Oncopeptides Presents Updated Efficacy and Safety Data from Pivotal Phase 2 HORIZON Study in Patients With RRMM at ASH Annual Meeting 2019
STOCKHOLM, Dec. 7, 2019 /PRNewswire/ -- 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.
Jakob Lindberg, CEO comments:
"These data from our pivotal HORIZON study confirm that melflufen is efficacious in this late stage patient population where currently available treatment options may not be sufficient. In particular, the ORR of 24% with a DOR or 7.5 months in patients with triple-class refractory disease is impressive. The responses seen in patients with EMD are also very encouraging as no other available single agent has shown similar efficacy in this very difficult-to-treat patient population. Taken together with a relatively clean safety profile from a patient perspective, these data lead us to believe that melflufen has the potential to play an important role in the treatment of patients with relapsed/refractory multiple myeloma. Consultations with regulatory bodies are ongoing and we are planning to submit an NDA in the first half of 2020. This represents a slight change compared to previously communicated timelines after regulatory interactions have resulted in minor changes to the planned submission package."