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Renal Cell Carcinoma Space in Focus: Some Key Developments

Renal cell carcinoma (RCC) is the most common form of kidney cancer in adults as about nine out of 10 kidney cancer patients are diagnosed with it. Per statistics, approximately 403,000 cases of kidney cancer were diagnosed worldwide in 2018 and about 175,000 deaths occurred due to the disease.

Recently, AVEO Pharmaceuticals AVEO announced positive updated data from a late-stage TIVO-3 study on its vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) Fotivda (tivozanib) for the treatment of patients with highly refractory metastatic RCC.

Last week, the European Commission approved the label expansion of Merck’s MRK PD-L1 inhibitor, Keytruda, in combination with Pfizer’s PFE Inlyta (axitinib) for the first-line treatment of advanced RCC. In April 2019, the FDA had approved this combination for the same indication.

Given its market potential, most pharma/biotech bigwigs are scurrying to grab a larger chunk of this pie. Evidently, the focus is on better and effective treatments. While Pfizer’s Sutent has long been used as a treatment for advanced RCC, the focus, of late, has shifted to checkpoint inhibitor–containing regimens in combination with a TKI as the first-line option for RCC patients like Keytruda (anti-PD-1 therapy) and Inlyta (a TKI).

In May 2019, the FDA approved the combination regimen of Bavencio (avelumab) and Inlyta for the first-line treatment of patients with advanced RCC. The approval was based on positive results from the phase III JAVELIN renal 101 study.

Another important player in this space is Exelixis EXEL whose lead drug Cabometyx is approved for both previously treated patients and treatment-naïve advanced RCC patients. The company is currently focusing on evaluating Cabometyx’s potential in combination with immune checkpoint inhibitors to determine if such combinations further improve outcomes for patients. CheckMate 9ER, a phase III study, is evaluating Cabometyx in combination with Bristol-Myers’ BMY Opdivo in previously untreated advanced or metastatic RCC. Exelixis has also initiated COSMIC-313, a phase III study evaluating the triplet combination of cabozantinib, Opdivo and Yervoy versus the combination of Opdivo and Yervoy in patients with previously untreated advanced intermediate- or poor-risk RCC.

Bristol-Myers’ immuno-oncology drug Opdivo is already approved for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. In addition, Opdivo in combination with Yervoy is also indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced RCC. The results from the phase III CheckMate-214 study showed that treatment with Opdivo plus low-dose Yervoy continued to demonstrate long-term survival benefits in patients with previously untreated advanced or metastatic RCC as compared to Sutent.

However, there have been a few setbacks as well. In 2018, Roche RHHBY withdrew its application with the FDA seeking approval of PD-L1 inhibitor Tecentriq (atezolizumab) and anti-VEGF drug Avastin (bevacizumab) as a treatment for advanced or metastatic RCC.

Given the spate of new approvals, competition is expected to be stiff in this space. As the survival rates for advanced and metastatic RCC are really low, it remains to be seen which regimen emerges as the market leader in the long run. We expect investor focus to remain on updates from the ongoing studies in this indication.

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