Bristol Myers Squibb’s Opdivo and Yervoy combo could become the new standard of care in first-line unresectable hepatocellular carcinoma (uHCC) according to Phase 3 data presented at the American Society of Clinical Oncology’s annual meeting.
In the interim analysis from the CheckMate 9DW trial, data showed that after a median follow-up of about 35 months, the median overall survival was 23.7 months with the combo and 20.6 months with either Eisai’s Lenvima or Bayer’s Nexavar, the current standard of care.
“These results support this combination as a potential new first-line SOC for uHCC,” researchers wrote in the trial’s Phase 3 ASCO abstract.
Samit HirawatWhen asked about the median OS and the close resemblance between the combo and its comparators, CMO Samit Hirawat told Endpoints News that uHCC has been a “challenging field.”
“So every step that we can take forward to be able to impact the overall survival is a step in the right direction,” Hirawat said. “Every bit that we can improve the outcomes for patients with these diseases which are very hard to treat, we certainly need to see it as a step in the right direction.”
Hirawat added that Bristol Myers is “not satisfied” and continues to look toward the next modality for uHCC.
Overall response rate in the 668-patient Phase 3 trial with the BMS combo was 36% versus 13% for Lenvima or Nexavar, with complete response seen in 7% with the combo versus 2%. The median duration of response was 30.4 months on Opdivo-Yervoy and 12.9 months on Lenvima or Nexavar.
Bristol Myers declined to comment on regulatory timelines for the label expansion.
The drugmaker pulled in about $9 billion in Opdivo revenue in 2023, about 9% more than the previous year, according to its earnings report, and $1.2 billion in the first quarter of this year. It’s scored several more approvals recently as well, including in first-line unresectable or metastatic urothelial carcinoma when combined with chemotherapy and completely resected stage IIB or IIC melanoma, among others.
It is also waiting on a decision from the FDA on a subcutaneous version of Opdivo in all of the solid tumors that the IV version is already approved as a monotherapy, monotherapy maintenance following the completion of Opdivo plus Yervoy, or in combination with chemotherapy or cabozantinib.