As Merck & Co prepares to chase Roche in first-line small-cell lung cancer it can today point to results in a third-line setting that show Keytruda to be at least the equal of Bristol-Myers Squibb’s Opdivo. This might not be saying much, however, as Opdivo’s third-line SCLC label is under threat after the drug flunked two potentially confirmatory studies, Checkmate-331 and 451. The Merck analysis, presented at the AACR meeting, concerns pooled data from the Keynote-028 and 158 trials of Keytruda, and shows the importance of PD-L1 status in this cancer: 14 of 16 reported responses were seen in PD-L1-positives, and the overall remission rate in the 47 PD-L1-positive subjects was 30%. Pooled median overall survival for Keytruda of 7.7 months compares favourably with the standard of care’s 3.8 months. Meanwhile, Pharmamar’s Zepsyre is in the second-line Atlantis trial, reading out at the end of 2019, and met a 30% response rate threshold in a monotherapy basket study. Roche’s Tecentriq was recently approved first line on the basis of Impower-133; Astrazeneca’s Caspian study of Imfinzi and Merck’s Keynote-604 trial – both front line – were due to yield data early this year, but have been delayed to September and December respectively.
|Cross-trial comparison in ≥3rd line SCLC|
|Patients||ORR||12mth OS||12mth PFS||Median OS||Median PFS|
|Checkmate-032*||109||12%||39%||8%||Not yet reported|
|Keynote-028** & 158 pooled||83||19%||34%||17%||7.7mth||2.0mth|
|Source: AACR & Asco; *basis for accelerated approval; **PD-L1+ves only.|