#ESMO20: Bristol Myers marks Opdivo's second adjuvant win — eyeing a standard of care gap
Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.
With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.
While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.
“There is no drug that is standard of care at this time,” he said. “In fact the standard of care treatment for these patients is just observation until progression.”
In the trial, patients receiving Opdivo had a median disease-free survival of 22.4 months compared to 11 months for those who got placebo after surgery. The hazard ratio came in at 0.69 (p = 0.0003).
DFS was the primary endpoint, and investigators are still tracking overall survival numbers. But Bristol is clearly enthusiastic here.
“These results make esophageal and gastroesophageal junction cancer the second cancer type — following melanoma — where Opdivo has demonstrated a benefit in the adjuvant setting,” Ian Waxman, the development lead in gastrointestinal cancers, said in a statement.
As with frontline GI cancer, Merck is in lockstep with Bristol here, with its own Phase III effort evaluating Keytruda in combination with chemo as a neoadjuvant or adjuvant treatment.