On March 24, 2020 OncoQuest Inc. ("OncoQuest" or the "Company"), a privately held, cancer immunotherapy company reported the publication of two reports relating to the recently completed Phase 2 trial conducted in the US and Italy utilizing oregovomab, the Company’s lead investigational drug in frontline ovarian cancer (Press release, OncoQuest, MAR 24, 2020, View Source [SID1234555804]).
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The first report which appears in the journal Gynecologic Oncology is titled Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study, reported the clinical results in the completed 97-patient randomized controlled multi-site study in which 47 patients were randomized to receive chemoimmunotherapy with standard carboplatin and paclitaxel chemotherapy combined with oregovomab or standard chemotherapy (standard carboplatin and paclitaxel).
The study was conducted with a median of 42 months follow up and shows highly statistically significant outcomes for both progression-free and overall survival favoring the chemoimmunotherapy arm. The risk of progression and of death was reduced by more than 50% in the chemoimmunotherapy arm. Safety data shows that the addition of orgeovomab did not add incremental toxicity to chemotherapy.
The second report published in Cancer Immunology, Immunotherapy is titled Translational immune correlates of indirect antibody immunization in a randomized phase II study using scheduled combination therapy with carboplatin/paclitaxel plus oregovomab in ovarian cancer. The report examined translational laboratory outcomes from a subset of the Italian cohort of patients in the above described study from the laboratory of Professor Scambia at Catholic University Hospital in Rome. The report confirms that chemoimmunotherapy increased the presence of CA125-specific CD8+T lymphocytes measured in the peripheral blood compared to chemotherapy, which correlated with favorable clinical outcomes. Myeloid derived immune suppression was measured by MDSC4 (flow cytometry) and NMLR (neutrophil-monocyte to lymphocyte ratio) and it was found that lower levels of these parameters at baseline predicted more favorable outcomes in the patients receiving chemoimmunotherapy compared to chemotherapy. These findings offer promise of development of a readily accessible prognostic indicator for guiding the therapeutic strategy for newly diagnosed patients who would be candidates for chemoimmunotherapy with orgeovomab.
"The publication of our Phase II clinical results in peer reviewed journals validates the quality of the clinical data generated from our clinical study", said Dr. Madiyalakan, CEO of OncoQuest "We have discussed our Phase 2 results in an End of Phase 2 meeting with the FDA and based on those discussions are proceeding with our planned Phase 3 registration trial."
The Company is currently planning to launch a Phase 3 trial in Q2 2020. The planned Phase 3 study is expected to enroll over 600 patients with newly diagnosed, advanced ovarian cancer globally. The double-blind, placebo-controlled trial design is expected to incorporate analyses of the effect of the addition of oregovomab in both the adjuvant and neo-adjuvant settings. In both the adjuvant and neo-adjuvant arms, the primary endpoint will be to evaluate progression-free survival of patients treated with oregovomab plus a standard-of-care chemotherapy combination, carboplatin and paclitaxel, compared to the chemotherapy alone.