|<FAQs from the investor meetings as of January 2022 >
|F A Q
<FAQs from the investor meetings as of January 2022 >
We (or “PharmAbcine”) prepared this FAQ (Frequently Asked Questions) to provide answers to questions frequently raised during investor meetings in January 2022. We recommend viewers to refer to the previous FAQs as this issue only addresses newly raised questions.
Q1. The data from the Phase Ib olinvacimab plus pembrolizumab combo trial in mTNBC (metastatic Triple-Negative Breast Cancer) looks very promising. What was the ORR (Overall Response Rate) in the pembrolizumab mono trial?
The pembrolizumab mono trial in mTNBC (KEYNOTE-119) only showed 9.6% ORR whereas olinvacimab and pembrolizumab combo therapy showed 50% ORR in the high-dose olinvacimab cohort (16mg/kg).
This significantly improved clinical result from the combo study provided a strong scientific rationale for both PharmAbcine and MSD to proceed to Phase II combo study in mTNBC patients, who have very few FDA-approved treatment options available.
Q2. What are the clinical designs for the ongoing Phase II mTNBC combo trial in Australia?
The Phase II olinvacimab plus pembrolizumab combo trial, which had the first patient dosing in December 2021, is designed to enroll 36 mTNBC patients regardless of their PD-L1 expression level. The study will recruit patients who received one or two prior lines of chemotherapy and have no history of anti-VEGF, anti-VEGFR, or anti-PD-1 antibody treatment. All patients in the study will equally receive 16mg/kg of olinvacimab and 200mg flat dose of pembrolizumab during the trial period.
Q3. We can see frequent uses of the word ‘cycle’ in clinical trials. What is its definition?
A ‘cycle’ means a period when the patients receive a single cancer drug or a combination of drugs and then have a rest to allow the body to recover before the next dosing. The dosing of drug(s) and rest time make up one treatment cycle. The length of a cycle depends on the drug, combination of drugs, or the treatment plan, which can usually range between two to four weeks.
In PharmAbcine’s case, all olinvacimab and pembrolizumab combo studies are designed to have three weeks as one treatment cycle. The patients in the studies are to receive treatments for up to 35 cycles, which will take about two years.