SLS009 Earns FDA Fast Track Designation for R/R PTCL

• SLS009 (GFH009) is a novel CDK9 inhibitor that has shown promising efficacy for the treatment of relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) as well as acute myeloid leukemia (AML).
• A phase 1 dose-escalation trial revealed SLS009’s favorable efficacy and safety profile.
• The FDA fast track designation is intended to facilitate the development and review of drugs that fill unmet medical needs.

DNA strand and cancer cell: ©catalin - stock.adobe.com

SLS009, a novel CDK9 inhibitor, has been granted a fast track designation from the FDA for the treatment of R/R PTCL, according to SELLAS Life Sciences.¹

The fast track designation is designed to expedite the development of investigational agents that fill a serious, unmet medical need.

“The FDA’s decision to grant SLS009 fast track designation signifies an important milestone towards developing a safe and effective treatment for PTCL, a group of aggressive and rare non-Hodgkin lymphomas, and underscores the urgent need for innovative therapies such as SLS009 that can significantly improve the outcome of PTCL patients,” said Angelos Stergiou, MD, ScD hc, president and chief executive officer of SELLAS, SLS009’s manufacturer, in a press release.¹

A phase 1 dose-escalation trial of SLS009 in R/R hematological malignancies was recently completed. Four out of 11 patients (36.4%) with AML or PTCL had complete or partial responses. Belinostat (Beleodaq), the current standard-of-care treatment for PTCL, demonstrated a 25.8% response rate in a similar patient population.

An open-label, single-arm phase 1b/2 trial (NCT05934513) of SLS009 will further evaluate its safety and efficacy in patients with R/R PTCL. The recommended phase 2 dose is 100mg once per week. This study will enroll up to 95 patients. The trial’s primary end points are adverse events in phase 1b and objective response rate in phase 2.²

SLS0009’s manufacturers are also pursuing breakthrough drug designation from the FDA.¹

Earlier this month, the FDA granted orphan drug designation to SLS009 for AML. This designation was based on findings from a phase 1 study (NCT04588922) evaluating SLS009 in patients with R/R AML.

Acute myeloid leukemia cells: ©LASZLO - stock.adobe.com

An open-label, single-arm, multicenter, phase 2a trial (NCT04588922) is further investigating the agent in this patient population who have failed venetoclax (Venclexta, Venclyxto) -based therapies. Topline data from this trial showed SLS009 in combination with venetoclax and azacitidine showed that 1 out of 5 patients achieved a complete response and remained alive after 5 months of treatment, and another patient is alive after 4 months of treatment.³

REFERENCES:

1. SELLAS Life Sciences receives fast track designation from FDA for SLS009 for treatment of relapsed/refractory peripheral T-cell lymphomas. News release. SELLAS Life Sciences. October 30, 2023. Accessed October 30, 2023. https://tinyurl.com/4wt5tetn

2. A study of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma. ClinicalTrials.gov. Updated August 24, 2023. Accessed October 30, 2023. https://clinicaltrials.gov/study/NCT05934513

3. SELLAS announces positive initial topline phase 2a data of SLS009 in acute myeloid leukemia. News release. SELLAS Life Sciences. October 16, 2023. Accessed October 30, 2023. https://tinyurl.com/3z58s8zj