Is Atezolizumab Plus Chemotherapy Effective for Urothelial Carcinoma?

At the European Society for Medical Oncology (ESMO) Congress held in Barcelona, Spain, from September 27 to October 1, 2019, Enrique Grande presented the results of the IMvigor130 Phase 3 clinical trial. This trial investigated the efficacy and safety of Atezolizumab (an anti-PD-L1 antibody) in combination with platinum-based chemotherapy for patients with untreated locally advanced or metastatic urothelial carcinoma.

Study Design: IMvigor130 Phase 3 Trial

The IMvigor130 trial randomized 1,213 patients with untreated locally advanced or metastatic urothelial carcinoma into three groups:

1. Atezolizumab + Chemotherapy Group (Atezolizumab + Gemcitabine + Carboplatin/Cisplatin, N=447)
2. Atezolizumab Monotherapy Group (N=369)
3. Placebo Group (Placebo + Chemotherapy, N=397)

The primary endpoints were progression-free survival (PFS) and overall survival (OS).

Key Results (Median Follow-up of 11.8 Months)

Progression-Free Survival (PFS)

• Atezolizumab + Chemotherapy: 8.2 months
• Placebo + Chemotherapy: 6.3 months
• The combination group showed an 18% reduction in the risk of progression (Hazard Ratio [HR] = 0.82).

Overall Survival (OS)

• Atezolizumab + Chemotherapy: 16.0 months
• Placebo + Chemotherapy: 13.4 months
• Although there was a 17% reduction in the risk of death (HR = 0.83), the improvement was not statistically significant at this interim analysis.
• The Atezolizumab monotherapy group had a median OS of 13.1 months, showing a 2% increase in risk compared to the placebo group (HR = 1.02).

Objective Response Rate (ORR)

• Atezolizumab + Chemotherapy: 47% (Complete Response [CR]: 13%)
• Atezolizumab Monotherapy: 23% (CR: 6%)
• Placebo + Chemotherapy: 44% (CR: 7%)

Safety and Conclusions

The safety profile of Atezolizumab in this trial was consistent with previous clinical studies, with no new safety signals observed. Discontinuation rates due to adverse events were 34% in the combination group, 6% in the monotherapy group, and 34% in the placebo group.

Enrique Grande concluded that Atezolizumab plus platinum-based chemotherapy significantly improved PFS in patients with untreated locally advanced or metastatic urothelial carcinoma, with a manageable safety profile.

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Source: Adding Atezolizumab to Front-Line Platinum-Based Chemotherapy Improves Progression-Free Survival in mUC [ESMO 2019 Oncology News]

#UrothelialCarcinoma #Atezolizumab #Tecentriq #Immunotherapy

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