The Spanish drug that spreads throughout the world

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Due to its high mortality rate, lung cancer constitutes one of the great challenges of Oncology, and specifically

.

It is very often lethal: it accounts for approximately 15% of all cases of lung cancer, and its survival rate is low, between 5 and 10% of cases at five years.

It is associated with tobacco use in 98% of cases.

To combat it, among other options

, the current therapeutic arsenal includes the

, the compound

that is reaching many corners of the world.

Approved by the US regulatory agency

(FDA)

in June 2020, it already has extensive experience in real-life clinical use in the North American market, and subsequently, between 2021 and January 2023, it has also received approval in the United Arab Emirates, Australia, Singapore, Canada, Korea South, Mexico and Ecuador.

Where, for the moment, it has not obtained approval is in the European Union, despite the fact that the compound is designated as an orphan drug by the

European Medicines Agency (EMA)

for this indication since February 2019.

, for which doctors can request it from the laboratory for administration in exceptional cases to specific patients with the approval of local authorities before its official approval.

"Lurbinectedin is a synthetic derivative of trabectedin, a drug that

.

Originally, he showed that he had activity in a series of tumors, especially in sarcomas", explains Luis Paz-Ares, head of the Medical Oncology service of the

University Hospital October 12

, from Madrid, who adds that few novelties have been developed in the last two decades for the treatment of small cell carcinoma.

"This new drug, in monotherapy, has shown that

, with better results in those who have had a longer period of disease control with the first treatment."

Many of the studies carried out with the drug have been carried out in Spain.

And several of them have been led by Paz-Ares, who points out that the combination of lurbinectedin with other drugs, such as the chemotherapeutic irinotecan or atezolizumab (a variety of immunotherapy), "provide

, and with acceptable security standards".

Evidence in different trials

Based on the positive data from these initial studies, there are now

that deserve particular attention.

In the first, patients are being treated with lurbinectedin and irinotecan in cases that have already received a first line of treatment.

"We want to confirm the previous data with the hope that, if the results continue to be repeated, the drug can even be approved by the EMA," explains Paz-Ares, also head of the Lung Cancer Unit at Hospital 12 de October/

National Center for Oncology Research (CNIO)

.

The

studies the combination of lurbinectedin with atezolizumab

, that is, to try to prolong its effectiveness.

For its part, the third study compares the usual treatment based on topotecan with the combination of lurbinectedin with irinotecan or with lurbinectedin alone.

The approved indication in the United States is as second-line treatment in patients with a chemotherapy-free interval of less than 45 days.

"I often use it as a second-line treatment in patients who are not in a clinical trial," says Jacob Sands, a thoracic medical oncologist at the

Dana-Farber Cancer Institute of Boston

and Assistant Professor of Medicine at the

Harvard Medical School

.

One aspect that Sands highlights is that

.

In the trial that led to FDA approval, low white blood cell counts—neutropenia—was common, but the study did not allow treatment with primary prophylaxis.

Only 5% of patients in the clinical trial developed fever caused by neutropenia.

And only 7% of patients developed third-degree fatigue.

In general,

.

And this is one of the reasons why I often use lurbinectedin as a treatment option."

One of the most relevant aspects of the new drug is its mechanism of action, which, for Sands, "includes many potential reasons for its efficacy."

Small cell carcinoma is a very active disease from the point of view of DNA transcription, the mechanism that leads to rapid replication of the tumor cell.

.

But it also impacts the tumor microenvironment, which is the various cellular and non-cellular components in and around the tumor: by transforming it, it makes immunotherapy more effective.

For Sands, this second action "could explain its efficacy, as it results in the elimination of local inflammatory cells that can stimulate tumor cell growth and vessel formation. By eliminating cells that can stimulate cancer -and also affect transcription

.

In short, for the specialist of the Dana Farber Cancer Institute, "small cell lung cancer is a terrible disease and difficult to treat after its progression after initial chemotherapy and immunotherapy. Therefore, we need more and better therapeutic options , illustrating the importance of lurbinectedin as a therapeutic option that contributes to disease control with limited toxicities. As an oncologist, my main goal is to protect the quality of life of my patients."

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