The pivotal study will assess the efficacy of plitidepsin plus dexa­meth­a­sone versus dexamethasone alone in patients with re­lapsed / refractory multiple myeloma

Madrid (Press Release) – PharmaMar announced today that the patient recruitment for the pivotal Phase III trial of APLIDIN® (plitidepsin) for the treat­ment of multiple myeloma, denominated ADMYRE, has been suc­cessfully com­pleted. The study, which originally planned to in­clude 250 patients, has enrolled 255 patients in 71 medical centers world­wide, in­­clud­ing the US, Europe, Asia, South America, Australia, and New Zealand. An appli­ca­tion for market­ing authori­za­tion in Europe is planned to be submitted in 2016.

ADMYRE is a prospective, pivotal, ran­dom­ized (2:1), open-label, multi­center study that compares plitidepsin in com­bi­na­tion with dexa­meth­a­sone versus dexa­methasone alone in patients who have re­lapsed or re­fractory multiple myeloma after at least three prior ther­a­pies, but no more than six. Patients must have pre­viously received bor­tez­o­mib and lena­lido­mide. In an interim analysis, the Independent Data Monitoring Committee (IDMC) recommended completion of the Phase III ADMYRE unmodified given that no safety issues were reported and the study comfortably met the estab­lish­ed efficacy threshold upon evaluation of data from 60 evaluable patients[i].

In this registration trial, the pri­mary end­point is progression-free survival (PFS), which will be used to com­pare the efficacy of plitidepsin plus dexa­meth­a­sone versus dexa­meth­a­sone alone. Secondary end­points will eval­u­ate tumor response rate, duration of response and over­all survival.

“Our com­­pound rep­re­sents a first-in-class drug in the therapeutic paradigm of multiple myeloma” said José María Fdez. Sousa-Faro, PhD, Chairman of PharmaMar. “We are on track now to bring this inno­va­tive ther­a­peutic ad­vance a step closer to these patients.”

About multiple myeloma

Multiple myeloma is a relatively uncommon type of blood that accounts for 10% of all hema­to­logical ma­lig­nan­cies and that is caused by malignant plasma cells that very rapidly multiply[ii].

Normal plasma cells are white blood cells found in the bone marrow that form part of the immune system and produce the anti­bodies nec­es­sary to fight infections[iii].

Abnormal cells produce a type of anti­body that does not benefit the body and accumulate, thus preventing normal cells from functioning properly. Almost all patients with multiple myeloma progress from an initial, asymptomatic pre-malignant stage to estab­lish­ed disease. In 2015, 26,850 new cases will be diagnosed in the US, and about 11,200 people will die of this disease[iv].In Europe, there will be 4.5–6.0 out of 100 000 people diag­nosed per year[v].

About APLIDIN® (plitidepsin)

Plitidepsin is an inves­ti­ga­tional anticancer agent of marine origin, originally obtained from the tunicate Aplidium albicans. It specifically binds to the eEF1A2 and targets the non-canonical role of this protein, resulting in tumor cell death via apop­tosis (programmed death). Plitidepsin is currently in clin­i­cal de­vel­op­ment for hema­to­logical cancers, in­­clud­ing a Phase III study in re­lapsed or refractory multiple myeloma, a Phase Ib trial in re­lapsed or refractory multiple myeloma as a triple com­bi­na­tion of plitidepsin, bortezomib and dexa­meth­a­sone, and a Phase II study in re­lapsed or refractory angio­immuno­blastic T-cell lym­phoma. Plitidepsin has received orphan drug desig­na­tion by the European Medicines Agency (EMA) and the US Food and Drud Admin­istra­tion (FDA)

About PharmaMar

Headquartered in Madrid, PharmaMar is the world-leading biopharmaceutical com­pany in ad­vanc­ing cancer care through the discovery and development of inno­va­tive marine-derived anticancer drugs. The com­pany has a rich pipe­line of drug can­di­dates and a robust R&D on­col­ogy pro­gram. YONDELIS® is the first anti­cancer drug of marine origin and is commercially available in 81 countries for the treat­ment of ad­vanced soft tissue sarcomas as a single-agent, and for re­lapsed platinum-sensitive ovarian cancer in combination with DOXIL®/CAELYX®. PharmaMar develops and com­mer­cial­izes YONDELIS® in Europe and has three clin­i­cal-stage pro­grams under devel­op­ment for several types of solid and hema­to­logical cancers, PM1183, plitidepsin, and PM60184. PharmaMar is a global bio­pharma­ceutical com­pany with sub­sid­i­aries in Germany, Italy, France, Switzerland and the United States. To learn more about PharmaMar, please visit us at www.pharmamar.com.

Disclaimer

This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the com­pany. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recom­men­da­tion of any type with regard to the shares of the com­pany.

References

[i] http://www.pharmamar.com/en/press/pharmamar%E2%80%99s-aplidin%C2%AE-phase-3-admyre-trial- re­lapsed-refractory-multiple-myeloma-achieves
[ii] http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-it
[iii] http://www.myeloma.org.uk/information/what-is-myeloma/
[iv] http://seer.cancer.gov/statfacts/html/mulmy.html
[v] http://www.esmo.org/Guidelines/Haematological-Malignancies/Multiple-Myeloma

Source: PharmaMar