
Bavencio’s forgotten lung cancer readout is a dud
It is a measure of the stranglehold that Keytruda has on front-line lung cancer that the failure of Bavencio in the Javelin Lung 100 trial in this setting was today revealed as a mere footnote in Pfizer’s fourth-quarter earnings. Not that Pfizer and Merck KGaA had not maximised the trial’s chances of success: Javelin had twice been enlarged, was refocused on PD-L1 expressers and had its primary endpoints overhauled. But protracted delays – readout had originally been slated for April 2019, before being put back four times – meant that Keytruda made hay while Javelin’s results receded into near irrelevance. Today Pfizer said Bavencio had shown “clinical activity” but failed to beat chemo on the OS and PFS co-primary endpoints. In the changing NSCLC environment it is possible that control cohort patients went on to receive efficacious anti-PD-(L)1 therapy, including Keytruda, but it is increasingly looking as though Bavencio simply is not a particularly good drug. Its last US approval, in first-line bladder cancer maintenance, occurred in mid-2020.
Selected trials of anti-PD-(L)1 MAbs in 1st-line NSCLC | |||
---|---|---|---|
Product | Company | Study | Outcome |
Monotherapies… | |||
Keytruda | Merck & Co | Keynote-042 | Positive, US approved for PD-L1 ≥1% |
Tecentriq | Roche | Impower-110 | Positive, US approved for PD-L1 ≥50% |
Libtayo | Sanofi/Regeneron | Empower-Lung 1 | Positive, US approved for PD-L1 ≥50% |
Tuoyi (toripalimab) | Shanghai Junshi/Coherus | Choice-01* | Positive for mPFS vs chemo in all-comers |
Bavencio | Merck KGaA/Pfizer | Javelin Lung 100 | Failed for mPFS & mOS vs chemo |
Imfinzi | Astrazeneca | Pearl | Completion (OS in PD-L1 ≥25% is primary endpoint) Jun 2022** |
…and combinations | |||
Keytruda + chemo | Merck & Co | Keynote-189 & 407 | Approved in all-comers |
Opdivo + Yervoy + chemo | Bristol Myers Squibb | Checkmate-9LA | Approved in all-comers |
Imfinzi + tremelimumab + chemo | Astrazeneca | Poseidon | Positive for mPFS & mOS vs chemo in all-comers, but no apparent regulatory action |
Tyvyt (sintilimab) + chemo | Lilly/Innovent | Orient-11* | Positive for mPFS vs chemo in all-comers; US adcom 10 Feb 2022 |
Libtayo + chemo | Sanofi/Regeneron | Empower-Lung 3 | Positive for mPFS vs chemo in all-comers; US Pdufa date 19 Sep 2022 |
Sugemalimab + chemo | Cstone/EQRX | Gemstone-302 | Positive for mPFS vs chemo in all-comers |
Notes: *China study; **completion was originally Jul 2020, and PFS was a co-primary endpoint. Source: clinicaltrials.gov & company statements. |