The first peptide-drug approved for refractory multiple myeloma is now available in Spain

The first peptide-drug approved for refractory multiple myeloma is now available in Spain
The first peptide-drug approved for refractory multiple myeloma is now available in Spain

Melphalan flufenamide (Pepaxti)first drug in the class of peptide-drug conjugates approved for the treatment of refractory triple multiple myeloma is now available in Spain. The newly landed company, Oncopeptides, has announced that the drug has been available in the National Health System since May 1.

Melphalan flufenamide is indicated, in combination with dexamethasonefor the treatment of adults with multiple myeloma who have received at least three prior lines of treatment, whose disease is resistant to at least one proteasome inhibitora immunomodulatory drug and a anti CD38 monoclonal antibody, and who have demonstrated disease progression during or after the last treatment. In the case of patients with an autologous stem cell transplantthe time elapsed until progression must be at least three years from the transplant

In this sense, the president of the Spanish Society of Hematology and Hemotherapy (SEHH), María Victoria Mateoshighlighted in a meeting with journalists the relevance of having a new therapeutic tool for a disease “for which 30 years ago there were no options.”

“In the history of multiple myeloma research there have been three fundamental pillars: protease inhibitors, immunomodulatory drugs and anti-CD38 antibodies, which are part of the standard of treatment. However, almost all patients have tried most lines of treatment and still end up relapsing. This is where innovation comes into play to rescue these patients“said the hematologist

The approval of melphalan flufenamide is based on the results of the study HORIZON and OCEAN.

In HORIZON (Phase II), patients achieved an objective response rate of 28.8 percent, sustained response duration of 7.6 months, progression-free survival (PFS) of 4.2 months, and overall survival (SG) 11.2 months. During OCEAN (PHASE III), compared to pomalidomide plus dexamethasone, patients achieved, in terms of PFS, 9.26 months versus 4.63 months, in OS, 23.56 months versus 19.84 months, and rate objective response of 42.1 percent compared to 26.4 percent.

“The majority of patients responded with melphalan flufenamide and we were able to verify that it was effective in a group of patients with extramedullary diseasea population that is difficult to treat in clinical practice,” he added.

With approval of several treatments against multiple myeloma in recent monthsthe oncologist has highlighted the importance of having more and more options to be able to individualize the approach, “Currently, we have patients who have undergone 6-7 previous lines of treatment, and having this broad arsenal will allow us to select the patients depending on whether they are candidates or not,” he continued.

For example, the oncologist explained that, although the first treatment option is CAR-T, not all patients are candidates for it, and CAR-T therapy cannot be administered if a bispecific antibody has previously been received. “However, it can be managed melphalan flufenamide while waiting for the CAR-T”, he highlighted to emphasize that “currently “We can use different strategies according to the needs of the patients”.

Disembarkation in Spain

Founded in 2000, Oncopetides was born with the aim of researching, developing and marketing therapies aimed at difficult-to-treat cancer, and with Spain as “a fundamental pillar” for the company, as explained Cristina Bando, general director of Oncopeptides In our country.

“Spain is a strategic pillar for the clinical development of the company’s drugs. They have participated 16 hospitals and a total of 106 patients from all over Spain in the clinical trial of melphalan flufenamide . Likewise, the company hopes that Spain will soon be able to lead new clinical trials to continue developing molecules,” Bando stated.

PDC platform.

Oncopeptides has two patented platforms: a peptide drug candidate (PDC) to develop compounds that rapidly and selectively release cytotoxic agents into cancer cells and other Spike platform (Small Polypeptide-based Killer Engagers)which harnesses natural killer (NK) cells, the immune system’s first line of defense, against viruses and other foreign cells.

“The PDC platform strategy allows us to attack cancer by taking advantage of the metabolic differences between healthy and cancerous cells,” he explained. Jacob Linder, scientific director of the company.

The specialist currently has three compounds in preclinical phases to lymphoma, resistant breast cancer and glioblastomas. “They are very risky trials, but the data is good. We expect positive clinical results,” he added.

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