“RDEB-associated SCC is a devastating disease with few if any treatment options for advanced patients. We are very pleased for additional data on the potential use of rigosertib in patients with RDEB-associated SCC to be presented as a ‘late breaker’ at EADV 2023,” said
Presentation Details
Date: | |
Time: | |
Abstract Title: | Efficacy and Safety of Rigosertib in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) Associated Advanced/Metastatic Squamous Cell Carcinoma (SCC) |
Presenter: | Prof. Dr. |
Session: | D2T01.3: Late breaking news |
Abstract Details
The abstract outlines promising results from an open-label, single arm safety and efficacy study of four patients with recessive dystrophic epidermolysis bullosa (RDEB) associated advanced/metastatic squamous cell carcinoma (SCC) treated with intravenous/IV or oral rigosertib. Two patients achieved complete cutaneous responses of 12 months or more, one patient experienced metastatic disease progression, and one patient remains on study. Responding patients included one patient who achieved both cutaneous and histological remission of 16 months. The patient’s rigosertib dose was reduced following the report of a grade 2 adverse event (irritative cystitis), which led to symptomatic relief. The other responding patient achieved a complete cutaneous remission and completed the protocol-specified 12-months of therapy. The authors suggest that the preliminary study results indicate rigosertib as a potential treatment for RDEB-associated SCC. Additional patients are being sought for the trial.
A copy of the Abstract will be available on the Scientific Presentations section of the Onconova website following the Presentation.
About
Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer.
Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395).
For more information, please visit www.onconova.com.
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