Bristol-Myers Squibb scored a huge win the other day because it was able to receive FDA approval of OPDIVO and YERVOY for 1st-line and 2nd-line treatment of adult and pediatric patients ages 12 and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).
The thing is that it was already granted Accelerated Approval of OPDIVO as a monotherapy or in combination with YERVOY for the treatment of 2nd-line patients with MSI-H/dMMR metastatic colorectal cancer. In this setting, such patients are in dire shape because they have progressed after already being given treatments such as fluoropyrimidine, oxaliplatin and irinotecan.
Thus, the win here is that the company was able to convert such an Acclerated approval of the OPDIVO and YERVOY combination to full approval. Besides nabbing this win, it was also able to receive FDA approval for 1st-line treatment of these adult and pediatric patients ages 12 and older with MSI-H/dMMR colorectal cancer.
The ability to convert FDA Accelerated Approval to full approval of the 2nd line setting, plus receive FDA approval in 1st-line setting, was thanks to the phase 3 CheckMate-8HW trial. This specific study was a large one, in that it recruited a total of 839 patients with this type of colorectal [CRC] cancer. In essence, it is believed to be the largest immunotherapy study of its kind to target MSI-H/dMMR CRC patients.
However, this study set up the ability to be split up in terms of what was being targeted. For instance, with respect to comparing the use of OPDIVO and YERVOY versus OPDIVO monotherapy, this was compared to that of targeting all-lines setting. On the flip side, the OPDIVIO and YERVOY combination in the other portion of the study was being compared to that of investigator’s choice of chemotherapy (mFOLFOX-6 or FOLFIRI) with or without AVASTIN [bevacizumab] in the 1st-line setting.
The basis for these FDA wins was because of achieving the primary endpoint of progression-free survival in both all-line settings and 1st-line setting. With respect to the first line setting, OPDIVO and YERVOY reduced the risk of disease progression or death by 79% versus chemotherapy. In the all lines therapy portion of this phase 3 CheckMate-8HW trial, it reduced the risk of disease progression or death by 38%.
The FDA was committed to getting this combination out to these patients because the Prescription Drug User Fee Act or PDUFA date was set for June 23rd of 2025. This approval occurred two months ahead of this date, which underscores the need for these therapies to help these MSI-H/dMMR CRC patients.
This is not the end of what can be achieved with respect to this particular phase 3 study. Investors can expect to see other types of data from it later on. That’s because Bristol-Myers Squibb is still in the process of evaluating secondary endpoints from the study, like overall survival (OS). This and other secondary efficacy endpoints are to be presented by investigators in the future. The bottom line here is that this marks the 9th indication of OPDIVO in the gastrointestinal space.
