First Patient Enrolled Onto Study Evaluating Zepzelca Monotherapy for Treatment of Certain Solid Tumors

The first patient has been enrolled onto a phase 2 clinical trial that is investigating the safety and efficacy of Zepzelca (lurbinectedin) in patients with advanced urothelial carcinoma (the most common type of bladder cancer), large cell neuroendocrine carcinoma of the lung and homologous recombination deficient (HRD) tumors that have worsened after a platinum-containing treatment regimen, according to the agent’s manufacturer, Jazz Pharmaceuticals.

The primary objective of the EMERGE-201 trial, according to the press release, is to determine if treatment with Zepzelca improves objective response rates (the proportion of patients whose disease shrinks or disappears after treatment).

The study authors also plan to analyze Zepzelca’s effect on progression-free survival (the time during and after treatment when the patient lives without their disease getting worse), as well as duration of response and overall survival.

Enrolled patients must be aged 18 years or older, have adequate organ and bone marrow function and have metastatic/unresectable cancers that fit into the study population requirements.

Some of the reasons a patient will be excluded from enrolling into the trial include, but are not limited to, a history of a prior cancer within two years of enrolling onto the trial and significant cardiovascular disease.

“Even with the rapid advancements in medical technology and care delivery across many tumor types over the last decade, there still remain many patients who continue to face unmet needs and experience a high burden of morbidity and mortality,” Dr. Arielle Heeke, a breast medical oncologist at Atrium Health Levine Cancer Institute in Charlotte, North Carolina, and a primary investigator in the EMERGE-201 trial, said in the release. “With the EMERGE-201 trial now underway, we look forward to seeing the potential clinical impact of Zepzelca on advanced solid tumor cancers, including HRD cancers, that have limited approved treatment options other than traditional chemotherapy. The trial will evaluate if this treatment can elicit tumor response based upon the underlying biology of these cancers and Zepzelca's novel method of action.”

Four trial sites in the United States hope to enroll 60 patients with an estimated study completion of June 2024.

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