New AML trial targets patients unlikely to respond to standard therapy
First patient enrolled in Phase 2 study of experimental therapy SLS009
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Sellas Life Sciences is seeking people with newly diagnosed acute myeloid leukemia (AML) for a clinical trial testing its experimental anticancer therapy SLS009 (tambiciclib).
The Phase 2 clinical trial (NCT04588922) is expected to enroll about 80 participants, according to a company press release. The broader study is investigating SLS009 in several blood cancers, but the newly announced portion is enrolling two groups of AML patients. Sellas said the first newly diagnosed AML patient has already been enrolled in the trial.
How the new AML trial is designed
One group includes patients newly diagnosed with AML who have not received treatment and who, based on molecular profiling, are unlikely to benefit from a standard first-line regimen using venetoclax and azacitidine (aza/ven). The second group will include patients who began first-line aza/ven treatment but did not respond after two treatment cycles.
The trial is evaluating SLS009 in these subgroups, with measures such as safety and antitumor activity among the outcomes being studied. The study is currently recruiting participants at sites in the U.S., and the company said enrollment will also take place at locations in Europe.
“Enrolling the first patient in this first-line AML Phase 2 study represents an important milestone in the advancement of our SLS009 program and reflects our precision medicine strategy to address challenging subgroups of AML patients through our extensive transcriptomics, genomics, and proteomics models we have established,” said Angelos Stergiou, MD, president and CEO of Sellas.
The launch of the trial in newly diagnosed AML patients comes less than a year after Sellas reported positive results from an earlier Phase 2 study testing SLS009 in patients with relapsed or refractory AML, meaning the cancer did not respond to initial treatment or returned after initially improving. That earlier study tested several doses of SLS009 in 54 participants.
Earlier Phase 2 trial showed promising results for SLS009
The study was designed to show that at least 20% of patients with relapsed or refractory AML would have a treatment response. It exceeded this goal, with results showing an overall response rate of 33% among patients treated with SLS009, including strong responses in patients with high-risk molecular features such as ASXL1 mutations. At the best-performing dose, median overall survival was 8.8 months in patients who had received a median of one prior therapy, compared with about 2.4 months reported with available therapies.
Following the trial in relapsed/refractory AML, Sellas met with the U.S. Food and Drug Administration (FDA) to discuss the results. Following FDA guidance, the company launched a new study to evaluate SLS009 as a potential first-line therapy for AML.
“The strength of our Phase 2 data in [relapsed/refractory] AML, particularly in high-risk molecular subtypes, together with the FDA’s guidance, provided a strong foundation for moving into earlier lines of therapy. By targeting molecularly defined subgroups and those demonstrating early non-response, we aim to address a critical need in frontline AML and position SLS009 for potential registrational development,” Stergiou said.
AML is an aggressive blood cancer caused by the uncontrolled growth of abnormal immune cells. SLS009, formerly called GFH009, is designed to kill these cancer cells by blocking CDK9, a signaling molecule that can help AML cells survive and grow when its activity becomes dysregulated.
