Bavencio scores an unexpected first in bladder cancer

Snippets

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)**
Opdivo NA Approved (Checkmate-275)
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.

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