Bristol Myers Squibb, Exelixis Drug Combo Helping Kidney Cancer

April 27, 2020 - Bristol Myers Squibb and Exelixis Inc recently announced that CheckMate- 9ER, a pivotal Phase 3 clinical trial evaluating two drugs, showed positive results against untreated kidney cancer patients. 

The clinical trial evaluated the safety and efficacy of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC). Bristol Myers Squibb manufacturers Opdivo, while Exelixis created Cabometyx.

Nivolumab was previously shown to be effective in patients with advanced kidney cancer that had progressed after their initial treatment, soon after becoming the standard of care for these patients.

In 2018, FDA approved the combination of nivolumab and ipilimuab (Yervoy) as an initial treatment for the disease, after a large clinical trial showed that the approach led to better survival compared with patients treated with sunitinib. 

CheckMate-9ER met its endpoint of progression-free survival (PFS) at final analysis and the secondary endpoint of overall survival (OS). The combination of cabozantinib plus nivolumab is beneficial in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients. 

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Researchers stressed that if approved, the combination may become a vital new option for patients with metastatic renal cell carcinoma.

“The positive topline results from the Phase 3 CheckMate -9ER trial evaluating Opdivo in combination with CABOMETYX build on our understanding of Opdivo-based regimens, and we look forward to working with global health authorities to help bring this new combination regimen to previously untreated patients, a population that despite recent advances, remains in need of additional therapeutic options that extend survival,” Brian Lamon, PhD, development lead for genitourinary cancers at Bristol Myers Squibb, said in the announcement.

There is a growing amount of data that shows Cabometyx may create an immune-permissive tumor environment, which could boost response to immune checkpoint inhibitors, said Gisela Schwab, MD, president, product development and medical affairs and chief medical officer, Exelixis.

“We’re delighted that the trial met its primary endpoint of progression-free survival as well as the secondary endpoints of overall survival and objective response rate, demonstrating consistent benefit for the combination in previously untreated renal cell carcinoma patients. We look forward to our continued collaboration with Bristol Myers Squibb as we work toward regulatory filings in the near future.”

The companies voiced that they will submit detailed results of CheckMate-9ER for presentation at an upcoming medical conference, but urge anyone with additional questions to go to ClinicalTrials.gov. 

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“We would like to thank the patients who participated in this trial, as well as the investigators and site personnel for their perseverance during the conduct of this study and in delivering this important result for patients in the midst of the COVID-19 pandemic,” Lamon said. 

Prior to the CheckMate-9ER clinical trial, there were significant care gaps in kidney care, which could affect tubes within the kidneys and lead to renal cell carcinoma.

A new study from July 2019 out of Kaiser Permanente Southern California found that more than half of kidney patients were going without follow-up care for abnormal estimated glomerular filtration rate (eGFR), a common kidney disease test.

An assessment of over 244,000 patients being treated by more than 7,000 different providers revealed that providers are not following up with the critical care that patients need. 

“This important study should serve as a wakeup call for healthcare organizations nationwide, that ordering lab tests will only change patient outcomes if the results trigger action,” said Kerry Willis, PhD, the chief scientific officer at the National Kidney Foundation.

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Although there are some issues with developing kidney care drugs, various drugs are currently FDA approved, including Afinator (Everolimus), Avelumab, Cabometyx, Ipilimumab, Lenvima, Nexavar, Proleukin, Sutent, Torisel, Votrient, and 35 others.

Before the emergence of drugs like sunitinib, kidney cancer had a poor prognosis, with a median overall survival of less than a year, Robert Motzer, MD, of Memorial Sloan Kettering Cancer Center, said in an article. 

With the use of VEGFR inhibitors, median survival improved to about 30 months. Now immunotherapies are helping extend survival beyond 3 years, he said.

“Ultimately, what’s most important to patients is the impact of these new approaches on long-term survival. How many patients have remissions? Are any patients actually cured of their kidney cancer?” David McDermott, MD, chief of medical oncology at Beth Israel Deaconess Medical Center said. “It’s going to take some time to figure those things out.”