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" One Patient  Experienced a Complete Response " .

Effective Second-Line Treatment for Mesothelioma Gaining Ground.

• by Melanie Ball
• Oct 17, 2019

Doctors at the Swiss Group for Clinical Cancer Research in Zurich, Switzerland, have uncovered a novel, anti-tumor compound that could become a needed second-line treatment for pleural mesothelioma cancer.

Their recent multicenter phase II clinical trial conducted in Switzerland and Italy revealed the safety and efficacy of lurbinectedin, a synthetically produced agent that inhibits the growth of mesothelioma cells.

“We believe this could represent a new treatment option for pleural mesothelioma,” Dr. Yannis Metaxas, oncologist at Kantonsspital Graubunden outside Zurich, told The Mesothelioma Center at Asbestos.com. “It could prove eventually to be a real breakthrough. This was a good first step, and the results were quite impressive.”

Metaxas presented his group’s findings at the European Society for Medical Oncology conference earlier this month in Barcelona, Spain.

There currently is no standard treatment for patients with unresectable mesothelioma that inevitably progresses after chemotherapy.

In May, the U.S. Food and Drug Administration approved Tumor Treating Fields — the first new treatment approval for mesothelioma in 15 years – but usefulness remains in question as a second-line treatment.

“There is a real need here,” Metaxas said. “We don’t know yet if it [lurbinectedin] can be more effective than current standard of care, but we do know it is active against these tumor cells.”

Survival Times Increased Significantly

The single-arm clinical trial included 42 patients, all of whom had experienced disease progression following first-line treatment of chemotherapy, surgery or radiation.

Patients were administered lurbinectedin every three weeks. More than half reached the trial’s three-month progression-free-survival goal.

The Median Progression-Free Survival was 4.1 Months and the Median Overall Survival was 11.1 Months. Both measurements were considerably longer than the two-month and six-month estimates, respectively, by researchers for typical second-line treatments for pleural mesothelioma.

One of those Patients Experienced a Complete Response and 20 more Experienced Stable Disease as a Best Response.

Next Step Is a Randomized Trial

Also notable was no significant differences with responses based on epithelioid vs. non-epithelioid histology.

Five of the 42 patients had sarcomatoid histology, typically the toughest-to-treat subtype.

“The big issue now is how this data would compare in a randomized trial,” Metaxas said. “We have yet to answer that. Until we do, there still are questions about effectiveness.”

Low-grade toxicity — fatigue and lowered white blood cell count — was seen in 33 of the 42 patients taking lurbinectedin, but none discontinued treatment because of it.

Lurbinectedin also has shown effectiveness recently in a second-line setting for the treatment of small-cell lung cancer. Results from that clinical trial were presented at the 2019 American Society of Clinical Oncology annual meeting.

Doctors in Japan and Europe have been using lurbinectedin in combination with chemotherapy to treat inoperable ovarian cancer.

Metaxas was a part of earlier research that detailed the effectiveness of lurbinectedin when used with cisplatin with two mesothelioma patients in Switzerland.

“Lurbinectedin showed promising activity compared to historical data,” Metaxas wrote in the most recent study’s conclusion. “But respective pts numbers are small for definitive conclusions. Further evaluation of lurbinectedin in a large randomized trial is warranted.”