The experimental drug Tam-Peli showed a significant improvement in the survival of patients with relapsed small-cell lung cancer—one of the most aggressive forms of the disease. Roche reported the results of the Phase III TAISHAN-302 clinical trial, writes UNN.
Details
The study involved 451 patients in China whose disease had returned after previous treatment. A total of 225 people received Tam-Peli, while another 226 received the standard drug topotecan.
The results showed that Tam-Peli reduced the risk of death by 54% compared with standard therapy. Median overall survival was 13.3 months versus 9.4 months in the topotecan group.
The risk of disease progression decreased by 71%
The difference in controlling cancer progression was even more pronounced. Median progression-free survival was 7.4 months for Tam-Peli versus 2.8 months for standard treatment, corresponding to a 71% reduction in the risk of progression.
Tumors responded to treatment in 59.1% of patients who received the new drug. For topotecan, this figure was only 9.7%. Tam-Peli's benefit was also observed among patients with brain and liver metastases.
Serious treatment-related side effects also occurred less frequently: grade 3 or higher adverse reactions were recorded in 46.4% of patients receiving Tam-Peli, compared with 74.7% in the standard-therapy group.
Tam-Peli is an experimental antibody-drug conjugate targeting the B7-H3 protein, which is present in significant amounts in many solid tumors. The drug has already received Breakthrough Therapy designation from the FDA for the treatment of relapsed small-cell lung cancer, but it has not yet been approved for widespread use. Roche plans to begin global clinical trials of the drug.