ALAMEDA, Calif. Exelixis, Inc. (Nasdaq: EXEL) recently made a significant impact in the oncology community with new findings from the CheckMate -9ER trial, evaluating the efficacy of CABOMETYX (cabozantinib) in combination with Opdivo (nivolumab) for patients with previously untreated advanced renal cell carcinoma (RCC). Presented at the American Society of Clinical Oncology s Genitourinary Cancers Symposium (ASCO GU) in 2025, these final five-year follow-up results underscore the sustained long-term benefits of this combination therapy over sunitinib, a standard treatment in the same patient population.
Sustained Long-Term Efficacy and Survival Benefits
The CheckMate -9ER trial, which was pivotal in establishing CABOMETYX as a front-line therapy for advanced RCC, has shown that the combination of cabozantinib and nivolumab can lead to prolonged overall survival (OS) and progression-free survival (PFS) compared to sunitinib alone. The extended follow-up period of more than five years has provided strong evidence that patients continued to benefit from this therapeutic regimen, with researchers reporting that the efficacy benefits observed during the initial trial phases remain robust.
Key findings from the trial indicated that not only did patients have improved survival rates, but they also experienced a favorable tolerability profile. This long-term data reinforces the notion that the cabozantinib-opdivo combination may offer a valuable treatment option for patients battling one of the most challenging forms of cancer.
Subgroup Analysis in Gastrointestinal Neuroendocrine Tumors
In addition to the CheckMate -9ER trial results, Exelixis also presented a subgroup analysis from the phase 3 CABINET pivotal study, focusing on patients with advanced gastrointestinal neuroendocrine tumors (NET). The analysis provided promising insights into the effectiveness of cabozantinib in this patient cohort, showing a significant improvement in progression-free survival compared to placebo for those with extra-pancreatic NET. These findings support the potential for cabozantinib as an effective agent in treating various forms of neuroendocrine tumors, particularly as more patients seek advanced therapeutic options.
Regulatory Pathway for Supplemental New Drug Application
Moreover, Exelixis announced that the U.S. Food and Drug Administration (FDA) has taken steps toward reviewing their supplemental New Drug Application (sNDA) for cabozantinib. This application seeks to expand the therapeutic indications for cabozantinib to include treatment for adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET. The FDA’s Oncologic Drugs Advisory Committee (ODAC) is set to review the sNDA during a meeting in March 2025, highlighting the growing interest and potential regulatory support for cabozantinib as a viable treatment option for these difficult-to-treat cancers.
Looking Ahead
The unveiling of these pivotal results at ASCO GU underscores Exelixis s commitment to advancing cancer treatment options and supports their ongoing efforts in clinical research. With the sustained efficacy demonstrated in RCC patients and promising data in gastrointestinal NETs, Exelixis is poised to make a substantial contribution to the landscape of oncology therapies.
As the anticipation builds for the upcoming ODAC meeting regarding the expanded indication of cabozantinib, healthcare professionals and patients alike are eager to see how these developments will ensure access to innovative treatments for those facing advanced neuroendocrine tumors.
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