Hun Ju Lee, MD, reviews results from part C of the phase 2 SGN35-27 trial for patients with early-stage classical Hodgkin lymphoma treated with brentuximab vedotin plus nivolumab, doxorubicin, and dacarbazine.
In an interview with CancerNetwork® during the 2022 American Society of Hematology (ASH) Annual Meeting, Hun Ju Lee, MD, spoke to data from the ongoing phase 2 SGN35-027 trial (NCT03646123) part C, which assessed brentuximab vedotin plus nivolumab (Opdivo), doxorubicin, and dacarbazine for patients with Ann Arbor stage I or II classical Hodgkin lymphoma without bulky disease.1
Lee, an assistant professor of medicine in the Department of Lymphoma and Myeloma at the University of Texas MD Anderson Cancer Center, discussed results from a poster presentation from the study that were presented at the 2022 ASH Annual Meeting.
The overall response rate for patients treated with the combination was 95% (95% CI, 87.1%-98.5%), the complete response rate was 92% (95% CI, 83.6%-97.0%), and the partial response was 3% (95% CI, 0.3%-9.2%).
Part C is very similar to part B in that the agents—the brentuximab vedotin, nivolumab [Opdivo], and AD [adriamycin and dacarbazine]—are the same, but this will be for stages I and II without any bulky disease.2
[Patients] will be given 4 cycles [of treatment]. We enrolled 125 patients and only have the efficacy data for 76. The majority of the patients—as is common in Hodgkin lymphoma—were very young with a median age of 33 years, and most were below the age of 65 years. In total, 90% of the patients had stage II [disease].
We had a tremendous response of 92% of the patients being in complete remission at the end of therapy and a response rate of 95%. We’re continuing with treatment.
In the next meeting, we anticipate either the European Hematology Association or the [International Conference on Malignant Lymphoma (ICML)], we will be presenting the completed [results]. For those patients who had received brentuximab vedotin, nivolumab, and AD, the toxicity profile was very consistent with that of the single agent brentuximab vedotin and nivolumab.
We did not see any significant increases in safety signals. We did have treatment-related serious adverse effects like pyrexia and pneumonitis. All of this has been resolved. The peripheral neuropathy was very problematic in the phase 3 ECHELON-1 study [NCT01712490] with 4 cycles of treatment, we saw about 40% of the patients having any grade peripheral neuropathy, and only 2% of the patients had grade 3 or higher peripheral neuropathy.3
It’s giving us a very good signal that in terms of safety, this appears to be a very well-tolerated regimen. Obviously, we await the complete data set when we present it at the next meeting either at [ICML] or the European Hematology Association meeting.