Agne Paner, MD of @RushMedical discusses updated data from the phase 2 HORIZON study.
Oncopeptides AB (Nasdaq Stockholm: ONCO) will today present follow-up data from the pivotal Phase 2 HORIZON (OP-106) study at the ASH Annual Meeting 2019.Melflufen showed an overall response rate (ORR) of 29% and clinical benefit rate (CBR) of 37% in patients with late-stage relapsed/refractory multiple myeloma (RRMM). The safety profile remained consistent with prior reports from the HORIZON study.These data reinforce Oncopeptides’ view that melflufen can play a role in the treatment of patients with RRMM and the Company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2020.
Overall Conclusions – HORIZON Poster Presentation
Patients in the HORIZON study had a median of five prior lines of therapy, 71% of patients were triple?class refractory, 97% were refractory to the last line of treatment, and 32% suffered from extramedullary disease (EMD).
In the ITT population (n=125), the overall response rate (ORR) was 29% and the clinical benefit rate (CBR) was 37%.
In patients with triple?class refractory disease (n=97), the ORR was 24% with a median progression?free survival (PFS) of 4.0 months, a median duration of response (DOR) of 7.5 months and a median overall survival (OS) of 11.3 months.
In patients with EMD (n=42), the ORR was 24% with a median PFS of 3.0 months, a median DOR of 5.1 months and a median OS of 8.1 months.
Grade 3 and 4 Adverse Events (AE) were primarily hematologic and the incidence of non-hematologic AEs was low.