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BMS’ Opdivo wins EU approval for second-line oesophageal cancer

Competition heats up with rival checkpoint inhibitor Keytruda

The European Commission has approved Bristol Myers Squibb’s (BMS) PD-1 inhibitor Opdivo for the treatment of advanced oesophageal cancer patients following initial chemotherapy treatment.

Opdivo (nivolumab) first gained approval in this setting in February, after Japan’s Ministry of Health, Labour and Welfare (MHLW) approved the checkpoint inhibitor for unresectable advanced, or recurrent oesophageal cancer that has progressed after chemotherapy treatment.

The US Food and Drug Administration (FDA) has already approved Opdivo for second-line advanced oesophageal cancer treatment, giving the immunotherapy a green light in June.

The new EU approval introduces an important new treatment option for patients with metastatic oesophageal cancer, which carries a five-year survival rate of 10% or less.

The EC approved Opdivo following positive results from the phase 3 ATTRACTION-3 trial, which investigated the PD-1 inhibitor versus chemotherapy docetaxel or paclitaxel – as a treatment for patients with unresectable advanced or recurrent oesophageal squamous cell carcinoma (ESCC).

Patients involved in the trial had not responded to or were intolerant to combination therapy with fluoropyrimidine and platinum-based drugs.

Opdivo met the primary endpoint of overall survival (OS), demonstrating a 23% reduction in the risk of death and a 2.5 month improvement in OS when compared to chemotherapy.

The Opdivo treatment group demonstrated 12- and 18-month OS rates of 47% and 31% respectively, compared to 34% and 21% in the placebo arm.

The survival benefit with Opdivo treatment was observed regardless of tumour PD-L1 expression levels.

“This approval marks a critically important milestone for those living with oesophageal squamous cell carcinoma, as this is the first time an immunotherapy treatment option has been approved in the European Union for this patient population,” said Ian Waxman, development lead, gastrointestinal cancers, BMS.

Opdivo’s main rival in the oesophageal cancer setting is Merck & Co’s (MSD) blockbuster checkpoint inhibitor Keytruda (pembrolizumab).

In September, Merck presented results from the KEYNOTE-590 trial at the 2020 European Society for Medical Oncology (ESMO) virtual congress, which evaluated Keytruda in combination with chemotherapy in first-line oesophageal cancer.

In this study, Keytruda plus chemotherapy demonstrated a median overall survival rate of 12.4 months versus 9.8 months for those given chemotherapy alone.

In addition, the 12-month OS rate for Keytruda plus chemotherapy was 51% compared to chemotherapy, while the 24-month rates were 28% and 16% respectively.

Opdivo is also chasing approval in the first-line setting, with BMS also revealing promising data for the PD-1 inhibitor at this treatment stage at ESMO 2020.

In the CheckMate-577 trial involving patients with oesophageal or gastroesophageal junction cancers who had previously received neoadjuvant chemoradiation therapy (CRT) and tumour resection, Opdivo doubled the median disease-free survival rate compared to placebo.

In addition, the median duration of treatment for patients in the Opdivo arm was 10.1 months, compared to nine months in the placebo, which is seen to be a modest improvement.

Article by
Lucy Parsons

25th November 2020

From: Regulatory



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