(Kidney Cancer) Phase II Results of Atezolizumab in Untreated Patients

(Kidney Cancer) Phase II Results of Atezolizumab in Untreated Patients

• March 6, 2017
• Reading time: 2 minutes

This is an article from ASCO GU 2017, the Genitourinary Cancers Symposium held in Orlando, Florida, from February 16–18. It was presented by Dr. David F. McDermott from Beth Israel Deaconess Medical Center. This Phase II study, named IMmotion150, compared the use of the anti-PD-L1 antibody atezolizumab alone, in combination with Avastin (bevacizumab), or in comparison with Sutent (sunitinib) in patients with previously untreated metastatic renal cell carcinoma (mRCC).

The trial enrolled previously untreated mRCC volunteers, including those who had undergone nephrectomy. Participants were stratified by PD-L1 expression (1%↑) and MSKCC risk classification. The groups consisted of: 1) Avastin + atezolizumab (101 patients), 2) Atezolizumab monotherapy (1,200 mg every three weeks), and 3) Sutent monotherapy (101 patients, 50 mg once daily for four weeks followed by a two-week break). There were no significant differences in the treatment backgrounds of the volunteers across the three groups.

Volunteers in the monotherapy and Sutent groups were eligible for crossover to the Avastin combination after disease progression. The evaluation criteria were Progression-Free Survival (PFS) based on RECIST v1.1 for the Intention-to-Treat (ITT)* population and PFS for PD-L1 positive patients.

Data were collected through October 17, 2016, with a median follow-up period of 20.7 months.

Based on the ITT analysis, the median PFS was 11.7 months (95% CI: 8.4–17.3) for the combination group, 6.1 months (95% CI: 5.4–13.6) for the atezolizumab monotherapy group, and 8.4 months (95% CI: 7.0–14.0) for the Sutent group. The Hazard Ratio (HR) for the combination group versus the Sutent group was 1.00 (95% CI: 0.69–1.45), with p=0.982. Additionally, the HR for the monotherapy group versus the Sutent group was 1.19 (95% CI: 0.82–1.71), p=0.358. For PD-L1 positive patients, the median PFS was 14.7 months (95% CI: 8.7–25.1) for the combination group (n=50), 5.5 months (95% CI: 3.0–13.9) for the monotherapy group (n=54), and 7.8 months (95% CI: 3.8–10.8) for the Sutent group (n=60). The HR for the combination versus Sutent was 0.64 (95% CI: 0.38–1.08), p=0.095, showing a favorable trend for the combination group though not statistically significant. The HR for monotherapy versus Sutent was 1.03 (95% CI: 0.63–1.67), p=0.917, showing no significant difference.

Regarding side effects, Grade 3/4 adverse events occurred in 40% of the combination group, 17% of the monotherapy group, and 57% of the Sutent group. Treatment-related deaths were 1% in the combination group, 0% in the monotherapy group, and 2% in the Sutent group.

The Phase III clinical trial IMmotion151, which further compares atezolizumab + bevacizumab versus sunitinib in untreated mRCC patients, is currently ongoing.

*ITT (Intention-to-Treat): An analysis based on the initial treatment assignment rather than the treatment eventually received. It is used in randomized controlled trials to maintain the integrity of randomization and provide a more realistic assessment of a treatment's clinical impact.

Article source: https://www.urotoday.com/conference-highlights/asco-gu-2017/asco-gu-2017-kidney-cancer/94193-asco-gu-2017-a-phase-ii-study-of-atezolizumab-atezo-with-or-without-bevacizumab-bev-versus-sunitinib-sun-in-untreated-metastatic-renal-cell-carcinoma-mrcc-patients-pts-session-highlights.html

Renal Cell Carcinoma # Kidney Cancer

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