While for some time Bristol Myers Squibb's US plans regarding Opdivo and Yervoy's success in the Checkmate-8HW study seemed vague, in the end the FDA approved the regimen two months ahead of its action date, making up much of the time lost to the agency's EU opposite number. The EMA already greenlit the indication in question, front-line MSI-high/mismatch repair-deficient colorectal cancer, last December, before the Checkmate-8HW data were presented in full at January's ASCO Gastrointestinal Cancers symposium. It was only in February that Bristol confirmed acceptance of its US BLA, with a 23 June PDUFA date, but the FDA nod came early, on Tuesday. As ApexOnco speculated at the time, data from Checkmate-8HW's Opdivo-only cohort were sufficiently strong for the FDA additionally to formalise that drug's monotherapy approval for second-line MSI-high/dMMR colorectal cancer; that was first granted on an accelerated basis in July 2017. Accordingly, Bristol is now on a similar footing to Merck & Co, whose Keytruda has a first-line US label for this cancer. On a cross-trial basis Opdivo plus Yervoy could even be argued to have better survival data, though for its part Keytruda holds an additional, cancer-agnostic label in second-line MSI-high/dMMR solid tumours. Approved US indications in MSI-H/dMMR cancers 1st line2nd lineKeytrudaMSI-H/dMMR colorectalMSI-H/dMMR solid tumoursKeynote-177Keynote-016, 164, 158 & 051OpdivoMSI-H/dMMR colorectal (Yervoy combo)MSI-H/dMMR colorectal (+/-Yervoy)Checkmate-8HWCheckmate-142 & 8HWJemperliMSI-H/dMMR endometrialdMMR solid tumoursRubyGarnetImfinzidMMR endometrial(None)Duo-ESource: OncologyPipeline.
While for some time Bristol Myers Squibb's US plans regarding Opdivo and Yervoy's success in the Checkmate-8HW study seemed vague, in the end the FDA approved the regimen two months ahead of its action date, making up much of the time lost to the agency's EU opposite number. The EMA already greenlit the indication in question, front-line MSI-high/mismatch repair-deficient colorectal cancer, last December, before the Checkmate-8HW data were presented in full at January's ASCO Gastrointestinal Cancers symposium. It was only in February that Bristol confirmed acceptance of its US BLA, with a 23 June PDUFA date, but the FDA nod came early, on Tuesday. As ApexOnco speculated at the time, data from Checkmate-8HW's Opdivo-only cohort were sufficiently strong for the FDA additionally to formalise that drug's monotherapy approval for second-line MSI-high/dMMR colorectal cancer; that was first granted on an accelerated basis in July 2017. Accordingly, Bristol is now on a similar footing to Merck & Co, whose Keytruda has a first-line US label for this cancer. On a cross-trial basis Opdivo plus Yervoy could even be argued to have better survival data, though for its part Keytruda holds an additional, cancer-agnostic label in second-line MSI-high/dMMR solid tumours.
Approved US indications in MSI-H/dMMR cancers
| 1st line | 2nd line |
|---|
| Keytruda | MSI-H/dMMR colorectal | MSI-H/dMMR solid tumours |
| Keynote-177 | Keynote-016, 164, 158 & 051 |
| Opdivo | MSI-H/dMMR colorectal (Yervoy combo) | MSI-H/dMMR colorectal (+/-Yervoy) |
| Checkmate-8HW | Checkmate-142 & 8HW |
| Jemperli | MSI-H/dMMR endometrial | dMMR solid tumours |
| Ruby | Garnet |
| Imfinzi | dMMR endometrial | (None) |
| Duo-E |
