Re-treatment with Opdivo (nivolumab) may be a safe and effective option to halt disease progression in patients with classical Hodgkin’s lymphoma (cHL) who previously achieved disease remission with the treatment, a study shows.
The results were presented in a scientific poster titled “Nivolumab re-treatment in patients with relapsed/refractory Hodgkin lymphoma” (page 50) at the 11th International Symposium on Hodgkin Lymphoma Oct. 27-29 in Cologne, Germany.
Opdivo, developed by Bristol-Myers Squibb, is approved in the U.S. and Europe for the treatment of classical Hodgkin’s lymphoma (cHL) in patients who relapsed or progressed after autologous hematopoietic stem cell transplant (HSCT) and treatment with Adcetris (brentuximab vedotin).
It works by counteracting a mechanism used by cancer cells to evade anti-cancer immune responses. This mechanism involves the production of PD-L1 by cancer cells to interact with the PD-1 receptor present at the surface of specific immune cells, which “shuts down” the immune response against them.
By suppressing PD-1/PD-L1 interaction, Opdivo restores the body’s capacity to activate the anti-tumor response and fight cancer cells.
Opdivo’s approval was based on integrated data from the CheckMate 039 Phase 1 (NCT01592370) and CheckMate 205 Phase 2 (NCT02181738) trials, which assessed the safety and efficacy of Opdivo in patients with relapsed or refractory cHL after undergoing HSCT and Adcetris treatment.
The results showed that 6% of patients achieved complete remission, and 60% showed partial responses. Over half of the patients had no signs of disease progression after one year of treatment.
However, the optimal duration of Opdivo treatment remains unclear.
Researchers have now evaluated the safety and effectiveness of Opdivo re-treatment in patients who participated in the two trials and stopped Odpivo treatment after disease remission, but later showed disease progression.
Participants were eligible for re-treatment if they showed confirmed disease progression within a year (CheckMate 039 trial) or two years (CheckMate 205 trial) after their last Opdivo dose.
By May 2017 (data cutoff), five participants (four women and one men) in the CheckMate 039 study had been re-treated with Opdivo. They ranged in age from 26 to 53 years. After initial treatment with Opdivo, two achieved complete remission and three achieved partial remission.
After eight to 18 weeks of re-treatment with Opdivo, all patients achieved disease remission, with one showing complete response and the remaining four showing partial responses.
One patient was still on re-treatment at data cutoff due to the persistent progressive disease.
Patients had only mild treatment-related side effects, except for one patient who showed moderate neutropenia (reduced levels of neutrophils, a type of white blood cell) after 18 doses.
At the congress, researchers also presented data collected until May 2018 from two participants in the CheckMate 205 trial who received Opdivo re-treatment.
“These data provide further evidence of re-treatment benefit in patients with disease progression after initial response,” the researchers said.
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