Data from the company’s Phase 1/2 O-12-M1 clinical study of lead candidate melflufen demonstrate that melflufen may offer positive disease stabilization and favorable time to next treatment (TTNT) outcomes in heavily-pretreated patients with relapsed/refractory multiple myeloma (RRMM).
Overall conclusions from the data presented include:
- Melflufen plus dexamethasone treatment results in disease stabilization in 76% of RRMM patients, which translates to a median TTNT of 7.9 months (10.6 months when censoring at time of death), which compares favorably with other relevant trials.
- A median OS of 20.7 months in an advanced RRMM population, suggesting that melflufen therapy is associated with a long‑term benefit and allows patients to receive further treatment to control disease.
- Results support those of previous data showing the promising efficacy profile of melflufen for the treatment of RRMM.
Oncopeptides recently announced that, following discussions with the U.S. Food & Drug Administration (FDA), the company has initiated the preparation for submitting a New Drug Application (NDA) for accelerated approval of melflufen for the treatment of patients with triple-class refractory multiple myeloma. The company targets to submit the application in the first quarter of 2020 based on the positive data from the ongoing Phase 2 HORIZON clinical trial.
“We are committed in helping patients with myeloma get access to melflufen given the safety and efficacy profile that is emerging from our clinical trials,” said Jakob Lindberg, CEO of Oncopeptides. ”In addition to the data presented, data from the melflufen clinical programs have also been selected for four presentations at the 2019 EHA Annual Congress, including updated data from the HORIZON Phase 2 pivotal clinical trial that will serve as the foundation for our NDA submission.”
The data was presented at the 2019 ASCO Annual Meeting
Photo of Jakob Lindberg: Oncopeptides