New Data on Myeloma Drug Candidates to Be Presented by PharmaMar at Oncology Meeting

Spain-based PharmaMar announced the company will present data from several clinical studies of three of its anti-tumoral compounds of marine origin — plitidepsin, Yondelis (trabectedin), and PM1183 — at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting June 3-7 in Chicago.

“The results that we are going to present at ASCO 2016 are an example of how we are progressing in this field, and that we can build on an innovative and promising pipeline of compounds for different types of cancers,” said Dr. Arturo Soto, PharmaMar’s director of clinical development in the Oncology Unit, in a press release.

Plitidepsin is an investigational anticancer agent obtained from the ascidian Aplidum albicans. It is thought to specifically bind to the eEF1A2, targeting the non-canonical role of the protein, resulting in tumor cell death through apoptosis (programmed death). Plitidepsin is currently in clinical trials for hematological cancers, including:

• A Phase 1b clinical trial in relapsed/refractory (r/r) multiple myeloma as a triple combination of plitidepsin, bortezomib and dexamethasone;
• A Phase 2 clinical trial in r/r angioimmunoblastic T-cell lymphoma;
• A Phase 3 clinical trial in r/r multiple myeloma, which has now been completed with positive results.

In the U.S., plitidepsin has been given orphan drug status by the U.S. Food and Drug Administration (FDA). PharmaMar will present the following abstract on plitidepsin at ASCO 2016:

• An oral presentation (abstract #8006) titled “Phase I study of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma” on June 3 in the session “Hematologic Malignancies – Plasma Cell Dyscrasia.” María Victoria Mateos, M.D., from the University Hospital of Salamanca, is the lead author of the study and speaker of the presentation.

Yondelis (trabectedin) is a novel, multimodal, synthetically engineered antitumor agent derived from the sea squirt Ecteinascidia turbinata. The drug is approved in 80 countries for treating advanced soft tissue sarcomas and specific L-sarcomas subtype as a single-agent. Yondelis is also approved in 70 countries for relapsed ovarian cancer as a combination treatment with Doxil/Caelyx (doxorubicin HCI liposome injection).

PM1183 (lurbinectedin) is an investigational compound thought to inhibit RNA polymerase II enzyme. It is critical to the transcription process for inhibiting tumor growth and thus leading to tumor death. The antitumor efficacy of PM1183 is being investigated in several types of solid tumors in studies including:

• A Phase 3 trial for platinum-resistant ovarian cancer;
• A Phase 2 study for BRCA 1/2-associated metastatic breast cancer;
• A Phase 3 trial for small cell lung cancer (SCLC).

“The principle objective of PharmaMar is to investigate new compounds of a marine origin with a novel mechanism of action that provides a progress in the treatment of certain types of oncological tumors, and an important contribution in healthcare for the patient,” said Dr. Nadia Badri, PharmaMar’s vice president of the Oncology Business Unit.