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GU Cancers 2023 | Final OS results of IMvigor130: 1L atezolizumab +/- chemotherapy in metastatic urothelial carcinoma

Aristotelis Bamias, MD, National and Kapodistrian University of Athens, Athens, Greece, shares the final overall-survival (OS) results of the Phase III IMvigor130 (NCT03547973) trial evaluating atezolizumab with or without chemotherapy in metastatic urothelial carcinoma. Previously, atezolizumab has been demonstrated to induce sustained response in metastatic urothelial carcinoma. Coprimary endpoints were progression-free survival (PFS) and overall-survival (OS). Secondary endpoints include duration of response (DOR)and percentage of participants with best overall response of complete response (CR). No difference was found in OS in the intent-to-treat population. There was no difference OS results by PD-L1 status when patients had low or no expression of PD-L1, however, an OS benefit was observed in patients with high expression of PD-L1. In patients who were ineligible for cisplatin, the OS benefit was significant, with a median OS of 18 months with atezolizumab versus 10 months with chemotherapy alone. This interview took place at the ASCO GU Cancers Symposium 2023 in San Francisco, CA.

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Transcript (edited for clarity)

I presented the overall survival results in Arm B, which is monotherapy with the tocilizumab, versus Arm C, which is chemotherapy alone.

In keeping with previous interim overall survival analysis (this was the final overall survival analysis) we do not find any difference in overall survival between these two arms in the whole population. The median overall survival for Arm B was 15.2 months, versus 13...

I presented the overall survival results in Arm B, which is monotherapy with the tocilizumab, versus Arm C, which is chemotherapy alone.

In keeping with previous interim overall survival analysis (this was the final overall survival analysis) we do not find any difference in overall survival between these two arms in the whole population. The median overall survival for Arm B was 15.2 months, versus 13.3 months for Arm C. But it’s important that one third of the patients in both arms was alive two years after study entry.

When we looked in overall survival analysis by PD-L1 status, we found that there was no difference in survival when the tumors did not express PD-L1 or had low expression of PD-L1, while there was suggestion of overall survival benefit in favor of atezolizumab when the tumors highly expressed PD-L1. The median overall survival for Arm B in this population was 27.5 months, compared to 18 months in Arm C.

Furthermore, when we specified this analysis in the cis-ineligible population, then this overall survival benefit became significant, with a median overall survival of 18 months for Arm B versus 10 months for chemotherapy alone, and the hazard ratio of 0.56.

This is an important finding because it justifies the label, the European label, for atezolizumab, which is first-line treatment in cis-ineligible PD-L1 positive population. This indication was recently voluntarily withdrawn in the States, but it still remains a recommendation of category 2B in the NCCN guidelines.

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