The IMvigor130 trial showed chemotherapy plus immunotherapy in patients with metastatic urothelial cancer could prolong the time to disease progression.
Patients with metastatic urothelial cancer treated with frontline Tecentriq (atezolizumab) plus chemotherapy experienced prolonged progression-free survival — or the time from treatment to disease progression or worsening — compared with chemotherapy alone, according to results of the IMvigor130 trial.
“This is a new option for the upfront treatment of patients with metastatic urothelial cancer,” Dr. Enrique Grande, from the MD Anderson Cancer Centre in Madrid, said in a press release issued by the European Society of Medical Oncology, adding that longer follow-up is still needed on results like overall survival. “… we will continue to search for biomarkers to identify which patients respond best to this therapy.”
In the IMvigor130 trial, the first to test the combination of chemotherapy and immunotherapy in patients eligible and ineligible for chemotherapy, researchers randomized 1,213 patients with metastatic urothelial cancer to receive either Tecentriq plus platinum-based chemotherapy, Tecentriq alone or platinum-based chemotherapy alone.
Progression-free and overall survival in the combination group and the chemotherapy alone group, as well as overall survival compared in the monotherapy groups, served as the primary endpoints of the study.
After a median follow-up of 11.8 months, chemotherapy plus Tecentriq improved median progression-free survival by almost two months, compared with chemotherapy alone (8.2 months versus 6.3 months). Moreover, patients who received the combination regimen had an 18% reduction in the likelihood of their disease progressing.
An interim analysis of overall survival showed a trend for improvement with the combination, compared with chemotherapy alone (16 months versus 13.4 months, respectively), but it was not statistically significant, according to the press release. There was also a trend for improved survival in patients with tumors that showed an overexpression of PD-L1, a protein targeted in certain cancer treatments, who were treated with Tecentriq alone compared with chemotherapy (15.7 months versus 13.1 months, respectively).
Lastly, objective response rates were 47% in the combination group, 23% in those who received Tecentriq alone and 44% in the chemotherapy only group, including complete response rates of 13%, 6% and 7%, respectively.
Side effects that led to treatment withdrawal occurred in 34% of the combination group, 6% of those who received Tecentriq and 34% of the chemotherapy only group.
However, Dr. Ignacio Durán, from the Hospital Universitario Marques de Valdecilla-IDIVAL in Santander, Spain, cautioned that these findings may not support regulatory approval at this stage. But, he added, the results still appear promising.
“(The improved complete responses) is remarkable. We are now eager to see if patients receiving the two therapies together live longer, and with a similar quality of life, than those receiving chemotherapy and immunotherapy alone or sequentially,” Durán said. “The interim analysis of overall survival seems to be promising, but data are immature: overall survival data are needed to consider the combination of chemotherapy and immunotherapy as a new standard of care.”