Oncopeptides has presented updated data from its ongoing Phase 2 ANCHOR (OP-104) triple combination study.
In the data presented at the ASH Annual Meeting 2019, melflufen and dexamethasone demonstrated positive efficacy in combination with daratumumab or bortezomib in patients with relapsed/refractory multiple myeloma (RRMM). Preclinical data supporting clinical development of melflufen in AL amyloidosis was also be presented for the first time.
- Patients in the ANCHOR study had a median of two prior lines of therapy. All patients were refractory to at least one agent.
- For melflufen and dexamethasone in combination with daratumumab (n=33) the overall response rate (ORR) was 76% with a median progression-free survival (PFS) of 14.3 months.
- 70% of the patients were still progression-free at the time of the data cut.
- For melflufen and dexamethasone in combination with bortezomib (n=6) the ORR was 67%.
- Responses improved with continued therapy for both combinations.
- Both combinations were well tolerated and the grade 3 and 4 Adverse Events (AE) were primarily hematologic.
“The ANCHOR data presented today are truly encouraging and support the future development of melflufen in triplet regimens. The ORR of 76% and median PFS of 14.3 months in the daratumumab arm, while immature, are among the highest reported in this patient population. This further validates the foundation for our next pivotal randomized Phase 3 study LIGHTHOUSE (OP-108), in which we will compare subcutaneous daratumumab with or without melflufen. We expect to enroll the first patient in early 2020 and are excited to embark on this next journey with melflufen in multiple myeloma,” says Klaas Bakker, MD, and Chief Medical Officer, Oncopeptides. “Based on our very positive preclinical data around AL amyloidosis and our experience of melflufen in a clinical setting, we are excited to initiate our first study with melflufen in patients with Immunoglobulin Light Chain (AL) amyloidosis. This lays the foundation for the use of melflufen in another indication with a high unmet medical need.”
Photo of Nicolaas Klaas BakkerMD, PhD, EVP och Chief Medical Officer Oncopeptides