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
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: & company statements.

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