BMS announce new positive data from oesophageal cancer study

pharmafile | June 4, 2021 | News story | Medical Communications Cancer, oncology 

Bristol Myers Squibb (BMS) has announced results from the Phase III CheckMate -648 trial in which nivolumab plus chemotherapy and nivolumab plus ipilimumab, demonstrated a statistically significant overall survival (OS) benefit compared to chemotherapy in patients with unresectable advanced or metastatic oesophageal squamous cell carcinoma (OSCC) with tumour cell PD-L1 expression ≥1%.

In the study the primary endpoint was met in both nivolumab-treatment combinations, with a median OS of 15.4 months vs. 9.1 months for the combination of nivolumab plus chemotherapy. For the combination of nivolumab plus ipilimumab, median OS was 13.7 months vs. 9.1 months for chemotherapy.

Dr Hubert Bland, Executive Medical Director UK&I, BMS, said: “The outcomes of the CheckMate -648 study highlight the potential of these first-line nivolumab combination treatments to support patients with unresectable advanced or metastatic oesophageal squamous cell carcinoma live longer versus chemotherapy.

“We remain committed to providing alternative treatments where options are currently limited, and these latest results add to the growing knowledge in upper gastrointestinal cancers.”

Oesophageal cancer represents 3% of all cancer diagnoses in the UK, with approximately 9,200 new cases each year. Of these, almost three-quarters are diagnosed at a late stage, and whilst oesophageal cancer survival rates have improved threefold over the last 40 years in the UK, around 16% of people diagnosed with advanced oesophageal cancer will survive for only five years or more.

No new safety signals were identified during the study, with the safety profiles of nivolumab plus chemotherapy and nivolumab plus ipilimumab remaining consistent with findings previously reported for other tumour types.

Grade 3/4 drug-related adverse events were experienced by 47% of patients in the nivolumab plus chemotherapy arm, 32% in the nivolumab plus ipilimumab arm, and 36% in the chemotherapy arm.

Dr Ian Chau, Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust, said: “Patients with unresectable advanced or metastatic oesophageal squamous cell carcinoma face a median survival of around 10 months when treated with chemotherapy alone and there is a very clear unmet need for treatment options beyond this current standard of care.

“The data being presented at ASCO (American Society of Clinical Oncology) show that both of these nivolumab-based treatment options resulted in significant improvements in survival over chemotherapy and could offer potential new treatment options.”

Kat Jenkins

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