A Look at Currently Available Data on Recently Approved, NCCN-Recommended Lurbinectedin for SCLC

In June, lurbinectedin became just the second approved treatment for patients whose metastatic small cell lung cancer (SCLC) has progressed on or after platinum-based chemotherapy, joining topotecan.

As the medical community awaits a readout from the phase 3 ATLANTIS trial to see how lurbinectedin (Zepzelca) shapes up against standard of care (SoC), a look at the currently available data on the recently approved treatment looks encouraging for patients with small cell lung cancer (SCLC) who have progressed following first-line therapy

In June, lurbinectedin became a welcome addition to the SCLC treatment landscape, with the FDA handing the alkylating drug an accelerated approval for adult patients whose metastatic SCLC has progressed on or after platinum-based chemotherapy. Lurbinectedin became just the second approved treatment for this indication, joining topotecan.

Shortly after, the National Comprehensive Cancer Network (NCCN) added lurbinectedin to its guidelines for SCLC as the network’s recommended regimen for patients with who relapse 6 months or sooner after prior systemic therapy, as well as for patients who relapse more than 6 months after prior systemic therapy. The NCCN guidelines list lurbinectedin as a preferred regimen for patients who relapse 6 months or less after prior systemic therapy.

At the time, Robert Iannone, MD, MSCE, executive vice president, research and development of Jazz Pharmaceuticals, said in a press release, “We appreciate the decision by the NCCN to quickly incorporate Zepzelca into the Clinical Practice Guidelines in Oncology as it supports our commitment to ensuring that patients with relapsed small cell lung cancer are able to access this important new treatment option.”

The FDA approval, and the quick inclusion of lurbinectedin in the NCCN guidelines, came after data from a phase 2, open-label, single-arm, basket trial showed that among 105 patients, lurbinectedin achieved a 35% overall response rate, with a median duration of response (DOR) of 5.3 months.

The data were encouraging, as they favored the new treatment over historical data for SoC topotecan. While a direct comparison cannot be made against topotecan from the single-arm trial, Iannone, in an interview with The American Journal of Managed Care®, pointed to a group of patients from a 2014 study he said is a suitable comparator to those included in the phase 2 basket trial. The study he referenced included 213 patients receiving topotecan, which elicited a 16.9% response rate and median DOR of 4.2 months.

Lurbinectedin, in combination with doxorubicin, and topotecan are currently being compared head-to-head in the phase 3 ATLANTIS trial, although the investigators will also have the choice of cyclophosphamide/doxorubicin/vincristine as an SoC option.

With topotecan typically being difficult to tolerate, pooled safety data of single-agent lurbinectedin versus topotecan from the randomized phase 3 CORAIL trial and the phase 2 basket trial presented at the American Society of Clinical Oncology 2020 Annual Meeting gave early indications that lurbinectedin also has a safety advantage.

“With the limitations of direct comparisons, in the pooled safety analysis, fewer lurbinectedin-treated [patients] had severe hematological toxicities, [serious adverse events], dose adjustments, treatment discontinuations and use of supportive treatments than topotecan-treat [patients],” wrote the study abstract authors.


1. Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020;21(5):P645-654.

2. Pawel J, Joote R, Spigel D, et al. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014;32(35):4012-4019.

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