Merck KGaA and Pfizer’s catch-up attempt in the checkpoint inhibitor market has hit a setback after their Bavencio drug failed a key lung cancer trial.
Fourth-to-market in the PD-1/PD-L1 checkpoint inhibitor category, Bavencio (avelumab) is already approved for skin cancer Merkel cell carcinoma and bladder cancer, but hopes of extending its use into the much bigger non-small cell lung cancer (NSCLC) category are looking shaky after the failure of the JAVELIN Lung 200 study.
Bavencio did not meet the objective of improving overall survival compared to chemotherapy drug docetaxel as a second-line therapy in NSCLC patients with PD-L1-expressing tumours who had seen their cancer progress despite earlier platinum therapy.
Merck and Pfizer have tried to put a brave face on the study, saying it had been compromised by a higher-than-expected proportion of patients in the chemotherapy arm being given checkpoint inhibitor drugs outside the confines of the study. They also pointed to improvements in overall survival in patents with moderate to high levels of PD-L1 expression. But that still leaves them with a negative trial and a delay to the programme in an increasingly competitive category.
First-to-market checkpoint inhibitors Opdivo from Bristol-Myers Squibb and Merck & Co/MSD’s Keytruda (pembrolizumab) are dominating the PD-1/PD-L1 inhibitor category at the moment, with Bavencio jostling for market share with other entrants, namely Roche’s Tecentriq (atezolizumab) and AstraZeneca’s Imfinzi (durvalumab).
Merck and Pfizer – which bought into the Bavencio programme in a $2.85bn deal in 2014 – still have a trial ongoing in first-line NSCLC but are not expecting the results from that until 2019. In the meantime, Keytruda is heading the pack in NSCLC thanks to approval for first-line use, with Opdivo and Tecentriq currently confined to second-line therapy and Imfinzi filed as a maintenance therapy after chemo last December.
It’s not the first setback for Bavencio, which failed a trial in third-line stomach cancer treatment last year, and in that indication too the partners continue to pursue a first-line indication in another trial. For now, it faces a tough marketing battle in bladder cancer – where all its rivals have regulatory approvals – although it is still the only player in the small Merkel cell carcinoma category.