WCLC 2022 | Palliative radiotherapy with lurbinectedin in patients with extensive stage SCLC
Lurbinectedin recently gained accelerated approval following the demonstration of a favorable response rate, duration of response, and toxicity profile in patients with platinum-refractory extensive-stage small cell lung cancer (ES-SCLC). Both lurbinectedin and radiotherapy induce lethal DNA damage which suggests they may be therapeutically additive or even synergistic. Neal Sean McCall, MD, Winship Cancer Institute, Emory University, Atlanta, GA, provides an overview of a Phase I study (NCT05244239) investigating whether radiotherapy can be delivered safely with concurrent, uninterrupted lurbinectedin in patients with ES-SCLC. The primary safety endpoint is grade 4 or 5 adverse events occurring within 30 days of radiotherapy or adverse event leading to prolonged delay or permanent discontinuation of lurbinectedin. This interview took place at the IASLC 2022 World Conference on Lung Cancer congress in Vienna, Austria.
Transcript (edited for clarity)
Lurbinectedin is a FDA-approved second-line systemic therapy for patients with platinum refractory extensive-stage small-cell lung cancer. It was approved, I believe about two years ago, at this point. So it’s a novel agent, a transcription inhibitor and an alkylating agent that culminates in DNA damage, which it happens to also be the way that radiotherapy works.
Now, clinically, patients with small-cell lung cancer often experience pretty rapid disease progression and tend to have a variety of indications for palliative radiotherapy, whether it be a bone metastasis that’s causing them pain, or a lung lesion, for example, that would be causing shortness of breath or hemoptysis...
Lurbinectedin is a FDA-approved second-line systemic therapy for patients with platinum refractory extensive-stage small-cell lung cancer. It was approved, I believe about two years ago, at this point. So it’s a novel agent, a transcription inhibitor and an alkylating agent that culminates in DNA damage, which it happens to also be the way that radiotherapy works.
Now, clinically, patients with small-cell lung cancer often experience pretty rapid disease progression and tend to have a variety of indications for palliative radiotherapy, whether it be a bone metastasis that’s causing them pain, or a lung lesion, for example, that would be causing shortness of breath or hemoptysis. And so there’s really a need to deliver palliative radiotherapy quickly to these patients with minimizing delays in their systemic therapy. And so that’s the foundation of this Phase I clinical trial, looking at the safety and efficacy of palliative radiation in combination with concurrent uninterrupted lurbinectedin in this patient population.
The primary endpoint of the study is essentially treatment or protocol-related adverse events, grade 4 or 5 primarily that we’re concerned about, or events that are leading to prolonged interruption in the patient’s lurbinectedin cycles, or alternatively, permanent discontinuation of lurbinectedin.
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