Details of the Phase III CheckMate -9DW trial toplined in March were presented Tuesday on the final day of the American Society of Clinical Oncology (ASCO) annual meeting.
Opdivo is already approved for HCC as a combination with Yervoy in the second-line setting after failure on Nexavar. According to CheckMate -9DW data presented at ASCO, the combination led to a median OS improvement of 3.1 months in first-line patients compared to investigator's choice of either single-agent Lenvima or Nexavar. Those receiving the immunotherapy duo survived a median 23.7 months, compared with 20.6 months for the comparator arm. BMS noted that survival benefit was generally consistent across patient subgroups. Opdivo-Yervoy also demonstrated superior efficacy on key secondary endpoints, including a 36% objective response rate (ORR), versus 13% for either Lenvima or Nexavar. Moreover, the combination yielded a higher complete response (CR) rate of 7%, compared to 2% for the tyrosine kinase inhibitor (TKI) group. Among responders, the median duration of response was 30.4 months for Opdivo-Yervoy versus 12.9 months for Lenvima or Nexavar. It also reduced the risk of symptom deterioration by 24% compared to the two TKIs. The combo's safety profile remained consistent with previously reported data. Treatment-related adverse events (TRAEs) of any grade were reported in 84% of patients receiving the immunotherapy regimen and 91% in the TKI group. Grade 3/4 TRAEs occurred in 41% and 42% of patients, respectively.
"The combination of Opdivo plus Yervoy has been an established second-line treatment for patients with advanced HCC," said Dana Walker, global me lead for gastrointestinal and genitourinary cancers at Bristol Myers Squibb. "With these results, we can demonstrate that Opdivo plus Yervoy significantly increases survival and other key efficacy measures in the first-line setting." She said the company would be discussing the CheckMate -9DW data with regulators for a potential label expansion.