Exelixis Announces Dose-Escalation Results from the Phase 1 STELLAR-001 Trial Evaluating XL092 Alone and in Combination with an Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors at ESMO 2022

–Both single-agent XL092 and XL092 in combination with atezolizumab demonstrated encouraging efficacy and safety in a heavily pretreated patient population –

– XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels, with a manageable safety profile –

– Based on the results, the 100 mg dose of XL092 was selected for the expansion phase, which is ongoing in a number of solid tumor types –

Excerpt from the Press Release:

ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced results from the dose-escalation stage of STELLAR-001, an ongoing phase 1b trial evaluating XL092 as a single-agent and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The data are being presented on Monday, September 12 during the Poster Session (481P) at 12:00 p.m. CEST at the 2022 European Society of Medical Oncology (ESMO) Congress.

“We are pleased to present these findings from the dose-escalation stage of STELLAR-001 at ESMO, which show XL092 demonstrated preliminary clinical activity similar to that observed with cabozantinib in phase 1 across a range of solid tumors and dose levels, with a manageable safety profile,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “We are particularly encouraged by the activity of XL092 in heavily pretreated renal cell carcinoma patients who have received prior treatment with immunotherapy and/or VEGF-targeting tyrosine kinase inhibitors, including approximately 70% of patients who received cabozantinib as a prior treatment. As we continue to enroll in the cohort-expansion stage across multiple solid tumors, we look forward to gaining additional insight into the potential of XL092 alone and in combination with immune checkpoint inhibitors as a potential new therapy for people with cancer in need of new treatment options.”

STELLAR-001 enrolled patients with advanced solid tumors for which standard of care did not exist or was not effective. For this analysis, patients received XL092 either as a single-agent (n=47) or in combination with atezolizumab (n=40). The most common types of cancer for patients enrolled in the single-agent XL092 cohort were clear cell renal cell carcinoma (RCC), metastatic castration-resistant prostate cancer (CRPC) and breast cancer.

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