It seems that Bristol-Myers Squibb is set to put its hat into the first-line liver cancer treatment space. The reason why is because just the other day it nabbed FDA approval of its drugs OPDIVO (nivolumab) and YERVOY (ipilimumab) for the treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).
The thing is that this immunotherapy combination regimen was already approved by the FDA to treat adult patients with unresectable or metastatic HCC who have been previously treated with sorafenib. In essence, the first approval happened for 2nd-line treatment. Sorafenib, marketed as Nexavar, is co-marketed in the United States by Bayer Healthcare Pharmaceuticals Inc. and Onyx Pharmaceuticals.
This latest approval, in the company being able to target 1st-line liver cancer patients, was thanks to the primary endpoint being met in the phase 3 CheckMate-9DW trial. It was revealed that the OPDIVO +YERVOY combination was able to keep 38% of patients alive after 3-years [Overall-Survival endpoint], compared to that of the comparator arm (standard of care sorafenib or lenvatinib) having 24% of patients alive over this period. Thus, the primary endpoint of this late-stage study of overall-survival (OS), being met with statistical significance.
Besides the primary endpoint being met in using this OPDIVO + Yervoy combination to treat these advanced HCC patients, there is another highly positive item to note, which is that this phase 3 CheckMate-9DW trial is the only one of its kind to show superior results compared to that of this particular comparator arm.
One major player in the advanced first-line liver cancer treatment space, would be Roche with its drugs TECENTRIQ + AVASTIN. Bristol-Myers Squibb hopes to establish its regimen as the lead standard of care (SOC) drug to treat these patients. Even AstraZeneca has a presence with this HCC patient population, with its drug combination IMFINZI and IMJUDO.
The thing about Bristol-Myers Squibb’s OPDIVO and YERVOY immunotherapy combination is that it is very versatile and can be applied towards the treatment of other types of cancers. For instance, the company notes that it has received nine FDA approvals of an OPDIVO-based regimen to treat patients with gastrointestinal cancers. Speaking of which, in the same week that it had received U.S. marketing approval of OPDIVO and YERVOY in the United States for advanced HCC, it also had received FDA approval for this combination to treat 1st-line adult and pediatric patients ages 12 and older with unresectable or metastatic instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
