New drug Lurbinectedin for small cell lung cancer is another success: 60% efficiency on the second line

What is Lurbinectedin? Lurbinectedin is a self-developed derivative of sea otterin developed by PharmaMar, an inhibitor of RNA polymerase II that binds to the double helix of human cell DNA.
This RNA polymerase II is very cattle, human cells are responsible for transcription of the coding gene, for normal people, it is precisely regulated and efficient; At this point, Lubrinectedin came in use, it can inhibit the over-active RNA polymerase II, not only can inhibit the cancer-causing transcription process of tumor cells, but also by inhibiting the tumor-related macrophage carcinogenic transcription process, thereby killing cancer cells.
Based on the Phase II basket trial, the FDA granted Lurbinectedin priority approval application For this Phase II basket trial (NCT02454972) from October 2015 to October 2018 included 105 patients with small cell lung cancer who had underwent first-line platinum chemotherapy, of whom 57% (n s 60) were sensitive and 43% (n s 45) resistant.
group received Lurbinectedin (3.2 mg/m2) single-drug treatment, every 3 weeks intravenous drips, drip time of 1 hour.
results showed that 8.6 percent of patients had a complete response (CR), 66.7 percent had partial remission (PR), a total remission rate (ORR) of 35.2 percent, a disease control rate (DCR) of 68.6 percent, and a medium response duration (DOR) of 5.3 months.
orR was 22.2% for patients with 21.1% disease control and 4.7 months for patients with medium resistance to chemotherapy (defined as the interval between medium chemotherapy-free ≥90 days), or 45% for patients with medium chemotherapy-free interval and 6.2 months for medium DOR; The total medium PFS in clinical trials was 3.9 months, the medium PFS in drug-resistant patients was 2.6 months, the medium PFS in sensitive SCLC patients was 4.6 months, and the total mesotype OS in clinical trials was 9.3 months.
5.0 months in patients with drug resistance.
11.9 months in patients with sensitive SCLC.
based on the results of this Phase II basket trial, the FDA granted Lurbinectedin a priority approval application for the treatment of patients with extensive SCLC progression after platinum-containing therapy.
first-line platinum chemotherapy, Lurbinectedin is fighting CTFI≥180 again, with amazing efficiency Recently, lung CANCER magazine published The results of Lurbinectedin's treatment in CTFI≥180 days of small cell lung cancer patients after a first-line recurrence, the data are amazing! The study included 105 SCLC patients.
was ≥ 18 years old and pathologically confirmed to be SCLC and had underwent first-line platinum-containing chemotherapy.
, CTFI was 180 days ≥ 20 patients in the study, with a median CTFI of 7.5 months (range 6.0-16.1).
main endpoints are ORR ≥ (RECIST v1.1) in patients with CTFI≥180 days, and secondary study endpoints include reaction duration (DoR), PFS, OS, and safety.
ORR60%, median OS 16.2 months, Lurbinectedin brushed a new high efficacy The median number of Lurbinectin cycles per patient was 6 (range 2-24), for a total of 159 cycles.
orR assessed by the researchers was 60.0% (12/20 patients) (95% CI, 36.1-86.9), DCR was 95.0% (95%CI, 75.1-99.9), and the medium DoR was 5.5 months (95% CI 2.9-11.2).
orR assessed by independent review was 50.0% (95% CI, 27.2-72.8) and the medium DoR was 5.5 months (95% CI, 2.8-8 8.5), DCR is 80% (95% CI, 56.3-94.3), and the medium PFS is 4.6 months (95% CI, 2.6-7.3).
A survival analysis was carried out on 11 patients (55.0%): 8 patients were followed up after the progression of the disease, 2 patients were undergoing Lurbinectin treatment, and 1 patient was discontinued due to adverse events related to treatment (after 6 cycles, the peripheral neuropathy of level 1 appeared, which later deteriorated to level 2).
15.6 months of follow-up and 16.2 months of mid-level OS (95% CI, 9.6-NR).
OS rate and two-year OS rate were 60.9% and 27.1%, respectively.
in terms of overall response, Lurbinectedin as a second-line treatment for small cell lung cancer is positive and has acceptable and manageable safety.
since 1997, no chemotherapy has been shown to improve patient survival by treating SCLC above the second line.
benefit of Lurbinectin as a second-line treatment for patients with sensitive SCLC is the extended platinum-free interval, which may re-sensitive the tumor to the original third-line treatment.
again congratulates Lurbinectin on its new high efficacy, a 30-year breakthrough for patients with small cell lung cancer.
and demarcation at platinum-sensitive intervals, providing a breakthrough ≥ patients with CTFI for 180 days.
we look forward to the early launch of the drug in China, for small cell lung cancer patients to bring more good news.
source: 1. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. 2. 3. PharmaMar announces the US FDA approval of lurbinectedin (Zepzelca) for the treatment of metastatic small cell lung cancer. News release. June 15, 2020. Accessed June 15, 2020. bit.ly/3hzSAAK.