As an also-ran in the immune checkpoint race Pfizer/Merck KGaA’s Bavencio rarely gets much attention, but yesterday it surprised: its success in the phase III Javelin Bladder 100 trial made it the first ever anti-PD-(L)1 MAb to prolong overall survival in first-line urothelial bladder cancer. This is quite a coup, notwithstanding the availability of numerous checkpoint blockers in this tumour type. Quick approvals of five such drugs second line were backed by some questionable data, and Roche’s Tecentriq failed a confirmatory second-line study, Imvigor-211. Meanwhile, Imvigor-130 has not comprehensively backed Tecentriq in the first-line setting, where the Roche drug is also approved (Esmo 2019 – PD-L1 status moves centre stage in bladder cancer, September 30, 2019). Still, the comparison against Bavencio is not direct, as Javelin Bladder 100 was a maintenance trial, rather than a pure treatment study like Imvigor-130. Nevertheless, Bavencio’s success – in all-comer and PD-L1-high populations alike – should soon see the drug add this setting to its US label.
|US status of anti-PD-(L)1 MAbs in urothelial bladder cancer (supporting studies in brackets)|
|1st line||2nd line|
|Tecentriq||Approved in ≥5% PD-L1+ves, & chemo-ineligible all-comers (Imvigor-210)*||Approved (Imvigor-210)**|
|Imfinzi||NA||Approved (Study 1108)|
|Bavencio||NA; OS benefit in 1st-line maintenance (Javelin Bladder 100)||Approved (Javelin Solid Tumor)|
|Keytruda||Approved in chemo-ineligible (Keynote-045 & 052)||Approved (Keynote-045 & 052)|
|*Imvigor-130 data were mixed; **failed Imvigor-211 study.|