PharmaMar has presented data from the Phase IV NIMES-ROC clinical trial with its marine-derived anti-tumor compound, Yondelis®, at the European Congress of Oncological Gynecology, being held from 2-5 November in Athens, Greece..
- The objective of this study is to evaluate the use of trabectedin with Pegylated Liposomal Doxorubicin (PLD) in routine real-life clinical practice in adult women with platinum-sensitive recurrent ovarian cancer.
- Progression Free Survival (PFS) was 11.4 months compared to 9.2 months in the pivotal OVA-301 trial.
Madrid, November 4th, 2019. – PharmaMar (MSE:PHM) has presented data from the Phase IV NIMES-ROC clinical trial with its marine-derived anti-tumor compound, Yondelis® (trabectedin), at the European Congress of Oncological Gynecology (ESGO), being held from 2-5 November in Athens, Greece.
PharmaMar has presented the poster entitled “European, non-interventional, phase IV NIMES-ROC trial of trabectedin plus pegylated liposomal doxorubicin in patients with platinum-sensitive recurrent ovarian cancer: an interim analysis”. The objective of this study is to evaluate the use of trabectedin plus pegylated liposomal doxorubicin (PLD) in adult women with platinum-sensitive recurrent ovarian cancer (PSROC) in a real-life routine clinical practice, given in accordance with marketing authorization and standard local clinical practice, regardless of prior use of antiangiogenics.
In this study, PharmaMar observed that the median PFS was 11.4 months, which compares very favorably with those obtained in the pivotal OVA-301 trial, where the PFS was 9.2 months, even with a larger population of pre-treated patients (39.9% with more than 2 previous chemotherapy lines). In addition, the overall response rate (ORR) and the safety profile are in line with the results of the pivotal study OVA-301 trial.
These results suggest that trabectedin in combination with PLD is effective for the treatment of recurrent ovarian cancer, regardless of the prior use of antiangiogenic drugs.
In the words of Dr. María Ángeles Forés, Director of Medical Department at PharmaMar, “these studies allow us to observe how drugs behaves in real life clinical practice. Although this is an interim analysis we can see that trabectedin obtains similar results, even better in some cases, than those observed when it was approved in 2009 with the OVA-301 study.”
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About PharmaMar
Headquartered in Madrid, PharmaMar is a biopharmaceutical company, focused on oncology and committed to research and development which takes its inspiration from the sea to discover molecules with antitumor activity. It is a company that seeks innovative products to provide healthcare professionals with new tools to treat cancer. Its commitment to patients and to research has made it one of the world leaders in the discovery of antitumor drugs of marine origin.
PharmaMar has a pipeline of drug candidates and a robust R&D oncology program. It develops and commercializes Yondelis® in Europe and has other clinical-stage programs under development for several types of solid cancers: lurbinectedin (PM1183), PM184 and PM14. With subsidiaries in Germany, Italy, France, Switzerland, Belgium, Austria and the United States. PharmaMar wholly owns other companies: GENOMICA, a molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.
About Yondelis®
Yondelis® (trabectedin) is a novel, synthetically produced antitumor agent originally isolated from Ecteinascidia turbinata, a type of sea squirt. Yondelis® exerts its anticancer effects primarily by inhibiting active transcription, a type of gene expression on which proliferating cancer cells are particularly dependent.
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