Photo: California BMS Building Exterior/iStock, hapa bapa
Bristol-Myers Squibb on Thursday announced data from the Phase 3 CheckMate-8HW study demonstrating first-line potential for Opdivo (nivolumab) and Yervoy (ipilimumab) combination therapy in metastatic colorectal cancer. .
BMS did not provide specific data in Thursday’s announcement, but the company said the combination therapy showed “statistically significant results” in progression-free survival (PFS) compared to the chemotherapy of the investigators’ choice. and clinically meaningful improvements.”
The safety profile of Opdivo and Yervoy was consistent with previously reported data and there were no new indicators of concern. According to BMS, all side effects were “manageable” using established protocols.
These positive data from CheckMate-8HW “further support the benefits of dual inhibition of PD-1 and CTLA-4” in the treatment of metastatic colorectal cancer (mCRC), particularly in first-line therapy, BMS said. said Dana Walker, President and Global Head. The program director for gastrointestinal and genitourinary cancers said in a statement:
Thursday’s results come from CheckMate-8HW, a randomized, open-label study that enrolled approximately 830 patients with microsatellite-high instability (MSI-H) or mismatch repair-deficient (dMMR) mCRC. This study looked at the combination of Opdivo and Yervoy, which work synergistically through blocking PD-1 and CTLA-4 receptors to boost the body’s anti-cancer immune response.
CheckMate-8HW has two primary efficacy endpoints. The first is PFS compared to chemotherapy in first-line therapy, and the second is PFS compared to Opdivo treatment alone across all treatments. The study will continue to evaluate its second primary endpoint, and BMS will conduct a full evaluation of the data and work toward presentation at a future medical meeting to share the results.
BMS said in a statement that the company will also discuss the study results with health authorities.
Opdivo and Yervoy were both first approved for the treatment of melanoma in December 2014 and March 2011, respectively.
Opdivo and Yervoy are the first to be approved as a combination therapy. October 2015 BRAF V60 wild type was used to treat unresectable or metastatic melanoma and was eventually expanded. January 2016 Include all BRAF status. This combination therapy was also approved as a first-line treatment for intermediate- and low-risk advanced renal cell carcinoma. April 2018for hepatocellular carcinoma March 2020 Metastatic non-small cell lung cancer May 2020.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Please contact tristan@tristanmanalac.com or tristan.manalac@biospace.com.