EXEL Reports Superior Efficacy Data From Kidney Cancer Study Cohort

Exelixis EXEL announced encouraging results from an expansion cohort of the early to mid-stage study of its next-generation oral TKI, zanzalintinib, in combination with either Bristol Myers' BMY Opdivo (nivolumab) or a fixed-dose combination of nivolumab and relatlimab (Opdualag) in patients with previously untreated advanced clear cell renal cell carcinoma (RCC).

The phase Ib/II STELLAR-002 study is evaluating the candidate’s safety and efficacy as a monotherapy or in combination with Opdivo, Opdualag, or the Opdivo/Yervoy combo in patients with advanced solid tumors.

Detailed Results From EXEL’s RCC Study Cohort

According to data from the expansion cohort of Exelixis’ STELLAR-002 study, the combination of zanzalintinib with Bristol Myers’ Opdivo demonstrated an objective response rate (ORR) of 63%, while the combination with Opdualag showed an ORR of 40%. Both treatment arms achieved a disease control rate of 90%.

At a median follow-up of 20.1 months for the Opdivo arm and 15.9 months for the Opdualag arm, the 12-month duration of response was 73.4% and 74.1%, respectively. Median progression-free survival was reported as 18.5 months and 13 months for the Opdivo and Opdualag combinations, respectively.

EXEL shares have risen 28.7% year to date against the industry’s decline of 5.6%.

The zanzalintinib/Opdivo combo has the potential to address the unmet medical need for RCC treatments. Based on the encouraging high rate of durable responses and long progression-free survival data observed, coupled with the lack of other effective therapies in the market, the company plans to further evaluate the regimen.

Treatment-emergent adverse events (TEAEs) occurred in all patients, with common grade 3/4 events, including hypertension, diarrhea and liver enzyme elevations in both treatment arms. Two grade 5 TEAEs were reported per arm (none treatment-related). Study drug discontinuation due to TEAEs was observed in 8% and 20% of patients in the Opdivo and Opdualag combination arms, respectively.

Exelixis shared additional data from several cohorts in the phase Ib/II STELLAR-002 study, evaluating different dose combinations of zanzalintinib with Bristol Myers’ Opdivo or Opdualag in patients with advanced solid tumors. Colorectal and prostate cancers were most common among patients receiving zanzalintinib with Opdivo, while RCC was the most frequent tumor type in the Opdualag cohorts. The combination therapies showed a manageable safety profile consistent with the individual agents. Early safety, efficacy, and pharmacokinetic data supported the selection of the 100 mg zanzalintinib dose for the ongoing expansion cohorts.

Please note that Bristol Myers’ Opdivo is approved, both as a monotherapy and in combination with Yervoy, to treat a plethora of cancer indications in many countries, including the United States and the European Union. BMY’s Opdualag is also currently approved in the United States and the EU for treating unresectable or metastatic melanoma.

Exelixis, Inc. Price and Consensus

Exelixis, Inc. price-consensus-chart | Exelixis, Inc. Quote

EXEL’s Zacks Rank & Other Stocks to Consider

Exelixis currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the biotech sector are Bayer BAYRY and Amarin AMRN, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 41.8%. 

BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%. 

In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.33 to $3.48 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $4.13 to $2.67. Year to date, shares of AMRN have gained 13.3%.

AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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