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FDA Approves OPDIVO® with CABOMETYX® as First-line Treatment for advanced Renal Cell Carcinoma

22 Jan 2021:  Bristol Myers Squibb announced that OPDIVO®(nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with CABOMETYX® (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). 

The approval is based on the Phase 3 CheckMate -9ER trial, which compared OPDIVO in combination with CABOMETYX (n=323) versus sunitinib (n=328) in patients with advanced RCC.

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This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. 

Please see below for additional CheckMate -9ER data context.

“At Bristol Myers Squibb, we are focused on developing transformative medicines that may improve survival for people living with cancer.

The role of OPDIVO YERVOY is well established for intermediate/poor-risk patients with advanced RCC, and today’s achievement extends the potential of an OPDIVO-based combination to even more patients,” says Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb.

OPDIVO in combination with CABOMETYX brings together the strong heritage of both medicines to now provide physicians a new combination in advanced RCC that may offer improved outcomes to patients for whom an immunotherapy plus tyrosine kinase inhibitor regimen is appropriate.”

OPDIVO and YERVOY are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when OPDIVO is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.

“This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib – progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects.

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The therapeutic benefit demonstrated in CheckMate -9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” said Toni Choueiri, M.D., director, Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School.

“With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.”

In the CheckMate -9ER trial, the primary endpoint was progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR), and the secondary endpoints included overall survival (OS) and BICR-assessed objective response rate (ORR).

In the trial, patients treated with OPDIVO in combination with CABOMETYX lived twice as long without their tumors progressing as patients who were treated with sunitinib (median PFS was 16.6 months [95% Confidence Interval [CI]: 12.5-24.9] versus median PFS of 8.3 months [95% CI: 7.0-9.7]; [Hazard Ratio [HR]: 0.51 [95% CI: 0.41–0.64], P<0.0001; median follow-up of 18.1 months]; range: 10.6-30.6 months).

OPDIVO in combination with CABOMETYX also reduced the risk of death by 40% compared to sunitinib (HR: 0.60 [98.89% CI 0.40–0.89]; P=0.0010; median OS was not reached for OPDIVO in combination with CABOMETYX and not available for sunitinib [range: 22.6-NR months]).1

Additionally, more patients responded to OPDIVO in combination with CABOMETYX than sunitinib, withan ORR of 55.7% (n=180/323) (95% CI: 50.1 to 61.2) versus 27.1% (n=89/328) (95% CI: 22.4 to 32.3); P<0.0001, respectively.

In the combination arm, 8.0% (n=26/323) of patients experienced a complete response and 47.7% (n=154/323) experienced a partial response versus 4.6% (n=15/328) and 22.6% (n=74/328) of those treated with sunitinib.

Among patients who responded, the median duration of response was 20.2 months for OPDIVO in combination with CABOMETYX (95% CI: 17.3 to NA) and 11.5 months for sunitinib (95% CI: 8.3 to 18.4).

Consistent results for PFS were observed across pre-specified subgroups of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk categories and PD-L1 tumor expression status.1

Adverse reactions greater than Grade 3 in the trial were similar with OPDIVO in combination with CABOMETYX versus sunitinib (75% versus 71%).

All-cause adverse reactions leading to discontinuation of either OPDIVO or CABOMETYX occurred in 19.7% of patients; 6.6% of OPDIVO only, 7.5% of CABOMETYX only and 5.6% of the combination due to same adverse reaction at the same time.

“While significant progress has been made in the treatment landscape for advanced kidney cancer over the last several years, patients still need more therapeutic options to treat this disease as we search for a possible cure,” said Bryan Lewis, president and co-founder of KidneyCAN.

“As patients are living longer with advanced kidney cancer, focusing on the safety and effectiveness of new treatments has become even more important.

The findings for the combination of OPDIVO and CABOMETYX in the CheckMate -9ER trial make the FDA approval of this combination a notable development for the patient community.”

https://news.bms.com/news/corporate-financial/2021/U.S.-Food-and-Drug-Administration-Approves-OPDIVO-nivolumab-in-Combination-with-CABOMETYX-cabozantinib-as-First-line-Treatment-for-Patients-with-Advanced-Renal-Cell-Carcinoma/default.aspx

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