- Bristol Myers Squibb and Exelixis on Monday announced a combination of their drugs Opdivo and Cabometyx kept patients with newly diagnosed kidney cancer alive and their disease in check longer than Pfizer's Sutent.
- In this setting, Bristol Myers and Exelixis' pairing would compete against Merck & Co.'s Keytruda and Pfizer's Inlyta, which received Food and Drug Administration approval a year ago. The data appear to roughly match the Keytruda-Inlyta results on both delaying death and disease progression, although there is no head-to-head comparison.
- RBC Capital Markets analyst Kennen MacKay called the data a "near best-case scenario," potentially allowing Exelixis to regain lost momentum in kidney cancer. Shares jumped 25% to $24.37 apiece in morning trading on Monday.
Exelixis recorded $1 billion in revenue in 2019, most of it from two products that are essentially the same molecule, cabozantinib, marketed either as Cabometyx or Cometriq. Cabometyx, used to treat kidney and liver cancer, earned the bulk of that total, or some $733 million.
Cabometyx won broad FDA approval in 2016 as a single agent to treat kidney cancer after patients progressed on Sutent or on similar drugs that starve tumors of the blood necessary to survive and grow.
However, the drug's market share has been under threat following the first-line approval of the Keytruda-Inlyta combination in April 2019. In order to respond, Exelixis needed to show Cabometyx could be successfully combined with an immunotherapy in the same setting.
The CheckMate-9ER trial appears to have provided the evidence. The Opdivo-Cabometyx combination reduced the risk patient tumors would return or grow by 49% when compared to Sutent. An interim analysis of patients also showed the combination reduced the risk of death by 40% versus Sutent.
Keytruda won its kidney cancer approval on the basis of the KEYNOTE-426 trial, which combined the immunotherapy with Inlyta and demonstrated a 31% reduction in the risk of cancer progression and a 47% reduction in the risk of death when compared to Sutent.
Though cross-trial comparisons are tricky and fraught with caveats, RBC's MacKay and Cantor Fitzgerald's Louise Chen both described the CheckMate-9ER data as "competitive" with KEYNOTE-426. MacKay noted that yet-to-be-disclosed data such as response rate could give the Opdivo-Exelixis combination a further advantage.
Safety data might also provide an edge. In KEYNOTE-426, around 60% of patients had elevated liver enzymes, with 20% having severe elevations.
Response and safety data will almost certainly be disclosed when the CheckMate-9ER researchers present the data at an upcoming medical meeting. Full results will not be ready for the meeting of the American Society of Clinical Oncology next month, however.
Exelixis recently got another boost when a combination of Cabometyx and Roche's Tecentriq showed it could also shrink or eliminate tumors in some metastatic prostate cancer patients.