When paired with the chemotherapy combination doxorubicin, vinblastine and dacarbazine, Keytruda resulted in 100% overall survival in the findings from a new study of adult patients with classic Hodgkin lymphoma.
Keytruda (pembrolizumab), when administered in conjunction with chemotherapy, resulted in total overall survival improvement among patients with untreated classic Hodgkin lymphoma (CHL) in what study authors have said is the first study of this treatment combination among this patient population.
Participating adult patients with CHL received the chemotherapy combination doxorubicin, vinblastine and dacarbazine (AVD) concurrently with Keytruda (a combination referred to as APVD) during the single-arm study sponsored by the University of Washington, results of which were published in May in the journal, Blood.
The two-year overall survival rate (the percentage of patients who were still alive at a given point) was 100% and progression-free survival (the time after treatment that a patient is alive without the disease spreading or worsening) rate was 97% among the 29 response-evaluable patients at a median follow-up of 2.1 years, according to the study.
The study, which launched in January 2019, is estimated to be completed by July 2029, according to its listing on clinicaltrials.gov. During the study, patients — at a median age of 33 and 60% of whom were female — received intravenous doxorubicin hydrochloride, vinblastine and dacarbazine on days 1 and 15, and intravenous Keytruda over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2, according to the clinicaltrials.gov listing, with the treatment repeating ever 28 days for up to two cycles if there was no disease progression or unacceptable side effects. Patients would then receive a total of six treatment cycles of the four-drug combination.
When measured at the end of the second cycle and then at the end of treatment, clearance of circulating tumor DNA (ctDNA) — which is cancerous DNA found in the bloodstream — was associated with superior progression-free survival, the authors noted, indicating that patients whose blood test did not have cancer DNA in it tended to live longer without their disease getting worse.
The study authors noted that 30 patients were enrolled in the study, which met the primary safety endpoint with no observed significant treatment delays in the first two cycles.
There were 12 participants who experienced moderate to severe (grade 3 or 4) nonhematologic side effects, most typically febrile neutropenia (a low count of a type of white blood cells known as neutrophils) and infection/sepsis, according to the authors, who stated that three patients experienced grade 3 or 4 immune-related side effects including alanine aminotransferase elevation and aspartate aminotransferase elevation (enzyme levels that are indicative of liver damage), while one patient had a grade 2 episode of colitis and arthritis.
Due to side effects, particularly grade 2 or higher transaminitis, six patients missed at least one dose of Keytruda.
“To date, no patient who has withheld or discontinued pembrolizumab because of toxicity has progressed,” the authors wrote.
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