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ASCO 2025 | CONTACT-03: subgroup analysis of 2L cabozantinib ± atezolizumab in aRCC

Cristina Suárez, MD, Vall d´Hebron Institute of Oncology (VHIO), Barcelona, Spain, discusses a subgroup analysis from the CONTACT-03 study (NCT04338269) of second-line cabozantinib with or without atezolizumab in patients with advanced renal cell carcinoma (aRCC) previously treated with immunotherapy. Outcomes, including progression-free survival and response rates, were comparable between treatment arms. Safety profiles aligned with known data, though combination therapy showed higher rates of serious adverse events. These findings provide guidance for post-IO treatment strategies in advanced RCC. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

So, as you know, the CONTACT-03 trial is a Phase III trial that investigated the role of adding atezolizumab to cabozantinib in patients that have already received immunotherapy. In this trial, patients that have been treated with anti-PD-1 or anti-PD-L1 inhibitors were randomized to receive atezolizumab plus cabozantinib versus cabozantinib. The primary objectives of the trial were progression-free survival and overall survival...

So, as you know, the CONTACT-03 trial is a Phase III trial that investigated the role of adding atezolizumab to cabozantinib in patients that have already received immunotherapy. In this trial, patients that have been treated with anti-PD-1 or anti-PD-L1 inhibitors were randomized to receive atezolizumab plus cabozantinib versus cabozantinib. The primary objectives of the trial were progression-free survival and overall survival. As you know, unfortunately, this trial was negative for both primary endpoints. In this subset analysis we have today, we are analyzing the patients that have received immunotherapy in first line. So patients treated in second line with cabozantinib or atezolizumab-cabozantinib. And we also investigated two different groups, patients that received immunotherapy in first line or patients that have received immunotherapy plus TKI in first line. So the results were consistent among all the subgroups, and we didn’t find any differences between cabozantinib or atezolizumab-cabozantinib in terms of PFS or overall survival in patients that receive first-line immunotherapy combinations. When we look at the two different groups, patients that have received IO-IO or patients that have received IO-TKI, we didn’t find any differences in terms of PFS, OS, and even in terms of overall response rate. And that is a little bit different to the CaboPoint trial, where we could find a difference in overall response rate in patients that have received first line with IO-IO with an overall response rate of 41% versus patients that have received IO-TKI, where the response rate was 28%. So, in conclusion, we didn’t find any differences between cabozantinib and atezolizumab-cabozantinib in patients treated in second line, and we didn’t find any differences either between patients treated in first line with IO-IO or IO-TKI.

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Disclosures

Consulting or Advisory Role – Astellas Pharma; Bristol-Myers Squibb; Eisai; EUSA Pharma; Ipsen; Merck Sharp & Dohme; Pfizer; Roche/Genentech (Inst)
Speakers’ Bureau – Bristol-Myers Squibb; Eisai; Ipsen; Merck Sharp & Dohme; Pfizer; Roche/Genentech
Research Funding – AB Science (Inst); Aragon Pharmaceuticals (Inst); Astellas Pharma (Inst); AstraZeneca (Inst); Bayer (Inst); Blueprint Medicines (Inst); Boehringer Ingelheim (Inst); Bristol-Myers Squibb (Inst); Clovis Oncology (Inst); Exelixis (Inst); GlaxoSmithKline (Inst); Novartis (Inst); Pfizer (Inst); Roche/Genentech (Inst); Sanofi Aventis GmbH (Inst)
Travel, Accommodations, Expenses – Bristol-Myers Squibb; Ipsen; Roche