Exelixis and Bristol-Myers Squibb are starting a Phase 3 trial called CheckMate 9ER to assess Cabometyx (cabozantinib) in combination with immune checkpoint inhibitors in patients with newly-diagnosed advanced renal cell carcinoma, the most common type of kidney cancer.
The study, which is not yet enrolling participants, will evaluate Cabometyx in combination with either Opdivo (nivolumab), or Yervoy (ipilimumab) plus Opdvio, and compare it with the standard of care, Sutent (sunitinib).
“While existing therapies have improved outcomes for some patients with advanced or metastatic kidney cancer, high rates of relapse and disease progression demonstrate a need for additional therapeutic options, especially among poor and intermediate risk patients,” Fouad Namouni, MD, head of development of oncology at Bristol-Myers Squibb, said in a press release.
“Combination therapy with agents that target different and complementary pathways — in this case, the combination of immune checkpoint inhibitors and tyrosine kinase inhibitors — may be a potential new approach for these patients,” Namouni said.
Cabometyx, developed by Exelixis, is a once-daily oral drug that specifically targets several receptors, such as MET, AXL, and VEGFR, that have tyrosine kinase activity and are commonly expressed by cancer cells. These receptors are known to be involved in several tumor mechanisms such as new blood vessel formation, tumor cell migration, and invasiveness.
“There is strong scientific evidence showing that Cabometyx results in a more immune permissive tumor environment, and we are eager to determine if combining these active agents with complementary and potentially cooperative mechanisms of action has the potential to further improve patient outcomes,” said Gisela Schwab, MD, chief medical officer and president of product development and medical affairs at Exelixis.
“We are excited to initiate this first clinical trial from our broad development program with Bristol-Myers Squibb looking at the potential of Opdivo in combination with Cabometyx, with or without Yervoy, in a variety of tumor types,” Schwab added.
Sponsored by Bristol-Myers Squibb, the international Phase 3 CheckMate 9ER trial (NCT03141177) is expected to include up to 1,014 patients with advanced or metastatic kidney cancer who have not received prior therapies. For more information about enrolling, click here.
Participants will be radomized to receive either Cabometyx plus Opdivo; Cabometyx plus Opdivo and Yervoy; or Sutent alone.
While the study’s primary objective is progression-free survival — the time it takes before the cancer progresses — survival and response rates will also be assessed. The effectiveness of both Cabometyx combo therapies will be compared to the effectiveness of Sutent.