In a clinical trial, the combination of Bristol-Myers Squibb (BMS) PD-1 inhibitor Opdivo and the melanoma drug ipilimumab extended prognostic survival compared with ipilimumab alone ( PFS).
Data reported at the annual meeting of the American Association for Cancer Research in Philadelphia showed that the combination therapy achieved an objective response rate (ORR) of 61% in advanced (stage III or IV) melanoma that was previously untreated. The objective response rate for ipilimumab monotherapy was 11%.
This appears to be encouraging, as Opdivo (nivolumab) as a monotherapy for this patient population showed an ORR of approximately 40%, but apparently no direct comparability of the different trial designs. However, Opdivo combined with the anti-CTLA-4 antibody, ipilimumab, produced complete remission in 22% of patients, while PFS increased by 60%, and at the time of the report, 11 months of follow-up did not reach the median follow-up time. .
Giordano, director of BMS oncology development, said, "The results of the trial reinforce our belief that the future lies in the combined use of immunological tumor preparations." CTLA-4 and PD-1 exert their effects through a complementary mechanism. In preclinical model inhibition, the two drugs appear to have synergistic improvement effects against tumor activity.
The results were also published on NEJM, and the study authors concluded that the combined drug compared with ipilimumab monotherapy resulted in "lasting remission and higher objective response rates, longer progression-free survival and Higher complete response rate."
After the launch, Ipilimumab quickly established its position as a basis for melanoma treatment, with sales of $1.3 billion last year. New evidence suggests that Opdivo should be treated in melanoma compared to current applications. Used earlier.
Currently, Opdivo, along with Merck's competitive drug Keytruda (pembrolizumab), has been approved as a second-line drug for ipilimumab or a BRAF inhibitor such as Roche Velophane and GlaxoSmithKalla Rafini (if patient tumor BRAF V600) Mutation was positive) melanoma after treatment.
Like Opdivo, Keytruda also showed superiority to Ipilimumab in a one-on-one clinical controlled trial, which was also reported in recent NEJM. In addition, both drugs are supported by the National Cancer Network as a first-line treatment, meaning that insurers will be able to use it as a first-line drug for melanoma and reimbursement before the two drugs are officially approved for first-line use. There is evidence of the use of a combination of the ipilimumab label.
ISI Evercore analyst Schoenenbaum pointed out in a research report that the combination of Opdivo and Ilibumab may be the standard of treatment for first-line treatment of melanoma. A further understanding of the benefits of the combination of the two drugs will begin with the results of the Phase 2 study CheckMate-067, which is scheduled for completion in September 2016.