EXEL Reports Superior Efficacy Data From Kidney Cancer Study Cohort

Exelixis (EXEL) reported positive results from its STELLAR-002 study, showing that its zanzalintinib in combination with Bristol Myers Squibb's (BMY) Opdivo achieved a 63% objective response rate (ORR) in previously untreated advanced clear cell renal cell carcinoma (RCC), while the zanzalintinib/Opdualag combination showed a 40% ORR, both with a 90% disease control rate. The 12-month duration of response was 73.4% and 74.1% for the Opdivo and Opdualag arms, respectively, with median progression-free survival of 18.5 months and 13 months. Exelixis plans to further evaluate the zanzalintinib/Opdivo regimen, citing the unmet medical need for RCC treatments.

Analysis

Exelixis (EXEL) has reported encouraging efficacy data from an expansion cohort of its phase Ib/II STELLAR-002 study for zanzalintinib in patients with previously untreated advanced clear cell renal cell carcinoma (RCC). The combination of zanzalintinib with Bristol Myers Squibb's (BMY) Opdivo demonstrated a 63% objective response rate (ORR) and a median progression-free survival (PFS) of 18.5 months, while the combination with Opdualag showed a 40% ORR and a 13-month median PFS; both treatment arms achieved a 90% disease control rate (DCR). The 12-month duration of response was robust at 73.4% for the Opdivo arm (median follow-up 20.1 months) and 74.1% for the Opdualag arm (median follow-up 15.9 months). Exelixis plans to further evaluate the zanzalintinib/Opdivo regimen, citing its potential to address unmet medical needs in RCC. While treatment-emergent adverse events (TEAEs) occurred in all patients, with common grade 3/4 events including hypertension, diarrhea, and liver enzyme elevations, and study drug discontinuation due to TEAEs observed in 8% (Opdivo arm) and 20% (Opdualag arm) of patients, the overall safety profile was described as manageable. This positive clinical development is reflected in EXEL's share performance, which has risen 28.7% year-to-date, significantly outperforming the industry's 5.6% decline, and aligns with its current Zacks Rank #2 (Buy) status.

Key Decisions for Investors

• Investors should view the reported efficacy data for zanzalintinib, particularly in combination with Opdivo, as a significant positive development for Exelixis, potentially enhancing its oncology franchise and competitive positioning in the RCC treatment landscape.
• Close monitoring of further clinical trial progress for the STELLAR-002 study, including detailed safety data from ongoing expansion cohorts and any forthcoming regulatory interactions for the zanzalintinib combinations, is warranted, especially considering the reported TEAEs and discontinuation rates.
• Given Exelixis's substantial year-to-date share price appreciation of 28.7%, investors should evaluate the current valuation in light of these positive results, balancing the promising pipeline update for zanzalintinib against the inherent risks and timelines associated with advancing this RCC regimen through further clinical evaluation and potential regulatory approval.