PharmaMar presents encouraging results at ASCO for Small Cell Lung Cancer

PharmaMar is a biotech company world leader in the discovery, development, and commercialization of marine-derived cancer drugs. More than half of the patients, 52,7%, in a PharmaMar study attained an objective response (tumour shrinkage of ≥30%) from a combination treatment for Small Cell Lung Cancer with a chemotherapy-free interval greater than 30 days responded to treatment.The study was presented at the world’s largest clinical oncology congress held in Chicago, USA between May 31st and June 4th.

MADRID, June 4, 2024 /PRNewswire/ — PharmaMar (MSE: PHM), world leader in the discovery, development and commercialization of marine-derived cancer treatments,  presented data from a Phase II trial evaluating PharmaMar’s lurbinectedin in combination with irinotecan in patients with relapsed Small Cell Lung Cancer (SCLC) after prior platinum-based treatment at the American Society of Clinical Oncology (ASCO) meeting, which took place from 31st May to 4th June in Chicago, United States.

PharmaMar has a unique technological platform: the sea. Since 1986, it has been researching the marine ecosystem to discover innovative therapeutic alternatives for serious diseases, such as cancer, for this purpose it has invested more than one billion euros since its foundation. After reaching patients all over the world and changing the paradigm of sarcoma treatment, in addition to having three therapies commercially available, it is currently working to improve the lives of patients with Small Cell Lung Cancer, the most aggressive type of lung cancer.

Regarding this disease, the results presented by the company at ASCO show that the combination of its drug for this pathology, Zepzelca® (lurbinectedin), in combination with irinotecan produces a synergy that enhances the activity of lurbinectedin, resulting in high and durable response rates in populations that are sensitive, with a chemotherapy-free interval greater than 90 days (CTFI> 90 days), and platinum-resistant with a chemotherapy-free interval of less than 90 days (CTF< 90 days).

Particularly encouraging are the data drawn from the subgroup of 74 patients with a chemotherapy-free interval greater than 30 days (CTFI>30 days) with a response rate of 52.7% and a median response duration of 7.6 months.

Among the study data within this subgroup, the overall survival (OS) data is also encouraging, with a median of 12.7 months. The safety profile has proven to be manageable with a low percentage of treatment interruptions.

Zepzelca® (lurbinectedin) is a synthetic compound derived from the tunicate Ecteinascidia turbinata found by PharmaMar in the Caribbean Sea, the Gulf of Mexico and the Mediterranean Sea. It is approved in 16 territories around the world. It received FDA accelerated approval in 2020 and has become the standard of care for second-line treatment in the United States. Confirmatory trials are currently underway, which may eventually lead to approval in Europe as well.

One of the confirmatory studies, LAGOON, consists of three arms, one of which is lurbinectedin with irinotecan. The results presented at ASCO reinforce the rationale for including this combination as an experimental arm with this type of patient in this ongoing pivotal trial.

 

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About PharmaMar
PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.

PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (lurbinectedin), in the US; and Aplidin® (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: lurbinectedin, ecubectedin, PM534 and PM54. It also has a preclinical and clinical program in virology. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and The United States. PharmaMar also wholly owns Sylentis, a company dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com

 

PM1183-A-014-15
PM1183-A-014-15 is a multicenter, open-label Phase I/II Basket study of lurbinectedin in combination with irinotecan in relapsed first lines patients. The study enrolled 101 patients in the SCLC cohort, and the results showed a good outcome in this patient population, included in one arm of the lurbinectedin plus irinotecan combination of the LAGOON study. These results refer to the Overall Response Rate (ORR), Duration of Response (DoR), Progression-Free and Overall Survival (PFS and OS), along with a manageable safety and tolerability profile.

About Zepzelca®

Zepzelca® (lurbinectedin), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinascidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.

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