monotherapy and combination therapy with fulvestrant. Part B is a dose-expansion cohort evaluating INX-315 monotherapy specifically in ovarian cancer. Part C will assess the combination of INX-315, abemaciclib (Verzenio), and fulvestrant (Faslodex) in patients with advanced or metastatic HR-positive/HER2-negative breast cancer.
Primary end points being assessed in the study include safety and tolerability, the incidence of dose-limiting toxicities (part A), the determination of recommended doses for expansion (part A), overall response rate (part B), selection of the recommended phase 2 dose (part B), and the antitumor activity of INX-315 in combination with abemaciclib and fulvestrant (part C). The characterization of INX-315 pharmacokinetics serves as a secondary end point, and additional efficacy end points are being evaluated.
The study is actively recruiting patients and has an estimated enrollment of 150 patients. The primary completion date of the study is set for December 2025, and the estimated study completion date is June 2026.
