BMS' Opdivo shows survival benefit in head and neck cancer
Bristol-Myers Squibb's cancer immunotherapy Opdivo may gain another string to its bow, after a phase 3 trial showed it gives a survival benefit compared with three established drugs in head and neck cancer.
BMS announced data from the open-label, randomised CheckMate -141 trial in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after platinum therapy compared to investigators choice of either methotrexate, docetaxel, or Merck KGaA's Erbitux (cetuximab).
A PD-1 immune checkpoint inhibitor, Opdivo is already approved in melanoma and non-small cell lung cancer and is being evaluated in a range of other tumour types. Its main rival is Merck & Co's Keytruda (pembrolizumab), which is in the same class and has similar uses.
In the trial, which evaluated overall survival (OS) as primary endpoint, patients treated with Opdivo experienced a 30% reduction in risk of death.
Median OS was 7.5 months for Opdivo compared with 5.1 months for investigator's choice and the one year survival rates were 36% and 16.6% respectively.
Safety profile of Opdivo in CheckMate -141 was consistent with prior studies, with no new safety signals identified.
The trial was stopped early in January following a planned interim analysis, because an independent data monitoring committee concluded the study met its primary endpoint of OS in patients receiving Opdivo compared with the control arm.
Data were announced at the Annual Meeting of the American Association for Cancer Research.
Lead investigator, Maura Gillison, chair of cancer research at the Ohio State University Wexner Medical Center, said: "There are no systemic therapies that improve survival, and therefore, there is a tremendous unmet need for new treatment options for this patient population.
"In CheckMate -141, Opdivo demonstrated an improvement in survival compared to three standard of care options in this overall patient population, regardless of PD-L1 expression levels and HPV status."
DrugAnalyst research forecasts Merck & Co's rival Keytruda (pembrolizumab) will generate sales of more than $4.7 billion in 2020, and forecasts Opdivo sales will be around $9 billion in 2020.
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