The Fly

Syndax, Incyte report axatilimab Phase 1/2 data

Syndax Pharmaceuticals (SNDX) and Incyte (INCY) announced that results from the Phase 1/2 trial of axatilimab, Syndax’s anti-CSF-1R antibody, in patients with recurrent or refractory chronic graft-versus-host disease following two or more prior lines of therapy, were published in the Journal of Clinical Oncology. A total of 40 patients with refractory disease who received a median of four prior systemic therapies, some of which included ibrutinib, ruxolitinib and belumosudil, were treated in the Phase 1/2 dose escalation trial. Thirty-nine patients were evaluable for response as of the data cutoff. All study participants were treated for a median duration of 29 weeks, with all responding patients treated for a median duration of 38 weeks at the time of data cut-off. Results showed: Overall response rate by cycle 7 day 1 was 82% in the Phase 2 cohort and 67% among all evaluable patients treated in the dose escalation study. Best ORR observed at any point during the study in all patients treated was 69%. Median duration of response for Phase 2 responding patients was not reached; 33% of patients experiencing sustained response lasting 20 weeks or longer. A decrease in glucocorticoids doses was observed in 52% of responding patients. Responses were observed across a range of organ systems with difficult to treat manifestations such as lung, skin, and joints and fascia. A clinically meaningful disease improvement using the Lee Symptom Score of at least 7 points was seen in 58% of all evaluable patients. Axatilimab was well tolerated with a favorable safety profile in this refractory population. The most common adverse events were consistent with on-target effects of CSF-1R inhibition. In the Phase 1 cohort, two dose limiting toxicities were reported, both at the 3 mg/kg every two weeks dose. There were no greater than or equal toGrade 3 on-target toxicities of CSF-1R blockade seen in the Phase 2 cohort. There was no incidence of cytomegalovirus or other viral reactivation, and no apparent increases in risk for infection. Serious adverse events occurred in 40% of patients, with seven patients discontinuing the study intervention due to adverse events, four of which were deemed treatment-related.

Published first on TheFly

See the top stocks recommended by analysts >>

Read More on SNDX:

Tired of arriving late to the Big Returns Party?​
Most investors don’t have major gainers like TSLA or NVDA on their radar from the start.
The profusion of opinions on social media and financial blogs makes it impossible to distinguish between real growth potential and pure hype.
​​For the past decade, we have developed and perfected technology designed to help private investors, just like you, find the best opportunities, with the greatest upside potential, in any financial climate.​
Learn More