Immunopulse IL-12 monotherapy and in combination with pembrolizumab was associated with encouraging response rates and safety data in patients with melanoma who may not respond to anti-PD-1 therapy, according to a press release.
The findings were presented at the 9th World Congress of Melanoma — A Joint Meeting with the Society for Melanoma Research. The data include a phase 2 Immunopulse IL-12 (OncoSec) monotherapy study with 51 patients and a phase 2 study of the immunotherapy in combination with pembrolizumab, which included 22 patients.
Monotherapy in 90-day cycles yielded a 25% to 34.6% best overall response rate as assessed by RECIST criteria, according to the findings. The complete response rate was 19.2%, the partial response rate was 15.4%, and 34.6% had stable disease. The researchers noted this totaled a 69.2% total disease control rate.
There were no life-threatening or grade 4 adverse events in this arm of the study, although there was a serious adverse event rate of 9.8%.
In a protocol addendum that included 20 patients who underwent therapy on a 6-week cycle, the complete response rate was 0%. However, 25% had a partial response, and 40% had stable disease. This accounted for a total disease control rate of 65%, according to the findings.
Combination therapy yielded a 50% best overall response rate at 24 weeks, with 42.9% of the cohort reaching RECIST v1.1 response.
When in combination, 41% of patients were complete responders, 9% had a partial response, and 9% had stable disease. This accounted for a total disease control rate of 59%.
The serious adverse event rate in the combination study was 8.7%.
"We are encouraged by the data from these analyses, which continue to show that ImmunoPulse IL-12 can prime the immune system to help improve patient response to anti-PD-1," Alain Algazi, MD, associate professor in the department of medicine (Hematology/Oncology), at the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, and lead author of the study, said in the press release. "The complete response rates observed in the phase 2 study assessing the combination of ImmunoPulse IL-12 and pembrolizumab in the predicted anti-PD-1 nonresponder patient population provide compelling early evidence that the combination could lead to a clinically meaningful impact on patient outcomes." – by Rob Volansky
Algazi A, et al. FC05-3. Clinical immune monitoring and biomarker data of pIL-12 monotherapy compared to pIL-12 with pembrolizumab in metastatic melanoma supports the rationale for combination therapy. Presented at: 9th World Congress of Melanoma — A Joint Meeting with the Society for Melanoma Research; Oct. 18-21, 2017; Brisbane, Australia.
Disclosure: Algazi reports that he participates in research funded by Acerta, AstraZeneca, Bristol-Myers Squibb, Dynavax, Genentech, Incyte, MedImmune, Merck, Novartis and OncoSec. He also reports serving as an unpaid advisor to OncoSec Medical Incorporated.