A landmark trial
In June 2019, PharmaMar presented the results of the second phase of the lurbinectedin trial at the American Society of Clinical Oncology (ASCO) meeting in Chicago. The study was conducted in 105 adults with recurrent small-cell lung cancer. The data showed that, in this type of cancer, lurbinectedin monotherapy had a response rate of 35%, a much higher percentage than historically achieved. The median duration of response was 5.3 months, i.e., the time that the treatment responded and the tumor shrank or stopped growing. And the median Overall Survival – time to death – was 9.3 months.
It is important to note that this drug is provided only for second-line treatment, that is, after chemo or immunotherapy. It is for those patients who relapse in less than one year because of poor response to first-line treatment.
First market, United States
In December 2019, PharmaMar and Jazz Pharmaceuticals Ireland Limited signed an exclusive license agreement to introduce the drug in the U.S. market.
“With Jazz we have found a committed partner to bring lurbinectedin to patients in the United States. This is a strong candidate to become a therapeutic alternative for patients with recurrent small-cell lung cancer, for whom there are few treatment options.”PharmaMar’s president, José María Fernández Sousa-Faro, said.
In June 2020, PharmaMar announced, together with Jazz Pharmaceuticals, that the U.S. Food and Drug Administration (FDA) approved the antitumor compound under the brand name “Zepzelca” for the treatment of adult patients with metastatic small cell lung cancer. This ‘accelerated approval’ by the FDA was the first change in 22 years in the treatment of lung patients with these characteristics.
In response to this news, the chief of the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center, Dr. Charles Rudin, claimed that. “the oncology community welcomed lurbinectedin as a new standard option for patients with small-cell lung cancer.”.
Currently, this drug is the most chosen option for second-line treatment of metastatic lung cancer in the United States.
PharmaMar is currently awaiting full approval in the United States. Once this approval is granted, it will also be able to distribute the drug in Europe, which is in Phase III of the trial. The company also has other trials awaiting results, such as the one combining lurbinectedin with immunotherapy to treat cancer, and the one proposing the drug for treating mesothelioma.