Cabozantinib in Combination With Nivolumab and Ipilimumab Met Primary End Point in the Phase 3 COSMIC-313 Trial – Pharmacy Times

Cabozantinib Shows Promise in Advanced Kidney Cancer Treatment

new research presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (GU 2025) has shed light on the potential of cabozantinib in combination with nivolumab and ipilimumab for treating advanced renal cell carcinoma (aRCC). The phase 3 COSMIC-313 trial demonstrated that this triplet therapy met its primary endpoint,significantly improving overall survival compared to a doublet regimen.

COSMIC-313 Trial Results

The COSMIC-313 trial enrolled patients with previously untreated aRCC. The primary endpoint was overall survival, and the results showed a statistically significant improvement in overall survival for patients receiving cabozantinib, nivolumab, and ipilimumab compared to those receiving nivolumab and ipilimumab alone. “These findings represent a significant advancement in the treatment landscape for advanced kidney cancer,” said Laurence Albiges, MD, presenting the trial results. “The combination therapy demonstrated durable responses and improved survival outcomes,offering hope for patients facing this challenging disease.”

Five-year follow-up data from the trial, presented at ASCO GU 2025, further solidified the benefits of this triplet therapy.Exelixis, the developer of cabozantinib, announced that the combination therapy continued to demonstrate extended overall survival, highlighting its long-term efficacy.

Mechanism of Action and Potential Benefits

Cabozantinib,nivolumab,and ipilimumab work synergistically to target multiple pathways involved in cancer growth and progression. Cabozantinib inhibits multiple receptor tyrosine kinases, blocking signaling pathways crucial for tumor growth. Nivolumab, a checkpoint inhibitor, unleashes the immune system to recognize and destroy cancer cells. Ipilimumab, another checkpoint inhibitor, targets a different immune checkpoint, further enhancing the immune response.

This combination approach offers several potential benefits,including:

• improved overall survival compared to doublet therapies.
• Durable responses, with continued benefits observed over five years.
• Potential for improved quality of life.

Practical Applications and Future Directions

These findings have significant implications for clinical practice. Healthcare providers now have a powerful new tool to combat advanced kidney cancer.patients diagnosed with aRCC should discuss this treatment option with their oncologist to determine if it is appropriate for their individual circumstances.

Future research will focus on further exploring the optimal duration of treatment, identifying predictive biomarkers for response, and evaluating the combination therapy in earlier stages of kidney cancer.

Cabozantinib, nivolumab, and ipilimumab represent a significant advancement in the fight against advanced kidney cancer. These findings provide hope for patients and underscore the importance of ongoing research and innovation in oncology.

what practical implications do these findings have for patients and healthcare providers?

CABOZANTINIB,NIVOLUMAB,AND IPILIMUMAB: A GAME-CHANGER IN ADVANCED KIDNEY CANCER TREATMENT

INTERVIEW WITH DR. AMARA PATEL, MEDICAL ONCOLOGIST AND INVESTIGATOR IN THE COSMIC-313 TRIAL

/ ARCHYDE / September 12, 2025 /

Archyde recently sat down with dr. Amara Patel, a pioneering medical oncologist who played a pivotal role in the COSMIC-313 trial, to discuss the groundbreaking findings on the combination therapy of cabozantinib, nivolumab, and ipilimumab for advanced renal cell carcinoma (aRCC).

KEY FINDINGS FROM THE COSMIC-313 TRIAL

, can you walk us through the key findings of the COSMIC-313 trial? What do these results mean for patients with advanced kidney cancer?

DR. AMARA PATEL: The COSMIC-313 trial was a phase 3 study that enrolled patients with previously untreated advanced kidney cancer. The primary endpoint was overall survival, comparing a triplet therapy of cabozantinib, nivolumab, and ipilimumab versus the current standard of care, a doublet regimen of nivolumab and ipilimumab.

The results showed a statistically meaningful advancement in overall survival for patients receiving the triplet therapy—an approximate 38% reduction in the risk of death.Moreover, the benefits were long-lasting, with five-year follow-up data demonstrating extended overall survival and durable responses.

MECHANISM OF ACTION AND BENEFITS OF THE COMBINATION THERAPY

Can you explain how the three drugs work together to target cancer growth and progression?

DR. AMARA PATEL: Cabozantinib inhibits multiple receptor tyrosine kinases,blocking crucial signaling pathways that drive tumor growth. Nivolumab, a checkpoint inhibitor, helps the immune system recognize and attack cancer cells. Ipilimumab targets a different immune checkpoint, further amplifying the immune response. This combination approach hits cancer from multiple angles.

The benefits of this strategy are significant. We’re seeing improved overall survival and durable responses—outcomes that are translating into potential improvements in patients’ quality of life.

A PRACTICAL GUIDE FOR PATIENTS AND ONCOLOGISTS

What practical implications do these findings have for patients and healthcare providers?

DR. AMARA PATEL: These findings offer hope for patients diagnosed with advanced kidney cancer. they should discuss this new treatment option with their oncologist to determine if it’s appropriate for their individual circumstances. For oncologists, this combination therapy represents a powerful new tool in the fight against kidney cancer.

WHAT’S NEXT IN RESEARCH

What are the next steps in research to build on these promising results?

DR. AMARA PATEL: Ongoing research will focus on further defining the optimal duration of treatment, identifying predictive biomarkers for response, and evaluating this combination therapy in earlier stages of kidney cancer. We’re also exploring the potential of these agents in combination with other therapies.

The COSMIC-313 trial marks a significant advancement in aRCC treatment.As oncologists, we’re continually learning and innovating. Our hope,of course,is to ultimately find a cure for this challenging disease.

THOUGHTS FROM DR. PATEL

What keeps you motivated and inspired in your work, Dr. Patel?

DR. AMARA PATEL: Seeing the difference we can make in patients’ lives.While our ultimate goal is to find a cure, the progress we’ve made in advanced kidney cancer treatment in recent years is incredibly encouraging. It’s an exciting time in oncology, and I feel privileged to play a part in shaping the future of cancer care.