Preliminary lurbinectedin results ‘remarkable’ for relapsed SCLC
medwireNews: Lurbinectedin has potential for the treatment of patients with relapsed small-cell lung cancer (SCLC) as a single agent or in combination with another chemotherapy drug, suggests research reported at the ESMO 2017 Congress in Madrid, Spain.
M Eugenia Olmedo Garcia (Hospital Universitario Ramon y Cajal, Madrid, Spain) reported findings for three trials of the agent, which inhibits activated transcription and induces apoptosis via double-stranded DNA breaks.
The objective response rate was 67% for the 21 patients who were included in a phase I trial assessing lurbinectedin 3–5 mg given on day 1 of a 21-day cycle alongside doxorubicin 50 mg/m2, including a complete response in 10% and a partial response in 57%. The disease control rate (DCR) was 81%.
A second cohort of 27 patients in the same study received lurbinectedin 2 mg/m2 plus doxorubicin 40 mg/m2 on day 1 of a 21-day cycle; this achieved an ORR of 37%, with a complete response in 4% and a partial response in 33%, giving a DCR of 70%.
In addition, a second phase I trial tested lurbinectedin 2.2 mg/m2 given on day 1 of a 21-day cycle plus paclitaxel 80 mg/m2 on days 1 and 8 in seven patients. This achieved an ORR of 71%, derived from a complete response in 14% and a partial response in 57%, with the DCR reaching 71%.
Finally, 24 participants in a phase II basket study received lurbinectedin 3.2 mg/m2 on day 1 of a 21-day cycle; the ORR was 25%, made up entirely of partial responses, and the DCR was 75%.
Duration of response in the trial participants ranged from 2.3 months to at least 6.2 months.
Progression-free survival (PFS) among patients with platinum-sensitive disease was a median of 5.8 and 5.7 months for the two lurbinectedin plus doxorubicin trial arms, 4.8 months for the patients given lurbinectedin plus paclitaxel, and at least 3.2 months for those given lurbinectedin monotherapy.
Grade 3–4 hematologic side effects were the most common toxicities, including neutropenia, thrombocytopenia, and febrile neutropenia. This “transient myelosuppression” was manageable with dose reductions and granulocyte colony-stimulating factor support, Garcia said.
“Lurbinectedin shows activity as a single agent and in combination with other agents […] in relapsed SCLC,” the presenter concluded, describing the findings as “remarkable” in terms of PFS, DCR, and duration of response.
Lurbinectedin given in combination with doxorubicin is now being assessed in the phase III ATLANTIS study, she added.
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