Exelixis Provides ‘A Highly Defensive Investment Profile:’ Analyst

EExelixis Inc. NASDAQ: EXEL) on Monday reported final overall survival data from the Phase 3 STELLAR-303 trial.

The data showed that the investigational combination of zanzalintinib and atezolizumab demonstrated a numerical overall survival benefit, but failed to achieve statistical significance in a subgroup of metastatic colorectal cancer patients without active liver metastases.

Zanzalintinib (formerly known as XL092) is an investigational, third-generation oral tyrosine kinase inhibitor (TKI) designed as a next-generation successor to Exelixis flagship cancer medicine, cabozantinib.

Final Analysis Shows Numerical Survival Advantage

The final analysis of one of the trial’s dual primary endpoints evaluated overall survival in patients with previously treated non-microsatellite instability-high metastatic colorectal cancer (mCRC) who did not have active liver metastases at baseline.

Results showed a non-statistically significant trend favoring zanzalintinib in combination with atezolizumab over regorafenib. The combination therapy produced a stratified hazard ratio of 0.83 (P=0.1185).

Patients treated with the zanzalintinib combination achieved a median overall survival of 15.9 months, compared with 12.7 months for those receiving regorafenib.

FDA Review Underway

Exelixis is also advancing regulatory efforts for the therapy.

In February 2026, the FDA accepted the company’s New Drug Application seeking approval of zanzalintinib in combination with atezolizumab for previously treated mCRC patients who had received fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy and, when appropriate, anti-EGFR therapy.

The FDA assigned the application a Prescription Drug User Fee Act target action date of December 3, 2026.

Analyst Take

William Blair on Monday wrote that, “Given Phase III STELLAR-303’s statistical design, the trial could be deemed successful if one of two dual primary endpoints met statistical significance.”

Analyst Andy Hsieh wrote, “…given its substantial and likely durable cash flow generation into early 2031, we continue to believe Exelixis provides investors with a highly defensive investment profile.”

EXEL Price Action: Exelixis shares were down 0.89% at $51.45 at the time of publication on Monday, according to Benzinga Pro data.

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