Health Canada approves Ipsen’s CABOMETYX® (cabozantinib) in combination with OPDIVO® (nivolumab) as a first-line treatment for adults with advanced or metastatic renal cell carcinoma

Pivotal phase III trial data showed CABOMETYX^® in combination with OPDIVO^® demonstrated superior efficacy compared to sunitinib across all key endpoints, reducing the risk of death by 40 per cent,¹ giving Canadians living with kidney cancer another treatment option.

Mississauga, ON – October 20, 2021 – Ipsen Biopharmaceuticals Canada Inc. today announced the Health Canada approval of CABOMETYX^® (cabozantinib) in combination with Bristol Myers Squibb’s OPDIVO^® (nivolumab) for the first-line treatment of advanced (not amenable to curative surgery or radiation therapy) or metastatic renal cell carcinoma (RCC).² This decision marks the first approval for CABOMETYX^® in combination with another therapy in Canada and the third indication of CABOMETYX^® in renal cell carcinoma.

“This new combination treatment, an immunotherapy and tyrosine kinase inhibitor (TKI), offers Canadians living with advanced renal cell carcinoma another effective option that controls disease progression and reduces the risk of death,” says Dr. Sebastien Hotte, associate professor and medical oncologist at the Juravinski Cancer Centre.

It’s estimated that 7,500 Canadians were diagnosed with kidney cancer in 2020 and nearly 2,000 succumbed to the disease.³ As the most common type of kidney cancer, RCC accounts for 80 per cent of all kidney cancers⁴ and is considered advanced when the cancer has spread beyond the primary tumour site⁵ Unfortunately, RCC does not have many obvious symptoms and is sometimes found only once it has reached an advanced stage.⁶

This approval is based on the Phase III CheckMate 9ER trial, which demonstrated that CABOMETYX^® in combination with OPDIVO^® showed significant improvement across all three efficacy endpoints.¹ After a median follow-up of 18.1 months, progression-free survival was doubled for patients receiving the combination therapy compared to those receiving sunitinib alone (16.6 months vs 8.3 months, HR: 0.51; 95% CI: 0.41–0.64; p<0.0001).¹ Similarly, CABOMETYX^® in combination with OPDIVO^® led to significant improvements in overall survival, reducing the risk of death by 40 per cent when compared to sunitinib (HR: 0.60 [98.89% CI: 0.40-0.89]; p=0.001; median OS not reached in either arm).¹ An objective response was also observed in twice as many patients receiving CABOMETYX^® in combination with OPDIVO^® versus those receiving sunitinib (55.7% vs. 27.1%; p<0.0001).¹

“The results of the CheckMate 9ER trial provide further evidence demonstrating the efficacy and safety of CABOMETYX^®. We’re proud to see this new treatment option come to market and build on the positive impacts CABOMETYX^® has already made in the second-line treatment of advanced renal cell carcinoma in patients previously treated with a VEGF TKI,” said Ed Dybka, General Manager, Ipsen Biopharmaceuticals Canada Inc. “It’s our mission to improve patient lives and we’re delighted to offer ongoing support to Canadians living with advanced renal cell carcinoma by continuing to deliver more options in their fight against this disease.”

About the CheckMate 9ER trial

CheckMate 9ER is an open-label, randomized, multi-national Phase III trial evaluating patients with previously untreated advanced or metastatic RCC. A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk) were randomized to CABOMETYX^® plus OPDIVO^® (n= 323) versus sunitinib (n= 328). The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS) and objective response rate (ORR). The primary efficacy analysis was comparing the doublet combination versus sunitinib in all randomized patients.² The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

 About CABOMETYX^® (cabozantinib)

CABOMETYX^® is the first multi-targeted tyrosine kinase inhibitor (TKI) to target VEGFR, MET and AXL pathways that are involved in tumour progression in RCC. It works by blocking the action of proteins called receptor tyrosine kinases (RTKs). RTKs are involved in cell growth and the development of new blood vessels. These proteins can be present in high amounts in cancer cells. By blocking their action, CABOMETYX^® can slow down how fast the tumour grows, help to block the blood supply that the cancer needs and may increase the length of time before the cancer gets worse.²

In addition to its RCC indications, CABOMETYX^® is also indicated for the second line treatment of patients with advanced hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. The Health Canada approval, achieved in November 2019, was based on results from the CELESTIAL phase III pivotal trial, which randomized patients who previously received sorafenib to either CABOMETYX^® or placebo.²

About Ipsen in North America

Ipsen is a global biopharmaceutical company focused on innovation and specialty care. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing medicines in three key therapeutic areas – Oncology, Rare Disease and Neuroscience. Our North American operations are located in Cambridge, Massachusetts, one of the company’s three global hubs. Based in the heart of Kendall Square, our fully integrated biopharmaceutical business includes Commercial, Research & Development, Manufacturing, and Business Development. Combined with our Canadian headquarters in Mississauga, Ontario, and other locations, we employ approximately 600 people in North America. For more information please visit www.ipsen.com/canadaEN.

For further information:

1. Choueiri TK et al. Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2021; 384:829-841 DOI: 10.1056/NEJMoa2026982.   https://www.nejm.org/doi/full/10.1056/NEJMoa2026982
2. CABOMETYX® Product Monograph. Ipsen Biopharmaceuticals Canada Inc. October 6, 2021.
3. Canadian Cancer Society. Kidney Cancer Statistics: Incidence and mortality. https://cancer.ca/en/cancer-information/cancer-types/kidney/statistics. Last accessed September 23, 2021.
4. Kidney Cancer Canada, https://www.kidneycancercanada.ca/for-patients-and-caregivers/guide/types-of-kidney-cancer/#clearcell. Last accessed April 14, 2020
5. Kidney Cancer Canada, https://www.kidneycancercanada.ca/for-patients-and-caregivers/guide/understanding-kidney-cancer/#1564431995982-bc264b3d-fc6f. Last accessed April 14, 2020
6. UpToDate. Patient education: Renal cell carcinoma (kidney cancer) (Beyond the Basics). https://www.uptodate.com/contents/renal-cell-carcinoma-kidney-cancer-beyond-the-basics. Last accessed September 23, 2021.