The U.S. Food and Drug Administration (FDA) has approved a new combination medication for patients with extensive-stage small cell lung cancer (ES-SCLC), Roche reported, marking a significant advancement in the treatment of lung cancer. For adult patients whose cancer has not advanced following first chemotherapy, Tecentriq® (atezolizumab) and Tecentriq Hybreza® in conjunction with lurbinectedin (Zepzelca®) have been approved as maintenance treatments.
For the first-line maintenance treatment of ES-SCLC, a particularly aggressive kind of lung cancer with historically few therapeutic choices, this historic ruling represents the first and only FDA-approved combination therapy. The new regimen is designed for patients who have received carboplatin, etoposide, and Tecentriq or Tecentriq Hybreza induction therapy.
The Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by nearly half,
We are proud to deliver this advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals, as it reflects our abiding commitment to improving outcomes in the hardest-to-treat cancers.
Levi Garraway
This novel regimen has already been included to the Clinical Practice Guidelines in Oncology of the U.S. National Comprehensive Cancer Network® (NCCN) as a category 2A and recommended alternative for maintenance treatment in this patient population.
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The FDA’s approval is predicated on the findings of the phase III IMforte trial, which showed a 27% decrease in the risk of death and a 46% reduction in the risk of disease progression or death when compared to Tecentriq maintenance therapy alone. According to the study, Tecentriq alone had a median overall survival of 10.6 months, whereas the combo therapy had a median of 13.2 months. Tecentriq alone had a median progression-free survival of 2.1 months, whereas the combo had a median of 5.4 months.
Tecentriq’s recognized function in treating ES-SCLC is strengthened by this approval. For this patient population, Tecentriq plus chemotherapy was the first novel therapeutic choice in 20 years in 2019.
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660 individuals were included in the induction phase of the Roche-sponsored and Jazz Pharmaceuticals-co-funded IMforte research, whereas 483 patients were randomly assigned to the maintenance phase. In persons with ES-SCLC who had not improved following initial treatment, the trial assessed the combination therapy’s safety and effectiveness.
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The monoclonal antibody Tecentriq can stop T-cells from attacking cancer cells by inhibiting the PD-L1 protein. The immune system may be reactivated to combat the malignancy by Tecentriq’s inhibition of PD-L1. Both intravenous and subcutaneous versions are available, and it is approved for a number of malignancies globally.
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