Spanish biopharmaceutical company PharmaMar has initiated the pivotal Phase III ATLANTIS study of PM1183 combined with doxorubicin versus topotecan or the combination VCR (cyclophosphamide, adriamicine (doxorubicin) and vincristine) to treat small-cell-lung cancer (SCLC).

PM1183 (lurbinectedin) is a compound of marine origin, which acts as an inhibitor of RNA polymerase II.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

This enzyme is considered important for the transcription process that is largely expressive in tumours with transcription addiction.

Around 600 patients at clinical sites across 21 countries are expected to be enrolled in the multicentre, open-label, randomised and controlled Phase III ATLANTIS trial, which has been designed to evaluate the safety and efficacy of PM1183.

"In the Phase IB study we have seen a complete response, with total remission of the symptoms of the illness in 10% of the patients."

The trial is primarily focused to determine the improvement in progression free-survival (PFS) within the patients, which will be examined by an Independent Review Committee after response evaluation criteria in solid tumours.

The secondary goals of the trial are the evaluation of overall survival (OS), duration of the response (DR), along with quality of life indicators, response rate (RR), as well as determining the pharmacokinetics and pharmacodynamics profile of PM1183.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

PharmaMar oncology business unit clinical development director Dr Arturo Soto said: “We are pleased to start this pivotal Phase III clinical trial after PM1183 demonstrated encouraging results of the Phase IB study, where 67% of the patients responded to the treatment of lurbinectedin in combination with doxorubicin.

"In the Phase IB study we have seen a complete response, with total remission of the symptoms of the illness in 10% of the patients.”

PM1183 is also being investigated for its anti-tumour efficacy in addressing platinum-resistant ovarian cancer within a Phase III trial and in treating BRCA 1 and BRCA 2-associated metastatic breast cancer in a Phase II trial.